The US could authorize COVID-19 vaccines for younger kids before Thanksgiving, Pfizer's new timeline suggests
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- Kids from 5 to 11 could start getting COVID-19 shots sometime between Halloween and Thanksgiving, Pfizer's new timeline suggests.
- The company submitted data to the FDA for that younger age group on Tuesday.
- But Pfizer likely won't seek FDA authorization until mid-October, The Wall Street Journal reported.
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Until recently, many experts and parents alike had hoped the Food and Drug Administration would authorize Pfizer's COVID-19 vaccine for young kids before Halloween. That timeline may have been a bit too optimistic.
Pfizer submitted data to the FDA on Tuesday showing that a lower dose of its COVID-19 shot was safe and effective among kids ages 5 to 11, based on clinical trial results. But the company will likely wait until mid-October to formally ask the FDA to authorize its vaccine for this younger age group, according to The Wall Street Journal.
That means the FDA probably won't greenlight the shot for young kids until sometime between Halloween and Thanksgiving.
Data for kids between 6 months and 5 years old could arrive as soon as next month, Pfizer said in a press release. During an investor conference earlier this month, Pfizer's Chief Financial Officer, Frank D'Amelio, said the company would likely submit trial data for that youngest age group to the FDA in early November, putting it on track for authorization in late November.
Moderna, meanwhile, expects to have data about its vaccine's efficacy among kids ages 6 to 12 later in the fall or early this winter. Morgan Stanley analysts recently estimated that Moderna's timeline to be around one or two months behind Pfizer.
"I believe both of them - with Pfizer first - will very likely be able to have a situation where we'll be able to vaccinate children," Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN's Jake Tapper earlier this month. "If the FDA judges the data sufficient enough, we could do it by the fall."
Moderna data for kids 6 months and older would then be available in late 2021 or early 2022, the Morgan Stanley analysts analysts said.
Johnson & Johnson is on a slower timeline. The company won't start studying its vaccine among children ages 12 to 17 until later this fall at the earliest. If the shot is shown to be safe and effective among those kids, J&J could then start enrolling 2- to 11-year-olds in its trial, followed by children younger than 2. That means a single-dose shot likely won't be available to kids until sometime in 2022.
Vaccines can reduce severe disease among young kids
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A recent study from the Centers for Disease Control and Prevention found that unvaccinated adults in the US are 11 times more likely to die and 10 times more likely to be hospitalized from COVID-19 than those who are fully vaccinated. In addition to offering kids protection, vaccinating them will probably make it harder for the virus to spread in the general population - particularly now that in-person school has resumed.
"Our fundamental problem is we don't have enough adults immunized right now, and we don't have approval for the kids," Chris Beyrer, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told Insider. "Until that changes, we're going to have ongoing transmission [at] unacceptably high rates."
Right now, just 55% of all Americans are fully vaccinated. If all 48 million children under 12 were to get vaccinated in the US, that figure would rise to around 70%.
Young children may receive a lower dose
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Since the FDA has fully approved Pfizer's vaccine for people 16 and older, pediatricians can legally prescribe the shot for "off-label" use in young kids. But health officials have warned not to do so yet.
Children tend to develop more intense side effects after vaccines than adults, likely because their immune systems rev up quickly. So Pfizer and Moderna are each testing a lower dose of their vaccines among kids to avoid unnecessary side effects.
Pfizer's late-stage trial indicates that the lower dose - 10 micrograms, instead of the 30 given to adults - was safe among nearly 2,300 children ages 5 to 11. The trial also demonstrated that the vaccine produced a strong antibody response among younger kids. These results were comparable to the ones observed among people ages 16 to 25, who received the standard 30 micrograms, Pfizer said.
The trial is administering an even smaller dosage, 3 micrograms, to children ages 6 months to 5 years.
Moderna is similarly comparing its standard dose (100 micrograms) with lower doses for all age groups. Children ages 2 to 12 in the trial are receiving either 50 or 100 micrograms, and kids between 6 months and 2 years are receiving either 25, 50, or 100.
Once vaccines are authorized for kids, parents might be able to talk to their doctors about options outside of the standard two-dose regimen on a case-by-case basis, former FDA commissioner Scott Gottlieb told CBS News.
"There's different ways to approach vaccination," he said. "You could go with one dose for now ... You could space the doses out more. So there's a lot of discretion that pediatricians can exercise."
This story has been updated with new information. It was originally published September 15, 2021.
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