FDA Says Pfizer-BioNTech Vaccine Meets Prescribed Success Criteria

In a detailed analysis, the Food and Drug Administration said that Pfizer and partner BioNTech vaccine “met the prescribed success criteria.” This is a step forward for the vaccine to be approved for distribution. The vaccine is expected to be distributed as early as this weekend.

The detailed analysis highlighted the vaccine’s benefits, stating that the vaccine reduces the risk of contracting the virus. The vaccine has greater side effects than the placebo – headaches, muscle pain, joint pain, injection site reactions, chills, and fever.

Panelist criticized the trial’s demographics, saying that the trial wasn’t offered to a diverse group of people. Over 80% of the almost 38,000 participants were white. 162 people received a placebo, and eight received the vaccine, 146 of them were white. The vaccine was 100% effective in Black people, with seven people in the placebo group and none having the vaccine.

A vaccine researcher at John Hopkins University, Dr. Anna Durbin, said that the vaccine offers some protection 10 days after the first dose.

“You may get protection earlier than we were anticipating,” she said.

Dr. Durbin said she would love to see more Black people participate in the research.

“There’s a lot of distrust in the [Black] community around research in general,” she said.

Six participants for the vaccine died during the trial, two received the vaccine, and four received the placebo. Investigators did not address the deaths.

Pfizer says that the vaccine is 95% effective at protecting against symptomatic COVID-19.

According to The Wall Street Journal, federal officials estimate that U.S. vaccine deliveries will be enough for around 20 million people.