The current slate of COVID-19 vaccines performing poorer against the XBB variant and its sub lineages prompted experts to urge upgrading the COVID-19 vaccines on June 15.
Less than a year after the vaccines were already revised because of worries about dwindling protection, FDA advisers unanimously decided to propose that the FDA clear new injections.
Dr. Eric Rubin, a Harvard Medical School professor of medicine and one of the advisers, stated, We need a better vaccine. Bivalent vaccines from Moderna and Pfizer that contain components of the Wuhan variant and the BA.4/BA.5 subvariants of the Omicron strain are expected to be approved by the FDA and recommended by the U.S.
Centers for Disease Control and Prevention (CDC) in the fall of 2022.
However, research and CDC data have shown that the revised vaccinations only offer fair protection against infection, and the protection against hospitalization is very temporary. The data presented to the panel was estimated for the XBB era, and the latter eventually goes negative.
In January, XBB, a different Omicron subvariant, took over in the US.
For the first time ever, a component of the Wuhan variety will not be present in the revised vaccines. Officials claim that’s because the immune response to more recent strains is hampered by immunological imprinting, or repeated exposure to the variant.
You won’t be competing with something that people have already seen two, three, or four times,” FDA scientist Jerry Weir said. A vaccine expert who isn’t on the panel, Dr. Robert Malone, told The Epoch Times that altering the vaccinations’ ingredients is “playing around at the margins.
The spike protein in the vaccine is “toxic,” he claimed, and it is the “real problem” that they are refusing to address. Regulators anticipate that the new vaccines will go on sale in or around September. A modification “would make this much easier for the companies to deliver and protect people around the world,” said Dr. Steve Pergram, a panelist and professor at the Fred Hutchinson Cancer Center.
In comparison to the currently available vaccinations, representatives from Moderna, Pfizer, and Novavax presented animal data showing that vaccines targeting just XBB induce larger levels of neutralizing antibodies. Additionally, Moderna published results from clinical trials that contrasted adults who had a monovalent XBB vaccination to those who received a bivalent BA.4/BA.5 + XBB shot. More antibodies were generated by the monovalent vaccination.
There was no trial data with comparators who had not received vaccinations, and there were no data for youngsters. The FDA refused to answer Dr. Paul Offit’s question about whether such information would be made available before the new vaccines were released.
The CDC would offer recommendations on which populations might or should receive revised immunizations if the FDA approved them as anticipated.
According to Offit, a pediatrics professor at the Children’s Hospital of Philadelphia, some patients do not require an additional dose. Because not everyone gets from booster dosing, he stated, I think we need to define who really benefits from booster dosing.
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