FDA Has Determined That Pfizer’s COVID-19 Vaccine Is Safe and Effective
Ever since the coronavirus pandemic began, there has been a race for a vaccine. In what feels like record time, not one but two vaccines have been created that have about the same effectiveness. Pfizer and Moderna have both developed vaccines that are roughly 95% effective, and they are both seeking emergency approval from the FDA.
It seems that we are getting closer to the Pfizer vaccine getting approval in the United States. It is already approved for use in the United Kingdom, and documents are under review at the FDA. The Vaccines and Related Biological Products Advisory Committee, or VRBPAC, is an advisory group to the FDA, and they have a meeting scheduled on Thursday to discuss whether or not the vaccine is safe and should be approved.
In the decision making process, VRBPAC will consider a 53-page document that describes in detail the phase 3 trial of the vaccine.
Dr. Greg Poland is director of the Mayo Clinic’s Vaccine Research Group but he is not involved in Pfizer’s COVID-19 vaccine trial; however, he sees “absolutely no reason why this emergency use authorization would not be granted.”
If the FDA approves the vaccine, here’s what you can expect. There are two doses in order to achieve maximum effectiveness, and the doses would be given 3 weeks apart; however, there is some protection after the first dose, about 50% one week after vaccination. The results of the vaccine are the same among all ages, races and genders as well as among those with conditions like obesity, high blood pressure and diabetes.
The vaccine does come with some common side effects, like fatigue, headaches, fever and muscle pain. There are also some rare side effects that may or may not be related to the vaccine. In four cases, participants in the phase 3 trial suffered from Bell’s palsy, but most recovered after a few days.
If the vaccine is approved, Pfizer will be ready to roll out the vaccine in mass. They expect to have roughly 50 million doses ready before the end of the year (which would most likely go to healthcare workers and people who are high risk). In 2021, the company expects to have about 1.3 billion doses ready.
Do you think the FDA will approve Pfizer’s COVID-19 vaccine? Will you get vaccinated when the vaccine is available to you?