The FDA Considers New Plan of Administering COVID-19 Vaccines

Hotez supports the new way of administering vaccines, but cautions against thinking that the plan is not without its risks.
Photo by Jack Gorman
Hotez supports the new way of administering vaccines, but cautions against thinking that the plan is not without its risks.
The Food and Drug Administration is considering a shift to a new way of administering the COVID-19 vaccine that is akin to receiving the flu shot.

The FDA’s vaccine advisory committee will meet Thursday to discuss this proposed change, as well as other updates concerning the status of current and future vaccine manufacturing.

The plan proposes creating a new COVID-19 vaccine that would be updated annually, reducing the need for multiple vaccines for most people.

Exceptions would be made for the immunocompromised and older populations who would receive two doses of this vaccine for extra protection, said Dr. Peter Hotez Co-Director of the Center for Vaccine Development at Texas Children’s Hospital and Dean of the National School of Tropical Medicine at Baylor College of Medicine.

According to Hotez, the FDA’S plan mirrors the way the influenza vaccine is administered and will provide immunity against COVID-19. But due to the two viruses being different in nature, it may create some obstacles in its protection.

“What they’re proposing is a new vaccine getting made every June or July to be ready by the fall, which wouldn’t necessarily cover variants that arise over the summer,” Hotez said.

Because influenza is a seasonal virus, annual vaccines that are updated at the cusp of a new season tend to protect against the virus. However, with COVID-19, the virus is not seasonal and often unpredictable, said Hotez.

Additionally, this new vaccine will most likely be another mRNA vaccine, and these vaccines are only lasting in optimal effectiveness for several months before another dosage is needed, said Hotez.

Hotez suggests there could be other alternatives for the new vaccine, like the Novavax particle vaccine or the protein-based vaccine technology developed by him and his colleague, Dr. Maria Elena Bottazzi, but neither of these options has gained federal traction.

“I think part of this choice is being driven by a compromise with the fact that the federal funding may not be there to give mRNA vaccines on a more frequent basis or to do the detailed level of surveillance that's required,” Hotez said. “The shortage of funds may be dictating some of the policy decisions.”

Hotez said there are several options the FDA can take when it comes to the actual vaccine composition, if it is an mRNA, as he predicts.

“They could make a monovalent XXB1.5 version or a version that would continue to include the original variants too,” said Hotez. “In theory, there is no real upper limit to valence, they could make a bivalent or even a trivalent version.”

Though this plan is a major portion of what will be discussed in the meeting, Hotez said it may be too soon to expect any clarity about the new vaccine from Thursday’s meeting.

In announcing the new vaccination proposal, the FDA is hopeful that this simpler approach to administering the vaccine will encourage those to get vaccinated.

“This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication,” the FDA said.

Hotez said that it could cause more people to get vaccinated, but that trends may indicate otherwise as vaccination rates in most states remain low.

“I mean it could be that people see it incorporated as a regular activity they do every year and get into the route of doing it, and that might make it happen,” Hotez said. “On the other hand, uptake of even the annual flu vaccines is not great in the United States, it’s less than 50 percent, so that’s like the best we could hope for.”