And if earlier revaccination was recommended for certain groups of the population, now the official position of the CDC is as follows: people aged 50 (even if they are not at risk) and older, as well as residents of nursing homes and long-term care institutions vaccinated with an mRNA vaccine against Pfizer or Moderna “should” get boosted, and people aged 18-49 “may” get an extra third shot. Those who received a single dose of Johnson & Johnson “should” have a second vaccine two months later, regardless of age. Thus, remarks about the risk of infection at the workplace were removed from the recommendations for revaccination. In addition, boosters are not yet recommended for children under 18.
The decision was expected and therefore came as no surprise; another thing is interesting – how it was accepted. The issue of the need for mass revaccination was repeatedly discussed at the meeting of the FDA Vaccine Advisory Group (VRBPAC). In September, the possibility of receiving boosters for those vaccinated with the Pfizer vaccine was considered, in October – Moderna and Johnson & Johnson. Despite all the efforts, the White House administration and developers failed to convince experts of the need for mass revaccination: the FDA stubbornly limited it, allowing only certain categories of the population to do the booster. And it is these categories that were, until recently, spelled out in the FDA’s Extended Emergency Vaccine Authorization (EUA).
As a result, the situation was completely ridiculous from a legal point of view. Since vaccine providers (doctors, pharmacists, vaccination center workers) cannot require confirmation that the person wishing to be vaccinated again belongs to certain categories of the population, virtually everyone could have injected again.
In addition, in an attempt to stem the looming wave of new infections, the governors of Colorado, California, New Mexico and Arkansas, as well as the New York City Department of Health, even before the FDA and CDC decided to allow everyone to receive additional vaccinations. Governors of West Virginia and New Jersey have also called on adults in their states to get revaccinated.
The question of responsibility naturally arose. Because the FDA has extended the EUA to only specific populations, healthcare providers vaccinating everyone against federal guidelines could potentially face fines and lose protection from liability for adverse reactions.
How the decision was made
That is why it was urgently necessary to legitimize the receipt of boosters for everyone. Interestingly, there was no open meeting of the FDA on this matter, which is very strange. Of course, there have been cases before when decisions were made behind closed doors, but during the pandemic, all meetings at which COVID-19 vaccines were discussed were held exclusively live. Moreover, Scott Gottlieb was the first to state that the FDA would consider the issue of mass revaccination, who, by an amazing coincidence, almost always says what the federal authorities later officially announce. It is a pity that it is not specified in what capacity Gottlieb made this statement – as a former head of the FDA or as a current member of the Pfizer Board of Directors. At the same time, this topic was not indicated at all in the FDA meeting calendar!
Thus, the public was informed ex post facto that the FDA had included an additional injection in the EUA for all Americans. Such secrecy unwittingly gives rise to suspicion: have the FDA experts considered this question and have they really come to an unexpected agreement on the benefits of mass revaccination?
Then the matter was small: after the FDA expanded the action of the order, the CDC had to decide on the recommendations. The ACIP meeting was held live on November 19, but in a very crumpled mode. If earlier each issue related to the pandemic was discussed within 5-6 hours, then the decision was made in just three hours. In other words, it was clear that the meeting was already an empty formality.
Sam Posner, acting director of the CDC’s National Center for Immunization and Respiratory Diseases, said the decision would help healthcare providers and consumers by “simplifying the booster dose recommendations would reduce confusion over who should be boosted.” Sara Long, MD from Drexel University in Philadelphia, noted that the extra shot “does not harm and may (!) Even help,” although she added, “I think protection against transmission of the virus can only last a couple of months.” Other participants in the meeting agreed, noting that an increase in diseases was expected due to the holiday season.
As for the adverse reactions to the third injection, the representatives of the companies Pfizer and Moderna, who conducted the research, noted that most often people complained of severe fatigue and muscle pain. Lymphadenopathy (swollen lymph nodes) occurred in 2.7%, more in those who had the third injection with Pfizer than those who complained about it after the second injection. Nervous system disorder was noted in 3% of the volunteers.
According to the VAERS Adverse Reaction Tracking System data, people complained more about “side effects” after the second dose than after the third. Those who have already done the booster had more than 11,000 non-serious adverse reactions (these are now classified by the CDC as headache, fever, fatigue) and just over 600 serious (shortness of breath, fever, chest pain, asthenia and, finally, death). Most of the deceased were between 69 and 90 years old. 60 people died after the injection by Pfizer, 22 – by Moderna. But from the VAERS data it is impossible to say that people died due to the vaccine, it is officially listed as a “coincidence”.
As for myocarditis and pericarditis, there were 54 reports in VAERS, all after receiving the third injection from Pfizer or Moderna. The age of the victims was 38-67 years, the inflammation of the heart muscle developed within 1-7 days after the booster. Only 12 cases of this disease are recognized by the CDC as “vaccine-associated” (8 after Pfizer and 4 after Moderna, seven victims are white, 10 people required hospitalization). Based on these data, it was noted that the incidence of myocarditis is less after the third dose than after the second.
The Lancet published a study based on data from 1.4 million Israelis, which says that a third dose of Pfizer prevents symptomatic illness by 93%, hospitalization by 92% and mortality by 81%. The problem is that the initial two doses of this vaccine were also initially highly effective. And it is not clear how long this effect from the third dose will last – and whether the fourth injection will have to be given soon. ACIP noted the lack of statistical data, but threw up their hands: federal regulators cannot yet offer other methods of fighting the virus.
There are more questions than answers
The very fact of booster vaccination is nothing special – there are vaccinations that require two or three doses to ensure complete protection. Why, in this case, the issue with the booster was not discussed initially? According to Anthony Fauci, chief medical adviser to President Joe Biden and permanent director of the National Institute of Allergy and Infectious Diseases, the vaccine makers “did not have enough time to determine whether three doses would be better than two because there was an urgent need to start vaccinating people like as soon as possible. ” Thus, he, in fact, recognized the fact that the current immunization campaign is a big experiment, and scientists still have no definite answers. But if there is no clear answer, then why did the FDA fully approve the two-dose regimen for Pfizer’s vaccine, even though it was clear back then that vaccine effectiveness would diminish dramatically over time?
Celine Gounter, an epidemiologist and infectious disease specialist at New York University who advised the Biden administration team on COVID-19, confirmed that any additional protection can be temporary: society. And so the best protection really is the primary vaccination of the unvaccinated, not additional doses. ” But now how to persuade people to get vaccinated if they see that revaccination is already needed – and it is not known how many more such injections are to be done?
According to the CDC, as of November 21, only 59.1% of the population was fully vaccinated, so the authorities have already lost the battle for mass vaccination – largely due to their uncoordinated actions and premature statements that only confuse the public even more. And in fact, there were not so many people who wanted to be revaccinated: by now, 18% of Americans have already received an additional injection. Among seniors aged 65 and over, who were strongly advised by the authorities to get a booster, 40.6% were drunk.
It is quite obvious that in the near future the regulators will be pressured to expand the concept of “fully vaccinated” to include a booster – then this will allow the authorities and employers to demand from people to inject again. Our ubiquitous Scott Gottlieb already stated on November 21 that “CDC will probably eventually require the booster shot to be included in the protocol.” But change is unlikely to come this year because of the ongoing debate about booster doses for young people, he said.
Anthony Fauci, in turn, said that “the federal government is not currently changing the definition of fully vaccinated.” This still applies to those who received two shots of Pfizer or Moderna vaccine, or one shot from Johnson & Johnson. But it is clear that the former federal official, and now the representative of the manufacturing company, Gottlieb, will not speak again. In vain, perhaps, in the official COVID-19 vaccination card issued last year by the CDC, not two, not three, but four columns that need to be filled out – and there is still space on the back.