Moderna Inc, the US drug maker, on Monday said that they will apply for US and European emergency use authorization for its covid-19 vaccine following results of a late-stage analysis which proved its vaccine to be more than 94 per cent effective with no adverse event.
Additionally, Moderna also said that their vaccine was 100 per cent successful in preventing severe cases of the infection irrespective of race, age, ethnicity and gender.
The analysis included 196 cases and none of the volunteers who had participated in trials reported any serious safety events.
of the 196 people who had covid-19 infection rampant in their body, 185 received a placebo while 11 received the vaccine. Moderna said that 30 were severe cases– all in the placebo group — who were successfully treated, thus, proving 100 per cent efficacy in preventing severe cases.
“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Tal Zaks said.
“We expect to be playing a major part in turning around this pandemic.”
“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.
Apart from applying for emergency use in US, Moderna said it also aims to seek conditional marketing authorisation in Europe.
Meanwhile, the US Food and Drug Agency will likely announce their decision on the vaccine on December 17 after holding a review meeting.
According to the company, they have already manufactured 20 million doses of the vaccine which are ready to pump in the market by the end of 2020.
Moderna is the second candidate to seek emergency use authorisation of its vaccine in the US. Prior to this, Pfizer, who reported 95 per cent efficacy, had also applied for the permission which will be reviewed on December 10.