COVID-19 booster shots: former acting HHS secretary weighs in after FDA advisory board endorsement

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‘Looks like political leadership was pushing for booster vaccine to be approved,’ Eric Haragan told Granthshala News

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Former Health and Human Services (HHS) acting secretary and deputy secretary Eric Haragan, who served under both the Bush and Trump administrations, says the Food and Drug Administration (FDA) is about to approve COVID-19 vaccine booster shots. I am rightly alert.

An FDA advisory panel on Friday afternoon endorsed emergency approval for a Pfizer-BioNTech COVID-19 vaccine booster shot for people 65 and older at least six months after the second dose in an 18-0 vote. was after.

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Hargan, who helped develop Operation Warp Speed, told Granthshala News: “I got vaccinated, my wife got vaccinated, my son got vaccinated. I think people should get vaccinated. That’s for sure. ” “We want to end this pandemic crisis, and … widespread vaccination is going to be the most reliable way to do that.”

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He said, however, that scientists were aware that it could lose efficacy over time in developing an mRNA vaccine or that mutations in the virus could affect its efficacy. Just as a new form of the flu shot is developed each year to combat individual mutations in the flu, some scientists have suggested that COVID-19 vaccines may see a similar future.

FDA panel endorses PFIZER’s COVID-19 booster for people 65 and older

Whether vaccines now available to the public prove effective enough in slowing the spread of COVID-19 will help officials determine whether booster shots are necessary.

Hargan also noted that thousands of people had participated in the third phase of Pfizer’s clinical trials and that by January millions would have “completed a year with this vaccine.”

Pfizer’s COVID-19 Vaccine Booster: What to Know

“It has taken a long time for millions of people to receive medical intervention without seeing their bad side effects,” he said. “… COVID also has long-term effects, and people need to keep that in mind.”

Friday’s support from an independent FDA panel came after members of the FDA on Wednesday refused to approve Pfizer’s application to seek FDA approval for its booster shots, according to a 23-page document posted on the agency’s website. states that “some observational studies have suggested a decline in the effectiveness of Pfizer’s vaccine against symptomatic infections or against the delta variant over time, while others have not.

Multiple studies support COVID-19 booster as FDA remains neutral in Friday vote

The document states that the observational studies cited in Pfizer’s application for approval have “known and unknown biases that may affect their reliability.”

“They’re not saying no. They’re not saying yes,” Hargan said of the document. “It shows how alert they are.”

Modern analysis: People who got vaccinated last year are twice as likely to get COVID-19 than those who were recently infected

For most people, efficacy peaked at about 96% within two months of the second dose, nearly 90% within four months, and slipped to 84% by the data cutoff date. However, the vaccine was 96.7% effective in preventing serious disease.

Hargan noted that two senior FDA vaccine executives resigned last year over what he believes is pressure from the Biden administration to approve the booster shot.

“It seems that the political leadership was pushing for the booster vaccine to be approved,” he said, “and the FDA officials felt they were being put under undue pressure and resigned.”

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But instead of interpreting his resignation as a reason not to trust the booster shot or the FDA’s role in approving it, Hargan said his decisions should be recognized as a dedication to the process.

“They know very well that if they do these things early, the public health impact will not be great,” he explained. They are very careful. The AstraZeneca vaccine is still being approved in the United States, and is approved worldwide. …they are also resigning because they feel they are under pressure to do something, and unless they think it is appropriate, they are not going to do it.”

Hargan concluded that “everyone should feel good about the level of transparency of the FDA with regard to vaccines and booster shots”.

Granthshala News’ Kayla Rivas contributed to this report.


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