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Former FDA heads, Sen Cassidy push back on FDA official’s claim of 10 COVID vaccine deaths


News brief

Today at 5:02 p.m.
Jim Wappes
Topics

COVID-19

Childhood Vaccines

Adult (non-flu) Vaccines

Public Health

Anti-science

Twelve former US Food and Drug Administration (FDA) commissioners yesterday published a commentary calling out Vinay Prasad, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, for proposing sweeping changes to vaccine safety regulation based on what he claims, without presenting evidence, are 10 deaths in children caused by COVID-19 vaccines.

In addition, Senator Bill Cassidy, MD (R-La.), on the social media platform X called for a full Senate briefing on the deaths.

Proposed changes are ‘major shift’ for FDA


“We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,” wrote the former FDA directors in the New England Journal of Medicine.

“The proposed new directives are not small adjustments or coherent policy updates,” the group add. “They represent a major shift in the FDA’s understanding of its job.”

FDA has not published any data around the alleged deaths or explained the process they took to verify it. I’ve asked FDA for a full briefing on this.

They ex-commissioners write, “The stated motivation for these sweeping changes is the deaths of 10 children, which the FDA leadership asserts were caused by Covid-19 vaccines. … The memo [from Prasad] offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation.

“The reanalysis relied on adverse event reports filed in the Vaccine Adverse Event Reporting System (VAERS), a passive postapproval surveillance system that collects unverified reports, from any source, of events occurring after vaccination. VAERS reports, by themselves, cannot be used to determine whether a vaccine caused a particular event.”

The group also note, “The memo asserts, incorrectly, that ‘we do not have reliable data’ on the benefits of Covid vaccination in children.”

On his post on X, Cassidy wrote, “FDA has not published any data around the alleged deaths or explained the process they took to verify it. I’ve asked FDA for a full briefing on this. The American people deserve clarity. Withholding this critical information is not radical transparency and will worsen confusion and fear among patients and parents.”


France reports MERS in 2 travelers who had been to Middle East


News brief

Today at 3:57 p.m.
Stephanie Soucheray, MA
The French Ministry of Health today confirmed Middle East respiratory syndrome coronavirus (MERS-CoV) infections in two travelers who had recently returned from the Arabian Peninsula. The patients were diagnosed after suggestive symptoms and are hospitalized in stable condition.

So far, no secondary transmission chains have been identified in France, authorities said. The two case-patients had traveled together on the same trip; other tour group attendees are being monitored.

84% of cases in Saudi Arabia


MERS-CoV has been primarily identified in Saudi Arabia, which has seen 12 cases this year, including 3 deaths. The virus was detected more often before the pandemic, after first being identified in 2012. Since 2012, a total of 2,639 cases of MERS, including 957 deaths, have been reported by health authorities worldwide. Of the cases, 84% have been in Saudi Arabia.

Dromedary camels are the main animal reservoir for the virus, and several cases have been linked to camel contact. Hospital-related transmission has also been a feature of previous MERS cases and outbreaks, with health care workers at time sickened after contact with patients.

ALL BRIEFS​