Saturday, December 3, 2022
Bringing the Latest in News Straight to Your Screen

Pfizer And Moderna Reportedly Expanding Covid Vaccine Studies Of Children To Better Understand Rare Side Effects

By News Creatives Authors , in Business , at July 26, 2021


Pfizer and Moderna are expanding the sizes of their Covid-19 vaccine trials in children ages five to 11, The New York Times reported Monday, characterizing the move as a precautionary measure to better understand rare side effects—including heart inflammation problems—that have turned up in some young people.

Key Facts

Multiple anonymous sources told The New York Times that vaccine makers are moving to expand their ongoing clinical trials at the request of the Food and Drug Administration (FDA). 

The agency reportedly indicated the size and scope of the current studies were inadequate to detect the rare side effects of myocarditis (heart muscle inflammation) and pericarditis (inflammation of the membrane surrounding the heart) that have been identified in a very small number of coronavirus vaccine recipients under 30. 

The Centers for Disease Control and Prevention (CDC) released data last month showing around 500 of the 1,200 Americans who developed heart inflammation issues after receiving mRNA vaccines were under the age of 30. 

This amounts to less than 13 cases per one million second doses administered of these diseases, which—marked by symptoms like chest pain and shortness of breath—typically clear up within a few weeks, but in a small number of cases can be chronic. 

What To Watch For 

It’s currently unclear how expanding the size of the trials will impact the timeline for getting these vaccines formally approved for use in children. The FDA said earlier this month it expects the emergency authorization for Covid-19 vaccines in children under 12 to come in early to midwinter.  

Key Background 

A CDC safety group previously said it found a “likely association” between a rare heart inflammatory condition in young people and the coronavirus vaccine, though the reported cases were minute compared with total inoculations and the risk of getting the diseases are even greater among those with Covid-19. While the CDC is continuing to research the link between the heart disease and the vaccine, research shows the risk of this heart inflammation is actually greater among those who are infected with Covid-19. A Yale University study released in May found that about one in every 1,000 children who get the virus go on to develop a condition called MIS-C (multisystem inflammatory syndrome in children) which for most involves some level of myocarditis. Covid-19 poses a more severe risk for unvaccinated adolescents and adults, and has led to a wide array of severe cardiac abnormalities. As a result, top pediatricians and pediatric cardiologists—along with the American Heart Association—continue to recommend the vaccine to adolescents.

Full coverage and live updates on the Coronavirus


Leave a Reply

Your email address will not be published. Required fields are marked *