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Photo: Michael M. Santiago/Getty Images

Pfizer and BioNTech said their COVID-19 vaccine was more than 90% effective at protecting children between the ages of 5 and 11 from symptomatic infections from the virus, according to a study posted online by the FDA Friday.

Why it matters: Pfizer is seeking an emergency use authorization to vaccinate children — one of the last groups of Americans still largely ineligible to receive a coronavirus vaccine.

How it works: Pfizer's study examined 2,268 people from that age group who received a placebo or two shots of a low-dose version of its coronavirus vaccine.

  • It then compared the number of cases among those who received the vaccine and the group that got the dummy shot, discovering that the vaccine was nearly 91% more effective than the placebo.

The big picture: The Biden administration released a plan on Wednesday to "quickly" vaccinate children between the ages of 5 and 11 after the FDA and CDC authorize a vaccine for that age group.

  • Since the start of the pandemic, there have been at least 1.8 million confirmed and reported COVID-19 cases among kids between the ages of 5 and 11 and at least 143 deaths and 8,622 hospitalizations, according to the FDA, citing data from the CDC.

What's next: The FDA is expected to release an independent review of Pfizer's trial data later Friday, according to AP.

  • If the FDA approves Pfizer's EUA application, it will still need authorization from the CDC, meaning large-scale vaccinations for children could begin next month.

Go deeper: Pfizer booster has 95.6% efficacy against COVID, large study shows

Go deeper

Updated 5 hours ago - Politics & Policy

Omicron dashboard

Illustration: Shoshana Gordon/Axios

  1. Health: It's very difficult to get access to antiviral COVID treatments — Axios-Ipsos poll: Omicron's big numbersAnother wave of death — FDA limits use of Regeneron and Lilly antibody treatments.
  2. Vaccines: Pfizer begins clinical trial for Omicron-specific vaccine — The shifting definition of fully vaccinated.
  3. Politics: New York Supreme Court grants stay for indoor mask mandate — Neil Young demands Spotify take down music over vaccine misinformation — Biden admin withdraws temporary vaccine-or-test mandate for large employers.
  4. World: U.K. to lift travel testing requirement for fully vaccinated — Beijing Olympic Committee lowers testing threshold ahead of Games.
  5. Variant tracker
Jan 14, 2022 - Health

America's vaccination drive runs out of gas

Illustration: Annelise Capossela/Axios

The U.S. is likely reaching the end of the road on new vaccinations, after the U.S. Supreme Court blocked the Biden administration's vaccine mandate for large employers.

Why it matters: Cash prizes and other incentives barely moved the needle on vaccinations. So the government turned from carrots to sticks — but now it has lost its biggest stick.

Jan 13, 2022 - Health

Democratic Reps call on FDA to revise blood donation policy for gay men

Photo: Justin Sullivan/Getty Images

LGBTQ advocates and Congress members are calling on the Food and Drug Administration to revise its blood donor policy on sexually active gay and bisexual men as the country faces a blood shortage.

Why it matters: The FDA requires gay and bisexual men abstain from same-sex sexual activity for 90 days in order to donate blood.