The Food and Drug Administration has begun to consider major changes in the country’s COVID-19 vaccination strategy.
The goal of COVID vaccination is to make it easier and possibly adopt a similar approach to the flu vaccine. Annual updates will be made to ensure that the virus strains are updated. According to a federal official, who spoke on condition of anonymity as they weren’t authorized to speak publicly.
NPR reported the shift Monday morning. Later Monday, the FDA made it public in a set of documents. This was in advance of a meeting of the Vaccine & Related Biological Products Advisory Commission (VRBPAC) on Thursday. The proposal will be voted on by the committee.
People who wish to become fully vaccinated against COVID must first have their primary vaccines. This is two doses of the original vaccine, spaced out over several weeks. The booster shot, which is currently the bivalent shot to protect against omicron, should be followed by another two months.
The new approach would allow most people to get the latest vaccine each fall, just like the flu vaccine. They would not have to think about how many shots were received and which one. For those who need two doses, such as children or older, the same formula would be used for all three shots.
The annual shot would be updated by vaccine makers. This process would start each spring in order to match the vaccine to the variant that will be most dominant in the following winter. This is how each flu vaccine is made.
The FDA stated in its briefing that it anticipates conducting an assessment for SARS-CoV-2 strains at minimum once a year and engaging VRBPAC in June to discuss strain selection for the fall season. It also noted that the FDA would prepare updated vaccines for use in September every year.
According to the agency, if a COVID variant that is more dangerous emerges, the agency might reconsider the vaccine strain at other time of the year.
Many vaccine researchers and immunologists believe that simplifying the process to the level of the flu vaccine is the best option at this stage in the pandemic. There are many questions about the emerging booster strategy.
“As far the tools we have at the moment, I believe it makes the most sense to plan for updating each year as close to the current circulating variant as possible,” states Deepta Battacharya an immunologist from the University of Arizona. “So, I believe all the FDA’s ideas make sense.”
Questions regarding the efficacy and safety of new shots
It is a hot topic of debate whether it makes sense to update the COVID vaccines frequently to ensure that they match the latest variants. Researchers question whether this makes vaccines more efficient. They argue that the low demand for boosters shows that the public doesn’t want to continue boosting vaccines even after they have been updated with new strains.
“The public is voting with its arms if they will, and said, “No. This is not what I want. This is not logical to us,” says Dr. Gregory Poland a Mayo Clinic vaccine researcher.
Some question whether current boosters for high-risk groups, such as the elderly and the elderly, offer greater protection than the original bivalent vaccines. They state that most people are still protected against severe diseases by the immunity they have.
John Moore is an immunologist at Weill Cornell Medical College. He says that there are no reliable data on the performance of bivalent boosters. “The evidence is inconclusive, and there is little hard evidence.”
Moore and others contend that the virus is constantly changing, so it’s futile to try to keep up with the latest vaccines.
“We shouldn’t be chasing these variants,” Dr. Paul of University of Pennsylvania, one of FDA’s advisors, says.
Offit and others question whether all people will need to have their blood pressure boosted or only those who are at highest risk like the elderly.
Alternative vaccine strategies: Arguments
The FDA’s new strategy is being criticized by critics who argue that it would be better for the FDA to invest in vaccines that are more attractive to people and in campaigns to get more people immunized. A nasal spray vaccine, which can prevent people from contracting the virus and not only from becoming seriously ill, could be a better vaccine. Perhaps vaccines that offer longer protection or can be taken in pill form to make them more accessible to needle-averse people.
“Especially now that Congress isn’t allocating additional funds for COVID response,” Dr. CelineGounder, a senior fellow with the Kaiser Family Foundation, says, “Particularly now, when Congress isn’t allocating new funds for COVID treatment, we have to exercise judicious spending our money and be cost-effective.” It’s not clear whether updating booster formulations and repeatedly giving boosts to people is the best way to control COVID at this point.
Researchers are also concerned that the FDA still relies on antibody levels for vaccine efficacy testing.
Dr. Eric Rubin is a Harvard professor of immunology who also serves as a member on the advisory committee. Rubin, for example, believes that the FDA should demand proof that the new vaccines reduce the chance of infecting, dying, or getting sick.
Others believe that updating vaccines is a good idea to ensure people are protected while researchers work to create new vaccines.
David Martinez is an immunologist at University of North Carolina Chapel Hill. He says that even if your booster doesn’t match 100% of what’s currently circulating, you can still have a booster which matches 75% to 88% to 90% of what’s actually circulating. That will be enough. It would likely benefit most people.
FDA anticipates endemic COVID
Researchers believe it is too early to rely on annual boosters. They note that COVID is not yet in a seasonal pattern, like the flu. Also, the SARS-CoV2 virus changes more rapidly than the flu virus. They suggest that people need to be given more frequent steroid injections, as protection against severe diseases may not last for four to six months.
“We’re going be reaching that pretty soon avec the early adopters of bivalent boosters,” Dr. Peter Hotez says. He is codirector of the Center for Vaccine Development, Texas Children’s Hospital, and dean of Baylor College of Medicine’s National School of Tropical Medicine. “I don’t know if an annually-based strategy will cut it.”
COVID is moving towards becoming an endemic condition, so FDA’s plan was made. It doesn’t mean that COVID isn’t a threat or going away. Experts predict that the disease will be a significant threat in the future. It can make many people sick, and potentially kill hundreds of people every day. This makes it a serious public health problem as well as a leading cause for death.
The world may finally settle into a predictable co-existence with it unless a more dangerous form of the virus emerges. According to NPR, the federal official who spoke with NPR said that the new vaccine strategy aims to simplify and make vaccines more attractive. There are very few people who will take up the latest boosters.
It is believed that the vast majority of people are immune to the pandemic at this stage. This could be because they have been vaccinated, boosted or infected once or twice. While this immunity seems to protect most people against severe diseases, it does seem to diminish over time.
The FDA is considering making the shots interchangeable. This would eliminate the need to choose which brand of shot they are receiving. The change was made to make COVID shots more similar to flu shots. The brand of flu vaccine that they get is not something people are concerned about.
Different doses of the vaccine would be given to different ages. Two shots would be given each year to very young children and the elderly, just like the flu vaccine.
The FDA advisory committee would endorse the approach on Thursday and work with vaccine companies and the Centers for Disease Control and Prevention in finalizing the details. The FDA advisors would then meet again in spring to select the strain of virus that should be targeted by the new shots.
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