(RxWiki News) The US Food and Drug Administration (FDA) authorizes two bivalent vaccines to be given as booster shots.
These two vaccines are:
- Moderna COVID-19 Vaccine, Bivalent
- Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Both of these are now authorized to be given as a single booster dose at least two months after you have either completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
These "bivalent" vaccines will also be referred to as “updated boosters." These vaccines are expected to offer better protection against the Omicron subvariants because they include the original virus strain plus a component in common between the omicron variant BA.4 and BA.5.
According to the FDA, the omicron variants BA.4 and BA.5 are causing the most cases of COVID-19 in the country. It is predicted these variants will continue to circulate this fall and winter.
According to the Centers for Disease Control and Prevention (CDC), BA.5 accounts for over 88 percent of new Covid cases in the country.
In regards to age, the boosters are authorized for those 12 years and older (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) and for those ages 18 years and older (Moderna COVID-19 Vaccine, Bivalent).
Those who receive this new bivalent vaccine can expect similar side effects seen with the first COVID-19 vaccines (monovalent vaccines).
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert M. Califf, M.D. in a press release. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” he continued.
The FDA will continue to look at the data to support authorization of these bivalent vaccines for additional age groups.
"We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in a press release. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” he continued.
Speak with your health care provider if you have any questions.