EMA confirms Novavax shot causes cardiac inflammation

The European Medicines Agency (EMA) said on Aug. 3 that
the Maryland-based drug firm's Nuvaxovid vaccine should list
myocarditis (heart muscle inflammation) and pericarditis (heart
lining inflammation) as potential side effects. It has asked
Novavax to provide additional data on the side effects
(https://bit.ly/3zKlvMm).
According to the agency, both healthcare professionals and
people wanting to get the vaccine should be warned about the
risks of Nuvaxovid. Cardiac inflammation has also been noted
as risks linked to the mRNA COVID-19 vaccines from Pfizer
and Moderna.
Novavax told the Epoch Times in an email that during the vaccine's
clinical trials, the rate of myocarditis observed between those
injected with the actual shot and a placebo were close.
"As more data becomes available, we will better understand the
nature and magnitude of any potential risk of myocarditis and
pericarditis," it wrote. "We will work with the relevant regulators
to assure our product information is consistent with our common
interpretation of the incoming data.
A month prior, the EMA added anaphylaxis  -  severe allergic
reaction  -  as a side effect of the Novavax shot.
"The product information [for] Nuvaxovid will be updated with
severe allergic reaction and unusual or decreased feeling in the
skin as new side effects," it said on July 14. The decision followed
the assessment of the EMA's Pharmacovigilance Risk Assessment
Committee. "A few cases" of anaphylaxis linked to the vaccine
were reported, but the EMA refused to disclose the actual figure.
According to The COVID Blog, the Novavax sub-unit protein
vaccine delivers the SARS-CoV-2 spike protein using an insect
virus. It also utilizes saponin from the soap bark tree (Quillaja
saponaria) native to South America to trigger an immune response
in the body.
US regulators also flag Novavax's cardiac inflammation risks
The U.S. Food and Drug Administration (FDA) granted the Novavax
shot an emergency use authorization (EUA) on July 13. Dr. Robert
Califf, the head of the American regulator, said
(https://bit.ly/3QrX24U) in a statement that the EUA granted
to Novavax "expands the available vaccine options for the prevention
of COVID-19."
Under the EUA, the two-dose Novavax vaccine is permitted for use
on adults aged 18 and older  -  with an interval of several weeks
between the two doses.
The FDA later remarked that the vaccine's clinical trials did raise
concerns about cardiac inflammation, and that it alerted both
recipients and healthcare providers about these. Furthermore, the
regulator also ordered Novavax to conduct post-authorization
observational studies to evaluate a potential connection between
its vaccine and "adverse events of special interest"  -  including
myocarditis and pericarditis.
The Novavax shot's product label for the U.S. market warned against
injecting it to people with a history of allergic reactions to any of
its components. But even before it was granted EUA in July, staffers
at the FDA pointed out that the vaccine increased the risk of
myocarditis.
In documents released June 3, staff (https://bit.ly/3d6vtzL) members
at the regulator cited four events of myocarditis  -  inflammation
of the heart muscle  -  that occurred during clinical trials of the
vaccine. Novavax conducted trials of its sub-unit protein vaccine
on almost 30,000 patients between December 2020 and September
2021.
"These events raise the concern for a causal association with this
vaccine, similar to the association documents with mRNA COVID-19
vaccines. Data from passive surveillance during post-authorization
use in other countries also indicate a higher than expected rate of
myocarditis and pericarditis [heart lining inflammation] …
associated with the vaccine," they wrote.
"Further evaluation is needed to inform the risk of myocarditis and
pericarditis, and their outcomes, as additional data emerge over
time."