US drug authority to skip standard testing for COVID vaccines?

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US drug authority to skip standard testing for COVID vaccines?

The head of the U.S. Food and Drug Administration (FDA) has indicated that his agency is willing to skip critical Phase III testing for potential COVID-19 vaccines, raising concerns about the safety of the final product.

In an interview with the Financial Times on Sunday, FDA commissioner Stephen Hahn said, “It is up to the sponsor [vaccine developer] to apply for authorisation or approval, and we make an adjudication of their application. If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

According to the Centers for Disease Control and Prevention (CDC), vaccine trials involve three phases, with a fourth sometimes added after the vaccine has already been approved.

“During Phase I, small groups of people receive the trial vaccine,” the government agency explains on its website. “In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.”

Phase IV would comprise ongoing studies.

Hahn clarified that his agency would not technically approve any vaccine that has not undergone Phase III testing, but only issue what is called an emergency authorization.

“Our emergency use authorisation is not the same as a full approval,” he explained. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”

He did not specify how benefits and risks would be assessed.

On the one hand, the risk of a vaccine that has been tested only on few people is not clear.

On the other, the risk of dying from the coronavirus is low for people without an underlying condition. The CDC reported that 94 percent of deaths related to COVID-19 had, on average, “2.6 additional conditions or causes per death.”

Robert F. Kennedy, Jr., whose organization Children’s Health Defense points to the dangers associated with many vaccines, explained in an online debate in July that early testing already showed concerning results.

“The Moderna vaccine, which is the lead candidate, skipped the animal testing altogether,” he said during his debate with renowned Harvard law professor Alan Dershowitz.

Kennedy is part of a political family, being the son of Senator Robert F. Kennedy and the nephew of President John F. Kennedy. Both were murdered in the 1960s.

Another aspect of testing was equally unsatisfying, Kennedy said. The Moderna vaccine was tested “on 45 people. They had a high-dose group of 15 people, a medium-dose group of 15 people, and a low growth [sic] group of 15 people.”

“In the low-dose group, one of the people was so sick from the vaccine they had to be hospitalized,” he explained. “That’s six percent. In the high-dose group, three people got so sick they had to be hospitalized. That’s twenty percent.”

In spite of these significant problems, “they’re going ahead, and making two billion doses of that vaccine.”

Another problem with the testing of the coronavirus vaccine is that it’s tested not on “typical Americans,” but a carefully selected group of people who don’t suffer from certain conditions.

“They use what they call exclusionary criteria,” Kennedy said. “They are only giving these vaccines in these tests that they’re doing to the healthiest people.”

“If you look at their exclusionary idea criteria: You cannot be pregnant, you cannot be overweight, you must have never smoked a cigarette, you must have never vaped, you must have no respiratory problems in your family, you can’t suffer asthma, you can’t have diabetes, you can’t have rheumatoid arthritis or any autoimmune disease. There has to be no history of seizure in the family. These are the people they’re testing the vaccine on.”

He asked, “What happens when they give them to the typical American? You know, Sally Six-Pack and Joe Bag of Donuts who’s 50 pounds overweight and has diabetes.”

Kennedy stressed several times that “any other medicine ... that had that kind of profile in its original phase-one study would be [dead on arrival].”

“No medical product in the world would be able to go forward with the profile that Moderna has,” he reiterated.

Apart from questions about the safety of the vaccines, many Catholics and other Christians have also pointed out that at least some of the vaccines are developed and produced using cells from aborted babies.

 

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