Two recently published studies show that Bivalent COVID-19 shots don’t provide better protection than the dismal protection conferred by the original vaccines.
The first study published on Jan. 11 in the New England Journal of Medicine found “boosting with new bivalent mRNA vaccines targeting both the BA.4–BA.5 variant and the D614G strain did not elicit a discernibly superior virus-neutralizing peak antibody response as compared with boosting with the original monovalent vaccines.”
A second study led by Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, also published Jan. 11 in the New England Journal of Medicine, showed bivalent shots failed to promote higher antibody levels and did not produce a better immune response than original COVID-19 vaccines.
These two studies “suggest that with this rapidly evolving virus, vaccines developed for different strains are not going to add a huge difference in terms of protection,” said Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group.
“You really don’t develop any higher levels of antibody with this fourth bivalent booster than you do with the third because your body thinks, ‘Oh, it’s just the same thing,’” Poland added.
Vaccine experts theorize that the human immune system is primed to respond to elements of the original COVID-19 strain shared by all variants rather than novel mutations by newer variants.
“It may be that people’s immune systems are so primed to respond to the ancestral strain spike protein that a reformulated booster is unable to fully stimulate the immune system because it has been ‘imprinted’ by the original version of the virus,” said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security.
The U.S. Food and Drug Administration (FDA), on the same day these studies were published, issued a press release stating bivalent COVID-19 vaccines, which include a component of the original virus strain, provide “broad protection” against COVID-19 caused by the omicron variant.
According to the Centers for Disease Control and Prevention (CDC), 52.9 million people as of Feb. 15 had received a COVID-19 bivalent vaccine. U.S. taxpayers purchased 105 million doses of Pfizer’s bivalent vaccine at $3.2 billion and 66 million doses of Moderna’s bivalent vaccine for $1.7 billion.
The idea behind bivalent boosters was to alter original mRNA vaccines to facilitate an immune response to the Omicron BA.4 and BA.4 subvariants — similar to how influenza vaccines target flu strains — even though U.S. regulatory agencies acknowledge influenza vaccines are ineffective and the Omicron BA.4/BA.5 subvariants are no longer the dominant circulating SARS-CoV-2 strains.
“You cannot make mRNA vaccine boosters and get them approved fast enough to keep up with the rapid mutation in these variants,” Poland said, remarking that the XBB variants have now displaced the BA variants that bivalent vaccines were designed to target.
Vaccine advisors to the CDC and FDA say they were not provided with the “real-world data” to show how well the bivalent vaccines actually worked prior to authorizing it as a booster. However, vaccine advisors shouldn’t have signed off on a product they didn’t have data for in the first place.
Data reported by CNN showed that 1.9% of people who got the original booster were later infected versus 3.2% of people who got the updated bivalent vaccine.
“I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” Dr. Paul Offit, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, told CNN. “Decisions that are made for the public have to be made based on all available information — not just some information, but all information.”
Two weeks later, the FDA’s vaccine advisors recommended replacing original COVID vaccine doses with bivalent vaccines.
Poland says initial vaccination makes one more susceptible to asymptomatic, mild, or moderate COVID-19 but claims boosters are needed to prevent complications of long COVID, despite no data to support the assertion.
The risks of experiencing long COVID, assuming vaccines could prevent it, have not been compared to the risk of experiencing a life-long or potentially fatal COVID-19 vaccine injury.