FDA authorizes updated Covid-19 booster, awaits CDC approval; Beshear says could be available in Ky next week

medpagetoday.com photo

By Melissa Patrick
Kentucky Health News

The new, updated Covid-19 booster shots that targets both the original strain of the coronavirus and Omicron subvariants could be available to Kentuckians as early as next week, according to Gov. Andy Beshear. 

The U.S. Food and Drug Administration authorized the updated booster shots from Moderna and Pfizer-BioNTech on Wednesday, Aug. 31. They are called bivalent Covid-19 vaccines.

“The Covid-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of Covid-19,” FDA Commissioner Robert M. Califf said in the news 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.”

Omicron variants are currently responsible for nearly all of Covid-19 cases in Kentucky and are expected to circulate throughout the fall and winter. The FDA says that the updated booster vaccines are designed to provide broad protection against Covid-19 and better protection against Covid-19 that is caused by the currently circulating Omicron variants.

The new vaccine arrives at a time when Covid-19 "continues to spread across Kentucky," Beshear said at his weekly news conference. This week's state report showed an increase in all of the metrics used to measure the impact of the coronavirus in the state, with new cases up 15.6%, to 14,312, an increase of cases among school-aged children and a positivity rate -- which does not include at-home tests- over 20%. 

"We continue to recommend that everyone six months of age or older stay up to date on their vaccinations and receive any booster doses," said Beshear. 

So far, state data shows that less than half (46.6%) of the 2.6 million fully vaccinated Kentuckians have been boosted. 

The updated booster shots will become available after they are recommended by the Centers for Disease Control and Prevention, which is scheduled to vote Thursday. Then, the CDC director must sign off on the recommendation. 

The updated Moderna booster is authorized for use in individuals 18 years of age and older if it has been at least two months since they completed their primary vaccination or have received the most recent booster dose. 

The updated Pfizer booster is authorized for use in individuals 12 years of age and older if it has been at least two months since they have completed their primary vaccination  or have received the most recent booster dose, according to the FDA.

The FDA no longer authorizes the original boosters for administration to those 12 and older, but does authorize it for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer Covid-19 vaccine, says the release. 

Further, the FDA says, " you are eligible for an updated Covid-19 vaccine booster, the updated booster you receive does not need to be from the same manufacturer that made the vaccine you received for your primary vaccination or previous booster." 

“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.” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the release.