The European Medicines Agency (EMA) has announced that it will conclude its assessment of the safety and efficacy of Pfizer’s COVID-19 vaccine on December 29 and Moderna’s vaccine on January 12.
On Tuesday, he began evaluating applications for the use of two vaccines developed by pharmaceutical company Moderna, as well as one presented by Pfizer and BionNtech.
The EMA associates these dates with the quality of the data provided by the companies and explains in a press release that the assessments will be carried out urgently.
In any case, the EMA’s evaluation of the two vaccines will not be the last step in the process so that they can be marketed on a preliminary basis in the EU, as they must then be officially approved by the European Commission. in a process which will be “a matter of days” and requires prior consultation with Member States.
“If the EMA issues a positive recommendation after its detailed analysis on the safety and efficacy of vaccines, the European Commission will do everything possible to quickly reach a decision on the authorization”, assured the spokesperson of the Health at a press conference. from Community Executive Stefan de Keersmaecker.
The Pfizer and Moderna vaccines have been shown to be close to 95% effective and are part of the joint purchase made by the European Union. Specifically, an agreement has been reached with Pfizer and BioNTech for 200 million doses, with the possibility of requesting an additional 100 million. Likewise, it was agreed to purchase 80 million Moderna vaccines, plus an additional 80 million.
The timelines for the authorization of COVID-19 vaccines have been shortened as the EMA has already reviewed some vaccine data during an ongoing review. During this phase, he evaluated the data on the quality of the vaccine, as well as the results of laboratory studies. The EMA also reviewed the results on vaccine efficacy and initial safety data from large-scale clinical trials.
In the EU, conditional marketing authorizations allow the approval of medicines if the benefit to the patient may outweigh the risk of not having all the data. These types of permissions are being used in the coronavirus pandemic to quickly respond to the threat to public health.