The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) to Pfizer-BioNTech’s COVID-19 vaccine on Dec. 11.
The vaccine is given in two doses that are 21 days apart from each other and is reported to be 95% effective at preventing COVID-19.
Pfizer’s vaccine is the first mRNA vaccine that received EUA by the FDA.
What is different about an mRNA vaccine?
Although mRNA vaccines — also known as messenger RNA vaccines — are now being approved for the first time, they have been a topic of study by researchers for decades.
The difference between mRNA vaccines and more traditional ones comes down to what is contained within the vaccine.
“MRNA vaccines do not contain live virus, so they cannot cause an infection,” Dr. Fryhofer said. “They cannot give someone COVID. MRNA vaccines do not affect or interact with our own DNA in any way. The messenger RNA never enters the nucleus of the cell and it doesn’t hang around. The body breaks it down with hours.”
What’s different about an EUA compared with the normal vaccine approval process?An EUA is different than approval of a vaccine. According to the FDA website, an EUA “is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.” A product can receive EUA if it meets an effectiveness standard and an assessment of its benefit compared with its risk is favorable.
The FDA has been transparent in its review process and expects any manufacturer that receives EUA to continue its clinical trials and eventually pursue official FDA approval, Curtis said.
If you’ve already had COVID-19 or received monoclonal antibodies, should you still get the vaccine?
Yes, although people who received monoclonal antibodies or convalescent serum should wait at least 90 days before getting the vaccine.
Should pregnant women get the vaccine?
Pregnant or lactating women may receive the vaccine if they choose, however, safety data is not known about this population at this time. A woman who is pregnant or lactating should consult with her physician about what is best for her and her baby.
Is there anyone who should not get the vaccine?
According to ACIP, people who have a history of allergic reactions to any vaccine should not get vaccinated at this time. There were no signs of allergic reactions during the Pfizer trials, she said, but several people in the United Kingdom had severe allergic reactions to the vaccine earlier in the month.
“The COVID vaccine should not be given in combination with other vaccines right now,” she said. “The study protocol for these vaccines did not allow co-administration with other vaccines, so don’t do it. We want this vaccine to do its best job.”
The Centers for Disease Control and Prevention (CDC) recommends at least a two-week window between getting Pfizer’s COVID-19 vaccine and any other vaccine.
Are there any expected side effects to the vaccine?
As with any vaccine, patients may experience some side effects, and it is important for physicians to make sure their patients understand the side effects, which include pain or swelling at the site of the shot, as well as fever, chills, tiredness or headache.
The symptoms are usually worse after the second dose, and they’re usually worse in younger as compared to older patients.