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Moderna today requests vaccine approval in the US and EU

US pharmaceutical company Moderna will submit its corona vaccine candidate today for approval to US and European authorities, the company announced.

Moderna also announced results of a follow-up study of the vaccine with 30,000 participants. It shows that the vaccine is 94.1 percent effective in preventing infection with covid-19, the company says.

Of the 196 subjects who contracted covid-19, 185 participants were in the placebo group who did not receive the vaccine. The virus would be 100 percent effective against a severe form of the disease. Thirty participants received a severe form of covid-19, all in the group that did not receive the vaccine. Protection is also consistent across age, ethnicity and gender.

Need two doses

The first injections could be given as early as December 21 if the process goes smoothly and approval is granted, said Stéphane Bancel, the company’s CEO.

Moderna is on track to produce 20 million doses by the end of December, and 500 million to a billion by 2021. Each person will need two doses administered one month apart. 20 million doses are enough for 10 million people.

America claims the first deliveries. The drug company received $ 2.48 billion in US federal funds for the development of the vaccine. Europe may only receive the first smaller delivery from Moderna in a few weeks / months.

If Moderna actually files an application with the European authorities today, it will be the first to take that step in the EU. In the US, competitor Pfizer has already submitted an application.

EU Commission President Ursula von der Leyen announced last week that the EU has signed a contract with Moderna over 160 million doses, 80 million for a first delivery and an option for that much more at a later stage.

When in Belgium?

If this were a classic case, vaccines such as those from BioNTech-Pfizer and Moderna would probably not be able to hit the Belgian market until mid-June. ‘But this is not a classic case’, says Ann Eeckhout of the Federal Agency for Medicines and Health Products (FAMHP).

‘The European Commission has already reached an agreement with the companies on pricing in recent weeks and our country recently decided that the vaccine will be made available to everyone free of charge. There is therefore no longer any question of reimbursement, which means that both traditional intermediate steps are now omitted. ‘

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