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A Covid-19 vaccine for children ages 5 to 11 could be authorized by early November.

A Food and Drug Administration review this week determined that Pfizer-BioNTech’s Covid-19 vaccine is safe and effective for children ages 5 to 11, paving the way for a shot to be authorized for that age group as soon as early November.

Pfizer also announced on Friday that the vaccine is more than 90 percent effective at protecting school-age children from serious illness or hospitalization from Covid-19, similar to the level of protection it provides in adults.

The FDA analysis looked at data from Pfizer clinical trials in four different scenarios and concluded that any risks — in particular, a vaccine-related pediatric myocarditis that typically lasts a few days — were negligible in comparison to the benefits for the age group.

Previous data from Pfizer showed that young children were able to tolerate the vaccine well and produced a strong immune response, and the results of Friday’s FDA review are further confirmation of its effectiveness.

The 2,268 children ages 5 through 11 in Pfizer’s clinical trials received doses a third the size of an adult vaccine dose, spaced 21 days apart.

Now that the initial review is complete, there are just a few steps left before Pfizer’s coronavirus vaccine can be authorized for the approximately 28 million American children ages 5 through 11.

Next week, the FDA’s panel of independent experts will examine the research and make specific recommendations to the FDA about administering the Pfizer vaccine to this age group.

Much as with recommendations about booster shots, the advisory committee is able to offer specific, granular guidance about the vaccine’s safety and necessity. For example, in September of this year, after the Biden administration had planned a widespread rollout of vaccine boosters, the FDA panel recommended that only certain populations receive an additional shot.

However, as Vox’s Dylan Scott points out, “the groups already okayed by the FDA and Centers for Disease Control and Prevention for booster shots are quite broad and cover much of the adult population.”

The FDA panel will meet Tuesday and offer FDA leadership its assessment. The FDA typically follows the advice of its expert panel, but its guidance isn’t binding.

If the advisory committee’s advice conforms with the agency’s initial review of the data, the FDA will likely authorize the vaccine soon after.

After that, Pfizer then must present its data to the CDC’s Advisory Committee on Immunization Practices or ACIP. It’s a similar body to the FDA’s advisory committee — a rotating, independent panel of scientists and other experts who can make specific recommendations to the CDC about administering the vaccine. That panel is scheduled to meet November 2 and 3 to discuss pediatric vaccines, according to CNN.

Then, ultimately, it’s up to CDC director Dr. Rochelle Walensky to guide the CDC’s decision on pediatric Covid-19 vaccines. As with the FDA’s advisory body, ACIP’s recommendations aren’t binding, but the CDC typically follows them.

Both bodies have to authorize the vaccine; the FDA is first and foremost concerned with the safety of anything submitted for emergency use authorization or full regulatory approval. That means asking not only whether the drug itself is safe, but also inspecting manufacturing facilities and practices while the drug in question is licensed. Meanwhile, the CDC’s concerns are geared more toward how the drug should be administered and to whom, in addition to its safety and efficacy.

As the White House waits for authorization, President Joe Biden announced a plan earlier this week to distribute pediatric vaccines in 25,000 pediatrician’s and primary care offices, as well as in children’s hospitals and school- and community-based clinics. The administration has already purchased enough doses to inoculate all children in this age group; the shots come in reconfigured packaging, with smaller needles for smaller arms.

“Kids have different needs than adults and our operational planning is geared to meet those specific needs, including by offering vaccinations in settings that parents and kids are familiar with and trust,” Jeff Zients, the White House’s Covid-19 response coordinator, told reporters on Wednesday.

The plan aims to avoid the bumpy, chaotic rollout adults faced earlier this year, as well as to build trust with families who may be hesitant to vaccinate their children by relying heavily on trusted sites like pediatricians offices, and messaging through schools.

Children aren’t as vulnerable to Covid-19 as adults, but they’re still testing positive

The likely authorization of Pfizer’s Covid-19 vaccine for children ages 5 through 11 stands to make schools a much safer place as Covid-19 continues to spread in the US.

Though children don’t often experience symptoms from Covid-19, as Vox’s German Lopez explained earlier this month, the combination of the delta variant and a return to classrooms last month resulted in a sharp rise in pediatric Covid-19 cases relative to earlier in the pandemic.

According to the the American Academy of Pediatrics, almost 6.2 million children have tested positive for Covid-19 since the pandemic began. In just the six weeks prior to October 14, 1.1 million children tested positive.

About 280 children under the age of 18 died of Covid-19 between January and September this year, according to Lopez.

“In this latest wave of Covid-19, particularly down south, there have been thousands of children hospitalized. And, frankly, it’s an embarrassment in a developed country to have even 100 children, like we’ve had, die of infectious disease that’s preventable,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a town hall earlier this month.

Since US school districts have implemented a patchwork quilt of vaccine and mask recommendations — with some states like Texas and Florida ignoring scientific evidence on the efficacy of masking and banning mask and vaccine mandates in school systems — both students and teachers are vulnerable to the illness.

And despite the eagerness of many children, teachers, and parents to get students back in the classroom, high infection rates across the US mean there have been some stops and starts, from quarantining exposed students to shutting down whole campuses after an outbreak. Vaccinating school children would help reduce the virus’s spread — not to mention reduce the number of disruptions to the school year.

Despite the upsides, however, some parents say they are still wary of vaccinating their children, or will opt not to do so. According to a September study by the Kaiser Family Foundation, only about a third of parents surveyed — 34 percent — said they would vaccinate their 5- to 11-year-olds as soon as that age group becomes eligible. Thirty-two percent said they would “wait and see” how well the vaccine works before having their child get the shot, and 24 percent said they wouldn’t have their children vaccinated at all.

More vaccines for more children are likely coming soon

The authorization of a Covid-19 vaccine for children ages 5 through 11 would mean that nearly everyone in the US is eligible for a vaccine, and drug companies are already making headway on shots for even younger children.

Pfizer, which along with BioNTech manufactures the only vaccine authorized for use in children under 18, is also performing clinical trials on children ages 2 to 5, and separate trials for children as young as six months.

Data from those trials is expected before the end of the year, according to Pfizer.

Moderna, which manufactures the other mRNA vaccine authorized for US adults, is also recruiting for its pediatric clinical trials on children ages 6 months to 11 years. The company submitted its clinical trial data on the vaccine’s effectiveness in teenagers ages 12 to 18 in June, but the FDA has pressed pause on authorizing it due to a possible elevated risk of myocarditis in young men. Health authorities in Sweden and Denmark have stopped administering Moderna vaccines to people under 18 in those countries due to this possible elevated risk.

With more authorizations on the horizon, many parents will likely be relieved to add Covid-19 shots to their kids’ vaccination schedules: As Friday’s FDA review confirmed, the vaccine is safe and effective for young children, and the Biden administration plans to make it widely available as soon as it’s authorized. And if Covid-19 is something we’ll have to live with as a society, as experts increasingly believe, then getting one step closer making the Covid-19 vaccine routine for young kids is very good news indeed.

href=“https://acl.gov/sites/default/files/Aging%20and%20Disability%20in%20America/2020ProfileOlderAmericans.Final_.pdf”>54 million people. People with certain medical conditions such as heart disease (as much as 48 percent of adults) and people who are obese (about 42 percent) are also eligible for a booster. So are people in occupations deemed to be higher risk, such as first responders, manufacturing workers, teachers, and grocery store employees.

The bottom line for now: If you were vaccinated at least six months ago with the Pfizer/BioNTech or Moderna shot and you’re at higher risk for Covid-19 based on your age, job, or medical history, it’s recommended that you receive a booster. So should anyone vaccinated at least two months ago with the one-dose Johnson & Johnson vaccine, according to the FDA.

Who is recommended for a booster shot?

The FDA has approved booster shots of the Pfizer/BioNTech, Moderna, and J&J vaccines, and the CDC has finalized matching recommendations for who should receive a booster.

Under the FDA’s authorization, the following people are eligible for an additional Covid-19 vaccine dose:

The lists of medical conditions and occupations that qualify for a booster shot extend eligibility to a lot of Americans. Those medical conditions include not only heart disease, diabetes, and cancer but also depression and pregnancy. High-risk jobs include the people in the food and agriculture industry, nursing home workers, and US Postal Service employees. Check the list — more people are eligible than you may think.

Age is the strongest indicator for a booster shot, according to the experts I’ve spoken to. Even those who think the case for booster shots for younger and healthier people is not as strong agree that people over 65 would likely benefit from an additional dose. Most experts also support boosters for immunocompromised people, though the vaccines are still not as effective for those people to begin with.

There is less consensus among experts about workers in jobs considered to be high risk, if they don’t already qualify because of age or health. Experts stress that research continues to show strong protection against severe illness for younger people without any significant medical conditions. But senior government health officials have insisted on including those workers in the groups eligible for a booster shot.

 
Alejandra Villa Loarca/Newsday RM via Getty Images
Sandra Lindsay gets a Pfizer booster shot at Northwell Health in New Hyde Park, New York, on October 6. Lindsay, an intensive care unit nurse at Long Island Jewish Medical Center, became the first American to receive the Covid-19 vaccine in December 2020.

For the eligible people whose first doses were either the Moderna or Pfizer/BioNTech vaccine, they can receive their next dose at least six months after their initial vaccine course was completed, the FDA said. For people whose first dose was the J&J vaccine, they can get a booster shot two months after their first shot.

The federal guidance matches what many experts have said is appropriate based on the current scientific evidence. There have been indications of the Covid-19 vaccines waning in effectiveness over time and against the delta variant. But the protection they provide against severe disease — resulting in hospitalization or death — remains strong for many people.

The exceptions are older people, who have seen a greater drop in efficacy over time, and people with compromised immune systems, for whom the vaccines are often not as effective to start with. They are the focus of the booster guidelines, along with workers in higher-risk settings.

What about mixing and matching different shots?

All of the Covid-19 vaccines offer good protection against severe illness, but they are not equal.

The Moderna vaccine has held up the best over time, including since the delta variant became dominant. Pfizer/BioNTech performs the next best, while Johnson & Johnson was the weakest of the three in its original one-dose regimen (though it has not seen much waning over time).

Those differences have led some people — J&J recipients, in particular — to wonder whether they should get a dose of one of the better-performing vaccines for their booster shot.

As the Atlantic reported last week, research from the National Institutes of Health (NIH) has found the people who received a first dose of J&J and a second dose of Moderna or Pfizer/BioNTech showed higher antibody levels than the people who got J&J for both doses. Antibody levels are not the only metric by which immunity is measured, but they are a useful proxy.

The evidence is not as clear about whether it’s better to get a Moderna booster if you previously received the Pfizer/BioNTech vaccine (or vice versa) because the NIH study used a full dose of the Moderna vaccine for its booster, whereas, in the real world, the Moderna booster will be a half dose.

The new FDA guidance does say that people should be okay mixing and matching different vaccines. Generally speaking, they can get whichever booster shot they like if they fall in one of the subgroups recommended for an additional dose and sufficient time has passed: again, two months for J&J recipients or six months for Pfizer/BioNTech or Moderna recipients.

Different vaccines also have different side effects, another consideration for booster shots. Younger men who receive the Pfizer/BioNTech or Moderna mRNA vaccines have been found to be at a slightly higher risk of heart inflammation. Younger women who receive the J&J vaccine may be at a somewhat elevated risk of a rare blood-clotting problem.

Both of those side effects, though serious, have been rare, and the FDA said the expected benefits of a booster shot for each of the vaccines outweigh the risks.

 Francine Orr/Los Angeles Times via Getty Images
Wanda Shaffer, 83, got her Pfizer booster shot at a California McDonald’s in September, as the California Department of Public Health and local McDonald’s franchisees held pop-up vaccine clinics at locations throughout Southern California.

Should I get a booster shot?

First off: The vaccines work. Recent waves of Covid-19 hospitalizations and deaths have been concentrated in the remaining unvaccinated population. People who receive a vaccine are less likely to contract Covid-19 in the first place, much less likely to develop severe symptoms, less likely to transmit the virus to other people, and less likely to develop long Covid.

But the vaccines aren’t perfect. There are going to be breakthrough cases. For some people, they don’t work as well. The recent death of former Secretary of State Colin Powell — who was fully vaccinated but immunocompromised because of blood cancer — served as a reminder that some people remain at risk so long as the virus is still circulating.

The current federal guidance is concentrated on those people, to provide them more protection ahead of the winter. In the best-case scenario over the next few months, at-risk people get this additional immunity, more people get their first vaccine dose, and the virus slows down without new variants emerging. We should see fewer deaths than we did during last winter’s devastating wave.

Still, Covid-19 isn’t going to disappear entirely, and experts expect booster shots may eventually be authorized for most people. A lot of Americans had already gone ahead and gotten an extra dose before the FDA officially approved it.

Wafaa El-Sadr, a professor of epidemiology and medicine at Columbia University, told me she thought people who are already eligible should get their booster “as soon as possible.”

Other people might consider it, she said, if they were expecting to congregate with a lot of others during the holiday season or if they have to spend a lot of time around unvaccinated people or individuals whose vaccination status they don’t know.

Covid-19 is here to stay, and booster shots are a reflection of that reality. They are one way to make it more palatable to live with this disease.

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