Looking back: COVID-19 vaccines turn 1
The FDA’s authorization on Thursday of booster shots for adolescents aged 16 and 17 years came just 2 days before the 1-year anniversary of the first emergency use authorization of a COVID-19 vaccine in the United States.
The decision last Dec. 11 to authorize the Pfizer-BioNTech vaccine for people aged 16 years or older marked a historic moment in the pandemic. What followed was a slew of authorizations and one approval of vaccines and subsequent booster doses.
To mark the occasion, we compiled stories from the past year on the various FDA approvals, authorizations and notable moments that have been announced since that first EUA.
‘There will be a solution’: FDA committee OKs Pfizer’s COVID-19 vaccine
A day before that first EUA was issued, an FDA advisory committee voted 17-4 with one abstention in favor of authorizing the vaccine for people aged 16 years and older. The fast development and authorization was touted as “a remarkable success.” Read more.
FDA committee recommends authorizing use of second COVID-19 vaccine in US
A week later, the same advisory committee voted to recommend authorizing a second COVID-19 vaccine — made by Moderna — for emergency use in the United States. Read more.
‘Another huge milestone’: FDA panel endorses one-shot J&J vaccine
In February, the panel voted unanimously again to recommend authorizing the single-shot COVID-19 vaccine made by Johnson & Johnson for emergency use, giving the country three vaccine options. Read more.
Pfizer, BioNTech formally ask FDA to make vaccine available to adolescents
In early April, Pfizer and BioNTech formally asked the FDA to make their COVID-19 vaccine available to adolescents aged 12 to 15 years through an EUA. Read more.
CDC, FDA recommend pausing rollout of J&J vaccine over six blood clot cases
In mid-April, federal health officials recommended that the U.S. “pause” the rollout of Johnson & Johnson’s COVID-19 vaccine so experts could review six reported cases of a rare but severe type of blood clot in people who had received the vaccine. Read more.
As CDC, FDA lift pause of J&J vaccine, poll indicates ‘eroded confidence’ in shot
The CDC and FDA lifted the pause around 2 weeks later, but the results of a poll taken in the days before the pause was lifted indicated that the delay may have damaged the public’s perception of the vaccine. Read more.
‘Monumental’: US backs waiving intellectual property protections for COVID-19 vaccines
In early May, the Biden administration said it would back an effort to waive intellectual property protections for COVID-19 vaccines that was proposed as a way to make the vaccines more available and affordable for developing countries. Read more.
Pfizer, BioNTech begin process of seeking full FDA approval for COVID-19 vaccine
On May 7, Pfizer and BioNTech started the process of seeking full FDA approval for their vaccine for use in people aged 16 years or older. Read more.
FDA authorizes Pfizer-BioNTech vaccine in children aged 12 to 15 years
The FDA authorized the use of the Pfizer-BioNTech vaccine in children aged 12 to 15 years on May 10. Read more.
FDA authorizes longer refrigeration time for Pfizer vaccine, improving availability
On May 10, the FDA authorized a longer refrigeration time for the Pfizer-BioNTech vaccine, a change it said could help make the vaccine more available. Read more.
Moderna seeks EUA for COVID-19 vaccine for use in adolescents
Moderna announced in June that it had requested an EUA from the FDA for adolescents aged 12 to 17 years. The authorization, which remains on hold, would make Moderna’s vaccine the second available for children in the U.S. Read more.
FDA sets 2022 deadline to decide on full approval of Pfizer-BioNTech vaccine
On July 16, Pfizer and BioNTech announced that the FDA set a deadline of January 2022 to decide on the full approval of their vaccine, although there were indications it could happen much sooner than that. Read more.
FDA allows third dose of COVID-19 vaccine for immunocompromised patients
The first authorization of booster doses came Aug. 13, when the FDA said certain immunocompromised patients could receive a third shot. It continued to say that other fully vaccinated people did not need a booster. Read more.
‘A milestone’: FDA approves Pfizer-BioNTech COVID-19 vaccine
On Aug. 23, the FDA approved the Pfizer-BioNTech vaccine for people aged 16 years or older, making it the first — and still only — fully approved COVID-19 vaccine in the U.S. Read more.
FDA committee votes against blanket recommendation for COVID-19 vaccine boosters
The FDA committee voted 16-2 on Sept. 17 not to recommend a booster dose the Pfizer-BioNTech vaccine to all Americans aged 16 years and older. However, the committee unanimously voted to recommend booster doses for people aged 65 years and older, as well for as those at risk for severe COVID-19. Read more.
FDA authorizes booster shots for older adults and people at high risk
Nearly a week later, the FDA authorized booster doses of the vaccine for people aged 65 years or older, people at high risk from severe COVID-19 and people who face a high risk for serious complications based on “frequent institutional or occupational exposure to SARS-CoV-2.” Read more.
FDA advisory committee unanimously recommends Moderna booster shot
On Oct. 14, the FDA committee unanimously recommended the authorization of a booster dose of Moderna’s vaccine for certain people, to be given at half the regular dose. Read more.
FDA committee recommends second J&J shot at 2 months
The committee then also unanimously recommended a day later that anyone who received the Johnson & Johnson COVID-19 vaccine should be able to receive a second dose at least 2 months after receiving their initial shot. Read more.
FDA authorizes ‘mix and match’ booster doses for COVID-19 vaccines
On Oct. 20, the FDA authorized the so-called “mix and match” strategy for boosting COVID-19 vaccines at the same time it amended EUAs to allow booster doses of the Moderna and Johnson & Johnson vaccines. Read more.
FDA authorizes Pfizer’s pediatric COVID-19 vaccine for emergency use
On Oct. 29, the FDA authorized the emergency use of the Pfizer-BioNTech pediatric COVID-19 vaccine for children aged 5 to 11 years, noting that the benefits of the vaccine outweigh the risks in this age group. Read more.
FDA delays decision on Moderna vaccine for adolescents over myocarditis risk
Months after receiving the application, the FDA said it would need even more time to review Moderna’s request for an EUA for in adolescents in order to further review the risk for myocarditis. Read more.
FDA authorizes messenger RNA COVID-19 boosters for all adults
On Nov. 19, just 8 weeks after it authorized booster doses of the Pfizer-BioNTech vaccine for people at high risk for severe disease, the FDA announced that any adult was now eligible for an extra shot. Read more.