US biotech company Moderna said on Monday its candidate vaccine for Covid-19 has turned out to be nearly 95% effective in thwarting the deadly coronavirus and it planned to apply for regulatory authorisation in 10 days’ time, setting up limited-capacity distribution in the United States before year-end.
This is the second vaccine on the way. US pharmaceutical company Pfizer and German BioNtech announced last week that their candidate vaccine tested 90% effective.
“This is a pivotal moment in the development of our Covid-19 vaccine candidate,” said Stephane Bancel, chief executive officer of Moderna, in a statement. “We look forward to the next milestones of submitting for an EUA (emergency use authorisation in the US, and regulatory filings in countries around the world.”
Bancel told The Washington Post the company planned to apply for EUA shortly before November 26, and that he hoped to make it available to those at high risk in the second half of December.
It could not be immediately ascertained if and when Moderna would be able to make the vaccine available in India. Pfizer has said it is in talks to sell its vaccine in India.
More than 1.3 million people have died from Covid-19 around the world and more than 54 million have been infected. The pandemic has begun surging again with experts warning of a grim winter. The US and India are the two worst-hit countries, with 11 million and 8 million infections and 246,000 and 130,000 fatalities respectively, according to the Johns Hopkins University’s coronavirus tracker.
The US National Institute of Allergy and Infectious Diseases (NIAID, which is headed by leading epidemiologist Anthony Fauci and which co-developed the drug, said the “data suggests that the vaccine is safe and effective at preventing symptomatic Covid-19 in adults… The findings are statistically significant, meaning they are likely not due to chance”.
US President Donald Trump, who has been more focused in recent days on seeking to overturn his defeat in the election, welcomed Moderna’s announcement with a swipe at his critics. “Another vaccine just announced. This time by Moderna, 95% effective. For those great ‘historians’, please remember that these great discoveries, which will end the China plague, all took place on my!”
Moderna received substantial funding from the US government as part of Trump’s Operation Warp Speed, a project launched to expedite the search for a Covid-19 vaccine. As mentioned, Fauci’s NIAID collaborated with it. Pfizer and BioNtech developed their vaccine candidate independently, without any government funding, though the Trump administration sought to claim credit for it as well.
The Moderna vaccine candidate was being tested on 30,000 volunteers, half of whom received two doses of it and the rest were on placebo. Among the 95 people who tested positive for Covid-19 two weeks after the second dose, 90 were those who were in the placebo group, as were the 11 who developed severe symptoms.
The 95 Covid-19 cases included 15 older adults (ages over 65 and 20 who identified themselves as belonging to diverse communities (including 12 Hispanic or Latinx, four Black or African-Americans, three Asian-Americans and one multiracial, Moderna said in the press announcement.
Moderna added that it expected to apply for EUA with the US drug regulator FDA in the coming weeks, with an unspecified time-frame for other counties. A response was awaited to a request for plans for India.