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According to Ton de Boer, president of the Dutch Drug Evaluation Board (MEB), there are still too many questions to answer regarding the vaccine developed by Moderna.
The EMA will reconsider the application for approval for the use of the vaccine developed against Kovid-19 in Europe, in line with information from the US pharmaceutical company.
The Scientific Committee for Humanitarian Medicines (CHMP) of the European Medicines Agency, which includes representatives from 27 EU member countries, met on Monday to discuss the application for approval of the Moderna vaccine.
It was previously announced that the CHMP will meet on Wednesday 6 January. However, the meeting was moved forward after the manufacturer delivered the requested documents to the EMA headquarters in Amsterdam last Thursday.
‘THIS IS NOT EXCEPTIONAL’
In making a statement after the meeting, which continued into the evening, de Boer, chairman of the Dutch Drug Evaluation Board, said the expected approval for the Moderna vaccine was not obtained.
According to the BBC, the Dutch official said: “We expected otherwise, but such things can happen. This delay is not unusual, it is an indication of a careful vaccine approval process,” he said.
According to De Boer, there are still many questions about the Moderna vaccine, and without the proper answers to these questions, it will not be possible to launch it in Europe.
The Dutch official did not answer questions about what obstacles exist with the Moderna vaccine.
De Boer stated that the issue will be reconsidered at the CHMP meeting to be held on Wednesday.
MODERN IS USING RNA TECHNOLOGY
The European Medicines Agency approved the coronavirus vaccine developed by BioNTech, led by Pfizer, Özlem Türeci and Uğur Şahin, on December 21.
The Moderna vaccine, which is said to provide 94.5 percent protection against Covid-19 as a result of testing, uses RNA technology similar to the vaccine developed by Pfizer-BioNTech.
However, Moderna vaccine can be stored at -20 degrees, not -70 degrees like the Pfizer-BioNTech vaccine. It can be kept in the refrigerator for 30 days after defrosting. Pfizer-BioNTech vaccine can only stay in the refrigerator for 5 days after thawing.
THE EU SIGNED AN AGREEMENT WITH MODERNA FOR 80 MILLION DOSES
The EU Commission signed an agreement with Moderna to buy 80 million doses of vaccine. The deal includes the EU option to buy an additional 80 million doses.
The Moderna vaccine, if approved, will be the most expensive vaccine bought by the EU. By paying 12 euros per dose for the Pfizer-BioNTech vaccine, Europe will buy the Moderna vaccine at 18 euros per dose.
The vaccines will be administered to European citizens aged 16 and over.
