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.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 tpohe 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?
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.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.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.
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.
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.
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.
This is the same as claiming that almond butter is safe, so peanut butter is safe too because it is manufactured using the same process. Is that really the best excuse for failing to perform its regulatory functions that FDA can offer?
What Happened at the CDC ACIP (Advisory Committee on Immunization Practices) Meeting on September 1?
CDC knew that it would have a hard time convincing the public to take these vaccines, since almost everyone has already had COVID, the earlier vaccine benefits were overpromised, the disease has become milder, the vaccines do not prevent infection or transmission and the fearfulness around COVID is mostly gone. Therefore, CDC needed to employ new strategies.One strategy was to invoke the ‘bandwagon effect.’ You try to convince the public that everyone else is getting the shot, so they too should jump on the bandwagon. A poll was presented at the ACIP meeting that claimed that 72% of people that were eligible planned to get the new boosters.
CDC says that 224 million Americans are ‘fully vaccinated.’ The ACIP members were told that of this number, 210 million are already eligible for the new boosters. The government has bought 171 million bivalent booster doses so far (105 million from Pfizer and 66 million from Moderna) which can be used for those aged 12 and up.
FDA and CDC have yet to allow the rollout of new bivalent boosters for children under twelve, who have in the past received lower dose COVID vaccines than adults. But the agencies said they plan to do so within weeks.
Another testy issue for the ACIP committee was the question of how long these boosters will work, and how frequently they will be recommended. The ACIP members are responsible for giving advice on all vaccines, and they don’t want the COVID vaccines to sour the public on other vaccines.
How Long Will It Work?
According to this week’s NEJM article,“increased neutralizing antibody titers, as well as clinical effectiveness, have been shown to wane by four months after a third messenger RNA immunization. After a fourth messenger RNA immunization, protection against infection with SARS-CoV-2 omicron has been reported to wane after just 4 weeks, although protection against severe disease lasts longer.
Hybrid immunity from both vaccination and infection provides greater and more durable protection than either alone.”Four weeks! Antibody titers sink 4 weeks after the 4th dose. No wonder CDC is allowing, and may encourage, such frequent boosters.
How Was This Rollout Justified?
Omicron variants have been present since last November, and it was soon discovered that both vaccine-induced and natural immunity due to earlier variants were very limited for omicron variants, because they are so different from the ancestral strain. The health agencies and manufacturers have been testing omicron vaccine prototypes for up to 9 months.Most of those tests involved BA.1 and BA.2 omicron strains. However, 90% of current cases are caused by omicron BA.5, which is genetically far from BA.1 and BA.2.
But there was some human data (involving a few hundred subjects each) for several of the earlier omicron vaccine prototypes, so the health agencies decided to simply pretend that mRNA designed for BA.1 and BA.2 was close enough to BA.5 that the data were comparable.
Since 50% of the vaccine contents would be the old vaccine, FDA claimed it had already established the safety and efficacy of that half. Then, to round things out, there were data from mice, which generated comparable antibody levels to the new vaccines as they had to older vaccines. And of course, we can rely on mice to behave exactly like people, right? After all, they have been ‘humanized’ to contain a human ACE-2 receptor.
Having Discussed How Long This Booster Might Last, One Needs to Ask How Well It Might Work
Predictions from Nature magazine and Dr. Fauci’s NIAID Vaccine Research Center (VRC) at the NIH are that the new vaccines will not improve on the old vaccines.Neither of these studies was discussed at the ACIP meeting. No discussion was provided regarding why and how the bivalent vaccines were chosen.
The reason why the omicron vaccines won’t stimulate a good omicron response is attributed by the NIAID VRC authors to antigenic priming, also known as original antigenic sin. This means that the immune system has been programmed to respond over and over again to the first coronavirus infection or vaccine it encountered, even when it encounters different coronavirus antigens later.
Negative efficacy means that the vaccinated are more prone to being infected with COVID than the unvaccinated. This is consistent with what we are seeing from the UK and some other countries: the vaccinated become more likely to get COVID. And it is this effect that the public health agencies are probably trying to stave off, or hide, with perpetual boosters.
How Safe Are the New Vaccines?
That is anybody’s guess, because you cannot assess human safety from animal models, since they don’t predict the human response. What was done to evaluate the safety of the bivalent vaccines?Reactogenicity
Reactogenicity is a word that refers to short term vaccine adverse reactions, like fever, redness, fatigue or muscle aches. According to the CDC briefers, the degree of reactogenicity from the omicron prototype vaccines was comparable to that from the older, ‘ancestral’ COVID vaccines.There were no data on more serious side effects, and Dr. Shimabukuro of CDC said there was no way to assess the risk of myocarditis due to the small number of subjects who received the prototype vaccines.
Myocarditis
Presenters to the ACIP claimed that myocarditis was less common after booster shots of the old vaccine than after the second dose of the initial series. However, slide 39 shown by Dr. Shimabukuro, which was quickly passed over, showed the opposite. For 16-17 year-old boys and girls, and for men aged 30-39, the chance of myocarditis was increased after a booster. (See below.)Getting vaccinated soon after recovering from COVID is foolhardy, and any officials mandating the shots after recovery are putting those in their charge at even greater risk of adverse reactions, including myocarditis.
An ACIP member asked whether the Jynneos monkeypox vaccine, which can also induce myocarditis, could be given together with the new bivalent vaccines? Would this increase the myocarditis risk? The surprising response was, “Read the briefing book,” which may have meant that this was not to be discussed in public.
Speaking of what could be discussed in public, any discussion of pregnancy and COVID vaccination was forbidden at the ACIP meeting. Multiple committee members asked for information on pregnancy, but the briefers steadfastly refused to provide any. Nothing on hospitalizations, deaths, fetal outcomes.
The ACIP members were told they would be briefed on this at a future meeting. Dr. Miller, representing Moderna, said they were in the process of enrolling a total of 800 pregnant women in a study. Which would someday be completed. The only conclusion I can draw is that the CDC doesn’t like the results they have now. And they plan to delay providing them to the public for as long as possible.
It is difficult to justify why FDA would ask for these studies to take so long. Was FDA requesting such long study durations in order to delay its vaccine safety assessment until after the vaccines are no longer in use?
Long COVID
The committee was also interested in long COVID. Might the vaccines prevent this dread complication? CDC was mum. The CDC briefer claimed that CDC does not have “systematic data” on long COVID. Nor has CDC developed a case definition for long COVID. Why has CDC delayed investigating this critically important complication?You are not going to find a more public indictment from the NY Times of our Centers for Disease Control than that.
Does vaccination fail to prevent long covid? Does it cause long covid? FLCCC founder and esteemed intensive care physician Dr. Paul Marik has postulated that both long COVID and many COVID vaccine injuries are due to the same thing: the prolonged presence of spike proteins in the circulation.
FDA Revoked All Pfizer and Moderna Emergency Use Authorizations for the Old Boosters on August 31
This was sudden and unexpected. Appointments had to be cancelled, because starting on August 31 the old vaccines were limited to use in only young children or for the initial series. The FDA did not withdraw or recall the licensed Comirnaty and Spikevax vaccines, which have also been approved as a booster dose. Is this a tacit acknowledgement that there is no licensed Comirnaty or Spikevax available in the US?Might the FDA have rolled out the new vaccines so quickly to justify removing most of the old vaccines from use, soon after reports began circulating about their contents containing undisclosed and possibly harmful materials?
Conclusions
- The FDA and CDC have cooperated to issue emergency use authorizations 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.
- There is no evidence that the new vaccines are safe, while there is limited evidence that they may be more harmful than earlier COVID vaccines — but in the absence of human testing, there is no way to truly predict their safety. Safety data are being concealed by the federal health agencies. Messaging by them is misleading.
- There is no evidence the new bivalent vaccines will be more effective than the older vaccines, and existing evidence suggests that any efficacy they provide will persist no longer than 1 to several months.
- COVID vaccines appear to increase susceptibility to COVID infections, on average starting 6 months after an inoculation.
- Perpetual boosters briefly stave off the negative efficacy that develops a few months after a COVID vaccination. This may be why frequent boosters are being pushed. But frequent boosters may also weaken overall immunity and may even contribute to rising mortality rates in the US and UK.
- There is international coordination regarding bivalent boosters, and a major effort will be undertaken to get them into arms, despite historically low levels of severe COVID. Why?