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Tags: Coronavirus | Newsmax TV | Vaccines | dr jha | vaccines | covid | coronavirus

Dr. Jha to Newsmax: FDA Approval of Pfizer Vaccine a 'Good Sign'

Dr. Ashish Jha on Newsmax TV

By    |   Tuesday, 24 August 2021 09:09 AM

There's no doubt that the Food and Drug Administration will move to approve other COVID-19 vaccines now that it's given full approval for the Pfizer/BioNTech vaccine, Dr. Ashish Jha, the dean of the Brown University School of Public Health, said on Newsmax Tuesday. 

"I do see it as a really good sign," Jha said on Newsmax's "Wake Up America," adding that he expects the Moderna vaccine to have full approval in the "next month or so" and the Johnson & Johnson shots to come "several months" from now. 

"They've had a lot of time to look over all of the data," said Jha. "Remember, the emergency use authorization was back in December, so they've had about 8 (or) 9 months to be looking and pouring over the data."

He also disagreed with arguments that the FDA has fast-tracked its decisions on the vaccines or cut corners, given that full trials on the Pfizer vaccine are not expected to be finished until 2023. 

"We see that on a lot of drugs that are approved," said Jha, explaining that the FDA "almost always" tells companies to continue with drug trials even after the medications are approved. 

"This is what we're seeing here with the Pfizer vaccine approval as well," said Jha. "In terms of cutting corners, I can't think of a single corner that was cut. Basically, every single step was followed."

The Pfizer-BioNTech coronavirus vaccine has been given an "estimated study completion date" of Jan. 31, 2023, while the Moderna vaccine's studies are expected to end on Oct. 27, 2022, according to documentation from the companies.   

Both vaccines were granted the emergency use authorization after completing their Phase III trials and have said they'll continue to monitor trial subjects and assess long-term protection and safety, reports Reuters.

Jha said that the process for approval may have seemed faster, but "sometimes the bureaucracy at the FDA can take six or nine months to get certain types of things done. They did it (in) four to six months."

But he said he sees that as a "good thing" and a "model for what we should be doing in the future, not as a problem ... every step that you would want to (prove) the safety and effectiveness, all of it was followed."

Meanwhile, Jha said he thinks the FDA's approval of the Pfizer vaccine will spur some people who have been reluctant to get their vaccines. 

"I take care of patients at the VA and I've had a lot of veterans who basically have asked me about this specific question, about emergency use," said Jha. "My answer in the past has been that I thought there was plenty of data so whether emergency use or not, I thought it was worth getting the vaccine and I recommended it. But now that we have full approval, I think there are a lot of Americans. Have been waiting for this decision for whom this is going  offer that last bit of assurance to go out and get the shot."

Meanwhile, the country is in a "really bad place" with the delta variant of COVID, with 140,000 Americans getting infected and 1,000 dying every day, said Jha, but he believes that will "peak and turn around in the next few weeks."

He admitted to being a "little worried" about winter, but at the same time, places with the highest population immunity, like in South Dakota and Vermont are still seeing increases in cases. 

"That means we have got to do better nationally than where they are right now, and that's going to require, I think, a lot more vaccines," said Jha, adding that businesses should be able to enforce vaccine mandates for their employees. 

"I don't think the government should be telling businesses not to have mandates," said Jha. 

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There's no doubt that the Food and Drug Administration will move to approve other COVID-19 vaccines now that it's given full approval for the Pfizer/BioNTech vaccine, Dr. Ashish Jha said on Newsmax...
dr jha, vaccines, covid, coronavirus, fda
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2021-09-24
Tuesday, 24 August 2021 09:09 AM
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