Comirnaty and Spikevax Recommended by CHMP for Standard Authorization

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended full marketing authorizations for Pfizer and BioNTech’s Comirnaty and Moderna’s Spikevax.

The two messenger RNA (mRNA) vaccines currently only have conditional marketing authorizations in the EU pending results from ongoing clinical trials and additional quality data in light of scaled-up production.

The EMA panel said the data indicated that the two vaccines are effective in preventing severe COVID-19 infections. The EMA said it will continue to assess any new data on the two vaccines and will take action to protect patients if needed.