A: The CDC reports that over 357 million doses of COVID-19 vaccines have been given in the United States from December 14, 2020, through August 16, 2021.The vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history. The FDA has granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people ages 16 and older. To receive full approval, the vaccine had to meet FDA standards for safety, effectiveness, and manufacturing quality. Moderna completed submission for FDA full approval in August of 2021 and is awaiting FDA approval.
The safety monitoring has identified several, yet very rare, types of health problems after vaccination including:
1. Anaphylaxis (after mRNA vaccines)
Anaphylaxis to the mRNA COVID-19 vaccines is currently estimated to occur in 2.5 to 5.0 cases per 1 million doses, compared to 1 per 1 million doses, which is the incidence of anaphylaxis associated with other vaccines.
The anaphylaxis rate for the Johnson & Johnson COVID-19 vaccine has not been reported.
The CDC has provided recommendations for COVID 19 vaccine providers about how to prepare for the possibility of a severe allergic reaction. All people who get a COVID 19 vaccine are required to be monitored on site. People who have a history of severe allergic reactions to vaccines or other injectable therapy are monitored for at least 30 minutes after getting the vaccine. All other people are monitored for at least 15 minutes after getting the vaccine.
2. Thrombosis with Thrombocytopenia Syndrome (TTS) – a syndrome of blood clots occurring with low platelets (after J&J)
TTS has occurred after receiving the J& J/Janssen COVID 19 vaccine and not after the mRNA vaccines at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old. For women 50 years or older and men of all ages, this adverse event is even more rare.
3. Myocarditis and Pericarditis (mRNA vaccines)
The FDA issued a warning in June about heart inflammation. Since April 2021, there have been more than one thousand reports to the Vaccine Adverse Reporting System (VAERS) of myocarditis and pericarditis occurring in adolescents and young adults more often after getting the second dose than after the first dose of one of the two mRNA vaccines. Symptoms typically occur within several days after vaccination and patients have been able to return to their normal daily activities after their symptoms improve. Because the known and potential benefits of COVID 19 vaccination outweigh the known and potential risk, including the possible risk for myocarditis or pericarditis, the CDC continues to recommend COVID-19 vaccination for everyone 12 years of age and older.
4. Guillain-Barre Syndrome
There’s a possible, but rare risk in developing Guillain-Barre syndrome after the Johnson and Johnson vaccine .To date, no cases of GBS have been seen in people vaccinated for COVID-19 with the mRNA vaccines.
Although these are the first mRNA vaccines licensed for use, researchers have been studying and working with mRNA vaccines for decades. mRNA vaccines have been studied for flu, Zika, rabies, and cytomegalovirus and no safety concerns were identified.