Last Updated on September 1, 2022 by BVN
Breanna Reeves |
U.S. Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle P. Walensky endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendations for the use of updated COVID-19 boosters from Pfizer-BioNTech and Moderna on September 1, following the U.S. Food and Drug Administration’s (FDA) authorization.
The FDA authorized an update to COVID-19 vaccines for booster doses that will target the highly transmissible Omicron variants on August 31.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant. They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants,” Dr. Walensky stated.
“This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”
Bivalent vaccine components
The “updated boosters” are bivalent vaccines that contain components of the initial strain of the COVID-19 virus and components of the BA.4 and BA.5 Omicron sublineages of the virus. The Omicron variant continues to dominate the number of COVID-19 cases in the U.S. Over the past week, from August 21 to August 27, the CDC reported that approximately 88% of cases were identified as BA.5.
The bivalent boosters are only for individuals who have completed their primary vaccinations. The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.
“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 Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research in a statement.
In June, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-2 to recommend the inclusion of a COVID-19 booster shot that will target Omicron-specific variants after weighing the pros and cons of developing a new formula. Committee members questioned if producing a new formula that specifically targets Omicron variants BA.4 and BA.5 would be effective in the fall.
Bivalent booster recommended for all eligible
“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,” said FDA Commissioner Dr. Robert M. Califf, in a statement.
According to the FDA, the update booster vaccine is expected to provide increased protection against the Omicron variants that are currently circulating. The FDA’s decision to authorize the bivalent vaccines is based on the results of available evidence such as data from the initial vaccine formulas and safety data “obtained from a clinical study of a bivalent COVID-19 vaccine.”
“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. We sought input from our outside experts on the inclusion of an Omicron component in COVID-19 boosters to provide better protection against COVID-19,” said Marks.
The updated boosters are expected to be available in the next week. The FDA’s authorization comes just ahead of the winter season where traditionally the U.S. experiences surges in cases, as seen over the past two