Infectious Disease

Review: COVID-19 vaccines will be 1

December 10, 2021

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The FDA approved the booster for teens 16 and 17 years old on Thursday just 2 days before the one-year anniversary of the first emergency COVID-19 vaccine approval in the United States.

The December 11th decision to approve the Pfizer BioNTech vaccine for people 16 years and older marked a historic moment in the pandemic. What followed was a series of approvals and approval of vaccines and subsequent booster doses.

COVID vaccine stock image

The first emergency approval for a COVID-19 vaccine was granted to Pfizer and BioNTech on December 11, 2020. Source: Adobe Stock.

To mark the occasion, we’ve compiled stories from last year about the various FDA clearances, approvals, and notable moments that have been announced since that first EEA.

“There will be a solution”: FDA committee approves Pfizer’s COVID-19 vaccine

One day before the first EEA was issued, an FDA advisory committee voted 17 to 4, with one abstention, to approve the vaccine for people aged 16 and over. The rapid development and approval was touted as a “remarkable success”. Continue reading.

FDA committee recommends approval of second COVID-19 vaccine in the US

A week later, the same advisory committee voted to recommend approval of a second COVID-19 vaccine – manufactured by Moderna – for use in the United States in an emergency. Continue reading.

“Another Big Milestone”: FDA Panel Approves One-Shot Vaccine Against J&J

In February, the panel again voted unanimously to recommend approval of the one-time emergency COVID-19 vaccine manufactured by Johnson & Johnson, giving the country three vaccine options. Continue reading.

Pfizer, BioNTech officially requests FDA to make vaccine available to teenagers

In early April, Pfizer and BioNTech officially requested the FDA to make their COVID-19 vaccine available to adolescents ages 12-15 through an EUA. Continue reading.

CDC, FDA recommend suspending J&J vaccine rollout over six cases of blood clots

In mid-April, federal health officials recommended that the US “pause” the rollout of Johnson & Johnson’s COVID-19 vaccine to allow experts to review six reported cases of a rare but severe type of blood clot in people who had received the vaccine. Continue reading.

As CDC, FDA is lifting the J&J vaccine hiatus, a survey shows “eroded confidence” in the shot

The CDC and FDA lifted the break about two weeks later, but results of a survey conducted in the days leading up to the breakdown showed that the delay may have hurt public awareness of the vaccine. Continue reading.

“Monumental”: The US supports the renouncement of the protection of intellectual property for COVID-19 vaccines

In early May, the von Biden government said it would support efforts to abandon intellectual property protections on COVID-19 vaccines proposed to make the vaccines more available and affordable to developing countries. Continue reading.

Pfizer and BioNTech begin the process to obtain full FDA approval for the COVID-19 vaccine

On May 7, Pfizer and BioNTech began filing for full FDA approval of their vaccine for use in people aged 16 and over. Continue reading.

FDA Approves Pfizer BioNTech Vaccine in Children Ages 12-15

The FDA approved the use of the Pfizer BioNTech vaccine in children ages 12 to 15 on May 10. Read more.

FDA Approves Longer Cooling Time for Pfizer Vaccine, Improving Availability

On May 10, the FDA approved a longer cooling time for the Pfizer BioNTech vaccine, a change that could help make the vaccine more available. Continue reading.

Moderna applies for EUA for COVID-19 vaccine for use in adolescents

Moderna announced in June that it had applied to the FDA for an EUA for adolescents aged 12 to 17 years. Its approval, which remains on hold, would make Moderna’s vaccine the second vaccine available for children in the United States. Read more.

FDA sets deadline until 2022 to decide on full approval of the Pfizer BioNTech vaccine

On July 16, Pfizer and BioNTech announced that the FDA had set a deadline of January 2022 to decide on full approval of their vaccine, although there were indications that it could come much sooner. Continue reading.

FDA approves third dose of COVID-19 vaccine for immunocompromised patients

The first approval of booster doses came on August 13, when the FDA said certain immunocompromised patients could receive a third vaccination. It also said that other fully vaccinated people did not need a booster vaccination. Continue reading.

“A Milestone”: FDA Approves Pfizer-BioNTech COVID-19 Vaccine

On August 23, the FDA approved the Pfizer BioNTech vaccine for people ages 16 and older, making it the first – and still only – fully approved COVID-19 vaccine in the United States. Read more.

FDA committee votes against blanket recommendation for COVID-19 vaccine boosters

The FDA committee voted 16-2 on September 17 not recommending a booster dose of the Pfizer BioNTech vaccine to all Americans 16 years and older. However, the committee unanimously voted to recommend booster doses for those aged 65 and over, as well as those at risk for severe COVID-19. Continue reading.

FDA approves booster vaccinations for older adults and people at high risk

Almost a week later, the FDA approved booster doses of the vaccine for those aged 65 years or older, those at high risk for severe COVID-19, and those at high risk for serious “frequent institutional or occupational exposure to SARS” Complications are exposed to -CoV-2. ”Read more.

FDA Advisory Committee unanimously recommends a booster dose of Moderna

On October 14, the FDA committee unanimously recommended approving a booster dose of the Moderna vaccine for certain people at half the regular dose. Continue reading.

FDA committee recommends second J&J shot after 2 months

The committee then also unanimously recommended a day later that anyone who received the Johnson & Johnson COVID-19 vaccine should receive a second dose at least 2 months after the first vaccination. Continue reading.

FDA Approves Mix-and-Match Booster Doses for COVID-19 Vaccines

On October 20, the FDA approved the so-called “Mix and Match” strategy to refresh COVID-19 vaccines while changing the EUAs to allow booster doses of the Moderna and Johnson & Johnson vaccines. Continue reading.

FDA Approves Pfizer’s Pediatric Emergency COVID-19 Vaccine

On October 29, the FDA approved the emergency use of Pfizer-BioNTech’s pediatric COVID-19 vaccine for children ages 5-11, finding that the vaccine’s benefits outweigh the risks in that age group. Continue reading.

FDA postpones decision on Moderna vaccine for adolescents due to risk of myocarditis

Months after receiving the application, the FDA said it would need more time to review Moderna’s application for an EEA for adolescents to further assess the risk of myocarditis. Continue reading.

FDA Approves Messenger RNA COVID-19 Boosters for All Adults

On November 19, just 8 weeks after the approval of booster doses of the Pfizer BioNTech vaccine for people at high risk of serious illness, the FDA announced that every adult is now eligible for an additional vaccination. Continue reading.

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