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FDA review spotlights risk of heart inflammation linked to Novavax's Covid vaccine — shares tumble.


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2022 Jun 3, 11:36am   210 views  5 comments

by Al_Sharpton_for_President   ➕follow (5)   💰tip   ignore  

Shares of Novavax $NVAX cratered after the FDA’s briefing papers hit Friday morning spelling out concerns about potential heart safety issues with their long-awaited Covid-19 vaccine.

Ahead of the expert panel review slated for Tuesday, the agency reviewers applauded the vaccine’s ability to meaningfully reduce the risk of mild to severe Covid-19. But they attracted much more attention to a note on the FDA’s request for Novavax to change two kinds of heart inflammation — myocarditis and pericarditis — to an “important identified risk.”

Adds the FDA: “At the time of this writing, the Sponsor had not agreed to make this change.”

That triggered an 18% drop in the biotech’s share price today.

There were 6 cases of inflammation in the vaccine arm, in a 30,000 person study, the FDA reported, compared to 1 in the control group. And the company’s researchers found the numbers unalarming, saying that they fit within well-established ranges. The FDA, though, was not so sanguine.

(T)he events of myocarditis/pericarditis are concerning for a causal association with NVX-CoV2373 for the following reasons: 1) five events were reported within 2 weeks of vaccination, 2) only 1 event had a clearly identified alternative etiology (COVID-19) strongly associated with myocarditis, and other events had only circumstantial evidence of potentially plausible alternative etiologies, and 3) four of the events occurred in young men, a subject population known to be at higher risk for mRNA COVID-19 vaccine-associated myocarditis.
Novavax is making a late bid for entry in the US Covid market, which has been essentially under the control of Pfizer/BioNTech and Moderna — the two key mRNA rivals who quickly scored emergency approvals and reaped billions in quick rewards. J&J recently pulled their vaccine, the only other one approved in the US.

Aside from the mRNA rivals, though, other vaccines have been bedeviled by worries about safety issues, something that afflicted both J&J and AstraZeneca, though the numbers of people who might have been threatened were always tiny, sparking a row over the benefit/risk profile as the country fought off a virus that has now killed more than a million Americans.

Novavax — which is looking to field its first product — had promised to get a much earlier start on this, then kept delaying the filing after talks with regulators. Now it has to navigate a critical passage through the expert panel, looking beyond that to what they hope is their first approval.

Still struggling to get an EUA, Novavax paints early rosy picture of combo Covid-19/flu vaccine
There’s no shortage of Covid-19 vaccines in the US market, given a still strong level of resistance to any jab. But Novavax thinks it can make inroads among the unvaccinated, noting that the virus is still uncontrolled. Still, any hint of safety issues could prove to be a big barrier to reaching that group.

https://endpts.com/fda-review-spotlights-risk-of-heart-inflammation-linked-to-novavaxs-covid-vaccine-shares-tumble/

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1   mell   2022 Jun 3, 11:51am  

This is so stupid they are delaying it in purpose. No jab with spike is safe but nvax is 1000 times safer than the mna clot shots.
2   mell   2022 Jun 3, 11:51am  

Pfister did this
3   mell   2022 Jun 3, 11:55am  

Nvax jab has been approved already around the world with no sign. increase in myo. They are hell bent on forcing mrna onto US citizens
4   Patrick   2022 Jun 3, 11:57am  

People are dying because of the corruption of public health agencies by massive pharma companies.
5   mell   2022 Jun 3, 12:05pm  

Patrick says

People are dying because of the corruption of public health agencies by massive pharma companies.

Yes but note that nvax is a pharma startup compared to pfister and they have the only traditional/non mrna jab effective against omicron. They fast tracked the clot shots and are now slowing down safer jabs. I think it will get approved (with warning label) since it's the only one providing protection against omicron but you can clearly see the corruption. Reuters/ap they all have connections with pfister into the boards thus hit pieces against competitors

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