On 11 September 2023, the US FDA authorized and approved updated COVID-19 booster vaccines from Pfizer-BioNTech and Moderna. The new vaccines were designed to better target the COVID-19 Omicron variant called XBB.1.5.
This article will review both the FDA approvals and ACIP recommendations so that everyone understands what is recommended. Spoiler alert — Everyone over the age of six months should get the new vaccine.
FDA approval of the new COVID booster vaccines
According to the FDA, the new booster shots are better than older vaccines because they were designed to target the Omicron variant, which is more contagious than previous virus variants. The FDA also stated that these new COVID-19 booster vaccines have been updated to handle better the most dominant virus strains circulating at this time and adapt to the virus’ mutations.
The FDA also stated that the studies conducted for the updated vaccines have been shown to neutralize the current circulating SARS-CoV-2 variants that cause COVID-19, including EG.5 (called Eris) and BA.2.86 (called Pirola). This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.
Officially, the FDA approved the updated booster vaccines for COVID-19 for individuals 12 years of age and older. However, the Pfizer-BioNTech and Moderna vaccines received an Emergency Use Authorization (EUA) for children between six months and 11 years old. Just so everyone is on the same page, an EUA requires the same amount of research and a vote by the expert vaccine committee, the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
VRBPAC voted for the EUA for six-month and 11-year-olds because the clinical research had just been completed, and there was not enough time for a full FDA review. However, the differences between an EUA and full FDA approval are minor, and EUAs have detailed reviews by vaccine experts.
The updated vaccines have been shown to be safe and effective in clinical trials. The clinical studies conducted by Pfizer-BioNTech found that the updated vaccine was 95% effective in preventing severe COVID-19 infections. Another clinical study conducted by Moderna found that their updated vaccine was 93% effective in preventing severe COVID-19 infection.
Although it may appear that the Moderna vaccine was slightly less effective, you really can’t compare results from one clinical trial to another. Both are in the same range, so it would be impossible to say which is better than the other.
CDC recommendations on the updated COVID-19 booster vaccines
As I stated above, the CDC’s ACIP met after the FDA approval to make recommendations to the American public on who should get the vaccine. Here is a list of their recommendations:
CDC recommends everyone 6 months and older get an updated COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 illness this fall and winter. Updated COVID-19 vaccines from Pfizer-BioNTech and Moderna will be available later this week.
As the CDC states, the new vaccines are already being shipped to healthcare providers to meet the demand for the new vaccines.
I hate to repeat myself, but here are the key points:
- The updated COVID-19 booster vaccines are safe and effective as shown in large clinical trials.
- The CDC recommends that everyone over the age of six months get the updated vaccines because they might prevent the spread of new, emerging variants.