On August 23, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine.
What does that mean?
The FDA approves that the vaccine can be marketed as “Comirnaty”. In other words, the FDA acknowledges that the Pfizer vaccine helps the prevention of the COVID-19 disease in anyone over the age of 16. This also means that it prevents the serious outcomes caused by COVID-19, including hospitalization and death.
Additionally, this vaccine is approved under emergency use authorization (EUA) for 12-15-year olds, and a 3rd dose is recommended for immunocompromised individuals. EUAs are used during public health emergencies to prevent, diagnose, or treat a disease.
What is the approval process for the FDA?
Acting FDA Commissioner, Janet Woodcock, said the vaccine “met the FDA’s rigorous, scientific standards for emergency use authorization” . But what does this process look like?
The FDA studied the effects of the vaccine in over 40,000 people. Half of the study participants received the Pfizer vaccine and the other half received a placebo as part of the control group. All study participants were 16 years or older and were confirmed not to have contracted COVID-19 within a week of receiving the 2nd dose of the vaccine. The FDA’s analysis concluded that this vaccine proved to be 91% effective in preventing COVID-19.
How does the vaccine affect the body?
The vaccine is so effective due to its utilization of messenger RNA (mRNA) which essentially mimics one of the proteins found in the COVID-19 virus. While mRNA is a genetic protein, it does not have the ability to alter an individual’s genetics.
The vaccine does cause the immune system to act defensively for a short period of time. The most common side effects are short-term and include: “pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.”
Will there be more studies?
The FDA and the Center for Disease Control and Prevention (CDC) are monitoring the situation to make sure safety concerns are identified and handled.
The FDA is also requiring Pfizer to conduct post marketing studies to assess risks following the vaccine. These will look at the long-term outcomes of people who develop myocarditis and pericarditis after receiving the vaccine. The CDC reports that these outcomes are rare, and “most patients who received care responded well to treatment and rest and quickly felt better.”
Pfizer has also said it will conduct other studies not required by the FDA. They will evaluate pregnancy and infant outcomes from women who were pregnant and received the vaccine.
What is recommended?
The CDC continues to recommend that everyone over the age of 12 receives a COVID-19 vaccination, whether Pfizer, Moderna, or Johnson and Johnson. Moderna applied for full FDA approval in June, a month after Pfizer. Johnson and Johnson is expected to apply soon. Both vaccines are marked as EUAs by the FDA and are proven to protect against COVID-19.
According to the CDC, anyone who has had or can possibly have any kind of allergic reaction to the vaccine should not get Pfizer. However, there are vaccines available for people with allergies. If you have questions about your health situation and getting the vaccine, talk to your doctor about the best course of action for you personally.
How do I get the vaccine?
If you’re looking to get vaccinated, please click here to see ShiftMed’s comprehensive list of resources.
If you have questions about the vaccine and would like to talk to someone, please call the CDC at 1-800-CDC-INFO (1-800-232-4636).
If you are already vaccinated, please click here to learn more about booster shots.
If you are a ShiftMed employee, don’t forget to add your vaccine card to your credentials for a chance to win our Vaccinations Across the Nation raffle.