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Tag: FDAs

FDA’s Marks: Stricter Standards for COVID-19 Vax Were by Design

October 7, 2020
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| Health

The FDA’s stricter standards for a COVID-19 vaccine are meant to reassure the public about the safety and efficacy of a vaccine, and end the politicization of vaccine standards, the FDA’s top official for vaccines said Wednesday.

Data from phase III studies with a median follow-up duration of at least 2 months, and at least five severe COVID-19 cases in the placebo group, were standards proposed by the FDA for weeks. These standards were released in briefing documents the FDA made available to the public Tuesday.

Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research, emphasized the importance of tracking safety of the vaccine during an American Medical Association webinar on Wednesday.

“We asked for a median of 2 months of safety follow-up after the final vaccination of the population enrolled in the trial,” he said, explaining that when looking at adverse events, such as

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White House cited drug companies’ objections in overruling FDA’s vaccine standards

October 6, 2020
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| Health News

“In a normal procedure, the industry wouldn’t be talking at all to the White House about this,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. “The White House again is blurring and muddying the waters on all of this.”

Trump has repeatedly telegraphed his eagerness to deliver a vaccine before Nov. 3, and one drug maker – Pfizer – has said it could still meet that timeline. During last week’s presidential debate, Trump went as far as to assert he’d been personally assured a coronavirus vaccine could be ready within weeks.

“I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to – Moderna, Johnson & Johnson and others,” he said, dismissing his own health officials’ projections that a vaccine likely won’t be available until the end of the year. “They can go faster than that by a

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Recalls, additions to FDA’s Do Not Use hand sanitizer list

October 4, 2020
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Weakness, ‘toxic’ methanol and packaging that includes Barbie, Hot Wheels and Minions put 14 hand sanitizers on FDA’s Do Not Use list over the last two and a half weeks.

Two hand sanitizers on the list have been recalled over the last week.

The FDA’s list started in the middle of the COVID-19 pandemic with hand sanitizers from Mexico that tested positive for methanol, which the FDA terms as “toxic” if either ingested or rubbed into the skin, or were believed to be made in the same facility as those with methanol.

Now, it includes hand sanitizers from numerous countries that test as being “subpotent” (too weak) and having 1-propanol or being believed to be made in the same place as those hand sanitizers.

Or having Paw Patrol packaging.

Updates to the Do Not Use list

▪ The FDA said C&G Laboratorios’ Hand Sanitizer Disinfectant Gel tested positive for methanol,

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