US Health Regulators: No New Clinical Trial Data Needed for New Vaccines


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.

They’re comfortable with that.


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.


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.

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1 year ago

“US Health Regulators: No New Clinical Trial Data Needed for New Vaccines” because they already know its poison and are pushing it anyway. That’s the whole point!

Harrison Pendleton
Harrison Pendleton
1 year ago

Whatever these vaxx “companies” do or not parents of youngsters must keep in mind THEY are the caregivers and overseers of their kids and NOT these big-profit corporations.

1 year ago

US Health Regulators should spend the rest of their lives in prison. The Death Penalty is too good for them!

Harrison Pendleton
Harrison Pendleton
1 year ago
Reply to  GuvGeek

They’re regulators who guide their profits into their own accounts. The matter of anyone’s “health” is far from them.

Judyann Joyner, RN
Judyann Joyner, RN
1 year ago

It would not matter if there were more clinical trials.

If clinical trials would make any difference What-So-Ever, the COVID mRNA vaccines would have been BANNED before mass vaccinating ever began.

The very reason Pfizer (et al) sought to HIDE results of mRNA vaccines for 75 YEARS is because the results of those trials were DEVASTATING.

Real, HONEST scientists have been trying their might to level many warnings to the WORLD over the past year and half., Among those warnings, the WORST thing we could possibly be do is to VACCINATE into a pandemic.

When there is a viral outbreak, it is NORMAL for that virus to eventually create variants. However, during the normal course of events, those variants take a considerable amount of time. And each subsequent variant becomes a weaker semblance of its former self. Vaccines have put the virus’ creation of variances on a fast track. Couple that with vaccines, themselves, WEAKENING the natural immune systems and what results is EXACTLY what we are seeing.

The most vaccinated country in the world, Portugal, is having the WORST Covid outcomes right now. The notion of, “vaccinated the super-spreaders,” has been CONFIRMED, but this is NOT what will be presented to the public.

Those who actually READ, do their own research, will come to the very obvious conclusion: The COVID pandemic could NOT HAVE BEEN MORE POORLY, DANGEROUSLY managed. Any rational person could only conclude, this MUST be by design.

Many believe that, “design,” has been to cull millions of the world’s population. One need only look at the results to come to this conclusion. That and those megalomaniacs driving the worldwide, brainwashing referring to the general populous as, “Useless Eaters.”

This HAS become a pandemic of vaccinated super-spreaders. Those experiencing best outcomes are those who, despite THE most aggressive WORLDWIDE BRAINWASHING campaign in the history of mankind, managed to escape, “The Jab,” and the destruction of their innate immune system.