US Health Agencies Setback Intensifies Over Handling COVID-19 Vaccine Boosters


Push back the first two to the United States health agencies thrives on how officials handled compensation and recommendation COVID-19[female[feminine vaccine boosters.

The Food and Drug Administration (FDA) last month, authorized boosters of the three vaccines available in the United States for all adults were authorized. Soon after, the Centers for Disease Control and Prevention (CDC) recommended that any American 18 years of age or older receive a booster, regardless of a previous infection or underlying health issues.

Then, earlier this month, regulators authorized a recall of Pfizer’s shooting for 16 and 17 year olds.

Agencies failed to convene their vaccine advisory committees before making major decisions, causing a setback.

Philip Krause and Luciana Borio, two former senior FDA officials, said in a recent editorial bypassing panels means that “the costs and benefits of these policy measures, from a medical point of view, have not been fully publicized and discussed in advance.”

“At this point in the pandemic, the world faces a multitude of new vaccine and recall issues. The recommendations of the experts of the external advisory committees are needed more than ever – so that the scientific community can understand the empirical bases of decisions and the public can be assured that science, not politics, is the engine of vaccine policy ” , they added.

An FDA spokesperson told The Epoch Times in an email: “As we said in our November 19 press release, the FDA has determined that the data currently available allows for eligibility to be extended. of a single booster dose of Moderna and Pfizer-BioNTech COVID-19 vaccines for people 18 years of age and older Streamlining eligibility criteria and making booster doses available to all people 18 years of age and more will also help eliminate confusion over who can receive a booster dose and ensure that the booster doses are available to all who may need them. “

The CDC did not respond to requests for comment.

Dr Peter Marks, director of the Center for Biologics Evaluation and Research in the Food and Drug Administration, speaks during a Congressional panel at the we Capitol in Washington, May 11, 2021 (Greg Nash / Pool / AFP via Getty Images)

Push for boosters

The FDA and CDC have taken on greater importance in people’s daily lives during the COVID-19 pandemic. Drugs and vaccines are only available after receiving clearance from the FDA, while the CDC makes recommendations that have been widely adopted by state and local authorities. Most vaccine mandates, for example, cite the CDC and use its definition of fully immunized.

Strong political influence over key agency decisions was recorded in internal documents subsequently released, including major teachers’ unions who helped fabricate advice on the reopening of schools. Continuing a trend started under the Trump administration, the largest number of Americans are hearing from senior health officials during White House press briefings. In the case of recalls, senior administration officials in August announcement all adults should get one, even though the FDA had only allowed them for those who are immunocompromised.

Krause and another senior FDA official quit amid the push for widespread boosters.

This push was rejected the following month by the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which advises the FDA on vaccines. Members said there was little evidence to support the widespread use of boosters. FDA adopted the recommendation of the panel, which expanded the clearance for boosters but failed to clear the extra hits for all Americans. However, after the CDC’s Vaccine Advisory Committee advised shrinking who might get a booster, Dr. Rochelle Walensky, CDC director, exceeded recommendation.

Instead of consulting the panel again, the FDA in November boosters allowed for all adults. The CDC convened its panel before saying all adults can receive reminders, but haven’t called a meeting before recommend later all adults receive an additional injection. The FDA this month erased callbacks for 16 and 17 year olds without calling a VRBPAC and CDC meeting advised all adolescents in the population receive an additional injection without consulting their panel.

The FDA said in a statement that it did not convene VRBPAC because no new questions had arisen “that would benefit from further discussion by committee members” since a previous meeting had already passed the stage. reinforcement.

Krause and Borio said it was “unconvincing, given the views previously expressed by panel members.”

COVID-19 is the disease caused by the CCP Virus (Chinese Communist Party). The effectiveness of COVID-19 vaccines against the new variant of the CCP virus, Omicron, has declined significantly, especially against infection. Early studies show that vaccines offer little defense against the virus, but boosters restore some of the protection lost.

The CDC cited recent data as it recommended boosters for all adults. But the case for teen boosters is much weaker, because healthy young adults are at low risk of COVID-19 and at high risk of heart inflammation after being vaccinated with Moderna or Pfizer vaccines.

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A nurse fills syringes for patients as they receive their COVID-19 vaccination booster at a Pfizer-BioNTech vaccination clinic in Southfield, Mich., September 29, 2021 (Emily Elconin / Reuters)

Surprised

Some experts have been caught off guard by the authorization and recommendation of boosters for 16 and 17 year olds, especially given the lack of data on safety and efficacy in the age group. Some said it was clear panelists would have opposed the expansion proposals, and panels may have rejected them.

“I am surprised to see CDC push boosters in healthy 16 and 17 year olds just after the German reported that no 5 to 17 year old child (the most unvaccinated) died of COVID in this country, ”Dr Marty Makary, chief of the Johns Hopkins Islet Transplant Center, wrote on Twitter.

The surprise was heightened when the agency issued a review memorandum (pdf) explaining that Pfizer’s request was based on a clinical trial involving only 78 people, some of whom were given a placebo. More worryingly, one of the 78 suffered from post-vaccination heart inflammation.

Dr. Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of VRBPAC.

He looked at the memo and found it missing.

“I think the booster dose is safe and increases the level of neutralizing antibodies. But where is the evidence in the United States that this is necessary for the prevention of serious illness in healthy young people? Offit told The Epoch Times in an email.

At the heart of the FDA’s decision was a risk-benefit calculation from Pfizer that predicted that increasing 1 million children aged 16 and 17 would prevent 29 to 69 hospitalizations but cause 11 to 54 cases of heart inflammation. Pfizer predicted that the boosters would also prevent up to 43,143 cases of COVID-19.

Pfizer assumed higher vaccine efficacy than seen in some studies and assumed rates of myocarditis by submitting the reports to two U.S. reporting systems and reducing the data-based estimate of Israelis aged 16 to 19.

The numbers suggest that stimulation “is not associated with an unacceptable risk of myocarditis and pericarditis,” two forms of heart inflammation, the FDA said.

Dr Paul Alexander, a former World Health Organization / Pan American Health Organization and Department of Health and Human Services adviser during the Trump administration, disagrees.

He told The Epoch Times in an email that the FDA decision “is wrong and not based on any science.”

“This age group doesn’t even need the 1st and 2nd injections and a booster makes no sense and that’s all risk and no benefit, especially when you consider the increased risk of myocarditis in this group of people. ‘age, “Alexander added.

From The epoch of time