US Regulator – Manila Bulletin

The United States Food and Drug Administration (FDA) issued an information document Tuesday saying that the Pfizer-BioNTech Covid-19 vaccine is safe and effective, raising expectations that the regulator is ready to grant approval of emergency.

An independent committee that will advise the FDA will meet on Thursday on the matter, after Britain became the first country to approve the vaccine last week.

Data from 38,000 trial participants in the US revealed “suggests a favorable safety profile, with no specific safety concerns identified that would preclude the issuance of an EUA (emergency use authorization),” the FDA document said.

He added that the vaccine’s efficacy in preventing Covid-19 was 95 percent, it worked consistently across all age groups, genders and racial groups, as well as people with underlying conditions who are at high risk.

The FDA said more research is needed to confirm the evidence that the vaccine prevents even the worst cases of Covid-19, offers protection after the first of two doses, and works for previously infected people.

Companies have previously published some of their data in press releases, but the FDA has access to many more details.

In a larger group of 43,000 volunteers that included additional adults and teens who enrolled later, the most common side effects were injection site reactions (84 percent), fatigue (63 percent), headache ( 55 percent), muscle pain (38 percent), chills (31 percent), joint pain (23.6 percent), fever (14 percent).

Reactions classified as “severe” were more common after the second dose and less frequent in participants 55 years of age and older.

There were some adverse events classified as ‘serious’, the highest grade, but there was no significant imbalance in the frequency with which they occurred in the vaccine and placebo arms.

There were four cases of Bell’s palsy, a non-severe form of facial paralysis that usually resolves, in the vaccine group and none in the placebo group, but the paper said this was in line with the frequency seen in the population. general.

The advisory group will also consider what additional studies manufacturers will need to conduct after issuance of an EUA.

In particular, the FDA is not in favor of immediately offering the vaccine to people in the placebo group, which is currently an area of ​​heated discussion among the scientific community.