COVID-19 Vaccines Have a Good Safety Profile

An expansive group of international medicine regulatory authorities confirmed vaccines aimed at protecting people from severe outcomes of COVID-19 have a very good safety profile in all age groups.

European Medicines Agency (EMA) today announced it endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA).

The EMA stated evidence from more than 13 billion doses of COVID-19 vaccines administered worldwide shows that these vaccines aimed at protecting people from severe outcomes of COVID-19, including children, people with underlying medical conditions, immunocompromised patients, and pregnant women.

The EMA added that the vaccines had saved millions of lives worldwide by significantly reducing the risk of severe disease, hospitalization, and death from infection with the beta coronavirus SARS-CoV-2.

And while the vast majority of side effects of COVID-19 vaccines are mild and temporary, safety monitoring systems have identified some very rare (occurring in less than 1 in 10,000 people) but serious side effects.

Myocarditis and/or pericarditis are very rare side effects of mRNA vaccines. They normally affect younger males and resolve with appropriate treatment. And reports of deaths following vaccination are very rare. says the ICMRA.

As of July 2023, the World Health Organization (WHO) identified twelve COVID-19 Vaccines with Emergency Use Listing.

Recent additions include the GEMCOVAC®-OM vaccine received approval from the regulator Drug Control General of India.

And SKYCovione™ became the 12th COVID-19 vaccine Listed by the WHO on June 19, 2023. 

ICMRA brings together 38 medicines regulatory authorities from every region globally, with the World Health Organization (WHO) as an observer. Medicines regulators recognize the importance of facilitating access to safe, effective, high-quality products that are essential to human health and well-being. 

Moreover, the EMA has seven scientific committees that evaluate medicines along their lifecycle from the early stages of development through marketing authorization to safety monitoring once they are on the market.

In the U.S., the Food and Drug Administration (FDA) confirmed on June 6, 2023, that Novavax COVID-19 Vaccine, Adjuvanted (Nuvaxovid, CovoVax, NVX-CoV2373) is available under EUA in the U.S. to prevent COVID-19 in individuals 12 years of age and older and booster doses for certain people.

Furthermore, the FDA's Vaccines and Related Biological Products Advisory Committee met on June 15, 2023, and confirmed for the 2023-2024 Formula of COVID-19 vaccines, the FDA advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition.