UPDATED 12/10, 6:10 p.m. ET: Pfizer's COVID-19 vaccine, which was previously determined to be 95 percent effective, was endorsed for authorization by the F.D.A.’s vaccine advisory panel on Thursday, the Associated Press reports. The panel voted 17 to 4 to recommend the vaccine be given official approval for emergency authorization. One member on the panel abstained from voting.
The F.D.A. usually approves endorsements that come from the advisory panel. The New York Timesreports sources as saying that the F.D.A. is expected to vote and pass emergency authorization for the vaccine this Saturday.
In other news, hackers stole information from Pfizer and BioNTech about their COVID-19 vaccines from the European Medicines Agency. According to the New York Post, the two companies don't think that clinical study participants' information was stolen.
"It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed," a statement said. "At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyber attack will have no impact on the timeline for its review."
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After analyzing the first COVID-19vaccine from Pfizer and German partner BioNTech, the FDA has deemed that it has “met the prescribed success criteria” in a clinical study.
The Wall Street Journal reports that this indicates the vaccine will be green-lit soon, as the treatment is also consistent with the agency’s emergency use authorization recommendations.
The FDA’s study of the vaccine emphasized its “known benefits,” such as, “reduction in the risk of confirmed COVID-19 occurring at least seven days after Dose 2.” The Pfizer vaccine requires two doses about three weeks apart for full efficacy.
The agency also said the company’s vaccine helped decrease the risk of becoming infected between the two doses, writing that another benefit was “reduction in the risk of confirmed severe COVID-19 any time after Dose 1.” This was an important observation since those critical of the vaccine trials were worried that the vaccine would only prevent mild to moderate cases of the virus.
“As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency wrote on its website.
It's anticipated that the FDA will determine whether to approve Pfizer’s vaccine in mere days. The FDA is set to meet with its Vaccines and Related Biological Products Advisory Committee, a group of outside medical experts, on Thursday to reevaluate Pfizer’s vaccine for emergency use. If the meeting goes well and the advisory committee endorses the vaccine, then the FDA could announce authorization very soon.
Pfizer presented its COVID vaccine data to the FDA on Nov. 20 for review. In its analysis, the company said that it found its treatment to be 95 percent accurate in preventing the virus. The vaccine will be distributed within 24 hours of authorization, with the first doses given to health care workers and nursing homes.
In fact, the first person in the world to receive a clinically approved vaccine was a 90-year-old British woman. Britain has already approved Pfizer’s treatment.
“It means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year,” the woman, Margaret Keenan told NBC News. “My advice to anyone offered the vaccine is to take it. If I can do it, so can you.”
