Following the authorization for the BioNTech/Pfizer Inc. vaccine authorization late last year, the EMA was back in action this week.
Today, the EMA’s human medicines Committee (“CHMP”) recommended the COVID-19 Moderna Inc. vaccine for authorization.
According to the EMA, the CHMP thoroughly assessed the data on the quality, safety, and the efficacy of the vaccine.
The EMA recommended by consensus a formal conditional marketing authorization be granted by the EU Commission.
Emer Cooke, the Executive Director of the EMA, stated that the vaccine provides the EU with another tool to overcome the current emergency.
The EMA also noted:
- A very large clinical trial showed that the COVID-19 Vaccine Moderna was effective at preventing COVID-19 in people from 18 years of age.
- Efficacy was calculated in around 28,000 people from 18 to 94 years of age. All had no sign of previous infection.
- The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine.
- Additionally, the trial also showed 90.9% efficacy in participants at risk of severe COVID-19.
- Healthcare providers must give two injections of the COVID-19 Vaccine Moderna, 28 days apart.
As a result of the recommendation, the EU Commission will now fast-track the approval process.
Once the EU Commission has granted conditional marketing authorization for the vaccine, Moderna Inc. can begin to distribute the vaccine across the region.
Late last year, the EU had ordered an additional 80m doses of the Moderna Inc. vaccine. The latest order was in addition to 80m doses that had been previously ordered.
While the distribution of the Moderna Inc. vaccine likely to commence in a matter of days, the EMA has yet to review the AstraZeneca vaccine.
According to the latest reports, the EMA is awaiting additional data in order to being the review process.
Speed of distribution of the vaccine and vaccination rates will now be key in the fight against the pandemic.