Moderna to seek limited early use of Covid vaccine if it is 70% effective

Moderna to seek limited early use of Covid vaccine if it is 70% effective

Moderna’s vaccine candidate - mRNA-1273 - is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. File image: AP

If Moderna's Covid-19 vaccine proves to be at least 70% effective, the company plans to seek emergency authorisation for its use in high-risk groups, the company’s chief executive told Reuters.

Moderna’s vaccine candidate - mRNA-1273 - is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. 

Vaccines must demonstrate they are at least 50% more effective than a placebo to be considered for approval. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.

If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek US regulatory approval for Emergency Use Authorisation. 

“If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90% efficacy, we will indeed consider approval,” Stephane Bancel, Moderna’s chief executive officer, said in an interview. 

Public health officials have said that approving a vaccine for widespread use based on a small number of cases would not offer enough safety information to show how the vaccine would perform.

In a presentation this week, Pfizer said the company has enrolled more than 29,000 people in its 44,000-volunteer trial to test an experimental vaccine the company is developing with German partner BioNTech.

BioNTech is buying a production site for the vaccine. “A good vaccine should have an immunisation effect of at least 70% to 75%," said BioNTech chief Ugur Sahin. 

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