Moderna seeks US and European clearance for Covid vaccine

US company Moderna said it plans to request clearance for its coronavirus vaccine in the United States and Europe on Monday, after a new analysis showed the vaccine was highly effective in preventing Covid-19, with no serious safety problems.

The primary analysis, which included 196 cases, found the vaccine was 94.1 per cent effective, in line with preliminary findings released earlier this month.

None of the participants in the trial who’d received the vaccine developed severe Covid-19. All 30 severe cases observed in the study occurred in participants who received placebo shots, according to a company statement.

The new analysis showed the vaccine worked consistently well in older and younger adults, as well as minorities, the company said. It said the 196 clinical trial volunteers who contracted Covid included 33 people over the age of 65 and 42 people who identified themselves as being from diverse communities.

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Moderna didn't disclose the vaccine's exact efficacy in those groups, and chief executive Stephane Bancel said that more detailed data is still being finalised.

The company’s shares extended their gains to as much as 12 per cent before US markets opened, hitting a record of $142.85. They have risen more than sixfold since the year began.

Moderna becomes the second group to seek US approval for its Covid-19 vaccine. Pfizer and BioNTech applied last week for a green light to market their vaccine.

Emergency authorisation

Moderna said it plans to apply on Monday for an emergency-use authorisation for the vaccine in the US and for conditional marketing authorisation in Europe. Advisers to the US regulator, the Food and Drug Administration, will likely scrutinise the data at a public meeting on December 17th, the company said, one week after a similar review of Pfizer's vaccine is expected to take place.

“We have been working nonstop in the last few weeks” to get the vaccine data ready to submit to regulators, Mr Bancel, Moderna’s chief executive officer, said in an interview. Once authorities sign off, the company will move quickly to distribute the shots, part of a vast vaccination effort that will unfold as hospitals in the US strain under a surge in infections.

“We are ready today to ship the vaccine,” Mr Bancel said. “We have millions of doses ready, we have more and more every couple days.”

If the vaccine is cleared in the US, which Mr Bancel said could occur as soon as 24 to 72 hours after the December 17th meeting, Moderna’s entire inventory will be sent to the US federal government. The company expects to be able to ship 20 million doses in the US by the end of the year.

Safety signals

Overall, there were 185 cases of Covid-19 in trial participants who got a placebo, and 11 cases in people who got the vaccine.

As mandated by the FDA, Moderna said it had also accumulated two months of safety data from its final-stage trial of more than 30,000 participants. Reported side effects included injection-site pain, fatigue, muscle or joint pain and headache. The side effects were more common and severe after the second dose of the two-dose vaccine, Moderna said.

The results bolster an interim analysis released on November 16th, which showed the vaccine was 94.5 per cent effective in preventing symptomatic Covid-19 and successful in preventing the most severe infections.

Both the Moderna and Pfizer vaccines rely on a technology called messenger RNA that turns the body's cells into vaccine-making factories. Messenger RNA has never before been used to develop an approved vaccine. Moderna, which has co-developed the mRNA candidate with the National Institutes of Health, has already reached agreements to supply 100 million doses to the U.S. and 80 million to the European Union, among others. – Bloomberg