Kids in Line for U.S. Covid Vaccine as Soon as Week of Nov. 1

(Bloomberg) -- Kids ages 5 to 11 could get a Covid-19 vaccine as soon as the first week in November in the U.S., a relief for parents as children are increasingly contracting the virus and a potential political boon for President Joe Biden.

Pfizer Inc. and BioNTech SE said Thursday they’d finished submitting data to the Food and Drug Administration ahead of an advisory panel meeting set for Oct. 26. A Centers for Disease Control and Prevention meeting will be set for the week of Nov. 1, a person familiar with plans said, with clearance possibly coming as soon as the day of that meeting. 

Delays are possible but, taken together, that leaves the U.S. on the cusp of vaccinating kids -- a convergence of both Biden’s political needs and public-health goals. Reaching children younger than age 12 would be a crucial step toward ending the pandemic, insulating them from the worst risks of Covid and further shrinking the pool of Americans vulnerable to spreading the virus. 

Public approval of Biden’s handling of the pandemic, and other issues including Afghanistan and his economic agenda, has been falling. Many parents, including the suburban voters Democrats need to keep control of Congress in the 2022 midterm elections, are eagerly anticipating a vaccine for children. It could also help working parents return to their offices and boost the travel sector with more families finally able to be fully inoculated.

There will likely be vaccination holdouts as many adults express reluctance about inoculating their kids. Still, eligibility for ages 5 to 11 would advance the president’s vaccination effort and offer kids their first protection against the more potent delta variant.

“We no longer see children as having a protective force field around them. They are now as susceptible to this particular variant as adults are,” said Clay Marsh, a physician and vice president of West Virginia University who steers the state’s Covid response. 

Vaccinations would make schools safer and protect kids against both severe cases and mild ones that sometimes come with long-term symptoms. 

A crucial topic of conversation at the FDA advisory meeting is likely to be the potential risk of myocarditis, or heart inflammation, in young kids who get the vaccine. Researchers are carefully monitoring rare cases of myocarditis that have occurred after messenger RNA shots, such as Pfizer’s. So far, while still very uncommon, the adverse event appears to happen more often in younger men and teenage boys. 

“That final decision will depend on the very careful examination of that data,” Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told Bloomberg Television’s David Westin on Wednesday. 

Biden’s team sees approving vaccines for young children -- along with booster shots, which already have been authorized for some adults -- as significant steps toward returning the U.S. to pre-Covid life, officials familiar with their thinking said. 

To prepare for approval of kids’ shots, the CDC has been holding calls with states and localities to ensure doses will be quickly available, one official said. The CDC is also reaching out to 40,000 doctors enrolled in the Vaccines for Children program that provides other inoculations, and is in touch with pharmacies to prepare them, the official said. 

The FDA has been under fire for an opaque process on considering younger kids’ vaccines, including from Democrats.

“Parents shouldn’t have been left in the dark as we follow this process,” Representative Katie Porter, a Democrat from California, said in a statement. Porter and Representative Ro Khanna, another California Democrat, had pressured the FDA to offer more information. Peter Marks, a top FDA official, briefed them recently and said they expect to approve vaccines for 5 to 11 this fall, and for kids 2 to 5 in “the early part” of 2022, Khanna said in a statement. 

Public support for Biden’s handling of Covid has been declining, as has his approval rating. A Quinnipiac University poll released this week said 48% of Americans approve of Biden’s management of Covid while 50% disapprove. Overall, 38% approve of Biden’s performance while 53% disapprove. 

“Some might argue President expressed too much optimism, too soon, about the receding threat,” Quinnipiac’s Tim Malloy said. Covid’s resurgence, along with Biden’s messy Afghanistan withdrawal, “may well have been a double whammy that triggered the sagging numbers.”

So far, there are no obvious safety concerns for kids getting shots, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “We have every reason to believe that how the kids will respond will be very similar to what we see in adults in terms of safety signals,” he said.

Pfizer’s doses for 5- to 11-year-olds are planned for 10 micrograms, one-third the level being given to those 12 and up, but given at the same three-week interval.

It’s not clear how many kids will get shots. Many parents have been waiting for them since the FDA cleared shots for adults in December. But others have themselves refused to get vaccinated.

About 34% of parents of kids ages 5 to 11 plan to get them a shot right away, while another 32% say they’ll wait and see, according to KFF. Another 7% say they’ll only vaccinate their kids if required, while 24% say they definitely will not. 

“Imagine the parents who were in that wait-and-see group for themselves when it comes to a vaccine, they’re likely to be even more cautious when it comes to their children,” said Lunna Lopes, a survey analyst with KFF. 

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