“We haven’t had mRNA vaccines before, and when it goes into a large population you need to be sure” safety remains under review. Cooke, the first woman to run the EMA in its 25-year history, takes over at a pivotal time as the agency grapples with both the pandemic and Brexit. Europe’s equivalent to the U.S. Food and Drug Administration is also evaluating new products such as mRNA vaccines, which essentially teach the body’s cells to make their own protection and have never been approved for use in humans. Pfizer and partner BioNTech SE last week became the first drugmakers in the race to release advanced trial data, saying their mRNA vaccine was more than 90% effective in preventing the illness. The U.S. agency has said any shot would need to prevent disease or decrease severity in at least 50% of those vaccinated.

Source: Hindustan Times November 16, 2020 12:33 UTC