FDA panel recommends transitioning to single COVID-19 vaccine - CT Insider | By The Perfect Enemy


As a Food and Drug Administration advisory committee recommends phasing out the original COVID-19 vaccine in favor of the bivalent formulation use in boosters, uptake of the booster shot remains low in Connecticut at just 23.7 percent of state residents having received a dose.


The goal of the recent advised change is to increase the uptake of the bivalent booster, which promotes immunity against the alpha strain and the omicron strains of COVID-19. In Connecticut, the original shot is no longer available with only the bivalent booster offered.



The omicron family of subvariants dominates the pandemic in the United States, making up 99.9% of all new infections nationwide. XBB 1.5 is a subvariant of omicron and makes up approximately 60 percent of new infections nationally.





“We are at a time where we are all about simplicity,” said Paolo Verardi, a professor of virology and vaccinology at UConn. “If you’ve just recently become eligible for vaccination, why would you want to induce immunity against the original strain? That original strain, that ancestral strain, has gone extinct now.”


The advisory committee also proposed shifting the vaccination schedule that applies to COVID-19 vaccines. This would simplify when people could get vaccinated and boosted. Under the proposed dosing schedule, most adults would receive one dose of bivalent vaccine, possibly annually.



Older adults, high-risk adults, young, unimmunized children and people with compromised immunity would be on a different vaccination and boosting schedule that has yet to be established.


“I think it’s the right call to simplify things,” said Dr. Scott Roberts, Yale Medicine infectious disease specialist. “Getting the primary series, figuring out which booster to get, it’s confusing and arduous.”


Dr. Roberts said he had difficulty getting his infant son vaccinated due in part to all the conflicting rules.


While Connecticut is among the most vaccinated states, with roughly 83 percent of people fully vaccinated against coronavirus, far fewer have gotten updated boosters. A little less than a quarter of the state’s population, 23.7 percent, according to the Centers for Disease Control and Prevention, has gotten the new bivalent booster.


Nationally, the rate is lower, with only 69 percent of the population having been vaccinated and only 15.5 percent has been boosted. Boosters have been available since the fall of last year, but their uptake has been slow.



“Will this change help the low uptake? We don’t know,” said Jeffrey Townsend, a professor of biostatistics and evolution at the Yale School of Public Health. “But some of the thinking is that if we can align our vaccination against COVID-19 with yearly influenza vaccination, it will be normalized into people’s calendars.”


The idea would be to boost every fall before virus season, protecting people from severe infection during the winter months. Both vaccines could be administered at the same appointment.


Annual flu vaccination rates have hovered between 40-50 percent for the past decade among adults. Among children, the flu vaccination rate has wobbled between 50-60 percent nationwide. Connecticut tends to be among the better states for flu vaccination, but not so much that it bucks this trend.


“I am concerned that we are unlikely to achieve higher levels against COVID-19 than we do against flu with the plan of having them co-administered,” Townsend said.




He cautioned that focusing on an annual mRNA vaccine could prevent the investigation of other vaccination technologies that might provide more lasting immunity.


“There were over 200 vaccines that were at one point being worked on,” Townsend said. He pointed to vaccines that targeted parts of COVID that didn’t mutate quickly or involved non-needle administration. “These have the potential to be very good at preventing infection, preventing hospitalization and death as well.”


The changes come as the Biden administration signals that it wants to end the various emergency provisions for COVID this spring, according to a report in Politico.


According to an analysis by the Kaiser Family Foundation, the end of the various emergency provisions would mean the end of free COVID-19 testing, testing services, treatments and vaccines. These healthcare services would move to the private market, Medicare and Medicaid.


“There are structural inequalities in our medical system,” Townsend said. “Those inequalities remain and are coming back in more force when you normalize how this process happens because a normal process is one of unfairness in terms of access to medical treatment.”


The Food and Drug Administration’s emergency use authorization for COVID-19 vaccines, tests and kits, and treatments like Paxlovid might end with the end of the emergency. The bivalent boosters are not formally approved by the FDA and are administered under EUA.


Roberts cautioned that all of this could hinder efforts to boost vaccinations. While simplifying the vaccine schedule is a good idea, the private healthcare market has well-documented issues with respect to costs, access and efficacy. He said there had been no real advertising or effort to get the word out on boosters.


“The virus is circulating at significantly higher levels than anything that we’ve ever had,” said Roberts. “It’s a concerning message that they are not prioritizing” getting booster vaccines out.





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Published on The Perfect Enemy at https://bit.ly/3kVBCmk.

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