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Expert calls CDC advisory panel a ‘kangaroo court’

One of the nation’s top public health experts criticized the CDC’s top advisory panel for its approval of Covid booster vaccines for children up to five years old, just as leading vaccine maker Pfizer reveals plans to file an application to administer vaccines to babies as young as six months this week.

Dr. Marty Makary, a public health expert at Johns Hopkins University, told DailyMaill.com that the Advisory Committee on Immunization Practices (ACIP) is a “kangaroo court” filled with nothing but like-minded people who they promote what he describes as “low-value care.” ‘.

He also said that they have never seen a vaccine that they would not approve, and that others who had previously gone against pro-jab dogma had been kicked off the panel.

The committee, which leads vaccine decision-making for the Centers for Disease Control and Prevention (CDC), is made up of outside advisers from universities and research institutes across the country. It was convened to decide if children needed the additional vaccines, even when its Food and Drug Administration counterpart, the Vaccines and Related Biologicals Advisory Committee (VRBPAC) did not.

This is the second decision in a row that the VRBPAC was not convened for, since the committee Makary describes includes the nation’s top experts, and it also passed when the FDA approved the fourth injection for Americans age 50 and older.

Last week, Covid booster vaccines for children ages five to 11 received approval from US regulators, despite advisers who are part of the FDA's VRBPAC not being consulted.

Last week, Covid booster vaccines for children ages five to 11 received approval from US regulators, despite advisers who are part of the FDA’s VRBPAC not being consulted.

Makary points out that many VRBPAC members, including Dr. Cody Meissner, Dr. Paul Offit, and Dr. Eric Rubin, likely would have voted no on both decisions if asked based on the statements they made earlier and the approval. .

This criticism comes as another low-risk group may be added to the vaccine rotation, with Pfizer releasing data on Monday showing its three-dose regimen for children six months to four years is 80 percent effective in preventing infection. of the Omicron variant. This is likely to proceed with the filing of an official application for punctures to be approved in the coming days.

Dr. Marty Makary (pictured) described the CDC advisory panel that signed off on the injections as a

Dr. Marty Makary (pictured) described the CDC advisory panel that signed off on the injections as a “kangaroo court” that has never seen a vaccine it would not approve.

Last week, the FDA gave the green light for booster shots of the COVID-19 vaccine for all American children ages five to 11. Unlike previous decisions, VRBPAC was not consulted on the decision. On Thursday, ACIP met and all but one of the panel members approved the distribution of the additional injections.

Makary called the ACIP panel “the biggest slap in the face of science we’ve seen during the pandemic,” adding that “the rational…was flawed” for approval.

He points out that Dr. Rochelle Walensky, director of the CDC, cited several times in the past week that Covid cases are on the rise among the country’s youth, even though previous research released by the agency finds nearly three in four American children have already been infected, which means they already have natural immunity to the virus.

The level of risk among children from Covid is also extremely low, with the agency reporting that minors account for just over 1,000 of the million deaths the nation has suffered during the past two years of the pandemic, or about 0.1 percent. of the total burden of mortality.

The Johns Hopkins expert, who is also a best-selling author of pancreatic surgeons, also said that the trial conducted by Pfizer for the study did not include enough participants, with only 140 recruited. For comparison, trials for the approval of the original COVID-19 vaccine regimen approved in 2020 included more than 43,000 participants.

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1653318698 790 Expert calls CDC advisory panel a kangaroo court

Part of the ACIP approval included providing a “consistent message” to Americans, making it easier to receive immunizations and boosters across all age groups. This means it’s not a science-based clinical reason, Makary says.

“I’ve never heard of a simplified marketing message being a factor in choosing to highly recommend something,” he said.

The latest red flag was the omission of VRBPAC for the second time. The committee is comprised of the nation’s top vaccine experts, and many members have not been shy about publicly disagreeing with FDA and CDC decisions.

When fourth doses for fourth doses were approved, three spoke out openly against the decision.

Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and a member of the FDA’s Vaccines and Related Biologicals Advisory Committee (VRBPAC), which typically advises on these decisions, said last month that he didn’t see enough data to support the need for the shots.

“The only data I’ve seen is from participants followed for a few weeks,” Rubin said. CNN last month.

“The most important information will be how well a fourth dose protects highly vulnerable people against serious illness and death, and I don’t know when that will be available.”

Dr. Paul Offit, also a member of the VRBPAC and director of the vaccine education center at Children’s Hospital of Philadelphia, criticized the launch of the first booster dose and also disagrees with this approval.

‘Where is the evidence that someone over the age of 50 benefits from a fourth dose? Because the evidence to date seems to support the possibility for those over 65, although we haven’t seen all the data, but where is the evidence for a 50-64 year old? Where is that evidence? Because in the absence of that evidence, then there shouldn’t be this recommendation,” she told CNN.

Dr. Cody Meissner, chief of pediatrics at Tufts Children’s Hospital and a member of the VRBPAC, isn’t sure if the virus poses enough of a risk right now to warrant a fourth injection.

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1653318701 438 Expert calls CDC advisory panel a kangaroo court

Offit and Meissner have also been vocal critics of vaccinating young children who are at little risk from the virus. previous said earlier this year that he would not give his 17-year-old son the booster, and would advise his son, who is in his 20s, not to get the additional vaccine either.

Meissner told the Daily Mail in February: “I think we are reconsidering the way we look at this question, because even though people are properly vaccinated, they can still get infected and spread the virus to susceptible people around them.”

‘So this is a bit different to a lot of other infectious diseases like measles, mumps or rubella. If you are protected from infection with the vaccine, then you will not pass it on to other people.

1653318703 625 Expert calls CDC advisory panel a kangaroo court

‘But that’s not the same scenario with [this virus].’

Experts may finally get a chance to have their say on the subject heard next month, the FDA will schedule a meeting of the VRBPAC to discuss the approval of the Moderna COVID-19 vaccine for children six months to 18, and the Pfizer needle stick for children under five. .

The consultative meeting was scheduled in response to a new report from Pfizer showing that its vaccine, which is a joint project with the German company BioNTech, is 80 percent effective in preventing infection of the Omicron variant in six-month-old children. to five years.

Unlike previous versions of the vaccine, the regimen for this age group comes in three doses. The injections are also only three micrograms (mg) in size, one-tenth the dose of 30-mg injections for adults.

The New York City-based pharmaceutical giant had initially planned to make its injection for the youngest of Americans in just two doses, but early results from late last year found that the first two doses had little impact on immunity. against the virus in children older than three and four years.

This discussion of vaccines comes at a time when cases are rising again, but overall mortality from the virus is declining.

The United States is averaging 113,713 cases per day, recently eclipsing the 100,000 cases per day mark for the first time since February. However, deaths from the virus have fallen by seven percent, to 348 a day.

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