New ‘Bivalent’ COVID Boosters Are Here – With No Human Testing


    from 21st Century Wire:

    By Dr Meryl Nass

    On Wednesday, August 31, the FDA issued emergency use authorizations for new Pfizer and Moderna mRNA booster vaccines for COVID. The next day, September 1, the CDC’s advisory committee and CDC Director approved the immediate rollout of the new vaccines. They will be administered in the US starting this week.

    Fastest Vaccine Rollout in World History

    Surprisingly, more than a month before either agency had given its okay to the entirely new formulation, the federal government ordered 105 million doses from Pfizer and 66 million doses from Moderna.

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    The desired composition of the vaccine had only been formally determined by FDA after its advisory committee had met on June 24, 2022. The vaccines contain a mix of the old, original Wuhan strain vaccine mRNA (now also referred to as the ancestral vaccine) and a new omicron BA.4/5 mRNA coding for the omicron spike protein.

    The total amount of mRNA for the Pfizer and Moderna booster vaccines is the same as before: 30 mcg for Pfizer and 50 mcg for Moderna. Each is composed of 50% omicron mRNA and 50% ancestral mRNA, and they are termed bivalent vaccines.

    The new vials and their boxes do not list the dose, hinting that the decision regarding how much to use was made very recently. Even the members of the CDC’s advisory committee did not know the dosage of the new bivalent vaccines until their September 1 meeting.

    This is the fastest rollout of a new vaccine in world history. How did it happen? Instead of this being a tale of human grit and ingenuity, it is a tale of human weakness and recklessness. Let me ask again: how did such a rapid vaccine rollout occur?

    It occurred the only way it could possibly occur: by bending the rules, creating a new regulatory playbook and failing to obtain any human data for the new vaccines. The manufacturers did not have to go through months-long trials, and FDA did not have to pore over any human trial data, because there weren’t any. Let that sink in: the new BA.4/5 bivalent vaccines have only been tested in mice, not humans.

    Unexpected International Coordination

    Here is an amazing fact: On the same day that the CDC gave its approval to start the vaccine program, September 1, health agencies in Canada, Switzerland and the European Union’s FDA (the European Medicines Association) also rolled out new, bivalent booster shot programs. Almost simultaneously, the UK authorized 2 different bivalent boosters on August 15 and September 3.

    The UK has told people to expect the largest rollout in history for the new bivalent boosters. And it has started the program by promising large bonuses to doctors if they manage to vaccinate every single resident of a nursing home by October 23.

    These other countries are using an earlier omicron mRNA as the template for their omicron-ancestral bivalent vaccines, while the US is using the mRNA code for the later omicron variant BA.4/5 spike.

    How Can You Get Complete Information on These Boosters?

    How are the mainstream media telling this story? With their usual spin, avoiding the sticky parts. Instead of helping you understand what just happened, the New York Times asks, “When should you get yours?” Not should you get it, just when should you get it. The Herald Tribune tells you why you should get it.

    STAT News says it answers your questions, but it never asks the relevant questions about why such a rapid, unprecedented rollout occurred — especially when we are at practically historic lows for deaths and ICU stays due to COVID.

    The Associated Press did slightly better, at least posing the question of whether you should get a new booster. But then its answers don’t dig any deeper than its fellow media outlets.

    It looks like you won’t be getting the information you need to understand the boosters and the process by which they were ushered in from the major media.

    So the Defender has reviewed FDA documents, attended the all day CDC advisory committee meeting on September 1, studied a review of the boosters published in the New England Journal of Medicine on August 31, and evaluated a study of omicron boosters that were tested in non-human primates by Dr. Fauci’s Vaccine Research Center. We will provide you real science.

    What Did FDA Say About Its Emergency Use Authorization for the New Boosters?

    FDA did not convene its advisory committee before issuing the authorizations, and it is not hard to guess why. Last year, its advisors voted against authorizing the ancestral boosters, because the data they were given indicated the old vaccines were continuing to work well. Two top officials at FDA who disagreed with the 2021 booster rollout resigned, hinting that the decision to issue boosters had been imposed on the FDA.

    This year, FDA’s VRBPAC (Vaccine and Related Biological Products Advisory Committee) members have been complaining about being given less and less data as they are asked to sign off on vaccine programs for younger and younger ages.

    VRBPAC member Dr. Paul Offit, a professor of pediatric infectious diseases at the University of Pennsylvania and coinventor of a Rotavirus vaccine said last month that “the fix was in,” implying that the committee’s deliberations were a sham, because the White House announced it was purchasing the vaccine right after the meeting ended.

    Dr. Offit was quoted last week as saying the mouse data were not sufficient to roll out the new boosters. So FDA chose not to give him and the other members a public venue where they would predictably complain about FDA’s laxity — what some might call recklessness, insubordination or even gross malfeasance.

    After all, according to the FDA’s mission statement, FDA “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.” Not rubberstamping untested vaccines.

    The FDA justified its authorizations using language that was probably intended to confuse the public. Here are several examples.

    1.Everyone knows the term “safe and effective,” which is an official FDA stamp of approval for licensed drugs and vaccines. However, by law the term cannot be used by FDA to refer to unlicensed, experimental products, which is what all emergency use authorized drugs and vaccines are. So FDA tried to hint at the desired terminology without using it.

    In its press release on the new boosters, FDA used almost, but not quite identical terminology, quoting Dr. Peter Marks, the director of FDA’s vaccine center: “We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently.”

    2.Dr. Marks also said, “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.” Again, ‘safe and effective’ is implied but not exactly stated.

    3.What Dr. Marks expects the public to miss is the fact that there are no quality standards for emergency use authorizations (EUAs). The statute authorizing EUAs simply requires that the known and expected benefits outweigh the known and expected risks of the product. There are no quality requirements at all, and FDA is not even required to inspect the factories where EUA products are manufactured, as it must do for licensed products.

    Nor is it required to inspect the final product. So the FDA is fooling us when it claims the standards are rigorous. Furthermore, Dr. Marks and the FDA know that all EUA products have been granted an extremely broad waiver of liability that covers Dr. Marks, the FDA, CDC, HHS, the manufacturers, distributors, doctors, pharmacists, and everyone involved in the vaccine program.

    So they can tell us anything, because the public has no recourse to the courts to bring suit when an EUA product is involved.

    4.FDA justifies its assessment that the untested vaccines are safe using the following argument: “The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.”

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