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FDA review of Pfizer vaccine clears way for emergency authorization

08 December 2020
Dan Ackermann

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.

Transcripts show George Floyd told police "I can't breathe" over 20 times

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Newly released transcripts of bodycam footage from the Minneapolis Police Department show that George Floyd told officers he could not breathe more than 20 times in the moments leading up to his death.

Why it matters: Floyd's killing sparked a national wave of Black Lives Matter protests and an ongoing reckoning over systemic racism in the United States. The transcripts "offer one the most thorough and dramatic accounts" before Floyd's death, The New York Times writes.

The state of play: The transcripts were released as former officer Thomas Lane seeks to have the charges that he aided in Floyd's death thrown out in court, per the Times. He is one of four officers who have been charged.

  • The filings also include a 60-page transcript of an interview with Lane. He said he "felt maybe that something was going on" when asked if he believed that Floyd was having a medical emergency at the time.

What the transcripts say:

  • Floyd told the officers he was claustrophobic as they tried to get him into the squad car.
  • The transcripts also show Floyd saying, "Momma, I love you. Tell my kids I love them. I'm dead."
  • Former officer Derek Chauvin, who had his knee on Floyd's neck for over eight minutes, told Floyd, "Then stop talking, stop yelling, it takes a heck of a lot of oxygen to talk."

Read the transcripts via DocumentCloud.