US regulators find Moderna vaccine safe and effective

WASHINGTON • Moderna's vaccine is safe and effective for preventing Covid-19, US regulators said, clearing the way for a second vaccine to quickly gain emergency authorisation and add to the country's sprawling immunisation effort.

The Food and Drug Administration's (FDA) staff said in a report posted online yesterday that the experimental vaccine is 94.1 per cent effective at preventing symptomatic Covid-19, confirming results earlier released by the US drugmaker.

The report came ahead of a meeting tomorrow of agency advisers who will vote whether to recommend authorisation before a final FDA decision.

The agency does not have to follow the advice of the independent vaccine experts, though it often agrees with its advisory panels. Last week, the FDA authorised a similar vaccine from Pfizer and BioNTech after an advisory panel voted 17-4, with one abstention, to support its authorisation.

The FDA got a much deeper look at Moderna's clinical trial data than the numbers the firm had previously released to the public.

Notably, the agency was able to review the shot's effectiveness across a broad range of racial, ethnic and age groups, and look at how well the shot worked for people with pre-existing medical conditions that make them more vulnerable to severe Covid-19.

The agency found the shot was similarly effective across racial and ethnic groups and those with underlying medical conditions.

It was 86.4 per cent effective in people aged 65 and over, and 95.6 per cent effective in those aged 18 to 65.

Both the Moderna and Pfizer vaccines are based on messenger RNA technology that has not been previously used in inoculations. Both are two-dose vaccines, meaning once people receive an initial shot, they will need to return weeks later for a second shot.

Moderna's vaccine is not yet approved in any country and has not yet been used on anyone outside of a clinical trial. Once the US grants authorisation, advisers to the Centres for Disease Control and Prevention must meet, as they did last week on Pfizer's vaccine, to give Moderna's shot the green light and provide specific recommendations for use and monitoring.

BLOOMBERG