World News

Novavax COVID-19 Vaccine Can Cause Heart Inflammation: European Regulator

Distressed Patriotic Flag Unisex T-Shirt - Celebrate Comfort and Country $11.29 USD Get it here>>


The COVID-19 vaccine made by U.S.-based Novavax can lead to the same types of heart inflammation that have occurred after vaccination with the Pfizer and Moderna shots, Europe’s drug regulator said on Aug. 3.

The European Medicines Agency said the vaccine, known as Nuvaxovid, should have myocarditis and pericarditis listed as side effects in the product information for the vaccine.

Prospective recipients and healthcare professionals should be warned about the issue, the organization said.

It has asked Novavax to provide additional data on the side effects.

Anaphylaxis, or severe allergic reaction, is already listed in Europe as a side effect of Nuvaxovid, which European regulators cleared in December 2021.

Novavax told The Epoch Times in an email that in clinical trials of its jab, the rate of myocarditis was close between the vaccine and placebo arms.

“As more data becomes available, we will better understand the nature and magnitude of any potential risk of myocarditis and pericarditis. We will work with the relevant regulators to assure our product information is consistent with our common interpretation of the incoming data,” the vaccine maker said.

Just 250,091 doses have been administered in Europe in about eight months, according to the European Center for Disease Prevention and Control.

U.S. regulators only recently authorized and recommended the shot, and it remains unclear how many people have received it in the country since vaccinations started around Aug. 1.

Risk Flagged

Nations outside Europe, including Japan and the United States, have flagged heart inflammation as a risk following Novavax vaccination.

U.S. regulators said the Novavax trials did raise concerns about the conditions.

The trial data “provide evidence for increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart),” the U.S. Food and Drug Administration said.

Recipients and healthcare providers, in fact sheets, were alerted to the risk.

Myocarditis and pericarditis have occurred at higher-than-background rates in people receiving the Moderna and Pfizer vaccines, particularly young males.

Some countries have paused or curtailed administration of the shots because of the side effects since young people are already at much lower risk from COVID-19 than the elderly and infirm.

Novavax was ordered by the administration to conduct post-authorization observational studies to evaluate the link between Novavax’s vaccine and a list of adverse events of special interest, including myocarditis and pericarditis.

Zachary Stieber

Follow

Zachary Stieber covers U.S. and world news. He is based in Maryland.



Source link

TruthUSA

I'm TruthUSA, the author behind TruthUSA News Hub located at https://truthusa.us/. With our One Story at a Time," my aim is to provide you with unbiased and comprehensive news coverage. I dive deep into the latest happenings in the US and global events, and bring you objective stories sourced from reputable sources. My goal is to keep you informed and enlightened, ensuring you have access to the truth. Stay tuned to TruthUSA News Hub to discover the reality behind the headlines and gain a well-rounded perspective on the world.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.