Pfizer To Seek FDA OK For COVID-19 Vaccine ‘Within Days’

Advertisement

BEGIN ARTICLE PREVIEW:

Enlarge this image

Pfizer plans to file within days with the Food and Drug Administration to allow emergency use of its COVID-19 vaccine.

Bebeto Matthews/AP

hide caption

toggle caption

Bebeto Matthews/AP

Pfizer is ready to ask the Food and Drug Administration to authorize emergency use of the company’s COVID-19 vaccine, after an updated analysis of the clinical trial data found the vaccine to be 95% effective. The results from the final efficacy analysis of the vaccine study were released Wednesday. An interim analysis released Nov. 9 had indicated the vaccine was more than 90% effective. In the Phase 3 study involving more than 43,000 volunteers, half received the experimental vaccine and half got a placebo. Participants received two shots, spaced 21 days apart. In a news release describing the trial, Pfizer and its partner BioNTech reported there were 170 cases of COVID-19 among the participants: 162 cases in the people who got the placebo compared with eight seen in volunteers who got the vaccine. Ten cases of severe COVID-19 were seen in the trial: nine of them occurred in the placebo group and one was in the vaccinated group. The companies said the vaccine’s efficacy held up across gender, race, ethnicity and various ages. In people …

END ARTICLE PREVIEW

READ MORE FROM SOURCE ARTICLE