MODERNA SET TO SEEK EU, US CLEARANCE FOR EMERGENCY USE

Efficacy is consistent across age, race, 100% success in preventing severe cases of Covid

WASHINGTON: Moderna Inc. plans to request clearance for its coronavirus vaccine in the US 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% effective, in line with preliminary findings released earlier this month. All 30 severe cases observed in the study occurred in participants who received a placebo, according to a company statement, indicating 100% efficacy against severe disease for the shot.

The new results put the biotechnology company on track to have one of the first Covid-19 vaccines to be cleared in the US. A similar vaccine from Pfizer Inc. and BioNTech SE was submitted to US regulators earlier this month and is scheduled to be reviewed ahead of Moderna’s shot.

WASHINGTON: Moderna will apply for US and European emergency authorisation for its Covid-19 vaccine after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, it said.

Moderna also reported that its vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people. The filing sets Moderna’s product up to be the second vaccine likely to receive US emergency use authorisation this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate.

“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.”

Of the 196 people who contracted Covid-19 out of over 30,000 volunteers, 185 had received a placebo and 11 got the vaccine. Moderna reported 30 severe cases, all in the placebo group, which means the vaccine was 100% effective against severe cases. In addition to filing its US application, Moderna said it would seek conditional nod from European Medicines Agency, which is reviewing its data.

Will do everything to find virus origin: Tedros

World Health Organization chief Tedros Adhanom Ghebreyesus insisted on Monday it would do everything possible to find the animal origins of Covid-19. “We want to know the origin and we will do everything to know the origin,” he said, urging critics who have accused the UN agency of handing the reins of the probe to China to stop “politicising” the issue.

“We need to know the origin of this virus because it can help us to prevent future outbreaks,” he said. “There is nothing to hide. We want to know the origin, and that’s it.” He urged Brazil to be “very, very serious” about the worrisome rise in virus cases. US scientist Dr Anthony Fauci warned that America should prepare for a “surge upon a surge” in coronavirus cases as millions of travellers return home after the Thanksgiving holiday.