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FDA Authorizes Updated COVID Boosters for BA.5

Posted on September 1, 2022 By mediawiz No Comments on FDA Authorizes Updated COVID Boosters for BA.5

The US Food and Drug Administration on Wednesday authorized updated boosters from Moderna and Pfizer and BioNTech that target the BA.4 and BA.5 strains of COVID-19. 

Both boosters are bivalent, meaning they contain two parts: the original strain of COVID-19 and one that’s found in the BA.4/BA.5 subvariants of omicron, which make up most COVID-19 cases right now. Moderna’s vaccine is authorized for adults 18 and older, while Pfizer’s is for people 12 and older. In order to get either updated booster, you must have gone two months since your last vaccine dose or booster. 

Before shots start going out to the public, however, both boosters will need to be recommended by the US Centers for Disease Control and Prevention. The CDC has meetings scheduled for Thursday and Friday this week where an advisory committee will go over safety and effectiveness data for the updated vaccines. It will be up to the CDC to decide who should get a new booster right now and how the rollout process will begin.

The CDC’s meetings are public and you can watch live on the CDC’s website. Streaming starts Thursday at 7 a.m. PT/10 a.m. ET. 

Pressure to get new COVID-19 vaccines that target more relevant strains of the virus has been mounting ahead of fall and winter, when we should expect another wave of cases as people spend more time indoors. The BA.4/BA.5 vaccines have been on a fast regulatory schedule, and that might be partly due to the fact that bivalent vaccines are relatively easy to modify, according to a tweet from FDA Commissioner Dr. Robert Califf. 

“Bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients,” Califf said last week. “FDA has extensive experience with reviewing strain changes in vaccines, as is done with the annual flu vaccine.”

When it authorized Moderna’s and Pfizer’s and BioNTech’s updated boosters, the FDA said it based its decision on safety and effectiveness data from a clinical study on an updated vaccine that targets BA.1 — a similar vaccine but older strain of omicron. It also said it referred to the safety and effectiveness data on the monovalent vaccines (the original COVID-19 vaccines and boosters that have been given to millions of people in the US) and nonclinical data on the new bivalent vaccines. 

The COVID-19 vaccines and boosters have remained very effective at preventing severe disease and death from COVID-19, even as their infection protection has waned as the virus evolves. According to June data, adults 50 and older who received two booster doses were 14 times less likely to die from COVID-19 than unvaccinated adults of the same age, and three times less likely to die than adults who received one booster. However, only about 52% of American adults received the first booster dose, and a smaller number received the second, raising questions about how many will opt for maximum protection with the updated boosters turning into the fall season.

Read more: Free At-Home COVID Tests Are Ending. How and When to Order Them Online

Read more: Moderna Sues Pfizer Over mRNA Technology Used in COVID Vaccines

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

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