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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 19, 2021 - Health

U.S. surpasses 400,000 coronavirus deaths on Trump's final full day in office

Expand chart
Data: CSSE Johns Hopkins University; Chart: Andrew Witherspoon/Axios

Over 400,000 people have died from the coronavirus in the U.S. as of Tuesday, per Johns Hopkins data.

Why it matters: It only took a little over a month for the U.S. to reach this mass casualty after 300,000 COVID deaths were reported last month. That's over 100,000 fatalities in 36 days.

Dave Lawler, author of World
Jan 19, 2021 - World

Biden will bring U.S. into COVAX vaccine initiative, Blinken says

Data: Gavi, The Vaccine Alliance; Map: Naema Ahmed/Axios

Secretary of State designate Tony Blinken announced in a confirmation hearing on Tuesday that President-elect Biden would bring the U.S. into the COVAX initiative — the global effort from the World Health Organization and other groups to ensure that every country has access to COVID-19 vaccines.

Why it matters: Virtually the entire world has signed onto COVAX, apart from the U.S. and Russia. It's expected to be the only source of vaccines for some of the world's poorest countries, and it needs additional funding to fulfill its goal of vaccinating at least 20% of the population in every country by the end of 2021.

Jan 20, 2021 - Politics & Policy

Scoop: Joe Biden's COVID-19 bubble

Photo illustration: Aïda Amer/Axios. Photo: Joe Raedle/Getty Images

The incoming administration is planning extraordinary steps to protect its most prized commodity, Joe Biden, including requiring daily employee COVID tests and N95 masks at all times, according to new guidance sent to some incoming employees Tuesday.

Why it matters: The president-elect is 78 years old and therefore a high risk for the virus and its worst effects, despite having received the vaccine. While President Trump's team was nonchalant about COVID protocols — leading to several super-spreader episodes — the new rules will apply to all White House aides in "high proximity to principals."