Moderna seeking Covid-19 vaccine authorisation in US, Europe

Moderna Inc 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 percent effective with no serious safety concerns, the company has said.

"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 the company's CEO Stephane Bancel on Monday.

If the US Drug and Food Administration agrees it is safe and effective, the first of the drug's two doses could be injected into the arms of millions of Americans by the middle of December.

American pharmaceutical company Pfizer and Germany's BioNTech applied for similar approvals last week, and their vaccine could be greenlit in the US shortly after December 10.

Moderna planning one billion doses 

Of the 196 volunteers who contracted Covid-19 in the trial with more than 30,000 people, 185 received a placebo while 11 got the vaccine. 

Moderna reported 30 severe cases, all in the placebo group, which means the vaccine was 100 percent effective in preventing severe cases.

Moderna said it expects to have approximately 20 million doses of the vaccine, called mRNA-1273, available in the US by the end of the year.

It also expects to manufacture 500 million to 1 billion doses globally in 2021.

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Vaccines efficiency rates

AstraZeneca has also announced an average efficacy rate of 70 percent for its shot and as much as 90 percent for a subgroup of trial participants who got a half dose, followed by a full dose. 

But some scientists have expressed doubts about the robustness of the 90 percent efficacy figure for the smaller group.

Moderna's latest efficacy result is slightly lower than an interim analysis released on November 16 of 94.5 percent effectiveness, a difference that Zaks said was not statistically significant.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and were far superior to the 50 percent benchmark set by the US regulator FDA.

The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and comes as new infections and Covid-19 hospitalisations are at record levels across the United States.

Independent advisers to the FDA are scheduled to meet on December 17 to review Moderna's trial data and make a recommendation to the FDA. 

They will meet on December 10 to review Pfizer's data.

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