The EU’s drugs watchdog Friday said it expects the first application for approval of the COVID-19 vaccine by the end of this year.
Officials from the European Medicines Agency (EMA) told Anadolu Agency that none of the companies working to develop the COVID-19 vaccine has yet applied to EMA for market approval.
The EMA is conducting a rapid evaluation process about the vaccines that three companies are working on, although there are no applications yet. The vaccines are BioNTech and Pfizer’s “BNT162b2”, Oxford University and AstraZeneca’s “ChAdOx1-SARS-CoV-2” vaccine, and “mRNA-1273” from Moderna Biotech Spain.
Normally, all data on the efficacy, safety, and quality of a vaccine or a drug should be provided at the beginning of the evaluation process by the EMA. However, in emergency situations, the agency can start the assessment using information obtained from ongoing studies before the official application is filed in order to speed up the process.
In order for a drug or vaccine to be placed on the market in the EU, the EU Commission’s approval is also needed after the EMA’s approval.
The EMA officials have evaluated many data from large-scale clinical trials so far in the rapid evaluation process.
At this stage, data from several clinical studies continue to pour in. That’s why the EMA officials avoid specifying a precise timetable for approval.
However, vaccine producers are expected to apply for official approval to the EMA “very soon”. Therefore, the EMA officials think the first approval can be given before the end of the year.
The EU has made agreements to purchase about 2 billion doses of vaccine with six companies that have so far conducted “promising” vaccine studies.
The EU is expected to receive 400 million doses of vaccine from AstraZeneca, 300 million from Sanofi-GSK, 400 million from Johnson and Johnson, 300 million from Pfizer and BioNTech, 405 million from CureVac, and 160 million from Moderna.
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