Safety and Effectiveness of New COVID Bivalent Boosters Based on a Study of Eight Mice?

Safety and Effectiveness of New COVID Bivalent Boosters Based on a Study of Eight Mice?

With no safety and efficacy evidence from human clinical trials, on Aug. 31, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for Pfizer/BioNTech’s Comirnaty and Moderna/NIAID’s Spikevax messenger RNA (mRNA) COVID-19 biologics to distribute “bivalent formulations” (two-in-one) of the shots to use as a “single booster dose.”1 2

The so-called “updated boosters” contain two mRNA “components” of the SARS-CoV-2 virus—”one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the Omicron variant of SARS-CoV-2.”1 2

The FDA authorized Moderna/NIAID’s COVID Bivalent shot for use in individuals 18 years of age and older and authorized Pfizer/BioNTech’s COVID Bivalent for those 12 years of age and older. With this new EUA, the original “monovalent” versions of the Moderna/NIAID and Pfizer/BioNTech mRNA COVID shots will no longer be distributed as booster doses for individuals 12 years of age and older.1 2

FDA Evaluated Data from One Clinical Study on Eight Mice

According to the FDA, it “evaluated immunogenicity and safety data from a clinical study of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1.” The agency stated that it considered the data as “relevant and supportive” of the biologics “containing a component of the Omicron variant BA.4 and BA.5 lineages.”2

What the FDA failed to mention, however, is that the data from that single clinical study was obtained from mice. Eight mice, to be precise. There were no human trials.

“Both shots have yet to complete human trials,” noted a recent CNBC article. “The FDA based its decision off real-world evidence of existing COVID vaccine safety, plus clinical trial data of earlier bivalent vaccines targeting older forms of Omicron and current lab data on the BA.5 shot in mice.”3

Mouse Data Does Not Mimic Reactions in Humans

In response, John Moore, PhD, professor of microbiology and immunology at Weill Cornell Medical College, wrote:

To rely only on mouse data (for authorization) would be unprecedented in my knowledge and would certainly raise eyebrows. It doesn’t mimic the human situation.4

Additionally, Dr. Moore pointed out that the FDA was is also bypassing the normal protocol of earlier COVID shot reviews and not having a meeting of advisers who make recommendations on whether the agency should authorize a vaccine.4

On Aug. 31, Johns Hopkins University medical professor and National Academy of Science member Marty Makary, MD, MPH wrote:

FDA will likely authorize the Omicron vaccine later today/tomorrow based on data from 8 mice and no human clinical data avail to the public. Americans deserve to see the data. Why is the White House/Dr. Jha pushing it so hard & universally w/o public data?5

No Time to Wait for Results of Human Trials

The reason for this “fast-tracking” of the COVID Bivalent shots was explained by Rochelle Walensky, MD, director of the U.S. Centers for Disease Control and Prevention (CDC), who said:

If we wait for those data to emerge in human data, not just mice data, we will be using what I would consider to be a potentially outdated vaccine. And maybe it’s best, and I believe it is best, to use a vaccine that’s tailored for the variant that we have right now.3 6

So the strategy now is to tailor vaccines for giving us the largest breadth of response. Ideally one that would have less waning over time, and that is by targeting what I would say is the most proximal variant, the one that we have closest to us, which is BA.4 and BA.5. And I believe there’s significant upsides to doing that with this updated bivalent vaccine and very little downside in doing so.6

In a time of… We could either be too slow or too fast, I really would love to be ahead of this variant this season.6

In other words, the U.S. government simply may have felt it didn’t have the luxury of waiting for clinical data on humans because the fall “flu season” is fast approaching and there are predictions that the season will also bring on a surge of COVID cases, making for a potentially nasty “twindemic.”7

Some are pointing to upcoming U.S. mid-term elections in November as a reason for the rush to put a new COVID booster on the market without safety and efficacy data in humans so government health officials can reassure the public that the re-worked shot will cut down on the significant number of breakthrough COVID cases being reported in fully vaccinated and boosted people. Epidemiologist Vinay Prasad, MD, MPH tweeted:

If u have election in Nov, u’d approve anything to lower cases right before the vote. Who cares about safety/ severe dx5

Both Moderna and Pfizer are currently conducting clinical studies on humans, but the results of those studies are, reportedly, not due to be released until October or November. By then, millions of Americans will have received the COVID Bivalent boosters… in essence, making them the actual test cases for these experimental products.8


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Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers.  The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.

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5 Responses to "Safety and Effectiveness of New COVID Bivalent Boosters Based on a Study of Eight Mice?"

  1. Tom   September 13, 2022 at 10:10 am

    It’s a miracle that the FDA even required ANY mice.

    Reply
  2. Brian James   September 13, 2022 at 5:42 pm

    SEPTEMBER 9, 2022 Watch Out for The New Covid Injections There’s Nothing Good About Them

    The US FDA and CDC have co-operated to issue emergency use authorisations and rollout new, bivalent Pfizer and Moderna Covid vaccines this week, without any human trials, which is unprecedented.These vaccines continue to enjoy extraordinary protection from liability, while the recipient has no access to the legal system in the case of injury.

    https://expose-news.com/2022/09/09/watch-out-for-the-new-covid-injections/

    Reply
  3. Jo   September 13, 2022 at 7:20 pm

    The lost Exec. Branch unelected, gov.union, alphabet Agencies, receiving gov salaries AND huge provisions from the Medical Industrial (CONgressional) Complex, are afraid to continue injuring well-over a million and killing over 30,000 humans, in order to continue getting double or triple paid, who are not clowns—rather, serial killers; were willing to substitute yet-more new, untested vaccines, to kill off EIGHT MICE, including Mickey, Minnie, Millie, Melody, Morty, Ferdie and the other biggest money-makers—who will this time Not be re-issued, every five years.
    AND THE NEW MEDICAL PLAN REMAINS: NO AUTOPSIES, as seen the last two years (shhhh).
    _ Mainstream & social media are also paid-off /owned by BigPig Pharma; thus, no journalism can reach We The Poor People—if any journalists can be found.

    Reply
  4. Pam   September 14, 2022 at 9:44 am

    From the article on using 8 mice as evidence of the safety of covid shots, I reiterate the quote: “Both Moderna and Pfizer are currently conducting clinical studies on humans, but the results of those studies are, reportedly, not due to be released until October or November. By then, millions of Americans will have received the COVID Bivalent boosters… in essence, making them the actual test cases for these experimental products.8” End of that quote.

    For the supposed millions of adults receiving this new vaccine, it is incumbent upon them to do their research and decide if they want to be one of the many new lab mice who will be used to test this vaccine. Sadly, many of them cannot even rely upon the advice of their own doctors anymore. Still, everyone should have the right to make up his/her own mind. If you want to be a test subject, you get the good, the bad, and the ugly results. Your call, lab rats. But NEVER force our children to become one of those lab rats. That is akin to a medical form of child abuse. Perhaps we need a new term for forced covid vaccinations: VAX RAPE.

    Of course, the drug makers will make lots of money while getting free test cases; and there will be no real accounting of side effects or deaths. What a perfect scenario for Big Pharma. Every mRNA shot you accept is telling Big Pharma and our unethical agents in the CDC and FDA you trust and agree with their pronouncements. Evil prospers when good men do or say nothing.

    I applaud all those doctors, scientists and journalists who are brave enough to go after the real data and evidence. To speak up even when they know the consequences to their lives and reputations. Long time ago, I seem to recall there were far more of those good people speaking out against various forms of tyranny. Speak truth to power–Always.

    Reply
  5. Data Detective   September 22, 2022 at 9:19 pm

    Ware is the data?
    Are all 8 mice still alive and healthy?
    How effect is it?
    How did the 8 mice get exposed?
    How long does the vaccine last?
    Which previous COVID 💉☣️ did the mice revive?
    How old are the mice?
    What dosage did the mice receive?

    Reply

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