Friday, April 21, 2023

Some Americans Shouldn’t Get Another COVID-19 Vaccine Shot, FDA Says

A big change: The vaccines we have all been using are now de-authorized. Only the bivalents are now approved, despite there being little evidence of their effectiveness. Amazing. A "bivalent" targets more than one strain of the virus

Some Americans cannot receive another COVID-19 vaccine dose, U.S. regulators said on April 18, as they made sweeping changes to the vaccine system.

The U.S. Food and Drug Administration (FDA) announced the changes, including replacing the old Pfizer and Moderna vaccines with updated bivalent shots that had previously only been available as boosters.

Regulators are also scaling back the number of recommended doses for most individuals, including people who haven’t received a shot.

Key changes include:

Most unvaccinated Americans are still being encouraged to get a COVID-19 vaccine but only need a single dose of a bivalent, the FDA said. The exception is young children. Children aged 6 months through 5 years can receive two doses of Moderna’s bivalent while those aged 6 months through 4 years can get three doses of Pfizer’s bivalent.

Americans who have received a primary series of a COVID-19 vaccine and one of the bivalent boosters still cannot get an additional dose, unless they’re in certain groups.

Any individual 65 years old or older can receive a bivalent dose, even if they’ve already received one, provided four months or more has elapsed since their last shot.

People aged 5 and older and deemed immune compromised can get another bivalent at least two months after their last shot, even if it was a bivalent, and can get additional doses “at the discretion of, and at intervals determined by, their healthcare provider.”

Little Data to Support Bivalents

The FDA authorized the original vaccines in late 2020 based on clinical trial efficacy data. The original vaccines targeted the Wuhan virus strain, which hasn’t circulated since 2020.

The updated bivalents target the Wuhan strain and the BA.4 and BA.5 subvariants of the Omicron strain. The subvariants were displaced in 2022.

Regulators authorized the bivalents as boosters in 2022 despite no clinical trial data being available. In letters formally announcing the bivalents as replacing the old vaccines, the FDA made clear that scientists aren’t sure whether the bivalents protect against COVID-19.

“Based on the totality of the scientific evidence available, FDA concluded that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine, Bivalent may be effective in individuals 6 months of age and older for the prevention of COVID-19,” the letter to Pfizer states. The same language was used for Moderna’s shot.

Most of the data supporting Pfizer’s expanded authorization comes from the old vaccines and a bivalent that has never been used in the United States. The only trial data for the available bivalent showed that children had higher levels of neutralizing antibodies when they received a bivalent. Antibodies are thought to protect against COVID-19.

No clinical trial data for Moderna’s shot was cited, and no efficacy data was cited for either vaccine.

Dr. Peter Marks, a top FDA vaccine official, claimed in a briefing that “the available data continue [to] demonstrate that vaccines prevent all serious outcomes from COVID-19, including hospitalization and death.” It’s not clear which data he was citing, and the FDA did not respond to a request for comment.

The FDA cited a single observational study in its letter to Pfizer. English researchers reported in The Lancet that vaccination with an old vaccine in addition to previous infection provided strong protection against symptomatic COVID-19 through March 2022. Other research has found that prior infection alone is as good as or better than vaccination.

Other observational studies have found the updated vaccines provide transient protection against hospitalization and poor protection against infection.

Seroprevalence data indicates a majority of Americans have recovered from COVID-19, the FDA noted. That’s an important acknowledgement, Dr. Monica Gandhi, a professor of medicine at the University of California–San Francisco, told The Epoch Times in an email.

Gandhi said she agrees that only the elderly and immune suppressed should receive another dose, as opposed to the entire population. Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, said that he sees the vaccines as largely unnecessary.

“The current vaccines are out-of-date, any new ones will be out-of-date by the time they are generally available, and mostly everybody already has SARS-CoV-2 antibodies anyway,” Risch told The Epoch Times via email. “At this point, the vaccines are thus not generally useful products for serving a public health function.”

Change Made to Boost Uptake

Uptake of the vaccines was high after they were authorized, but has dropped considerably since. Just 16.7 percent of the U.S. population has received a bivalent shot, compared to 69.4 percent who received a primary series of the old vaccine.

FDA officials said the changes announced on April 18 were made to simplify the vaccine composition, reduce the complexity of the available doses, and increase uptake.

“This approach will help us achieve higher vaccination coverage across the country,” Marks told reporters. “If anything comes out of this action, we’re hoping that it can encourage people who have not received the bivalent booster to go out and consider getting one.”

The newly rolled out system is for the spring, as officials are planning to meet over the summer to discuss a fall regimen. They plan to adapt COVID-19 vaccines to the influenza model, updating strains in the vaccines each year.

Advisers to the agency backed the pivot to bivalents in a January discussion. Some said they favor updating the strains in the future.


Prominent AIIMS Physician-Scientist Suggests COVID-19 Booster Shot May Do More Harm than Good

A physician with India’s All India Institutes of Medical Sciences (AIIMS), New Delhi, a group of autonomous public medical universities of higher education under the jurisdiction of Ministry of Health and Family Welfare, went on the record for Indian media recently that for those that have already been infected by SARS-COV-2, the booster may “do more harm than good.” However, he didn’t elaborate on the basis for that statement. With rising numbers of COVID-19 cases in India, Dr. Sanjay Rai recently expressed his opinion that despite the fact that many experts are advising the COVID-19 booster, at this point during the pandemic, the booster may do more harm than good. The context is a rising COVID-19 infection rate in India but also in other Asian nations such as Japan, China, and South Korea. TrialSite’s founder Daniel O’Connor also had a fascinating discussion with Dr. Rai, who pointed to mounting evidence plus decades of public health science as backing his position. He also referenced that in addition to the 11 COVID-19 vaccines currently under emergency listing by World Health Organization (WHO), at least another 382 such products are listed by WHO in either clinical development or preclinical development. He pondered what could be driving such an enormous product development push?

Rising cases

According to multiple media and the Indian government, cases of COVID-19 have surged in India, with over 10,700 cases reported; 1,500 more cases were registered in New Delhi, with a purported infection rate at 33%. See a breakdown of India cases (and other data). Clearly, the number of cases is minuscule compared to previous waves. Hence the advisory for all to get the booster if they have not been vaccinated within a certain period of time based on the current Indian schedule.

A critical point of view

Yet Dr. Sanjay Rai, an AIIMS Hospital professor of Community Medicine in New Delhi, shared his opinion recently that the booster dose may not be advised, as reported in India Times Healthworld.

“Due to the mutation in the RNA virus, the cases will continue to increase and decrease. The situation will continue like this in the coming times as well. There is no need to panic about this. The people that will get infected with the new variants will create new immunity. But despite all this, the more important thing is whether the severity, hospitalization, or the death rate is increasing.”

He continued, “In the initial phase of COVID, when people were not infected in large numbers, people did not have herd immunity, then they needed more vaccines. But now, almost all the people have herd immunity, then they needed more vaccines. But now almost all the people in the country have been infected, after which natural immunity has been formed in them. This is more effective in protecting against any virus than the vaccine. Also, we cannot stop any new web with the vaccine, it only reduces death and severity. Giving more steroids to prevent infection may do you more harm than good.”

Further discussing the topic of natural immunity, Dr. Rai pointed to a growing body of research backing his position on natural immunity.

“And you have been protected from death and severity for a long time. At present, both corona and influenza are infecting people. Influenza is a viral infection that comes every year and infects people according to season. How effective will the booster dose of the vaccine be? No research has come to the fore regarding this. Only on the basis of possibilities we cannot say that booster dose will be beneficial for people at this time.”

Heavily vaxxed societies

Dr. Rai points out to heavily vaccinated societies such as Japan, where the cases of SARS-CoV-2 continue to come and go and come again.

“All these countries have been highly vaccinated, Japan has got 4 doses of the vaccine, yet the corona infection was once again spreading very fast there. COVID-19 spread rapidly even after vaccination in these countries because they kept zero COVID-19, people did not have natural infection due to which people got infected even after being vaccinated.”

Emphasizing the superiority of natural infection to vaccine-induced protection—not a discussion that will be as freely discussed in North America—the key point is that if a person hasn’t been infected then they should get vaccinated.

Rai continued:

“There is no research on how effective the booster dose will be if you are already infected. And if this new variant is infecting you by bypassing natural immunity, then it can also bypass the vaccine and infect you.”

TrialSite discussion

TrialSite had a brief discussion with Dr. Rai, who was familiar with the media platform. The AIIMS physician-scientist informed Daniel O’Connor that his position is based on the accumulation of evidence in clinical trials and real-world data over the past three years of the pandemic. Dr. Rai shared that the SARS-CoV-2 and COVID-19 aren't new now—“We have a lot of data, and that must truly be evidence-based, not acting out of a fear-based impulse.”

Rai emphasized that he has conducted at least ten COVID-19 vaccine clinical trials, including a booster study in India. He is very much pro-vaccine and simply is following what he knows is as the standard science and sound public health principles he has learned throughout his career.

The AIIMs doctor suggested a comparison with polio or smallpox, pointing to very good, stable sterilizing vaccines with the current COVID-19 reality. For example, Rai pointed to the World Health Organization (WHO) tracker with 11 vaccines granted emergency listing with 183 vaccines in various stages of clinical development and even another 199 vaccines in preclinical development.

Again, comparing the polio and smallpox or measles and mumps vaccine reality with COVID-19, with at least 382 COVID vaccines in either clinical or preclinical development, Rai suggested there could be other vested interests driving such a reality. See the WHO COVID-19 vaccine tracker.

Dr. Rai pondered aloud in the discussion, “What kind of vested interests are behind this global product development push?”

On to the endemic reality
The AIIMS doctor continued to emphasize that what Indian society (and other places around the world) are now dealing with will go on forever. So, assuming he is correct (and this media cannot be certain one way or another), this means that much like the flu, COVID-19 is here to stay.




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