Moderna shot boosters Unanimously approved by FDA panel
The advisory committee met on Thursday, 10/14 to discuss the issue of Moderna boosters for the public
The committee voted 19–0 after presenting and discussing for hours in a virtual meeting.
Moderna based any pro-booster data presented of a small trial that studied the safety and effectiveness of a booster shot, mirroring Israel, the infamous “lab of the world”, as titled by some officials. The FDA conducted an analysis of Moderna’s data but didn’t support or oppose the company’s request for an emergency use authorization expansion.
Moderna’s trial, consisting of just 171 people who received the regular primary set of shots, and a half-dose booster, showed a smaller amount could still bolster protection against virus infection.
Officials discussed how data from other trials signal that the vaccine is holding up against severe disease, but that there’s been falling efficacy against infection, particularly after the Delta variant became widespread in the United States.
Some panel speakers showed up skeptical on widespread boosters, looking to the small number of people who got another shot and were studied and highlighting how some populations, including young, healthy people, don’t seem to need another shot.
“I’m not wild about a bunch of 20-year-olds going out and getting a booster dose unless they’re at increased risk of either exposure or severe outcome,” Dr. Mark Sawyer, professor of clinical pediatrics at the University of California–San Diego School of Medicine and a temporary panel voting member, said before the vote.
Other statements included:
“If we can’t defend these recommendations based on evidence, it’s going to further complicate getting this vaccine into every single adult American, and that’s really what we want to do,” Meissner said.
Dr. Patrick Moore, a temporary voting member and a professor at the University of Pittsburgh Cancer Institute, said his vote was based on “more of a gut feeling” than serious data.
“We already approved it for Pfizer. I don’t see how we can possibly not approve it for Moderna and not have most U.S. folks be completely confused. I know that’s not part of what we’re supposed to think about, but I think it’s a pragmatic issue,” said Dr. Stanley Perlman
The CDC and Prevention advisory panel will end up making the final decision on who should get a Moderna booster, Sawyer said, though it’s in danger of being overruled by the agency’s head, like with Pfizer’s supplementary shot.
Federal agencies, as the sponsors of these programs being in charge of making these decisions and rulings, is a major conflict of interest, particularly in the case of Moderna, as there is evidence to support the case of the NIH holding joint ownership of the product, together with the company. The medical therapies, or Vaccines, as publicly called for legal reasons, were developed in partnership with Moderna.
In 2016, federal scientists in partnership with academic researchers developed a new way to stabilize coronavirus spike proteins. The approach required substituting two amino acids, known as prolines, between the central helix and heptad repeat(“the 2P approach”). The stabilized spike protein for an earlier coronavirus produced a stronger immune response at lower doses than the naturally occurring protein. The scientists filed a patent application. The patent application, in relevant part, claims:
Stabilized proteins produced using the 2P approach across a group of coronaviruses (Claims 1 and 5);
Nucleic acid molecules (e.g., RNA) encoding those proteins (Claims 39-41); and
Methods for generating an immune response and inhibiting infection with the coronavirus (Claims 45-49).
Moderna describes mRNA-1273 as an “mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein.” The vaccine uses the 2P approach to produce stabilized spike proteins. The patent owners could eliminate Moderna from using the invention. The application lists numerous inventors at the National Institutes of Health, along with other researchers. The application states that it is owned by the U.S. government, Dartmouth College, and the Scripps Research Institute. If the patent is granted, then the NIH likely has an ownership stake.
The Epoch Times helped contribute to this post.
-TamiCam