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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

Gov’t Bows to Vax Makers’ Demands? 2nd Wave Hits Europe; FDA Wants Makena Pulled

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The White House is blocking new FDA guidelines that would stiffen requirements for authorizing COVID-19 vaccines, after manufacturers reportedly objected to the guidance. (New York Times, Politico)

White House Press Secretary Kayleigh McEnany and Pastor Greg Laurie of the Harvest Christian Fellowship megachurch were the latest attendees at a recent White House event to report a positive coronavirus test. MedPage Today has a running list here.

Perhaps the most at risk White House staffers, however, are the 100 members of the White House’s residence staff. (The Atlantic)

Finally: the CDC acknowledges the potential for airborne SARS-CoV-2 transmission.

As of 8:00 a.m. ET Tuesday, the estimated U.S. COVID-19 toll reached 7,459,102 cases and 210,196 deaths — up 40,364 and 462, respectively, since the same time Monday.

The Northeast and Midwest are experiencing surges, and new cases have risen for at least two weeks in a row in 21 states. (Reuters)

Lockdown measures make a comeback in Europe. (The Guardian)

WHO official said roughly 1 in 10 people worldwide have been infected with COVID-19 and that we are now heading into a “difficult period.” (Reuters)

Three doctors met with HHS Secretary Alex Azar and Trump advisor Scott Atlas, MD, to push the herd immunity hypothesis. (The Hill)

European drug regulators are investigating reports of acute kidney injury in some COVID-19 patients who were on remdesivir. (Becker’s Hospital Review)

Moderna failed to enroll enough people of color in its vaccine trial and slowed enrollment to ensure more minority volunteers were recruited. (Reuters)

Trump issued an executive order establishing a Coronavirus Mental Health Working Group to respond to “mental-health conditions induced or exacerbated by the pandemic, including issues related to suicide prevention.”

Texas universities have plenty of tests, but participation rates are far lower than expected, prompting one school to offer prizes to students volunteering to be tested. (Texas Tribune)

PBS is airing a segment tonight on the nationwide scramble for personal protective equipment in the first wave of the pandemic.

In other news:

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    Elizabeth Hlavinka covers clinical news, features, and investigative pieces for MedPage Today. She also produces episodes for the Anamnesis podcast. Follow

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Offering Flu Vax at ED Discharge Boosts Uptake Rates

A Wisconsin pediatric emergency department (ED) implemented a screening protocol that significantly increased flu vaccination rates in a traditionally undervaccinated population, a researcher reported.

Compared with the 2018-2019 flu season, the proportion of children vaccinated increased from 9% to 20% in the 2019-2020 season after Children’s Wisconsin implemented an electronic health record (EHR) infrastructure that allowed nurses to screen, counsel, and refer all children presenting to the ED for flu shots at discharge, reported Shannon Baumer-Mouradian, MD, of the Medical College of Wisconsin in Milwaukee.

Of children vaccinated, about 75% had Medicaid, and half were racial and ethnic minority patients, who have been reported to have lower vaccination rates, Baumer-Mouradian said at the American Academy of Pediatrics (AAP) virtual meeting.

“Many of our children are uninsured or underinsured, and they do use the [ED] as their medical home,” Baumer-Mouradian told MedPage Today. “The ED breaks down barriers families have, whether it’s a lack of transportation to their primary care office or working weird hours and not being able to make it to appointments.”

Just 50% of children are vaccinated for influenza each year. In Wisconsin, vaccination rates are even lower at about 40%, Baumer-Mouradian said.

Health officials are warning of a “twindemic” this fall as the flu season approaches, but many Americans are hesitant to get a flu shot. In general, pediatric immunizations have plunged during the pandemic.

The AAP recommends all children receive a flu shot this year to reduce the chances of simultaneous influenza and COVID-19 outbreaks.

“If there was ever a winter to get a flu vaccine, it is this winter,” said Kenneth Hempstead, MD, of Kaiser Permanente in Roseville, California, who was not involved in the research.

After the program in this study improved immunizations only slightly in the 2018-2019 influenza season, Baumer-Mouradian and colleagues refined the protocol to also identify families who were more vaccine hesitant. In those settings, both a provider and a nurse counseled families in the 2019-2020 season.

“Identifying vaccine hesitancy meant not only did the nurse talk to the family about vaccines, but a trusted second-level provider also came in to spend time with families and encourage vaccines,” Baumer-Mouradian said during the virtual presentation. “I think that second step was an influential piece.”

Many families also reported that the wait time to get the flu shot in the ED was one of the main reasons they elected not to get it, so Baumer-Mouradian and colleagues started storing the vaccines in the ED refrigerators, she said.

The change resulted in a significantly reduced time to discharge for patients, from 20 minutes in the 2018-2019 season to 16 minutes last season. Also, the proportion of patients leaving prior to vaccination decreased from 30% to 10% between seasons, Baumer-Mouradian reported.

“Families didn’t want to wait around for the vaccine having already been in the [ED] for multiple hours in some cases,” Baumer-Mouradian said.

In total, 2,839 children were vaccinated at the hospital, which was a 2.3-fold increase from last year, the authors reported.