A panel of independent experts advising the Food and Drug Administration on vaccines has funded a proposal to use the same COVID-19 vaccine formula for the number one two-dose, booster immunization series in an effort to simplify the country’s vaccine administration.
The Advisory Committee on Vaccines and Related Biologics voted unanimously to introduce the handling of bivalent COVID-19 vaccines as a component of the number one two-dose vaccine, which is administered several weeks per component, eliminating the use of monovalent vaccines that target only the original COVID-19 strain beginning in 2020.
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“There’s so much confusion about those other formulations that I think anything we can do to alleviate that confusion and simplify things will be a smart thing to do,” said Dr. Brown. Archana Chatterjee, committee member. ” Having vaccines is not enough. We want to get them. ” used, so I voted yes because I think it’s a step in the right direction to get there. “
Harmonizing the composition of vaccination would be using multiple vaccine formulations and instead using the most up-to-date vaccine formulation, which lately is Pfizer and Moderna’s bivalent COVID-19 vaccine that targets the original virus strain and omicron. BA. 4 subvariants and BA. 5. La bivalent vaccine from Pfizer and Moderna is ultimately legal for use in other people as early as 6 months of age.
The European Union’s medicines regulator has already approved bivalent vaccines for use in the number one COVID-19 vaccines.
FDA officials cited recent information suggesting that the bivalent vaccine provides greater coverage rather than symptomatic infections, emergency room or emergency care visits, and hospitalizations to the monovalent vaccine. Several committee members expressed concern about the lack of sufficient information among young people about bivalent vaccines.
“I have some trepidation about the amount of knowledge in children under 2 with a number one series with bivalent reinforcement,” said committee member Dr. Mark Sawyer, who said he supported the recommendation.
Representatives from the FDA and the Centers for Disease Control and Prevention discussed the detection of a “safety signal” that showed an imaginable link between stroke in adults 65 and older and Pfizer’s bivalent vaccine, noting that upcoming analyses did not pinpoint a major threat and did not want to replace vaccination recommendations.
“We are in the process of comparing this sign and there is not enough evidence to conclude that there is a fear of protection regarding stroke. And the CDC’s recommendations are that all eligible people get a bivalent booster,” Dr. Tom said. Shimabukuro. with the CDC.
The advisory organization also discussed plans to change the country’s COVID-19 vaccination strategy to one similar to that of flu vaccines. The FDA is proposing that healthy adults get an annual dose of the maximum updated COVID-19 vaccine, while some more young children, immunocompromised people, and older adults should receive two COVID-19 vaccines per year.
Several committee members sometimes spoke in favor of simplifying the booster program, but argued that more knowledge was needed to decide who deserves to get one booster a year instead of two, as well as when vaccines are worth updating. The FDA has proposed updating vaccines each June to the most productive circulating strains for deployment in the fall to the public.
“The question of how they deserve to be administered is hard to say exactly at this specific stage,” said committee member Dr. Cody Meissner. “It turns out it’s extraordinarily early, for me, in this process. “
The panel did not ask to officially vote on the plan, but did ask to provide feedback to the FDA.
“I think it’s a moderate approach. We have to keep remembering that it’s not the flu and we want to keep paying attention to that to make sure we’re not following that dogma because we’re used to it,” said Bruce Gellin, a transitory voting member. “We would possibly have to adjust along the way. “
The United States will most likely set a precedent if it goes ahead with a flu vaccination strategy for COVID-19 boosters.
Dr. Joachim Hombach, executive secretary of the World Health Organization’s Strategic Expert Advisory Group on Immunization, told reporters earlier this week that there is no definitive answer on how COVID-19 boosters will be needed at this stage.
“It’s very good that we’re starting to define what could potentially be a way forward, but I don’t think we have, at the moment, definitive answers,” Hombach said. “We want to see where the evidence takes us. “
The discussion comes as acceptance of bivalent retirement has remained low since it became available to others over 18 last August. According to the CDC, about 15% of people received an updated vaccine.
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The FDA has indicated that it expects simplifying the composition and handling of the vaccine to increase the number of vaccines.
“The FDA expects that simplifying the composition of the COVID-19 vaccine and annual immunization schedules will likely contribute to less difficult vaccine implementation, fewer errors in vaccine management, and less complex communication, all of which have the potential for immunization policy rates and, ultimately, from the public. health,” the FDA wrote in a briefing paper ahead of Thursday’s meeting.