European Medicine Agency EMA has started the assessment of the first coronavaccins, those of Moderna and PFIZER/BionTech. It is the last major step that must be taken before vaccines can be released on the market in the Netherlands and the rest of the European Union.
The supervisor will check whether the vaccines are effective enough and meet all safety requirements. According to the EMA, the best scenario assessment of vaccines will be completed this month.
If the data comply with all requirements, the EMA will decide on the Pfizer vaccine by 29 December. By 12 January, the opinion on the Moderna vaccine should be issued. In the event of a positive opinion, the European Commission will issue the formal authorisation within a few days.
Tens of thousands pages
The assessment is faster than usual, because the companies have already shared a lot of data with the EEA in recent months. On behalf of the Netherlands, the Board for Evaluation of Medicines is involved in the evaluation. “Together with our European colleagues, we are going to turn all the new data submitted inside out. This is about tens of thousands of pages. So that we will soon be able to draw a conclusion on the basis of convincing evidence,” says College Chairman Ton de Boer in a press release.
The researchers from Pfizer and BionTech announced two weeks ago that they had collected enough data to apply for a European licence very soon. A study involving 40,000 participants would show that the vaccine is 95% effective.
Yesterday Moderna reported that they now have sufficient data and that they would apply the same day. The effectiveness appears to be almost the same as the PFIZER/BionTech vaccine, based on a study involving 30,000 participants. According to both companies, no serious side effects have been observed.
Better than expected
The companies applied for a conditional assessment. This means that manufacturers do not receive final approval but agree to continue to share the results of the studies – which are going through for a long time – in the coming years.
The fact that companies are already able to apply for a licence is in line with the most favourable scenarios available. That the claimed effectiveness would be more than 90 percent exceeds expectations.
Both vaccines already have a permit application for emergency use with the US regulator FDA. Pfizer filed that application on November 20th, Moderna did it yesterday.
The FDA announced that it will discuss PFIZER/BionTech‘s request on 10 December and Moderna’s request on 17 December. It could therefore be that vaccines are on the market in the United States rather than in the European Union.