EMA starts evaluating first Covid-19 vaccines
The European medicines agency EMA started its evaluation of the first two vaccines against Covid-19, developed by Moderna and Pfizer/BioNTech. This is the last big step that must be taken before the vaccines can hit the European, and Dutch, markets.
The EMA will evaluate the vaccines on how effective they are and on whether the meet all the safety requirements, NOS reports. If all goes smoothly and according to plan, the EMA will present its evaluation results for the Pfizer vaccine on December 29, and for the Moderna vaccine on January 12. If the results are positive, the European Commission can issue a formal permit for the vaccines within days.
Last month both Pfizer and Moderna reported that their vaccines were effective in 90 percent or more of test cases, with no serious side effects noted. In order to get these vaccines on the market as quickly as possible, while maintaining safety and quality standards, the EMA is doing a "rolling review" on them. This means that the pharmaceuticals have been sharing their trial results with the EMA as they came in, instead of giving the EMA all the data at once when all the trials were done.
The European Union already signed agreements with Pfizer and Moderna to buy millions of doses of their vaccines. The Netherlands will get 3.89 percent of all vaccines delivered to the EU. That amounts to 11.7 million Pfizer vaccine doses, and 6.2 million Moderna doses. Both vaccines require two doses per person.
Last month the Dutch government confirmed elderly people, medically vulnerable people, and healthcare workers who are in direct contact with Covid-19 patients, will be first in line to be vaccinated against the coronavirus - as per the advice of the Dutch Health Council.