U.S. health regulators will not require companies to submit new clinical trial data on COVID-19 vaccines that target the now dominant BA.4 and BA.5 Omicron subvariants to authorize those shots, but will instead rely on studies showing the efficacy of targeting the earlier BA.1 subvariant, a top official said on Thursday, as reported by Reuters.
Dr. Peter Marks, a senior official overseeing vaccines at the U.S. Food and Drug Administration, told Reuters the agency would also consider manufacturing data specific to a BA.4 and BA.5 vaccine, and that preclinical data from animal studies and safety data for those shots could also be available.
Preclinical Animal Data!
The FDA on Thursday recommended COVID-19 vaccine manufacturers Pfizer Inc/BioNTech SE and Moderna Inc change the design of their booster shots beginning this fall to include components tailored to combat BA.4 and BA.5. It plans to review them for emergency use authorization.
“It’s very similar to what we do with influenza strain changes where there will be a couple of amino acids difference, but we don’t expect any difference in the safety that we’re going to see,” Marks said.
He said he expects the immune response to the BA.4/5 booster shot to be similar to that seen with BA.1.
“We’re very comfortable doing this because it will help us get ahead of things,” Marks said.
We don’t need no clinical data! But Dr. Fauci said that was vital when we tried to push treatments instead of vaccinations.
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They’re comfortable with that.
BA.1 IS DIFFERENT FROM BA.4 AND BA.5
BA.1 no longer presents a problem and BA.5 is very different from BA.1.
Take BA.1, BA.2, and BA.3 as examples. The three sublineages share 39 mutations, which we include as the presumptive “Omicron parent.” The Omicron parent diverged into the Omicron family: BA.1, which contains an additional 20 mutations; BA. 2, which includes an additional 27; and BA.3, which consists of an additional 13.
“BA.1, BA.2, and BA.3 differ from each other as much as the Alpha, Beta, Gamma, and Delta variants differ from one another. Several mutations differ between the three as well. We suspect that these differences will be reflected in the septic characteristics of each variant affecting growth rate, suppression of innate immunity, virulence, and vaccine evasion,” says David Hazeltine, health contributor at Forbes.
7) What’s the data look like on weaker protection against #BA4 and #BA5 if you had previous BA1 original #Omicron? new results from @sigallab show that “previous infections with BA.1 will not be sufficient to prevent a second infection with BA.4 and BA.5.” (lab neutralization) pic.twitter.com/MV7k0nGt8P
— Eric Feigl-Ding (@DrEricDing) May 2, 2022
BA.4 AND BA.5 ARE DIFFERENT AGAIN
While BA.4 and BA.5 share some of the same features as the previous strains, they are different, much as each cold is different. Chasing a vaccine for each mutation is like chasing ghosts, so they just won’t bother with the clinical data.
At least one study points to the ineffectiveness of vaccines and natural immunity. However, some studies indicate that vaccines have more value than natural immunity.
One study indicates that BA.4 and BA.5 appear to escape antibodies from vaccines and prior infection.
Experts from UCSF and Stanford explain.
“Even if you had some immunity from prior infection like BA.1 you are still at high risk of getting reinfected with these variants. They potentially find a way around immune response also in cause of infection. This is why they outcompete the dominant strain. Because they are more transmissible and can get around the immune system,” said Abraar Karan, Infectious Diseases at Stanford University.
Another study suggests BA.4 and BA.5 may target the cells in our lungs.
There is also a possibility that the vaccines are causing the spread. The vaccinated could be the super spreaders. There are some suggestions for that.
In the end, the regulators, the experts, and the drug companies lie to us. If we don’t have clinical data, what does that mean for the vaccines?
Vaccinations don’t stop the spread and they don’t stop people from catching COVID-19. We were told something else. There are serious adverse effects for thousands of people.
Addendum: the vax does not stop people from catching covid. Powell’s explanation continues this government’s policy of stigmatizing the unvaxxed to avoid self reflection about its own policy errors.
— Jay Bhattacharya (@DrJBhattacharya) July 2, 2022
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