FDA Gives “Bivalent” Vaccine Booster Emergency Authorization

This week, the Food and Drug Administration made it possible for a new COVID-19 booster to be available within days.

The FDA gave a “bivalent” vaccine emergency authorization. It will target both the original virus and also the BA.4 and BA.5 variants that now dominate the world.
The next step will be for an advisory committee of the Centers for Disease Control and Prevention to meet this week to discuss who should receive the boosters first. The Director of the CDC will then sign off and the boosters will become available.

The Pfizer-BioNTech booster was authorized for anyone that is age 12 or higher, and Moderna’s vaccine is authorized for only adults. Both boosters can be taken after two months pass from a previous COVID-19 shot.

Both companies believe they can ship the boosters by September. Pfizer said they will have the capacity to provide 15 million doses by September 9.

Scientists have dampened some enthusiasm over these new boosters. They indicate that it is not likely to bring a huge benefit over the original vaccine. But government officials believe that any boost in protection is worthwhile, and it may prevent any more deaths, hospitalizations, and suffering from long COVID-19.
The virus still accounts for almost 80,000 cases with 5,000 hospitalizations and 400 deaths a day in the United States. The numbers are expected to surge again in the fall and winter, like in previous pandemic years.

FDA officials emphasized the importance of vaccination and boosting at a news conference this week. They focused on people who have not had any shots.
This new booster is targeted and will update protection for the most vulnerable, they said. It will also potentially prevent new infections and reduce the risk of long COVID.

According to Dr. Robert Califf, long COVID includes symptoms like exhaustion and brain fog that can last for months or longer after infection. And it is more likely to impact young people.

“It’s painful to see people dying when we have a free treatment available to save their lives,” he said.

The director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, said he hopes that targeting the current strains of the virus with this vaccine, will return the effectiveness that was experienced when they were first introduced.

Both Drs. Califf and Marks are comfortable with both the safety and effectiveness of the new booster. But the results of studies on it are not yet fully complete. Dr. Califf said if the agency waits for the studies to be completed, “the wave will have passed us by and the damage will have been done. We have to be a step ahead or at least we have to try to be.”

The doctor, 71, showed his confidence in the booster by saying that he will be at the front of the line at the pharmacy to get his vaccination.
Andrew Pekosz, a virologist at Johns Hopkins Bloomberg School of Public Health, believes that having a vaccine targeted at BA.5 is important because it is the most widely circulating variant. He said, “you can’t get better than this.”

He suggests that people get boosted six months after their last COVID-19 infection or vaccine. He counts infection as a booster and he said that it is not yet clear whether shots will be needed every six months indefinitely. People could build up enough immunity to avoid severe disease, only the high-risk people will need to keep boosting.

Dr. Richard Besser, president, and CEO of the Robert Wood Johnson Foundation, is concerned that there will not be enough federal funding to provide another shot to everyone who wants one. Congress has not allocated more money to fight COVID-19 for more than a year.
“One’s ability to pay for a vaccine should not determine whether or not someone receives a vaccine,” Besser said.