FDA fails to warn of mRNA vaccine link to MIS-C
There appears to be a double standard in how the FDA handles safety signals for mRNA vaccines compared to alternative vaccine technology.
Soon after receiving an mRNA covid-19 vaccine, six individuals aged 12 - 20yrs were hospitalised with an illness called Multisystem Inflammatory Syndrome in Children (MIS-C).
It’s a rare but potentially fatal illness causing various internal and external body parts to become inflamed and can occur soon after SARS-CoV-2 infection.
But none of these six individuals had any evidence of recent or prior covid-19 infection, suggesting the MIS-C was a vaccine-related adverse event.
The six cases were reported to FDA’s Vaccine Adverse Event Reporting System (VAERS) between Dec 2020 to Aug 2021 and published by FDA and CDC researchers in Lancet Child and Adolescent Health (Table 2).
The authors concluded that, “Continued surveillance for MIS-C illness after covid-19 vaccination is warranted” and encouraged doctors to “report potential MIS-C cases after covid-19 vaccination to VAERS.”
But so far, there has been silence -- no press release, no warning to doctors, no updates on surveillance, and no change to the Pfizer or Moderna vaccine label.
In stark contrast…
Six individuals developed rare but serious blood clots in the brain (cerebral venous sinus thrombosis) with low platelets, soon after receiving the J&J’s adenoviral vector covid-19 vaccine.
The six cases were reported to VAERS and the response from US authorities was swift and decisive.
In April 2021, there was an immediate pause on the roll-out of the vaccine, the FDA and CDC issued a joint press release, held a media briefing, deployed medical and scientific teams to examine the available data and alerted vaccine providers to be on the lookout for these types of adverse events.
Ten days later, after thorough investigation, US officials lifted the pause but not before adding a warning to the vaccine’s label.
Within weeks, authorities curtailed the use of the J&J vaccine due to safety considerations.
Why the double standard?
US agencies did not hesitate to sound the alarm on J&J’s adenovirus-vector vaccine, but have stayed quiet on adverse events related to mRNA vaccines (Pfizer/Moderna).
Patrick Whelan, Associate Clinical Professor of Paediatrics at UCLA said, “The cynical view might be that the regulators had it out for the J&J vaccine. But the more likely explanation is that the substantial public media attention given to blood clots in the brain, pushed the regulators to act.”
The media attention was first sparked in Europe after 18 people died from “unusual blood clots with low blood platelets” following receipt of AstraZeneca’s vaccine.
“My own impression is that there was a clear agenda to avoid alarming anyone [of the MIS-C/vaccine link], and they didn't want to muddy the waters and make people worry that the vaccines were not safe for children. So, I do feel that the FDA played down some of the dangers of it,” said Whelan.
“I wouldn't be surprised if there are many more cases of vaccine-associated MIS-C out there. It's something that merits much more scrutiny,” he added.
There’s also speculation that the FDA’s deference to mRNA technology serves to clear the path for other mRNA therapies in the pipeline -- it may also explain why AstraZeneca (adenovirus-vector vaccine) never got a foothold in the US, and why Novavax (protein-subunit vaccine) struggled to get authorised.
The CDC promised to continue monitoring reports of MIS-C in the surveillance database, but when I asked the agency for an update, it wrote:
CDC has not published any further reports of MIS-C occurring after covid-19 vaccination although we are in the process of publishing information in children aged 5 to 11 years. There have been reports of cases made by other institutions.
The CDC would not elaborate on these comments.
Time to update the label?
Last week, Whelan signed a Petition submitted to the FDA calling for the Pfizer and Moderna vaccine labels to be updated -- including adding MIS-C as a potential vaccine-related adverse event.
“There should definitely be an update added to the vaccine’s label,” said Whelan. “Virtually any drug you can think of, has a long list of side effects associated with it. And those are a consequence of post-marketing surveillance.”
He added, “It would give me a lot more confidence about whether the vaccines impose a risk of MIS-C if someone at the FDA would acknowledge that there's an issue and give us some assurance that they're looking into it.”
The FDA did not respond to enquiries.
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