The Wall Street Journal Sunday took vaccine makers and federal agencies to task for pushing the bivalent COVID-19 boosters without having any data to demonstrate that they are either safe or effective. Today, the U.S. Food and Drug Administration said it is eyeing changes to the booster program.
The Wall Street Journal (WSJ) Sunday took vaccine makers and federal agencies to task for pushing the bivalent COVID-19 boosters without having any data to demonstrate that they are either safe or effective.
In an op-ed, Allysia Finley, a WSJ editorial board member, said people shouldn’t be surprised by the “deceptive advertising” touting the boosters on radio stations across the country, which is sponsored by the U.S. Department of Health and Human Services.
“Federal agencies took the unprecedented step of ordering vaccine makers to produce them and recommending them without data supporting their safety or efficacy,” she wrote.
Today, the U.S. Food and Drug Administration (FDA) posted a briefing document indicating it wants to change the COVID-19 vaccine protocols by simplifying the composition of the vaccines, the immunization schedule and decisions about how the vaccines are updated.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on Thursday to discuss the future of COVID-19 vaccine regimens, and will be asked to vote on whether they recommend parts of the FDA’s plan.
Finley: 3 problems with ‘tweaking’ mRNA vaccines
According to Finley, the idea behind the mRNA technology was that vaccine makers could quickly “tweak” the genetic sequences in the vaccines to target new variants. The bivalent vaccines targeted a combination of the original Wuhan strain and the BA.4 and BA.5 Omicron variants.
But, she wrote, three major scientific problems have emerged. First, the virus evolves faster than the vaccines can be updated.
Second, the vaccines have “hard-wired” people’s immune systems against the original strain, so they “churn out fewer antibodies that neutralize variants targeted by updated vaccines.”
Third, the antibodies that are produced wane quickly — within just a few months.
Finley outlined several recent studies as evidence, beginning with two studies in the New England Journal of Medicine (NEJM) showing that bivalent boosters did not produce significantly more neutralizing antibodies against the BA.4 and BA.5 variants than the original boosters.
The authors hypothesized that immune imprinting “may pose a greater challenge than is currently appreciated for inducing robust immunity against SARS-CoV-2 variants,” Finley explained.
In other words, a person’s first exposure to a virus shapes the outcome of subsequent exposures to antigenically related strains.READ MORE
