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

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 Guillain-Barre syndrome and transverse myelitis, they tend to occur within a median of 2 months or before.

“Some people would like longer than that, some people would like shorter than that [but] … that seems like a reasonable compromise,” he added.

Notably, President Trump lodged his objection on Tuesday night, calling the standards a “political hit job,” and saying they “make it difficult for them to speed up vaccine approvals before Election Day,” though the White House did approve the new standards.

In the webinar, Marks discussed the importance of clinical outcomes for COVID-19 vaccines. With other diseases, “we understand the correlates of protection,” and how that correlates with clinical outcome. These are not yet known for SARS-CoV-2.

“We expect these vaccines to reach clinical endpoints versus immunologic endpoints,” he said, noting that hopefully once the first couple vaccines are approved, the correlates of protection will become clearer.

Commenting on the new guidelines, Matthew Spinelli, MD, of University of California San Francisco, noted the line in the document where the FDA said it advised sponsors the agency “would not consider availability of a COVID-19 vaccine under emergency use authorization (EUA), in and of itself, as grounds for stopping blinded follow-up in an ongoing clinical trial.”

“It is very important that we continue follow-up to understand duration of protection, safety, long-term efficacy even if EUA issued,” Spinelli told MedPage Today via email. “My hope is that clinical trials that are sufficiently large are performed with adequate sample size and follow-up to ensure there are no safety signals.”

Marks said one of the “core pieces” of the FDA guidance was that the vaccine must be 50% more effective in preventing SARS-CoV-2 infection, though he stated a vaccine with 70%-80% efficacy, and 70-80% of people taking it, could bring about herd immunity.

Spinelli also noted the efficacy point estimate the FDA is targeting is similar to the seasonal flu vaccine.

Marks would not completely rule out an EUA, saying, it was at the “outer realm of possibility” that a vaccine could reach the number of clinical events needed by the end of

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

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, but has neither a National Drug Codes (NDC) list number nor any evidence it’s reached the U.S. market.

Corporativo Bureli made SOHO Fresh Hand Sanitizer Gel Antibacterial. The SOHO Fresh with NDC No. 79081-000-03 tested positive for methanol. The rest were made at the same facility.

Guangshou Youxing Cosmetics’ V&W Advance Hand Sanitizer Refreshing Gel came up as subpotent for ethanol alcohol in FDA tests.

V&W Moisturizing Refreshing Spray Sanitizer, V&W Advance Hand Sanitizer Refreshing Gel and V&W Premium Disinfecting Wipes all made the list by association (believed to be made at the same facility).

Inovaker Lab’s Hand+ Sanitizer Ethyl Alcohol Antiseptic 75% Topical Solution also tested as subpotent for ethyl alcohol.

Two of the Inovaker Lab products on the list as made in the same place are EMHS1 Alcohol Hand Sanitizer and EMHS1 Advanced Isopropyl Alcohol Hand Sanitizer. They’re distributed by the Sayida Group, a company not registered with the state of Florida and with a Miami Beach virtual office address.

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EMHS1 Hand+ Hand Sanitizer, distributed by Miami Beach’s Sayida Group. National Drug Codes List

Inovaker’s other contributions to the list are El Bueno Hand Sanitizer; Hand Sanitizer Isopropyl Alcohol Antiseptic 75; Hand Sanitizer Ethyl Alcohol Antiseptic 75; and Inovaker Hand Sanitizer.

Rodriguez Fierro, Marco Antonio made Natural Gold Gel Alcohol Antiseptic 75% Topical Solution, which tested as subpotent for ethanol alcohol. FDA says this hasn’t hit the U.S. market yet, and put an import alert on Natural Gold to prevent it from getting to the market.

The child magnet packaging of Soleo Cosmetic’s Smart Care hand sanitizers makes the pouches look a little too much like kid-marketed snack food or drinks. Either by curiosity or carelessness, it’s too easy to imagine kids consuming the hand sanitizer instead of rubbing them into the skin.

So, as stated in this Miami Herald article, the FDA put the Barbie, Hot Wheels, Paw Patrol, Minions, Trolls World Tour and JoJo Siwa Dreamer hand sanitizers on the list on Sept. 24.

Smart Care hand sanitizer Hot Wheel_fitted.jpeg
Smart Care’s Hot Wheels hand sanitizer,