• National data analyzed by a CDC vaccine safety committee reveals that both Pfizer and Moderna’s vaccines are broadly safe, with severe side effects being rare.
  • A high mortality level was recorded for patients in long-term care facilities, but this is likely due to other variables including preexisting conditions.

The Centers for Disease Control and Prevention (CDC) confirmed that the first 22 million Americans have been vaccinated for COVID-19 during a Jan. 27 meeting, marking a new milestone in the nation's tumultuous vaccine rollout. 

The CDC’s Advisory Committee on Immunization Practices presented data on vaccine safety earlier this week, where it noted 23.5 million COVID-19 doses had been administered in the country amid “the most intense and comprehensive vaccine safety monitoring program in history.”

Additional safety data revealed that the COVID-19 vaccines approved by the Food and Drug Administration have primarily caused moderate side effects, such as injection-site pain, fatigue, fever and headaches within a week of inoculation.

"The safety profiles of COVID-19 vaccines are reassuring and consistent with that observed from the pre-authorization clinical trials," the report reads.

Looking into a database denoted as the Vaccine Safety Database, committee researchers reported “no signals” of serious adverse side effects, including seizures, heart attacks and other severe reactions among vaccine recipients included in the database. 

Anaphylaxis, or severe allergic reactions, were recorded early on as a potential side effect in patients with a history of allergies. Based on data from the CDC’s Vaccine Adverse Event Reporting System, 71 individuals were reported to have had an allergic reaction following a vaccination.

This event was still rare, with five anaphylactic responses occurring per million doses of Pfizer’s vaccine administered and just 2.8 allergic episodes estimated per million doses of Moderna’s vaccine.

Some 90 percent of observed individuals reported allergic reactions within the first 30 minutes of having been vaccinated.

The committee also looked at patient outcomes specifically for residents of long-term care facilities, one of the most dangerous environments for a COVID-19 outbreak. Among the 1.3 million COVID-19 vaccine doses administered in long-term care facilities, 11,440 deaths were reported over the same timeline, between Dec. 21 and Jan. 18.

Researchers emphasize, however, that “mortality in LTCF [long-term care facility] residents is high and substantial numbers of deaths in this population will occur following vaccination as temporally associated coincidental events,” meaning there is no direct relationship between the fatalities and a COVID-19 vaccination.

Overall findings indicate that COVID-19 vaccinations are safe to administer and that more data-centric measures to monitor vaccinated populations will be necessary moving forward.

President Biden’s aim is to have 100 million Americans vaccinated against COVID-19 within the first 100 days of his presidential term, setting an approximate deadline of April 29, 2021. 

Novavax, Johnson & Johnson and AstraZeneca have all made recent progress in announcing successful clinical trials data and achieving approval in select regions. Pfizer and Moderna are also on track to manufacture millions of additional doses to supply states in Biden’s push for a steadier rollout. 

Published on Jan 29, 2021