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Dr. Reynold Panettieri discusses the FDA approval of Pfizer and COVID vaccine warrants on the “Claman Countdown”.
Former Acting Secretary and Assistant Secretary of Health and Human Services (HHS) Eric Hargan, who served under both the Bush and Trump administrations, said the Food and Drug Administration (FDA) was right cautious about the approval of booster injections of the COVID-19 vaccine.
On Friday afternoon, an FDA advisory group approved emergency approval of the Pfizer-BioNTech COVID-19 vaccine booster for people 65 years of age and older at least six months after the second dose during a 18-0 vote.
“I got the shot, my wife got the shot, my son got the shot. I think people should all get the shot. That’s for sure,” said Hargan, who helped develop the vaccine. Operation Warp Speed, at Fox News. “We want to end the scourge of this pandemic, and … widespread immunization will be the most reliable way to do it.”
Former HHS Deputy Secretary Eric Hargan (Photo credit: Eric Hargan)
He added, however, that scientists knew that by developing the mRNA vaccine it might lose its effectiveness over time or that mutations in the virus could impact its effectiveness. Just as there is a new variant of the flu vaccine developed every year to fight different influenza mutations, some scientists have suggested that COVID-19 vaccines may have a similar future.
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Whether the vaccines available to the public are now proving effective enough to slow the spread of COVID-19 will help authorities determine whether booster shots are needed.
Hargan also noted that it had been more than a year since tens of thousands of people participated in the third phase of Pfizer’s clinical trials, and by January millions of people will have “completed a year with this vaccine.” .
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“It’s a good time for millions of people to have received medical intervention without seeing negative side effects,” he said. “… There are also long term effects of COVID, and people should keep that in mind.”
Pharmacy director Dana Rucco, center, shows medical director Richard Schwarz the container used to administer the Pfizer-BioNTech COVID-19 vaccine on Monday, December 14, 2020, at the Jewish Medical Center in the Queens neighborhood of New York. (AP Photo / Mark Le
Friday’s approval from the FDA independent panel came after FDA members on Wednesday refused to take a position on whether or not to approve Pfizer’s request to seek FDA approval for its injections of recall, stating in a 23-page document posted on the agency’s website that “some of the observational studies have suggested a decrease in the effectiveness of ‘Pfizer’s vaccine’ over time against symptomatic infection or against the variant. delta, while others did not “.
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The paper adds that observational studies such as those cited in Pfizer’s application for approval exhibit “known and unknown biases that may affect their reliability.”
“They don’t say no. They don’t say yes,” Hargan said of the document. “It shows how careful they are.”
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For most people, within two months of the second dose, efficacy peaked at around 96%, sliding to around 90% within four months and 84% by the data cut-off date. However, the vaccine remained 96.7% effective in protecting against serious illness.
Hargan noted that two senior FDA vaccine officials resigned last year due to what he believes was pressure to approve the Biden administration’s recall.
A worker gives a thumbs up while transporting boxes containing the Moderna COVID-19 vaccine to the loading dock for shipment at the McKesson distribution center in Olive Branch, Mississippi, Sunday, December 20, 2020 (AP Photo / Paul Sancya, Pool)
“It appears political leaders are pushing for the booster vaccine to be approved,” he said, “and FDA officials felt they were under undue pressure and quit.”
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But instead of interpreting their resignations as a reason not to trust the recall or the FDA’s role in its approval, Hargan said their decisions should be recognized as dedication to the process.
“They are well aware that if they rush these things, the effect on public health will not be great,” he explained. They are very careful. The AstraZeneca vaccine is still under approval in the United States and is approved worldwide. … They even quit because they feel they are under pressure to do something, and they won’t do it until they see fit.
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Hargan concluded that “everyone should feel good” about the FDA’s level of transparency when it comes to vaccines and recalls.
Kayla Rivas of Fox News contributed to this report.
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