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Deputy charge nurse Katie McIntosh administers the first of two Pfizer/BioNTech COVID-19 vaccine jabs to clinical nurse manager Fiona Churchill in Edinburgh, Scotland on Dec. 8. Photo: Andrew Milligan/pool/AFP via Getty Images

The FDA's vaccine advisory committee released a detailed analysis on Tuesday finding that Pfizer's coronavirus vaccine appears to meet the safety and efficacy requirements necessary for an emergency use authorization (EUA).

Why it matters: The FDA's initial review suggests that the agency will issue an EUA after its advisory committee meets on Thursday. The publication of the analysis comes the same day that the U.K. began administering its first doses of the Pfizer vaccine, which regulators cleared for emergency use last week.

Details: The FDA found that there are no specific safety concerns from Pfizer's vaccine by race, age, ethnicity, medical co-morbidities, or a prior COVID infection.

  • The most common negative side effects of vaccination were fatigue, headache, muscle pain, chills, joint pain, and fever.
  • Severe adverse reactions only occurred in 0.0% to 4.6% of Pfizer's study participants, and were more frequent after the second dose than the first dose. Adults under 55 experienced less serious side effects.
  • Pfizer's data suggests that the vaccine could help prevent COVID infections following the first dose, but available data did not allow for a firm conclusion, the FDA said.

Of note: Two people in the vaccine group died over the course of the study — one participant with pre-existing atherosclerosis and another participant that went through cardiac arrest after the second dose and died three days later.

The bottom line: The FDA writes that although Pfizer's data shows the vaccine is highly effective against symptomatic COVID-19 patients, data from more people is needed to determine how effective the vaccine is at saving lives.

  • It is also possible that the vaccine's efficacy against asymptomatic infection is lower than its efficacy against against symptomatic infection, per the FDA.
  • Additional testing is needed to see how effective the vaccine is in preventing the transmission of the virus.

What's next: The FDA's advisory committee will meet on Dec. 10 to discuss Pfizer's request for an emergency use authorization and whether further study on the vaccine is needed.

Go deeper

Jan 29, 2021 - World

EU grants conditional approval of AstraZeneca vaccine

Photo: Sunil Ghosh/Hindustan Times via Getty Images

The European Commission on Friday granted conditional approval of the Oxford-AstraZeneca coronavirus vaccine for people 18 years and older.

Why it matters: This is the third vaccine to receive approval from the commission, coming hours after the Emergency Medicines Agency recommended its authorization.

Jan 29, 2021 - Health

WHO says most pregnant women can now receive coronavirus vaccine

A doctor administering Moderna's coronavirus vaccine at a university hospital in Essen, Germany, on Jan. 18. Photo: Lukas Schulze/Getty Images

The World Health Organization has altered its guidance for pregnant women who wish to receive the coronavirus vaccine, saying now that those at high risk of exposure to the COVID-19 or who have comorbidities that increase their risk of severe disease, may be vaccinated.

Why it matters: The WHO drew backlash for its previous guidance that did not recommend pregnant women be inoculated with vaccines made by Pfizer-BioNTech or Moderna, even though data indicated that pregnancy increased the risk of developing severe illness from the virus.

Jan 29, 2021 - Health

Ex-CDC director Tom Frieden on the next COVID-19 vaccines

Americans fortunate enough to receive COVID vaccines now, outside of clinical trials, are getting shots made by either Pfizer or Moderna. But newly released data from Novavax and Johnson & Johnson suggests that more vaccines could be on the way, with J&J's requiring a single dose.

Axios Re:Cap digs into the news and why it matters with Tom Frieden, former head of the CDC, as COVID-19 variants spread globally.