Europe’s medical agency eyes safety of two COVID-19 vaccines

Europe’s medical agency eyes safety of two COVID-19 vaccines

The European Medicines Agency has said it would convene a meeting on December 29 to decide if there is enough data about the safety and efficacy of the COVID-19 vaccine developed by Pfizer and BioNTech for it to be approved.

The agency also said on Tuesday it could decide as early as January 12 whether to approve an experimental COVID-19 vaccine developed by Moderna Inc.

In a statement, the EU medicines regulator said it had already begun a “rolling review” of the vaccine based on laboratory data previously submitted by Moderna and would now assess data on how well the vaccine triggers an immune response and whether it is safe enough for broad use across Europe.

The agency said that “if the data are robust enough to conclude on quality, safety and effectiveness,” then it could approve the vaccine at a meeting scheduled for January 12.

Companies have been racing to find a treatment for the coronavirus, which has killed almost 1.5 million people and infected more than 63 million since it first emerged in China in December last year.

US giant Pfizer and German newcomer BioNTech said their vaccine could be rolled out “in Europe before the end of 2020” if the European Medicines Agency grants so-called conditional marketing authorisation.

Moderna had applied on Monday for both US and EU approval of its vaccine, based on the same new mRNA technology and with a similar level of effectiveness at around 95 percent.

The mRNA (messenger ribonucleic acid) is used to deliver genetic material to the body that makes human cells create a protein from the virus.

This trains the immune system to be ready to attack if it encounters SARS-CoV-2.