FDA requires Pfizer/BioNTech and Moderna new crown vaccines to add label warnings

CompilationFan Dongdong

Many new coronavirus vaccines are currently facing development delays and safety and supply issues, but the mRNA vaccines from Pfizer/BioNTech and Moderna have become the leader of similar products relatively unfettered

However, on June 24, according to foreign media reports, American experts concluded that there is a "possible link" between rare cases of cardiac inflammation and mRNA vaccines, which has brought certain harm to Pfizer/BioNTech and Moderna's vaccine injections.

The FDA said it will take swift action to require these companies to add label warnings stating that young people and teenagers are susceptible to side effects

Although the Centers for Disease Control and Prevention (CDC) concluded that the benefits of the vaccine clearly outweigh the risks, the ruling may force those with fear to favor adenovirus vaccines provided by Johnson & Johnson and AstraZeneca

The latest ruling is aimed at young people (mostly men), who developed myocarditis (cardiac inflammation) or pericarditis (cardiac membrane inflammation) mainly after the second dose of mRNA vaccine

CDC's vaccine safety data link shows that among people aged 12 to 39, the incidence of heart inflammation is 12.

Pfizer said in a statement: "Cardiac inflammation is an extremely rare side effect, and only a very small number of people will experience it after vaccination.

Moderna issued a similar statement, adding that the company will work closely with the FDA and other regulatory agencies to take appropriate next steps

Reference source: Pfizer, Moderna COVID-19 vaccines will get label warning over rare heart risk, FDA says