FDA considers possible myocarditis link in Novavax COVID-19 vaccine recipients

In reviewing clinical trial data related to the Novavax (Nasdaq:NVAX) COVID-19 vaccine, FDA expressed concerns about the product’s potential to cause myocarditis, a type of heart inflammation.

In a briefing document, FDA noted that the “identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern.” The agency goes on to say that if causally associated, “the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines (for which no cases were identified in pre-authorization evaluation).”

In a statement, Novavax concluded that the rate of myocarditis and a similar condition known as pericarditis was similar across vaccine and placebo recipients. In the vaccine arm, 0.007% experienced such heart inflammation, while 0.005% of placebo recipients did.

Myocarditis is a risk occasionally ass…

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CDC recommends eight-week interval for some COVID-19 vaccine recipients 

The CDC has recommended extending the interval between the first and second doses of the Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) COVID-19 vaccines up to eight weeks for some individuals.

The guidance for those vaccines was formerly 21 and 28 days, respectively. 

CDC notes that an eight-week interval could be preferred for some individuals 12 and older — especially males aged 12 to 39. The extended window may reduce the risk of myocarditis. 

A three-week interval for Pfizer-BioNTech and a four-week interval for Moderna is preferred for individuals who are moderately to severely immunocompromised and adults who are at least 65. 

While myocarditis associated with mRNA vaccines remains rare, passive surveillance reporting in the U.S. confirms an increase in the condition — especially in adolescent males and young men, according to a report in JAMA. 

Extending the interval between the first and second doses may result in superior vaccine ef…

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Pfizer and Moderna to expand clinical trials for school-aged children 

As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization.

In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech.

Since then, FDA has substantiated the risk of myocarditis, or heart inflammation, from mRNA vaccines, which is rare and tends to be minor.

According to The New York Times, federal regulators concluded that the proposed clinical trials to study the Pfizer and Moderna vaccines in school-aged children were insufficiently powered to detect rare side effects, including heart inflammation.

[Related: AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study]

Pfizer (NYSE:PFE) and BioNTech (NASDAQ: BNTX) announced in June that it was expanding its COVID-19 vaccine trial to include up to 4,…

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FDA plans to warn of rare myocarditis risk following COVID-19 vaccination

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39. 

The conditions appear to be more common in males. 

The FDA warning will state that health officials have observed myocarditis or pericarditis in a limited number of people after receiving the second vaccine dose. The onset of symptoms usually occurred within several days to a week. The warning will recommend that people with post-vaccination myocarditis or pericarditis symptoms seek medical care. 

Federal officials, however, continue to stress that the benefits of the mRNA vaccines clearly outweigh the risks. In an HHS statement, multiple health officials from the public and private sector stress that the heart issue is “an extremely rare side effect, and only an exc…

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Preliminary data point to possible link between myocarditis and mRNA COVID-19 vaccines

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The theme of myocarditis and pericarditis following mRNA vaccination emerged in today’s Vaccines and Related Biological Products Advisory Committee meeting, which reviewed preliminary safety data of Pfizer-BioNTech vaccine in children aged 12 to 15. The risk, however, appears to be small.

As of May 31, there were 116 reports of myocarditis or pericarditis after the first dose of Pfizer-BioNTech vaccine. There were 100 for the first dose of Moderna vaccine. The problem, however, appears to be more common after the second dose. The government has collected 372 reports of myocarditis or pericarditis after the second dose of Pfizer-BioNTech vaccine and 201 for the Moderna vaccine.

Early data suggests a connection between the mRNA vaccines and myocarditis and pericarditis. Out of 2.3 million doses administered to 16-to-17-year-olds, the VAERS database lists 79 cases of myocardit…

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