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Moderna asks US, Europe for emergency approval of vaccine

US biotechnology firm Moderna announced on Monday that the analysis of the Phase 3 study of its vaccine candidate “indicates” it is 94.1 per cent effective against Covid-19 infection, and 100 per cent effective in preventing severe cases of the illness.

Written by Kaunain Sheriff M | New Delhi | Updated: December 1, 2020 7:44:28 am
Moderna has said its vaccine is 94.1 per cent effective against Covid-19 infection. (AP Photo/Hans Pennink, File)

US biotechnology firm Moderna announced on Monday that the analysis of the Phase 3 study of its vaccine candidate “indicates” it is 94.1 per cent effective against Covid-19 infection, and 100 per cent effective in preventing severe cases of the illness.

Moderna, while announcing the primary efficacy analysis of the Phase 3 study of its vaccine candidate — mRNA-1273 — also, said it would on Monday request the US Food and Drug Administration (FDA) to authorise the vaccine for emergency use. It will also seek conditional approval from the European Medicines Agency (EMA).

The company, which is using mRNA technology that involves injecting genetic instructions to human cells for creating proteins to fight the virus, said that the primary analysis on 196 cases, revealed that 185 cases of Covid-19 were observed in the placebo group as against only 11 cases in the vaccine group, “resulting in a point estimate of vaccine efficacy of 94.1%”.

More significantly, it said, the secondary endpoint, where severe cases were analysed, showed that all the 30 cases occurred in the placebo and none in the vaccine group, indicating that vaccine efficacy against severe Covid-19 infection was 100 per cent.

“There was one Covid-19-related death in the study to date, which occurred in the placebo group. Efficacy was consistent across age, race and ethnicity, and gender demographics,” the company said.

“This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1% efficacy and importantly, the ability to prevent severe Covid-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death,” said Stéphane Bancel, CEO of Moderna.

While no other details on adverse reactions and immune response triggered by the vaccine candidate were shared by the company on Monday, it said the study would continue to be monitored by an independent Data Safety Monitoring Board (DSMB) and that it would submit the data from the Phase 3 study to a peer review publication.

Moderna has enrolled more than 30,000 participants in the US in its Phase 3 study.

On November 16, the company, through a press release, had announced that first interim analysis included 95 participants with confirmed cases of Covid-19, and said that Phase 3 study had met the required statistical criteria with a vaccine efficacy of 94.5 per cent. “Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose,” Moderna said on Monday.

“A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity… Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups,” the company had said on November 16.

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