EU's vaccine regulator recommended authorisation of Moderna's vaccine
- The EU's vaccine regulator Wednesday recommended that the European Commission authorizes Moderna's Covid-19 vaccine.
- The European Medicines Agency (EMA) said it had "thoroughly assessed" data related to the vaccine's quality, safety, and efficacy.
- If Moderna's vaccine gets sign-off from the European Commission, it will become the second Covid-19 shot to be authorized in the EU.
- The EMA authorised Pfizer and BioNTech's Covid-19 shot in December.
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The EU's vaccine regulator recommended authorisation of Moderna's Covid-19 vaccine on Wednesday after experts met to review the shot.
The European Medicines Agency (EMA), which assesses vaccines for use within the EU, recommended authorisation of the vaccine for people aged 18 and over.
If the vaccine gets sign-off from the European Commission, it will become the second Covid-19 shot to be authorized in the EU.
The EMA gave emergency use authorization to Pfizer and BioNTech's vaccine on December 21, and the first shots were distributed later that week.
In a statement about the Moderna vaccine, the EMA said it had "thoroughly assessed the data on the quality, safety, and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission."
The Commission will fast-track this decision-making process, it added.
A conditional marketing authorization is a regulatory mechanism that allows early access to medicines in emergency situations.
"This vaccine provides us with another tool to overcome the current emergency," Emer Cooke, the regulator's CEO, added.
The EMA will continue to monitor data on the safety and effectiveness of the vaccine, he added, and said the agency's work "will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens."
The FDA approved Moderna's vaccine for emergency use in the US in December.
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