Moderna to ask EU and US for emergency authorisation for vaccine

The final results of the study put its effectiveness level at 94.1%

American company Moderna has announced that it intends to request, this very Monday, an emergency authorisation for the use of its covid-19 vaccine from both the European Union and the United States. It will do so after the definitive results of its study have established the level of effectiveness of the vaccine at 94.1%, slightly below the 94.5% it had announced two weeks ago, based on provisional results. According to Reuters, however, the vaccine's effectiveness rate is 100% in preventing serious cases of covid-19.

In a statement, Moderna explains that the Phase 3 study of its vaccine has involved 30,000 participants. Of these, 196 contracted covid-19, but the vast majority of these (185) had received a placebo, while only 11 had been vaccinated. Among those infected, there were 30 severe cases and one death, but all were part of the group that had received a placebo, so the vaccine is considered 100% effective in preventing these types of cases. According to the company, the degree of effectiveness of the vaccine remains stable regardless of age, race and sex of the patients, "We believe we have a vaccine that is very highly effective. We have the data to prove it," Dr Tal Zaks, Moderna's chief medical officer, told Reuters.

Moderna has not detected any serious safety problems. The only side effects observed are those already noted in the preliminary results: mainly tiredness, headache, muscle pain and skin reactions in the area where the injection is administered.

The company intends to launch a new study of the vaccine with teenagers before the end of the year, and another with younger volunteers in early 2021. The goal is to have a variant of the vaccine adapted to young population by September next year.

Ten days ago, Pfizer requested emergency clearance for its covid-19 vaccine from the United States, and the regulatory body, the Food and Drug Administration, plans to analyse the data presented by this company on December 10. In the case of Moderna, the data will be evaluated on December 17.

On the other hand, the European Commission announced last week that it had signed a contract with Moderna for the purchase of 160 million doses of its vaccine. The main advantage of this prototype with respect to Pfizer's (which is 95% effective) is that it can be kept for six months at -20ºC (Pfizer's has to be under -80ºC), and that it can even be kept for one month in a conventional refrigerator, at between 2ºC and 8ºC.

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