FDA advisers vote in favor of authorizing Covid-19 vaccines for ...

(CNN) Vaccine advisers to the US Food and Drug Administration voted unanimously on Wednesday in favor of expanding the emergency use authorizations for the Moderna and Pfizer/BioNTech Covid-19 vaccines to include children as young as 6 months.

All 21 members of the FDA's Vaccines and Related Biological Products Advisory Committee voted "yes" in response to the question: "Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 micrograms each dose) outweigh its risks for use in infants and children 6 months through 5 years of age?"

And all the committee members voted yes in response to the question: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 3-dose series (3 micrograms each dose) outweigh its risks for use in infants and children 6 months through 4 years of age?"

The FDA, which typically follows the committee's decisions, will now decide whether to authorize the vaccines for emergency use in the youngest children.

However, shots can't be given until the US Centers for Disease Control and Prevention's own vaccine advisers have voted on whether to recommend them and CDC Director Dr. Rochelle Walensky has signed off on the recommendation.

The CDC's vaccine advisers are expected to vote Saturday. The White House has said shots could begin as early as next week.

Children younger than 5 are the only age group not currently eligible to be vaccinated against Covid-19. About 17 million kids will become eligible for Covid-19 vaccines once they're authorized for this age group.

"To be able to vote for authorization of two vaccines that will protect children down to 6 months of age against this deadly disease is a very important thing," said committee member Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University.

She compared the day to December 2020, when the first Covid-19 vaccines were authorized for adults and older teens.

'Benefits seem to clearly outweigh the risks'

"The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or in collective child care," committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School, said of the Moderna vaccine.

Committee member Dr. Art Reingold added that even though the risk of Covid-19 hospitalization and death is lower for young children than for adults, children already get vaccinations to protect them against diseases for which their risk is low.

"If we have a vaccine with benefits that outweigh the risks, then making it available to people is a reasonable choice," said Reingold, of the University of California, Berkeley.

"I would point out that we as a country continue to give a large number of vaccines to children where the risk of the child dying or being hospitalized of those diseases are pretty close to zero," he said, such as polio and measles.

The number of Covid-19 hospitalizations and deaths in children is concerning and much higher when compared with influenza-related deaths and hospitalizations, FDA official Dr. Peter Marks said at Wednesday's meeting.

"There still was, during the Omicron wave, a relatively high rate of hospitalization during this period," said Marks, director of the FDA's Center for Biologics Evaluation and Research. "That rate of hospitalization actually is quite troubling, and if we compare this to what we see in a terrible influenza season, it is worse."

Marks said the number of deaths for children 4 and under during the first two years of the pandemic "also compares quite terribly to what we've seen with influenza in the past."

"We are dealing with an issue where I think we have to be careful that we don't become numb to the number of pediatric deaths because of the overwhelming number of older deaths here. Every life is important," he said, adding that "vaccine-preventable deaths are ones we would like to try to do something about."

Marks said the Covid-19 vaccines are an intervention similar to the influenza vaccine, which has been broadly and routinely used and accepted to prevent deaths.

Moderna vaccine 'well-tolerated' in youngest children

The Moderna vaccine is already authorized for adults. In a meeting Tuesday, the FDA's advisers voted unanimously in favor of expanding the emergency use authorization to include older children and teens, ages 6 to 17, saying it would also offer more benefits than risks.

Moderna's Covid-19 vaccine, when given as a 25-microgram dose, is "well-tolerated" in children ages 6 months to 5, said Dr. Rituparna Das, Moderna's vice president of Covid-19 vaccines clinical development, during Wednesday's meeting as she described the safety profile of the vaccine among this age group and adverse reactions.

"Pain was the most common event," Das said. "Young children's events included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting and chills. For infants and toddlers, events included fever, irritability, crying, sleepiness and loss of appetite."

These reactions were more common after the second dose of vaccine and resolved within two or three days, Das said, adding that fever was an important assessment of the vaccine's safety for this age group.

Fever after any dose of vaccine happened in about a quarter of the children, but more often after the second dose, and one incident of febrile seizure was considered to be related to vaccination, Das told the committee members. The child who had the seizure remained in the vaccine study and got a second dose of vaccine with no serious events.

No deaths or cases of myocarditis or pericarditis were reported among vaccine recipients, Das said.

"In summary, mRNA-1273 was well tolerated," she said, using the technical name of Moderna's vaccine. "Local and systemic reactions were seen less frequently in these youngest groups."

Concern over number of doses

VRBPAC member Dr. Paul Offit said in Wednesday's meeting that children who get the Pfizer/BioNTech vaccine will have to complete a three-dose series to get sufficient protection.

" 'Do the benefits outweigh the risks' is something I can support, but I do have some concerns about this vaccine," said Offit, director of the Vaccine Education Center at Children's Hospital of Pennsylvania.

Committee member Dr. Jeannette Lee of the University of Arkansas for Medical Sciences also mentioned concern that some children might not complete all three doses and that uptake of the vaccine will be slow.

"Three doses will certainly benefit. I have a lot of concern that many of these kids will not get a third dose," she said. "My concern is that you have to get the three doses to really get what you need."

Data from a phase 2/3 trial of the Pfizer vaccine included 1,678 children who had received a third dose during the period when the Omicron coronavirus variant dominated. The vaccine appeared to be safe and had a strong immune response. The data has not been peer-reviewed or published in a medical journal.

Antibody levels tested one month after the third dose showed that the vaccine produced a similar immune response as two doses in 16- to 25-year-olds, the companies said.

In FDA briefing documents, it was noted that among young children who had received the vaccine in trials, there were no cases of anaphylaxis, myocarditis or pericarditis, and the most common adverse reactions among children 6 months to 23 months were irritability, drowsiness, decreased appetite and tenderness at the injection site. For children 2 to 4 years old, the most common adverse reactions were fatigue and pain and redness at the injection site.

Will these children get vaccinated?

There is already slow uptake of Covid-19 vaccines among children in the United States.

"Having vaccine options for the youngest children is very important; however, we have seen a relatively low uptake of Covid vaccines in children in the 5- to 12-year-old group, and so my concern is that uptake in the youngest children under 5 years old might also be lower than we would like," Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.

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Barouch, who is not a member of the FDA advisory committee, helped develop and study the Johnson & Johnson Covid-19 vaccine.

He said there were "striking" differences in how many adults are fully vaccinated compared with children and teens.

Children 5 to 11 were the most recent group to become eligible for vaccination, in November. But just 29% of these children are fully vaccinated with their two-dose primary series in the United States, according to the CDC , compared with about:

Biden administration lays out its plan for Covid-19 vaccinations for ...

CNN —

The White House has announced a highly anticipated Covid-19 vaccine rollout plan for children under 5.

The administration “has made 10 million vaccine doses available for states, Tribes, territories, community health centers, federal pharmacy partners, and others to pre-order,” according to a White House fact sheet shared with CNN Wednesday. It is partnering with those entities to ship and distribute vaccines across the country following next week’s meeting of the US Food and Drug Administration’s vaccine advisers – who will review data on these vaccines from Pfizer and Moderna – and expected authorization from the full FDA.

The first vaccinations could start “as early as the week of June 20 —with the program ramping up over time as more doses are delivered and more appointments become available,” according to the fact sheet. CNN previously reported Covid-19 vaccination shots for the youngest Americans could begin as soon as June 21.

FDA vaccine advisers are scheduled to meet next week to discuss authorizing emergency use of Moderna’s Covid-19 vaccine for children 6 months through 5 years of age and Pfizer’s Covid-19 vaccine for children 6 months through 4 years of age, and pending those decisions, the US Centers for Disease Control and Prevention will make final recommendations about the vaccines.

The administration estimates that 85% of children under the age of 5 live within five miles of a potential vaccination site at this time, though they’re anticipating most parents seeking a vaccination for young children will do so at their pediatrician’s or primary care provider’s office.

According to a senior administration official, however, additional vaccine clinics and sites will be set up at easy-to-access locations for parents, including pharmacies, schools, children’s hospitals, diaper banks, community health centers, clinics, museums, libraries and organizations serving minority communities across the country.

Jurisdictions across the country have been able to pre-order Covid-19 vaccine doses for children under 5 since last week – in that time, of the initial 5 million doses available for pre-order pending FDA authorization, the administration has received requests for 2.3 million vaccine doses, including 1.45 million doses of Pfizer and 850,000 doses of Moderna.

Still, the official suggested they anticipate an uptick in orders over time.

“Our experience has been that people are slow to order, and this has been true across each of the times we’ve opened up ordering, so I wouldn’t focus on those early numbers,” the official told reporters on a call Wednesday. “Our experience is that the longer the ordering stays open, the more likely the states come forward, so some of this is a matter of letting them know the ordering is available, and that they can begin that process.”

To spread awareness, the administration will partner with the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program, which it estimates serves over 6 million people in the US, including almost half of all infants; with Head Start Programs through the Administration for Children and Families at the Department of Health and Human Services, which it estimates services approximately 1 million families; with Department of Housing and Urban Development programs, which it estimates serves more than 800,000 children under 5; and with Medicaid and the Children’s Health Insurance Program (CHIP), which serves millions of children under 5, among others.

They’ll also partner with community organizations, including “What to Expect,” a platform serving mothers and expectant mothers, to author a series of blog posts to dispel vaccine misinformation.

Covid team warns of funding challenges

During Thursday’s Covid team briefing, the White House said that major reallocations made to US Covid-19 response resources in the absence of congressional funding would not affect the summer effort to vaccinate children under the age of five when those vaccines are recommended by the FDA and CDC.

“We do not have enough resources to have enough vaccines for every American for the next generation of vaccines. So the challenges are coming up in the fall. We need the money now. But the money we’re using for kids vaccines today is money that was appropriated previously by Congress,” Dr. Ashish Jha, the White House’s Covid-19 response coordinator said.

As CNN has reported, the administration is reallocating roughly $10 billion in existing funding from current efforts on testing, personal protective equipment, and research and development toward more immediate needs. Of that funding, $5 billion will be reallocated to support the purchase of Covid-19 vaccine doses for this fall, $4.9 billion for 10 million courses of Pfizer’s antiviral drug Paxlovid, and $300 million for additional monoclonal antibody treatments.

Jha indicated the timing of Wednesday’s announcement ensured that the US could “be at the negotiating table” with vaccine manufacturers, reiterating, “We do not have enough resources to make sure that every American who wants one of the next generation of vaccines will be able to get one.”

“We needed to be at the negotiating table and waiting longer – waiting for Congress no longer felt like an acceptable option,” Jha said.

Jha called those decisions to reallocate “very painful,” telling CNN that the administration is aware that it is “taking resources away from what we think are vital programs to make sure that we’re at the table when it comes to purchasing the next generation of vaccines to make sure that we have enough therapeutics for Americans as we get into the fall and winter.”

The White House requested $22.5 billion in funding for the administration’s Covid-19 response – money to pay for vaccines, testing, and treatments – earlier this year. Negotiators had been able to reach a scaled-back agreement on a $10 billion package, but left Washington for the Easter recess without passing that bill. Congress remains entangled in disagreement on how to proceed.

Jha said he had been communicating those difficult choices and consequences to bipartisan members of both the House and Senate.

“I think members of Congress that I’ve been meeting with and speaking with understand the situation we’re in, so we’ve got to keep making this point clear,” Jha said amid the congressional stalemate.

This story has been updated with additional reporting.

Donald Judd Betsy Klein
Donald Judd
Betsy Klein

US plans to roll out initial 10 million Covid-19 vaccine doses for ...

WASHINGTON, DC - DECEMBER 21: People pass a sign that reads "Face Mask Required" in a mall as COVID-19 cases surge in the city on December 21, 2021 in Washington, DC. District of Columbia Mayor Muriel Bowser reinstated the city's indoor mask mandate at 6am on Tuesday and announced a vaccination mandate for government employees after COVID-19 case numbers have surged to a new high. (Photo by Alex Wong/Getty Images)

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Johnson & Johnson's Janssen Covid-19 vaccine awaits administration at a vaccination clinic in Los Angeles, California on December 15, 2021. (Photo by Frederic J. BROWN / AFP) (Photo by FREDERIC J. BROWN/AFP via Getty Images)

TOPSHOT - Employees spray disinfectant and wipe surfaces as part of preventative measures against the Covid-19 coronavirus at the Pyongyang Children's Department Store in Pyongyang on March 18, 2022. (Photo by KIM Won Jin / AFP) (Photo by KIM WON JIN/AFP via Getty Images)

FILE - In this photo provided by the North Korean government, North Korean leader Kim Jong Un, center, visits a pharmacy in Pyongyang, North Korea on May 15, 2022. Independent journalists were not given access to cover the event depicted in this image distributed by the North Korean government. The content of this image is as provided and cannot be independently verified. Korean language watermark on image as provided by source reads: "KCNA" which is the abbreviation for Korean Central News Agency. (Korean Central News Agency/Korea News Service via AP, File)

CNN —

If the Pfizer/BioNTech coronavirus vaccine receives emergency use authorization from the US Food and Drug Administration for children 6 months to 5 years old, the tentative plan is to roll out about 10 million vaccine doses initially, according to a US Centers for Disease Control and Prevention document posted online.

The document, an updated pediatric Covid-19 vaccination planning guide, notes that “planning is for a sequenced rollout involving an initial total of approximately 10 million doses” and that providers and facilities that have ordered doses “must be able to receive vaccine shipment on Monday February 21.”

The FDA’s vaccine advisory committee will meet February 15 to discuss Pfizer and BioNTech’s request for an emergency use authorization of their vaccine for children as young as 6 months. The virtual meeting will give scientists a chance to go over the available trial data and make a recommendation on whether the vaccine would be appropriate for this age group.

If the FDA then gives the green light, the CDC’s independent vaccine advisory group will convene and make its recommendation. The CDC director needs to sign off before shots can be administered to children in this age group.

Operationally, the United States will be ready to roll out the vaccine for children under 5 once the FDA and CDC make their recommendations, Jeff Zients, the White House’s coronavirus response coordinator, said at a news briefing Wednesday.

“We can start packing and shipping the vaccine once FDA makes its decision,” he said.

According to the planning document, the doses for children under 5 will have a maroon cap and be distributed in cartons of 100 doses: 10 vials, each containing 10 doses.

The anticipated dosing size is 3 micrograms of vaccine per dose, with an anticipated three doses in a vaccine series. Pfizer and BioNTech are currently seeking authorization for a two-dose vaccine but are continuing to test a three-dose regimen. They say they will submit the additional data on a third dose in the coming months.

“This vaccine is specifically formulated for these young kids. So we’re launching a new program especially for kids under 5. The planning process is well underway. CDC is working with states to help them prepare. We’ve secured enough vaccine supply for all kids in this age group, all 18 million. We have enough needles, syringes and kits, and these are all specially formulated or made for this age group to send alongside the vaccine,” Zients said Wednesday.

“We’re working closely with pediatricians and family doctors and children’s hospitals and pharmacies to make sure the vaccine is available at thousands of locations across the country,” he said. “So we will be prepared for those parents that are eager to get their kids vaccinated.”

The rollout of the coronavirus vaccine for children younger than 5 is expected to mirror the rollout for children ages 5 to 11 in October, Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials, told CNN on Wednesday.

“There will be an emphasis on utilizing the current systems in place for the pharmacy program: registered pharmacies to get the vaccine as well as registered vaccine providers,” Freeman said, adding that children younger than 3 most likely could receive the vaccine at their pediatricians’ offices or other sites. Federal regulations do not allow pharmacists to administer vaccines to children under the age of 3.

State immunization boards are in conversation with providers to discuss who will be ready to receive the initial doses, said Claire Hannan, director of the Association of Immunization Managers.

“There’s obviously a lot of emphasis on making that vaccine available as soon as it’s authorized. But at the same time, especially with this age group, it’s not something that we want to rush,” Hannan said. “We want to make sure that the providers are comfortable with the product and they’ve had a chance to really look at the data.”

During the previous rollout of vaccine doses for children, about 35% to 40% of children ages 5 to 11 were vaccinated at pharmacies, according to data that NACCHO has received.

Because children 3 and under tend to visit the pediatrician regularly for well visits, Hannan said, there is an emphasis on incorporating the Covid-19 vaccine schedule into those visits. As a result, it might be a slower process than with other age groups.

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Recognizing that some parents will be ready to vaccinate their children immediately upon authorization, Hannan said, state health and immunization authorities are identifying clinics and pediatricians who can take on children outside of their regular patient base.

“That is a challenge because pediatricians are stretched very thin right now,” she said, due to staffing shortages, flu season and Covid-19.

There are about 18 million children ages 6 months through 4 years in the United States who potentially will be eligible to get vaccinated against Covid-19.

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COVID vaccine kids under 5: What to know about Pfizer, Moderna ...

Parents eager to vaccinate their youngest children may be able to do so as early as June 21, a top White House pandemic advisor said during a briefing Thursday.

Dr. Ashish Jha, coordinator of the federal COVID-19 response, told reporters the Biden administration is working closely with states, pharmacies and other health care providers to prepare for authorization from key regulatory agencies.

Covid-19 vaccine for younger children will face an 'odd ...

(CNN) About 18 million children under the age of 5 in the United States could soon be eligible to get a Covid-19 vaccine -- but first, the child-sized shot must go through a rigorous authorization process that's taking a different path than the Covid-19 vaccines that came before.

On Tuesday, Pfizer and BioNTech announced that they had initiated a rolling submission to the US Food and Drug Administration of data for their vaccine for children ages 6 months up to 5 years. The companies expect to complete the request for emergency use authorization soon.

It will still go through a thorough safety and efficacy review by US health agencies and experts, but it's a different plan than what was expected late last year.

In December, Pfizer announced that it decided to add a third dose to the primary vaccine regimen for young children. It said the original two-dose series did not provide the expected immunity in 2- to 5-year-olds.

Still, this week's request seeks authorization for the two-dose vaccine, which could make the vaccine available sooner. Pfizer and BioNTech plan to continue testing a three-dose regimen in this younger age group and say they will submit the additional data on a third dose in the coming months.

The company decided to submit for authorization of the two-dose vaccine now "with pediatric Covid-19 cases surpassing 10 million and at the request of the FDA," it said.

"Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge," acting FDA Commissioner Dr. Janet Woodcock said in a news release.

What changed since December

In December, Pfizer said that the vaccines appeared to protect the youngest children -- infants and toddlers up to 2 -- at the same levels seen in teens and young adults, slashing symptoms in 90% of kids who got the shot. However, the 3-microgram dose did not produce the same immune response in 2- to 5-year-olds.

The dose for infants and young children is about one-third of the dose given to children age 5 to 11 and a tenth the size of the dose given to people 12 and older.

The company decided to expand its trial to include a third dose, rather than the two doses older children and adults receive in a primary vaccine series.

What changed between December and this week's authorization request, public health leaders said, was the Omicron variant.

During the Omicron surge, cases among children "spiked dramatically," the American Academy of Pediatrics said Monday. There have been over 3.5 million child cases reported in January alone.

"It turns out that has actually facilitated the collection of more important additional clinical data that we did not have in December," US Surgeon General Dr. Vivek Murthy said at a White House Covid-19 briefing Wednesday. "Whether that changes the risk-benefit profile is what the FDA will be assessing, but there has been developments since December on the data front."

Some suggest that the FDA may be pursing a strategy of authorizing the first two doses of a vaccine that may not offer substantial protection until after a third dose, hoping to start kids on the series even as data on third shots is still pending.

Children have a lower risk of serious outcomes from a Covid-19 infection compared with elderly or immunocompromised adults. But about 1% of children who catch Covid-19 will be hospitalized. Infections can also lead to long-term consequences in children as they do in adults, increasing the risk for diabetes, autoimmune disease and a delayed reaction to infection called multisystem inflammatory syndrome, which requires hospital care.

"If the goal of the vaccine is to get baseline immunity in the kids -- to prevent really bad outcomes and you're really not using the vaccine as a tool to prevent infection in the first place -- two doses could do that," former FDA Commissioner Dr. Scott Gottlieb, who sits on the board of Pfizer, said on CBS on Sunday. "I think that may be why federal health officials are rethinking this. If, in fact, they decide to authorize this on the basis of two doses, it could be out much sooner, perhaps as early as early March."

Others agree that it could be a smart approach.

"When I was on hospital service last, there was a 7-month-old in the intensive care unit," Dr. Paul Offit, a pediatrician and vaccine expert at Children's Hospital of Philadelphia, told CNN. "If you can prevent that safely, and that's number one, and effectively, number two, then prevent it" with a vaccine.

Offit sits on the panel of experts that advises the FDA on its vaccine authorizations and will be one of the first to review the new data on the vaccine. The FDA's independent vaccine advisers will meet February 15 to discuss the company's data on the youngest children and make a recommendation on the vaccine.

The path to authorization

To authorize Covid-19 vaccines for emergency use, the FDA has previously set a bar of 50% effectiveness, meaning the shots have to prevent disease or decrease severity in at least 50% of the people who get them.

Since the data has not been released, it's unclear whether the Pfizer/BioNTech vaccine for younger children meets that standard after two doses.

Most experts CNN spoke with said they couldn't think of another vaccine review process quite like this.

One somewhat similar example is the Johnson & Johnson vaccine, which was authorized at one dose while the company tested a second, although the first dose proved sufficient to meet the FDA's authorization requirements.

The Pfizer/BioNTech coronavirus vaccine is expected to produce a "good efficacy signal" in children younger than 5, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday.

"The FDA is looking at the data very carefully, and in their typical fashion, they will be very careful in scrutinizing the data and making a recommendation of the decision based on that data," Fauci said.

That decision to go ahead and ask for the authorization, though, is still considered odd by some health experts.

"This does seem very unusual," said Dr. Eric Rubin, a member of the FDA's vaccine advisory committee and assistant professor microbiology and molecular genetics at Harvard Medical School.

"Regulators have to weigh risk and benefit. And in this case, we know a lot about the risks in older individuals, and they're very low, including older children," Rubin said. "It doesn't have to be that great, as long as we have something that's safe, and then a theoretical benefit could be that you are set up well for future vaccines. But having said all that, it does seem like a very unusual route to take."

Rubin thinks that with so many parents eager to get their kids vaccinated, there may also be some lobbying underway.

"FDA doesn't seem to be immune to political pressures," he said. "And I know that there are some who are saying that it would be good to get a couple doses of vaccine into kids now, in assuming that the third dose is going to be the one that makes a difference."

'We need a vaccine for kids'

Dr. Helen Talbot , an associate professor of medicine at Vanderbilt University and a member of the CDC's independent vaccine advisory board, the Advisory Committee on Immunization Practices, also hasn't seen the data. But she too believes there may be some pressure from parents.

"There's families of kids less than 5 who are really pushing. They feel like they're the last ones that don't have access, and there's nothing available for them," Talbot said. She knows this personally, since she gets a lot of emails asking about it, too.

Talbot said her questions are around safety data and the potential benefits and risks.

She is concerned about people in the middle who aren't quite sure if they want to get their child vaccinated. Only about 3 in 10 parents say they'll get their child under 5 vaccinated against Covid-19 right away, according to survey results from the Kaiser Family Foundation that were released Tuesday.

Communication may be key to help parents understand why they should vaccinate their small children, particularly if two doses may not be as protective as three.

"The FDA is really going to have to be able to eloquently explain the decision," she said.

For his part, Dr. Jay Portnoy, a member of the FDA's advisory panel on vaccines, says he's glad to see the FDA speeding up its process.

"I'm actually relieved," said Portnoy, who's a pediatrician at Children's Mercy Hospital in Kansas City. "Right now, our hospital is filled, not all Covid patients but many Covid patients, including our intensive care unit."

Portnoy says parents are anxious and worried.

"They're forced to send their kids to school, and the schools aren't allowed to mandate masks or anything else," he said."So what is a parent to do? That's just from my perspective. It's about time. We need a vaccine for kids."

What happens after authorization

White House Covid-19 response coordinator Jeff Zients said Wednesday that the administration is ready to "hit the ground running" to vaccinate young children as soon as Pfizer receives a green light from the federal government.

Zients said the US has enough kid-size needles and supplies to administer the vaccines. The administration is also working with local public health partners to make thousands of locations nationwide ready to vaccinate these children.

"We know many parents are eager to get their kids the protection of the vaccine. We know others have questions. So we're working with our partners to ensure all parents have access to the facts and information they need to make the right decision," Zients said.

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Pfizer has said it's testing a third dose administered eight weeks after a second dose. Data on a potential third dose, an updated authorization and third-dose rollout would come later on.

This may not be the last change to the Covid-19 vaccine schedule.

Former CDC Director Dr. Tom Frieden said this week that it may be a while before scientists figure out the best vaccine schedule for children.

"What the vaccine schedule should be is much more complicated, and that may take months or even years to optimize," Frieden, president and CEO of Resolve to Save Lives, told CNN's Anderson Cooper.

"It's probably a three-dose schedule for lots of people, but we really don't know that yet," Frieden said. "Nor do we know the right interval between doses. That's going to be with time, but we do know that vaccines are remarkably effective."

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Although parents welcomed the much-anticipated news, the BA.2 strain of the omicron variant continues to gain ground in the U.S., and access to these life-saving vaccines for 18 million of the nation's youngest is still weeks away.

COVID vaccine for kids: FDA panel likely to recommend Pfizer ...

An FDA expert advisory panel meets this week and will likely recommend two COVID vaccines for the youngest children.

The vaccines under review are Moderna's for ages 6 months to 17 years and Pfizer-BioNTech's for children ages 6 months to 5 years.

If the vaccines are authorized this week, they would become available as soon as June 21, the Biden administration has said.

A federal advisory panel is likely this week to recommend two COVID-19 vaccines for the youngest children, as well as a second option for older kids whose access has been limited to Pfizer-BioNTech shots.

According to detailed information made public Friday and Sunday, Food and Drug Administration staff reviewed safety and effectiveness data for the Moderna vaccine for people ages 6 months to 17 years and for the Pfizer-BioNTech vaccine for children ages 6 months through 4 years.

The review was positive, raising no new safety issues or concerns about trial data, most of which had been released by the companies.

An FDA expert advisory panel will hold all-day meetings Tuesday and Wednesday to discuss the data, but the staff review suggests that there will be no major surprises and that the panel will recommend authorization of both vaccines.

If that happens and the FDA commissioner signs off on the shots, the Centers for Disease Control and Prevention will follow the same process, and a different expert advisory panel will do a review Friday and Saturday. The CDC director would have to endorse the vaccines before the companies would be allowed to provide them.

The Biden administration said that if the vaccines are authorized this week, they would become available as soon as June 21 (a day after the federal Juneteenth holiday) at pharmacies, pediatricians' offices, libraries, children's museums, health centers and other outlets.

The federal government pre-purchased vaccine doses, which will be provided at no cost to families.

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Advocates are eager for vaccines to finally be extended to young children, the only major group of Americans left unprotected by vaccines.

"This moment is bittersweet," said Fatima Khan, co-founder of Protect Their Future, a grassroots group of physicians, parents and activists. "We're grateful to access a safe vaccine but also troubled by how long it took. … We must learn from this experience and fix root bureaucratic issues that caused the delays so that our children are never left behind again."

The only vaccine available for children has been Pfizer-BioNTech's, authorized for those 5 and up. Traditionally, drugs and vaccines are studied first in adults, then in adolescents and progressively younger children, moving down in age as safety and effectiveness are proved in older groups.

Babies younger than 6 months are not expected to receive a COVID-19 vaccine. Instead, vaccination during pregnancy, which has been safe, passes on protection that lasts for about the first six months of life.

Companies determined the most effective doses of COVID-19 vaccines for each eligible age group, while minimizing side effects.

Pfizer-BioNTech offers adults and adolescents a two-dose initial vaccine series, with 30 micrograms of active ingredients in each shot. Children ages 5-11 receive 10 micrograms of the vaccine, and the youngest children would get a 3-microgram dose.

Pfizer and its German partner, BioNTech, found that two doses were not adequately protective against the omicron variant of the coronavirus, so they asked the FDA and CDC to authorize a three-dose series for children ages 6 months through 4 years old. Older children are authorized to receive a booster dose to protect against the latest variants.

Adults get two 100-microgram doses of the Moderna vaccine, which is based on the same mRNA technology as Pfizer-BioNTech's, for their initial series. The company proposed the same dosage for teens, two 50-microgram shots for younger children and two 25-microgram doses for the youngest children.

Moderna tested its vaccine in two doses only, and it appears less effective in the youngest children.

On Tuesday, the FDA advisory panel, called the Vaccines and Related Biological Products Advisory Committee, will review data on Moderna's vaccine for children 6 to 17.

On Wednesday, the panel will decide whether to recommend Moderna and Pfizer-BioNTech's vaccines for children as young as 6 months.

Vaccine side effects, dosage for children and what studies have found

Vaccine side effects in the youngest age groups were similar to those in older children, including short-term fever and redness at the injection site, studies showed.

Neither vaccine trial in young children found any cases of allergic reactions to the shots or myocarditis, the swelling of the heart muscle occasionally seen among adolescent boys and young men after vaccination.

In the Pfizer-BioNTech trial, three shots – the third given at least eight weeks after the second – protected more than 75% of children ages 6 months to 2 years and 82% of those ages 2 to 5, and there was no significant increase in side effects. The trial included about 4,500 children in five countries; twice as many participants got the active vaccine than got a placebo.

The Pfizer-BioNTech trial had been designed to wait for results until 21 children in either the placebo or active vaccine group contracted COVID-19. Although cases have risen in recent weeks, only 10 had tested positive for the coronavirus this month, so technically, the effectiveness results are considered preliminary.

In Moderna's trial of 6,700 children ages 6 months to under 6, company researchers found that two 25-microgram doses led the children to develop levels of virus-fighting antibodies comparable to young adults who received two full-strength shots.

In the study, which took place during the omicron wave, researchers found the vaccine was 51% effective among children 6 months to under 2 and 37% effective among children 2 to under 6.

Among older children, a 50-microgram dose appeared to be safe and effective, according to company data and the FDA analysis.

Moderna filed a year ago for authorization of its vaccine in adolescents, but the FDA held the application, awaiting more information on the risks of myocarditis after vaccination. The committee will review more recent data and decide whether the benefits of the vaccine outweigh the risks of myocarditis in that age group.

Teens and young adults, particularly males, appear to be at the highest risk for this side effect, though it is generally milder than the myocarditis caused by infection with COVID-19.

5 million doses of each vaccine available by June 21

The FDA advisory panel is likely to make a recommendation at the end of each day's meeting: Tuesday on Moderna's vaccine for children ages 6-17 and Wednesday on both vaccines for young children.

Administration officials said last week they started accepting state and local orders for the shots and expect to have 5 million doses each of Pfizer-BioNTech and Moderna vaccines for young children available on June 21 and millions more soon thereafter.

"If the FDA and the CDC recommend these vaccines, this would mark an important moment in the pandemic," Dr. Ashish Jha, the White House COVID-19 response coordinator, said at a news conference last week. "It would mean that for the first time, essentially every American – from our oldest to our youngest – would be eligible for the protection that vaccines provide."

Contributing: Adrianna Rodriguez

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

White House lays out plans for distributing vaccines to youngest ...

COVID-19 vaccines could be available for America's smallest children as soon as June 21, assuming regulatory authorities sign off on the shots next week.

The Biden administration early Thursday released its plans for distributing low-dose vaccines for children ages 6 months to under 5, the last major group of Americans to receive access to the shots.

As with other groups, the vaccine will be made available free at pharmacies across the country, but the administration is also making a big push to make the vaccines accessible via pediatricians and primary care providers, children's museums, libraries, children's hospitals and health clinics.

Facilities have been able to pre-order vaccine doses since Friday, when the administration released 5 million doses. Another 5 million will be available before June 21 and millions more after, administration officials said. Doses will be evenly divided among the Moderna and Pfizer-BioNTech vaccines.

First, though, federal advisory committees will review safety and effectiveness data on the low-dose vaccines from Moderna and Pfizer-BioNTech and decide whether their benefits outweigh their risks in younger children.

Administration officials, in a call with media Wednesday night, said they were not preempting the regulatory process but rather planning for the possibility that the vaccines will soon be authorized.

The vaccines would be identical to those provided to adults, but at a lower dose, one-tenth the adult dose for the Pfizer-BioNTech vaccine and one-quarter of the adult dose for the Moderna vaccine.

Both companies have led studies showing their vaccines are safe and generated a comparable immune response in younger children as in older children and adolescents. Moderna tested two doses of its vaccine in children 6 months to 6 years, and Pfizer-BioNTech found that three doses were needed to provide equal protection for children 6 months to under 5 during the current omicron outbreak.

There are no plans to vaccinate children under 6 months old. Vaccinating pregnant women provides infants with some protection against the virus that causes COVID-19, studies show.

On June 15, an advisory committee to the Food and Drug Administration will hold an all-day meeting to review data on vaccines for the youngest children from both companies. (On June 14, the committee will consider authorizing Moderna's vaccine for children ages 6 to 17. The Pfizer-BioNTech vaccine has long been available to minors.)

A similar advisory committee to the Centers for Disease Control and Prevention is expected to take up the same topic on June 18, if the FDA commissioner authorizes the shots. (The same procedure will be followed on June 17 for Moderna's vaccine for children ages 6 to 17.)

If the CDC director signs off on the shots, they will become available as soon as June 21, officials said. (June 20 is a federal holiday to celebrate Juneteenth, which commemorates the emancipation of enslaved African Americans at the end of the Civil War.)

Administration officials said they have focused their planning on making vaccines available as soon as they are authorized and on providing information to families and trusted community leaders, such as pediatricians.

The national public education campaign will include 17,000 volunteers from health care, faith, rural, sports, and youth organizations, as well as national and local organizations.

Shots and educational information will also be made available through existing programs designed to reach young families, including the Women, Infants, and Children Program (WIC), Medicaid and the Children’s Health Insurance Program (CHIP), subsidized housing programs and the Head Start early education program, administration officials said.

Karen Weintraub can be reached at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

Pfizer and BioNTech seeking emergency use authorization from ...

(CNN) Pfizer and BioNTech are requesting emergency use authorization for their two-dose Covid-19 vaccine for children age 6 months up to 5 years, the companies said Tuesday.

Pfizer and BioNTech said they have initiated a rolling submission of data to the US Food and Drug Administration after a request from the agency. They expect to complete the EUA submission in the coming days and say they will also submit clinical trial data to the European Medicines Agency and other agencies around the world.

The FDA's vaccine advisory committee will meet February 15 to discuss the submission.

Safety and effectiveness are key, said Dr. Paul Offit, a member of the committee and director of the Vaccine Education Center at Children's Hospital of Philadelphia.

"The confidence of the American public depends on that, that you you're recommending something that you would give to your own children," Offit told CNN. "It all depends on the data. The data will tell us just how good these are. There should be a robust safety profile and a robust efficacy profile and immunogenicity profile. And if that's true, speed doesn't really matter, as long as they have those data."

Read More

White House says Covid-19 shots for kids under 5 could begin as ...

WASHINGTON, DC - APRIL 26: White House Coronavirus Response Coordinator Dr. Ashish Jha gestures as he speaks at a daily press conference in the James Brady Press Briefing Room of the White House on April 26, 2022 in Washington, DC. (Photo by Anna Moneymaker/Getty Images)

CNN —

Covid-19 vaccination shots for the youngest Americans could begin as soon as June 21, the White House said on Thursday.

The vaccination program for children younger than 5 would come more than 18 months after vaccines were first authorized for adults.

Dr. Ashish Jha, White House coronavirus response coordinator, laid out a timeline for authorization of vaccines for children younger than 5 at an afternoon news briefing. The US Food and Drug Administration’s vaccine advisers will review data submitted by Pfizer and Moderna during a meeting on June 14-15, and the agency will then decide whether to authorize the vaccines for emergency use.

“We expect an FDA decision shortly after the advisory committee meeting, and we look forward to this process playing out,” Jha said. “The FDA authorization is not the final step in the process before vaccinations can begin. CDC must also issue its recommendations. If the FDA authorizes the vaccines, the CDC will have its advisory committee meetings and ultimately the CDC director will make her recommendations.”

Jha said the White House was not going to “prejudge the outcome of the process,” but was already “hard at work” planning for the process to play out.

“We’ve been working very closely with states with local health departments, with pediatricians, family physicians, other health care providers and pharmacies to get ready,” he said, adding the administration expected “the vast majority” of kids would be “vaccinated by their primary care providers.”

The good news, Jha said, is the US has “plenty of supply” of both the Pfizer and Moderna vaccines to start the vaccination program for kids younger than 5, and 10 million additional doses would be made available for states, pharmacies, community health centers and federal entities to order starting this Friday. Jha said those doses were expected to start arriving at their destinations after the long Juneteenth weekend.

The Monday after the FDA advisory committee meeting is June 20, when the US celebrates Juneteenth, so Jha said the White House expects “that vaccinations will begin in earnest as early as Tuesday, June 21.” He noted it will take some time for the program to ramp up and for vaccines to be more widely available.

CORRECTION: A previous version of this story incorrectly stated when the first Covid-19 vaccines were made available to adults. They were authorized 18 months ago.


Ford recalls 2.9M vehicles for inability to shift into gear, risking crash

Ford Motor Co. is recalling 2.9 million vehicles that may shift into unintended gears or roll away while parked, the third major recall for the automaker this month.

The latest recall affects certain 2013-2019 Escape, 2013-2018 C-Max, 2013-2016 Fusion, 2013-2021 Transit Connect and 2015-2018 Edge vehicles, according to the National Highway Traffic Safety Administration.

Each vehicle model affected is listed separately on the NHTSA recall site, totaling 2,925,968 vehicles.

"A damaged or missing bushing may prevent the vehicle from shifting into the intended gear, and cause the vehicle to move in an unexpected direction," the government website says. "Additionally, the vehicle may roll after the driver selects the 'Park' position."

Earlier recalls:Ford Mustangs, F-Series, Chevy and GMC trucks among latest auto recalls

EV versus ICE:Considering an electric vehicle? Here's what to expect if you've never driven an EV before.

Ford details accident reports from defect

The agency acknowledged the automaker's June 10 report to safety regulators in a letter dated Tuesday.

Ford said in its filing that the company is aware of six reports alleging property damage and four reports alleging injury related to this concern.

"The transmission may not be in the park position, even though the shifter position indicates that the vehicle was shifted to park," Ford wrote in its recall letter to federal regulators. "The driver does not receive a warning message or audible chime."

"Root cause is unknown. Based on Ford’s root cause investigation, heat and humidity have the potential to contribute to the hydrological breakdown of the bushing material."

A Ford spokesman declined to provide additional comment Wednesday.

In the filing, Ford said its dealers will replace the shift bushing and add a protective cap over the shift cable bushing free of charge.

Ford said it plans to mail letters June 27 to approximately:

1,726,763 Escape owners

143,220 C-Max owners

439,483, Fusion owners

107,102 Transit Connect owners

509,400 Edge owners

Mustang Mach-E, Expedition recalls

Also this week, Ford confirmed recalling 48,924 model year 2021-22 electric Mustang Mach-E vehicles because they could lose power while driving. The 2021 Ford Bronco has also been recalled for "catastrophic" engine failure.

Ford recalled 350,000 SUVs, including about 39,000 for engine fire risk in May.

Electric trucks:They're the 1st owners of Ford F-150 Lightnings: What they're going to do with them

Engine fires:Ford recalls SUVs because of engine fire risk

Customers who own a 2021 Ford Expedition and 2021 Lincoln Navigator revealed last week they're suing for the fire risk that potentially affects 39,013 vehicles and currently has no identifiable fix.

In February 2020, prior to becoming CEO eight months later, Jim Farley said in a public speech that the company had to get control of warranty costs that were taking a huge bite out of profits.

"We know what we need to do," he said. "We need to lower our warranty spending."

Contact Phoebe Wall Howard at 313-222-6512 orphoward@freepress.com.Follow her on Twitter@phoebesaid.

Toyota recalls 2.9 million cars to fix airbag defect

Toyota issued a massive recall on Tuesday to fix an airbag sensor defect on 2.9 million U.S. vehicles made over the course of nearly a decade.

The automaker said it is recalling certain versions of the 2011-19 Corolla, 2011-13 Matrix, 2012-18 Avalon, and 2013-18 Avalon Hybrid.

The vehicles have a faulty electronic control unit, which is designed to assess incoming signals from crash sensors and trigger an airbag deployment and seatbelt tightening, if necessary.

The unit "may not have adequate protection against certain electrical noise that can occur in certain crashes, such as severe underride crashes," Toyota said in a statement.

As a result, the airbag may not deploy correctly or at all, which could increase the risk of injury or worsen the outcome.

Toyota spokesperson Tania Saldana declined to comment on how many injuries, deaths or crashes the company has linked to the defect.

The recall also affects more than 500,000 additional vehicles outside the U.S.

Airbag defects:Takata recalls 10 million more airbags from 14 automakers

The faulty units were made by "a specific supplier" that Toyota did not identify.

To fix the units, Toyota will install a noise filter, if necessary, at no cost to vehicle owners.

Car owners can check Toyota.com/recall or NHTSA.gov/recalls to see if their specific vehicle is affected.

Follow USA TODAY reporter Nathan Bomey on Twitter @NathanBomey.

Chrysler gives in, makes air bag recall global

James R. Healey

USAToday

Chrysler will give in to government pressure and make worldwide its existing regional recall to fix driver's-side Takata air bags, adding 3.3 million vehicles, including 2.9 million in the U.S.

The sweeping action brings to 3.67 million the number of Takata-equipped vehicles that Chrysler — now officially FCA US — has said qualify for free inflator replacements.

Neither Chrysler nor Takata acknowledges that there is a known safety defect with the bags, which means the repairs and replacements technically need not be labeled "recalls." Chrysler calls them "field actions."

The National Highway Traffic Safety Administration has been pressuring five automakers to expand what have been regional Takata recalls for driver's side bags into national actions. Including separate actions for passenger-side front bags, 10 automakers are involved. But NHTSA says the driver's bag risk is greater and more widespread.

Chrysler is the first to identify its expanded move as a "worldwide" action. Ford Motor, Honda and Mazda recently promised to make their driver's side Takata recalls national. The last of the five, BMW, has not announced its plans.

The impact of the expanded recalls is illusory for now. Lacking enough replacement parts for the Takata bags, automakers are funneling the ones they get into the high-humidity regions where the problem seems most likely to occur.

About 11 million vehicles with Takata air bags have been recalled in the U.S. Close to 20 million have been recalled worldwide.

Five deaths are linked to faulty Takata bags.

Though the big Japanese safety-equipment supplier refuses to flatly say there is a safety flaw in the bags, it previously said the explosive propellant used to inflate the air bags was mishandled.

That left it vulnerable to some conditions — so far believed to be the high humidity in certain places — that degrade the propellant. When it malfunctions, it deploys the air bags with too much force, ripping them free from their housings and blasting bits and pieces — shrapnel — into vehicle occupants.

Takata has refused NHTSA's demand that it declare a safety defect and begin a nationwide recall, instead of leaving it to the automakers who buy its air bags.

Takata bought big newspaper ads with a statement from Shigehisa Takada, Takata's chairman and grandson of the company founder.

The ads, which ran Thursday, quote Takada as saying: "Even one failure is unacceptable and we are truly and deeply saddened that five fatalities have been attributed to auto accidents where Takata air bags malfunctioned." Takada, 48, added, "We understand the public's concerns, and we take them seriously."

He said production of replacement parts is being increased, but — again — he did not specifically say the bags have a safety defect.

NHTSA says it will sue Takata to require a recall, if the company won't do it voluntarily, but that process can take months.

Chrysler has emphasized in its Takata-related announcements that it is taking what it calls "field actions" out of "an abundance of caution" and not because there is a known defect.

The automaker said Friday:

"Neither FCA US, nor Takata Corporation, the supplier, has identified a defect in this population of inflators. These components also are distinct from Takata inflators cited in fatalities involving other auto makers.

"More than 1,000 laboratory tests have been performed on these components. All deployed as intended, but FCA US continues to study the suspect inflators, which are not used in the company's current production vehicles.

"Outside of Florida, one of the areas covered by the original action, no FCA US vehicle has been linked to an air-bag deployment of the type that has raised public concern. Nevertheless, the Company is replacing the Takata components tied to that concern.

"FCA US is aware of one related injury involving one of its vehicles, an older-model sedan. It occurred in a southern Florida region marked by persistent, high, absolute humidity — a condition believed to be a contributing factor in the air-bag deployments under investigation."

The original, regional recall was announced in June, and recently expanded.

The latest action affects an estimated 2,89 million vehicles across the U.S., another 258,586 in Canada, 66,436 in Mexico, and 99,030 elsewhere.

Newly covered by the recall are these 2004-2007 models:

•Dodge Ram 1500, 2500 and 3500 pickups

•Dodge Ram 3500 chassis-cab trucks

•Dodge Durango and Chrysler Aspen full-size SUVs

•Chrysler 300 and Dodge Charger full-size sedans

•Dodge Magnum full-size station wagons

•Mitsubishi Raider and Dodge Dakota small pickups

Chrysler said it will notify the newly affected owners when they can get free repairs, but noted that it first will use its supplies of replacement parts in high-humidity areas. It made no forecast of how long it will take to begin replacing inflators in other areas.

Toyota recalls 2.9M SUVs over seat belts

Associated Press

TOKYO - Toyota said Thursday it is recalling nearly 2.9 million sports utility vehicles, including more than 1.1 million in the U.S., because of seat belts that might fail in a crash.

The recall covers RAV4 SUVS from the 2005 through 2014 model years, the RAV4 electric vehicle from 2012 through 2014, sold in North America, and the Vanguard sold in Japan from 2005-2016, the Japanese automaker said.

Toyota says it’s possible the belts in both second-row window seats could come in contact with a metal seat cushion frame in a severe frontal crash.

If that happens, the belts could be cut and would not restrain passengers.

The company says it will add plastic covers to the metal frame at no cost to customers.

The recall also affects 625,000 vehicles in Europe, 434,000 vehicles in China and 177,000 in Japan.

Toyota recalls cars to fix air bags, emissions

Nathan Bomey

USA TODAY

Emissions problems and air bag defects — quality issues that are bedeviling the auto industry — have triggered new global Toyota recalls.

An air bag defect unrelated to the ongoing Takata air bag crisis covers 1.4 million Toyota cars, including 482,000 in the U.S. The Japanese automaker also issued a global recall for 2.9 million cars over potential defects related to emissions controls, though none are located in the U.S.

When eliminating certain models covered by both recalls, the number of total vehicles affected worldwide by the two new recalls is 3.4 million, Reuters said.

A small crack can develop in air bag inflators, causing partial inflation. Toyota said North American models affected by the air bag recall are the 2010 to 2012 Prius hybrid, the 2010 and 2012 Prius plug-in and the 2011 to 2012 Lexus CT 200h.

Sweden-based auto supplier Autoliv, which made the air bag inflators, acknowledged Wednesday in a statement that it had documented seven cases of a side curtain air bag partially inflating in Prius vehicles while the cars were parked and unoccupied. No injuries were reported.

Autoliv shares (ALV) fell 4.2% in pre-market trading to $105.49. U.S.-traded shares of Toyota (TM) rose 0.6% to $100.45.

Autoliv signaled that it would spend about $10 million to $40 million to aid Toyota in the recall.

”For Autoliv, safety and quality are our priorities and we are fully committed to support Toyota's action in resolving this issue, and will support Toyota in the implementation of solution to the issue," Autoliv CEO Jan Carlson said in a statement.

Follow USA TODAY reporter Nathan Bomey on Twitter @NathanBomey.

Fire engulfs Kia on Michigan highway; group wants 2.9M recalls

Matthew Rose described his beloved 2012 Kia Optima as a “big toasted marshmallow.”

Seeing a car burst into flames for no apparent reason was a new experience. And, it seems, Rose isn’t the only Kia or Hyundai driver to experience something so scary.

Rose said his Optima delivered great gas mileage for his 45-minute commutes back and forth to work in Grand Rapids. He really loved that midsize car.

But then it burned to a crisp on Feb. 28.

“This was the first brand-new car I’d ever purchased in my life. I never had any real major issues with it, except for some recalls and guest service bulletins here and there,” said Rose, 53, a systems analyst from Holland, Michigan. “When I took it in, people were friendly at the dealership. It was a comfortable car to drive. It was kind of a shock that it just, all of a sudden, it did this.”

The company said in a statement that Kia has taken proactive steps to address an engine manufacturing issue that “can, in rare instances, result in a non-collision fire, including the recall of more than 680,000 vehicles, and is committed to taking any necessary actions in a timely manner.”

But a consumer advocacy group wants a total 2.9 million Kias and Hyundais recalled: 2011-14 Kia Sorento, Kia Optima, Hyundai Sonata and Hyundai Santa Fe; and 2010-15 Kia Soul.

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Rose is among hundreds of drivers who have reported such fires to the National Highway Traffic Safety Administration and independent Center for Auto Safety involving certain 2011-18 Kia and Hyundai vehicles. These fires have led to higher-than-average insurance claims and a public plea that Congress launch a defect investigation.

“Recently, Hyundai and Kia acknowledged there are additional millions of their vehicles experiencing engine failure, a frequently cited precursor to fire events, yet they have refused to recall almost any of these vehicles to address the risk of fire,” said Jason Levine, executive director of the nonprofit Center for Auto Safety, which has called for the broader recall.

“Instead of presenting the public a solution for these fires, or a satisfactory explanation, or simply taking responsibility for continuing to sell what appear to be defective engines," both manufacturers have recalled only a portion of the "potential fire-prone vehicles and hoped no one would ask about the rest,” Levine said.

James Bell, Kia spokesman, said, “Customer safety is one of Kia’s top priorities and we are taking this matter seriously."

A Hyundai spokeswoman referred inquiries to Bell. Kia is part of the South Korea-based Hyundai Motor Group.

Levine said he has reviewed more than 300 reports since June 2018 filed with his organization and federal safety officials.

Rose surfaced as one of many.

Rose worries that the service campaigns don’t go far enough, and lives are at risk.

'Car is definitely on fire'

He was driving about 70 mph on his way home during rush hour, merging from Michigan Highway 6 onto I-96 westbound near Hudsonville, when the engine stalled. Just died. Rose used his blinker and coasted through traffic to the shoulder to call for roadside assistance. While sitting in the driver’s seat while using the phone, smoke began “coming up from the front of the hood.” At that point, he told the tow operator he planned to call 911 “in case of fire.”

Then things took a turn for the worse.

“About a minute after I hung up, smoke started coming in through the vents,” Rose said. “I had my insurance information, which I put in my pocket, grabbed my laptop and was able to get out of the car. There was still quite a bit of traffic. I was going to try and open the hood. I had popped it but didn’t look inside. I could see there were flames inside the engine compartment. I called 911 back and said, ‘Hey, the car is definitely on fire.’ And they said they were on the way. By the time I hung up, the engine was engulfed, the whole hood, everything.”

So a guy who paid off his $28,000 vehicle about six months ago is waiting for an insurance settlement check. His son-in-law gave the family a 2005 Kia Sportage.

Rose agreed to an interview because he wants to get the word out that if people see smoke, they should exit their Kia or Hyundai immediately. “If a person stays in the car too long, it would overtake you quite quickly. I’d hate to hear of people getting injured or dying.”

Rose explained, “We are frustrated and kinda upset. Here we were, no car payments. And we were kinda focusing in remodeling the house. Now we’re looking at getting a used Lexus hybrid.”

He has owned a Ford Explorer, Ford F-150 pickup, Ford Expedition, Ford Taurus, Buick Regal and a Volvo S80 T6 sedan. He was attracted to the fuel efficiency of the Asian brands.

Thing is, Rose took his vehicle to the Kia dealership in 2018 for an engine bearing recall and other repairs. No engine replacement was done. On Feb. 9, Rose’s vehicle had a “knock sensor detection system upgrade” that is part of Kia's Product Improvement Campaign and intended to warn the driver prior to catastrophic engine failure that can result in stalling and engine fires.

“I was reading more about the issues other people are having and why there’s an issue with the recall,” Rose said. “Even though my car has the same motor, same year and same model as other recalls, my particular VIN is not on the recall list. Yet it caught fire. I’m not real pleased.”

He applauded the Center of Auto Safety for pushing to get Kia to do a “full-on recall and not pick and choose.”

Kia says it will help

Meanwhile, Rose tried filing a complaint online with Kia but the system timed out.

“Perfect, right?” he said, laughing. “I found a link to consumer affairs and I think, in all fairness, I should give them the opportunity to make it right. I was enjoying the car with no payments.”

Upon hearing that the customer planned to reach out, Bell said, “I’m happy to hear he is planning to contact us. … We welcome the opportunity to investigate and provide assistance when and where appropriate.”

But consumer watchdogs aren’t so sure.

“The engines in question are all exactly the same. The part is the same part, the problem is the same problem. Their recalls have been identical,” said Levine, who has been tracking the data over the past year.

”There’s a history of manufacturers who have defects that contribute to car fires that are brought to their attention and they are not addressed soon enough," he said. "Fortunately, so far only one death is associated with these models. That’s dumb luck. Over 300 car fires on just ones we’re tracking. This has been going on for years now and their response has been pushing it off, kicking the can down the road, to do an improvement campaign, with a resistance to actually addressing the problem. We want to stop it before someone does die.”

He emphasized, “It’s like, ‘We know it’s going to catch fire but here’s a knock sensor.’ How does that help? So you’ve got an open wound and here’s a blood pressure cuff. If it goes up, come back to the hospital?”

Engine can be off

The Insurance Institute for Highway Safety’s Highway Loss Data Institute, which analyzes data from insurers, has noticed the Kia and Hyundai non-collision fires.

“When these vehicle fires occur, typically it results in a total loss. The consumer loses use of the vehicle,” said Matt Moore, senior vice president at the Highway Loss Data Institute financed by the insurance industry to track patterns. "Second, these problems can manifest themselves when the vehicle is turned off. That vehicle can be in a garage, attached to a home, and there can be a significant loss of property and possible loss of life. That’s the reason we pay attention to these things.”

Tracking shows higher insurance claim rates for the 2011-15 Kia Optima, 2011-14 Hyundai Sonata, 2011-15 Kia Sorento, 2011-12 Hyundai Santa Fe and 2013-14 Hyundai Santa Fe Sport.

A U.S. Senate committee in November asked the CEOs of Kia and Hyundai to testify about fire risk in the vehicles in response to the Center for Auto Safety’s concerns, according to the Associated Press.

The executives refused to testify, Levine noted.

The automakers had recalled 1.7 million vehicles starting in 2015 because of possible oil flow blockage, increasing fire risk, AP said. Kia acknowledged that dealer fixes in response to an initial recall hadn’t been done properly.

Kia also encourages customers who drive certain Optimas, Sorentos and Sportages to contact the dealership to address pending recall issues. In addition, the company issued non-repair “service campaign” alerts for an additional 3.7 million vehicles including Hyundai Sonata (2011-18), Hyundai Santa Fe Sport (2013-18), Kia Optima (2011-18), Kia Sorento (2012-18) and Kia Sportage (2011-18).

Rose drove one of the models that hasn't yet been recalled.

Contact Phoebe Wall Howard: 313-222-6512 orphoward@freepress.com.Follow her on Twitter@phoebesaid. Read more on Ford and sign up for our autos newsletter.

Toyota, Honda add 2.7 million more cars to air bag recall

Chris Woodyard

USA TODAY

Toyota added 1.36 million cars Tuesday to its list of those needing repairs due to the government's expansion of the Takata air bag recalls.

Toyota's action comes a day after Honda said it will recall another 1.39 million cars to replace the same component, the front passenger air bag inflators.

These recalls were expected as part of the National Highway Traffic Safety Administration's expanded recall of the faulty airbags, to which it says it added 33.8 million cars. Since the announcement, 11 affected automakers have been trying to figure out which of their models need to be included.

In the case of Toyota, the additional models will include 2003 to 2007 Corolla and Corolla Matrix; 2005 to 2006 Tundra; 2005 to 2007 Sequoia; and 2003 to 2007 Lexus SC430 vehicles. Toyota says the new additions bring the number of Toyota and Lexus vehicles covered by Takata recalls in the U.S. to about 2.9 million.

"Toyota's focus remains on the safety and security of our customers, and we will continue to respond promptly to new developments," said Dino Triantafyllos, chief quality officer at Toyota Motor North America, in a statement.

Honda said Monday it was adding certain 2001 to 2005 Civic and 2003 to 2007 Accord models to its list of vehicles under recall. The air bags are susceptible to inflating with too much force in a crash, spraying occupants with metal or plastic shrapnel. Several deaths have been blamed on the inflators.

GM UAW workers to get bigger profit sharing checks amid solid ...

General Motors reported solid fourth-quarter and year-end results Wednesday despite an eight-week production shutdown caused by the COVID-19 pandemic and the impact of the Takata airbag-inflator recall announced in November.

GM's total market share rose to 18.32% compared with 17.09% in the year-earlier quarter, said Cox Automotive. It is the largest year-over-year gain in total U.S. market share since 1990.

As a result, about 44,000 U.S. hourly workers at General Motors will receive a profit-sharing check of $9,000, said GM spokesman Jim Cain. The before-taxes payout for its UAW-represented workforce is an increase from $8,000 in 2019, but down from the $10,750 paid to workers in 2018.

More:GM to pay UAW workers $8,000 in profit sharing

More:Ford UAW hourly workers earn $3,625 profit-sharing checks amid 2020 earnings dip

For the full year, GM's pretax profits were $9.7 billion, up from $8.4 billion a year earlier, driven, in part, by the fact that GM's third- and fourth-quarter earnings in 2019 were hit hard by a 40-day strike by the UAW.

Additionally, GM gained traction last year with its redesigned full-size SUVs and big demand for pickups, both of which deliver fat profits.

In a letter to shareholders Wednesday, GM CEO Mary Barra said GM's brands were well prepared when plant production restarted and consumer demand recovered faster than expected — "Chevrolet and GMC with their outstanding full-size and midsize pickups; and all four brands with a mix of new small- and full-size SUVs, which we launched on time despite the pandemic."

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"These products helped drive our largest year-over-year gain in total U.S. market share since 1990. Just as important, their profits are helping us create a new chapter for GM that is electric, connected, sustainable, inclusive and growth-oriented."

In the fourth quarter, GM's pretax profits surged to $3.72 billion from $105 million in the year-ago period.

The UAW issued a statement commending GM on the results.

"Despite a year of a pandemic and loss of production in 2020, General Motors reported a solid profit for North America," said Terry Dittes, UAW vice president of the General Motors Department. "This is a testament to our UAW-GM Membership, who produce some of the finest and most sought-after vehicles in the world, right here in the U.S.A.”

GM's results beat Wall Street’s expectations in the fourth quarter, said Michelle Krebs, executive analyst for Cox Automotive.

"It should not have been a surprise. GM outperformed the overall market in the fourth quarter, with sales up 5% to the industry’s 2% rise," Krebs said. "Further, GM sold more of the right products in the quarter — pickup trucks and SUVs, especially its new large ones, that generate the biggest profits for the automaker. GM’s biggest challenge is inventory. Its supply of those profitable models is tight."

Looking ahead, GM said it's well-positioned in 2021. The industry-wide semiconductor chip shortage will not affect electric vehicle development.

To mitigate the chip shortage impact, GM said it will prioritize production of full-size trucks, SUVs and EVs. For 2021, GM expects to report $10 billion to $11 billion in pretax profits, which includes a hit of $1.5 billion to $2 billion because of the chip shortage.

GM is continuing to hire some 3,000 employees to help it accelerate its development of EVs and self-driving cars. GM has hired half of them so far, Barra said. The company expects to hire the other half over the next quarter. The majority of those hired will work remotely, a GM spokesman said.

Profit sharing

GM's North American pretax profit for 2020 was $9.1 billion, up from $8.2 billion in 2019, it said in its earnings release.

The GM-negotiated formula with the UAW for profit-sharing checks is $1,000 per every $1 billion in annual earnings before interest and taxes.

Ford's 56,000 union represented factory workers in the U.S. will receive $3,625 profit-sharing checks, down from $6,600 paid a year ago as reflected by Ford's profits in 2019. Ford reported its 2020 earnings last Thursday. Its earnings before interest or taxes — EBIT — of $2.8 billion, down from $6.4 billion in 2019. Ford's North America's pretax profit was $3.6 billion — down from $6.6 billion in 2019, $7.6 billion in 2018 and $8.1 billion in 2017.

Last year, about 44,000 Fiat Chrysler workers averaged $7,280, up from $6,000 for 2018. Fiat Chrysler, now called Stellantis, will release 2020 earnings later this month.

GM gained market share

For the year, GM's annual global revenue in 2020 was $122.5 billion compared with $137.2 billion for 2019. GM's annual net income was $6.4 billion compared with $6.7 billion in the year-ago period.

For the quarter, GM's reported a net gain of $2.9 billion compared with a net loss of $194 million a year ago. Quarterly, global revenue was $37.5 billion, up from $31 billion in the year-ago period.

GM reported full-year earnings per share of $4.33. Despite the gains, GM reported it spent $900 million on Cruise, its self-driving subsidiary. GM CFO Paul Jacobson told reporters that the Cruise "run rate has been pretty consistent for us and that’s what we expect in 2021. They are making tremendous process, but we expect the costs to remain consistent."

For the quarter, GM sold 2.1 million total vehicles globally, up from 2 million in 2019. For the year, GM sold 6.8 million vehicles, down from 7.7 million a year ago.

Buick, which is in the midst of transforming itself to an all-SUV brand, was the only GM brand that reported lower sales in the quarter, selling 44,188 vehicles, down 10%, Cox Automotive reported.

GM cut incentives overall by 5% in the quarter to an average of $5,115 per vehicle, but that was still the second-highest incentive spend for any fourth quarter over the past five years, Cox Automotive said.

GM’s average transaction price rose 5% to $44,690, its highest level, according to Kelley Blue Book calculations.

GM ended the year with an auto cash balance of $22.3 billion and total auto liquidity of more than $40 billion.

For the first time in GM's history, it will spend more on EVs and self-driving cars than on gasoline and diesel vehicle development. GM plans to spend $9 billion to $10 billion this year in research and development with more than $6 billion on EV development and $1 billion on autonomous vehicles.

600 Cadillac stores left

Meanwhile, Cadillac has finished its dealer buyouts, costing GM about $99 million last year.

Cadillac offered its 870 dealers nationally the chance to give up their franchise for $300,000 to $700,000 rather than make the investment for tools, training, equipment and charging stations to sell and service EVs. About 270 of them took the buyout, leaving the network at about 600 dealerships nationwide, a source familiar with the matter told the Free Press.

More:'Handful' of Michigan Cadillac dealers take a buyout rather than sell EVs

Cadillac reported record global sales for six straight months, including January. In January, Cadillac captured 7.6% of the market share in the U.S. luxury segment, a 1.9% increase over the year-ago period. It was the brand's best January since 2015.

For the year, GM's luxury brand finished down 17.1%, selling 129,495 vehicles in the United States. Globally, the brand sold 380,000 vehicles, down from 390,458 units in 2019.

But Cadillac struggled with inventory in 2020 because of the eight-week plant shutdown amid the pandemic. Inventory levels are still lean, said Mahmoud Samara, Cadillac North America’s vice president of sales, service and marketing. He declined to provide a day-supply figure.

More:GM reports strong 4th quarter — but tight inventory hampered bigger sales

Samara told the Free Press this week that the global shortage of semiconductor chips has not affected Cadillac vehicle production yet but, "is it a concern? Yes. It’s something we have our eye on and we have a world-class supply chain team working to mitigate that risk."

But for the quarter, Samara said Cadillac's average transaction price is over $56,000, the second highest in the segment after Mercedes Benz, up $2,300 from the year-ago period. In January, the number is inching closer to $60,000, he said, lifted by strong sales of the full-size Escalade SUV that often goes for $100,000.

GM plans for Cadillac to lead its all-electric future. Cadillac will launch the all-electric Lyriq early next year, followed by the hand-built Celestiq next year.

Cadillac will build the Lyriq in Spring Hill Assembly in Tennessee. Samara declined to say where GM will make the Celestiq or how much it will cost. But Car and Driver reported last month that the car should arrive by 2025 with a starting price in the $100,000 range.

Cadillac will have internal combustion vehicles for sale as it transitions to all-electric by 2030, Samara said. And there will still be super high-performance EVs. Cadillac offers V-series Blackwing high-performance sedans now.

"It’s a strong part of our heritage so just because we go EV, we don’t have to leave that behind," Samara said.

China

GM China weathered a softening market and the residual impact of the pandemic. It reported equity income of $500 million for 2020 compared with $1.1 billion for 2019.

GM and its joint ventures delivered 2.9 million vehicles in China in 2020. Sales were affected by the pandemic in the first quarter, but began to recover in the second quarter. Fourth quarter sales increased by 14.1% from a year earlier.

Cadillac posted record sales in China of over 230,000 cars for the year, up 7.9% from 2019. The surge led by sales of the XT4, XT5 and XT6 SUVs and the introduction of the CT4 luxury sedan. GM said Cadillac now has its strongest portfolio ever in China to compete in the steadily growing luxury vehicle segment.

GM Financial reported full-year revenue of $13.8 billion, down from its record revenue last year of $14.6 billion.

GM's EV initiatives

So far, the first quarter has been filled with EV news.

GM looked back 50 years to recall putting one of its first electric cars on the moon, noting if it can do that, it can deliver 30 new EVs to the market by 2025.

GM's biggest news came on Jan. 28 when it said that it "aspires" to offer all light-duty vehicles as zero emissions by 2035 and be carbon neutral by 2040.

As part of the 2021 virtual Consumer Electronics Show, GM showed renderings and animation of its Cadillac Halo concepts: the Cadillac Personal Autonomous Vehicle, which would be a fancy self-driving taxi, and Cadillac Vertical Take-off and Landing (VTOL) vehicle, a sleek and futuristic drone-like flying car.

More:GM shows off flying car idea, the Cadillac Halo

GM announced on Jan. 12 that it is launching a new business, BrightDrop, that will make electric-delivery vehicles and offer other technology and services to companies such as FedEx and UPS.

More:GM startup to make new electric truck for FedEx, other delivery services

BrightDrop's first customer is FedEx, which will buy 500 of the EV600 trucks later this year. Merchants Fleet, a fleet management company, will be the second customer. It plans to buy 12,600 of the EV600 trucks, GM said on Feb. 2.

Merchants Fleet, headquartered in Hooksett, New Hampshire, said it expects BrightDrop EV600s to enter its clients’ fleets starting in early 2023.

Late last month, GM also announced it was partnering with Navistar Inc. and hydrogen provider OneH2 to develop a complete zero-emissions long-haul truck system across the United States. Also, last month, GM and its self-driving car subsidiary Cruise said they will partner with Microsoft to bring self-driving cars to market faster.

More:GM partnership will put more electric long-haul trucks on American roads

More:GM, Cruise partner with Microsoft to speed up self-driving EV technology

Contact Jamie L. LaReau: 313-222-2149 or jlareau@freepress.com. Follow her on Twitter @jlareauan. Read more on General Motors and sign up for our autos newsletter. Become a subscriber.

FCA US -- former Chrysler -- earns $2.4B in 2014

Brent Snavely

Detroit Free Press

FCA US said today it earned a profit of $2.4 billion in 2014 as its sales of Ram trucks and Jeep SUVs soared, giving the automaker a 31% increase over its 2013 profit.

FCA US, the company previously known as Chrysler, said its 2014 profit increased even after $1.2 billion in costs related to purchasing shares of stock from the UAW Retiree Medical Benefits Trust and higher recall costs.

FCA US is a subsidiary of the new Fiat Chrysler Automobiles N.V. (FCAU), which reported global earnings last week. FCA US reports earnings separately because it has publicly held debt.

The automaker also reported a modified operating profit of $3.5 billion for the year, up 10% from 2013. While the automaker did not announce a profit sharing amount for its U.S. hourly workers, it should come to about $2,750, based on a formula adopted when a contract was ratified by UAW workers in 2011.

Last year, workers receive profit-sharing of about $2,500 before taxes, based on the company's 2013 earnings. General Motors will announce its earnings Wednesday.

FCA US said its revenue increased 15% to $83.1 billion in 2014.

That revenue increase was driven by an increase in global sales, which rose to sales of 2.9 million cars and trucks, a 12% increase for the year.

The automaker said profit sharing for its U.S. hourly workers increased because sales of cars and trucks increased in North America. However, the profit sharing results also were hurt by higher than normal warranty and recall costs.

In 2011, UAW workers agreed to forgo annual pay increases in return for a simplified profit sharing formula in a four-year contract.

Last week, Ford said it would issue average profit-sharing checks of $6,900, down from a record $8,800 the prior year.

The profit sharing formula for Chrysler workers is based on the company's pretax profit in North America.

About 85% of Chrysler's profits come from North America, according to a summary of Chrysler's 2011 labor contract with the UAW.

Auto sales to remain strong in 2018, after topping 17M in 2017

Greg Gardner

Detroit Free Press

First, the good news.

Americans bought more than 17 million new cars and trucks for the third straight year in 2017. More of them were high-profit pickups that are selling for higher prices than ever before. Consumer sentiment also remains high.

Now, the warning signs.

Interest rates are rising, which means lenders may rethink the generous auto loan credit standards that have stimulated sales for the last half-decade.

There also will be a surge of leased vehicles returning to auctions this year, which could drive down the price of 3- and 4-year-old cars, especially sedans and some crossovers. Some shoppers will be tempted to choose nearly new over new.

The Federal Reserve raised short-term rates three times in 2017, most recently in December from 1.25% to 1.5%. The Fed is expected to hike rates two or three times this year.

"Rising interest rates haven’t hit the market yet," said Charles Chesbrough, senior economist for Cox Automotive, "but sooner or later they will."

Tax reform will be a mixed blessing. Some high-income consumers will see a little more money in their paychecks.

"The flip side is we may see stronger economic growth and that could force the Fed to be more aggressive in raising interest rates," Chesbrough said.

Read more:

Ford's December sales tick up slightly, fueled by F-150; FCA, GM and Toyota down

November car sales: Fiat Chrysler down 4%,GM slipped 2.9%, Ford up 6.7%

While those who can afford it are paying record prices for new vehicles — the average selling price surpassed $36,000 in December, a record, according to Kelley Blue Book and Edmunds.com.

But manufacturers are offering about $4,000 per vehicle in incentives to move vehicles.

Even so, most economic forecasters estimate the industry will sell between 16.5 million and 16.8 million new vehicles this year. For anyone who can recall the dark days of 2009 and 2010, that's a banner year.

While crude oil prices rose above $60 a barrel in the last week, there is scant evidence that demand for pickups is likely to wane in the near term. Ford sold nearly 90,000 F-Series pickups in December.

Chevrolet will take the wraps off its redesigned Silverado, and Fiat Chrysler will unveil a new 2019 Ram pickup next week at the Detroit auto show.

Somewhat more concerning is the steady growth of ride-sharing Lyft and Uber and short-term vehicle rental (think ZipCar or General Motors' Maven), meaning that most everyone who needs a vehicle has one or has access to one.

The ratio of vehicles to registered drivers hit a record high of 1.26-to-1 in 2017, according to Jessica Caldwell, executive director of industry analysis at Edmunds.com. That is up from 1.1-to-1 in 2011.

"That probably reflects the growth we’ve seen over the last seven years, and it can't go on forever," Caldwell said.

Then there is the prospect of fleets of autonomous ride-sharing vehicles that General Motors and others say could be deployed in major U.S. cities by 2019. Will mobility as a service encourage a significant number of consumers to reject car ownership ?

"I think that kind of impact is still a ways off," Caldwell said. "But in 2017 we did see daily rental volume drop. Now part of that was automakers trying to reduce their fleet sales, but part of that is because of ride-sharing and car subscription services that luxury brands are offering in select markets."

Contact Greg Gardner: 313-222-8848 or ggardner99@freepress.com. Follow him on Twitter @GregGardner12