The FDA Just Authorized Pfizer’s COVID-19 Vaccine for Use in Kids Ages 12-15

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The U.S. Food and Drug Administration (FDA) just authorized the Pfizer/BioNTech COVID-19 vaccine for emergency use in children ages 12 to 15. Today the FDA announced that the two-dose mRNA vaccine, which was initially authorized for people 16 and older in December 2020, can now also be given to kids as young as 12.

Results from the clinical trials show that the Pfizer vaccine, which is about 95% effective at preventing symptomatic infections in adults over 16, is even more effective among adolescents. In one clinical trial, there were 16 cases of COVID-19 among 978 adolescents who received a placebo—and no cases among 1,005 participants who got the vaccine, according to the FDA authorization.

The side effects of the vaccine are similar to those seen in adults and most commonly include pain at the injection site, headache, tiredness, fever, chills, muscle pain, and joint pain, the FDA says. And, as with adults, more participants in this age group reported side effects after the second dose than after the first one.

The vaccine advisory panel at the Centers for Disease Control and Prevention (CDC) is expected to meet soon to look over the trial data and make its recommendations for how the vaccine should be used in this age group, according to the New York Times. (Authorities in Canada, which authorized the vaccine for use in adolescents between age 12 to 15 on May 5, approved the same regimen as is recommended for adults, as the Washington Post reported: two doses spaced two weeks apart.)

This good news comes at an important moment in the country’s vaccination efforts. The vaccine rollout started off at a frustratingly slow pace before picking up the pace in March and April. But that progress now appears to be stalling, as supply exceeds demand and vaccination rates plateau or fall in multiple states, as the New York Times reports.

At this point, 34.8% of the population has been fully vaccinated, according to the Centers for Disease Control and Prevention (CDC), while 46% have received at least one dose. President Joe Biden recently announced a plan to get 70% of adults in the U.S. vaccinated by July 4, as SELF reported, which includes improving vaccine allocation among the states, directing pharmacies to offer walk-in vaccinations, and supporting mobile vaccination sites. And the White House has been getting ready to “mobilize immediately” upon FDA authorization of the vaccine in 12-to-15-year-olds.

While kids are less likely to experience severe illness from a COVID-19 infection, they can certainly still get sick. And getting them vaccinated will be essential to enable a return to relative normalcy in the U.S. High vaccination rates in children and teens will make in-person learning safer for students and their families, as well as teachers and school staff. And getting people under 16 getting vaccinated is crucial for achieving herd immunity, the point at which enough of a population is inoculated against a pathogen that it limits community spread, creating a protective effect for people who are unable or unwilling to get vaccinated. (While research on how effective the COVID-19 vaccines are at curbing transmission of the infection is ongoing, a growing body of evidence suggests vaccinated people are in fact less likely to infect others, according to the CDC.)

Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Disease, previously estimated that 75% to 85% of the population needs to get vaccinated to reach herd immunity against COVID-19 in the U.S. In March, Dr. Fauci told lawmakers that while the exact percentage is unknown, children and adolescents are crucial for getting the overwhelming majority of the population vaccinated. “We ultimately would like to get, and have to get, children into that mix,” Dr. Fauci said. He estimated that high-school students could begin getting vaccinated by fall 2021, with kids 12 and under able to get the shots at the start of 2022.

While this is the first vaccine to be approved for use in kids ages 12 to 15 (and remains the only vaccine available to 16- and 17-year-olds, other vaccine makers are expected to seek similar authorizations in 2021. Moderna and Johnson & Johnson have already conducted or are currently running trials testing the safety and efficacy of their COVID-19 vaccines in various age groups, from infants to teens. Pfizer is also testing its vaccine in babies and children under 12. As the New York Times reports, the company recently said that it plans to ask the FDA for emergency use authorization of their vaccine in kids between the ages of 2 and 11 in September 2021.

 

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