Moderna says its candidate shows 94.5% efficacy, can stay stable for a month at 2-8°C

Our Bureau Mumbai | Updated on November 16, 2020

(FILES) In this file photo taken on May 18, 2020, a man stands outside Moderna headquarters in Cambridge, Massachusetts. - US biotech firm Moderna on November 16, 2020 announced its experimental vaccine against Covid-19 was 94.5 percent effective, marking a second major breakthrough in the vaccine hunt. (Photo by Joseph Prezioso / AFP)   -  AFP

At 2 -8 degrees C, stays stable for a month; no need for onsite vaccine dilution

Moderna Inc has said that an independent review of its Covid-19 vaccine candidate showed efficacy of almost 95 per cent.

The biotech company added, in a separate statement, that its vaccine candidate remained stable at 2°C to 8°C, the temperature of a standard home or medical refrigerator, for 30 days.

These announcements come days after Pfizer claimed over 90 per cent efficacy on its vaccine candidate. However, the vaccine required storage temperatures of about -80°C, putting it beyond the reach of low and middle income countries. Also, last week, Russia’s Sputnik V vaccine also claimed efficacy of 92 per cent from an initial analysis of late-stage trials.

Giving details on the findings, Moderna said a Data Safety Monitoring Board appointed by the National Institutes of Health (NIH) for the phase III study of its mRNA-1273 vaccine said the trial had met the pre-specified criterion — an efficacy of 94.5 per cent.

Moderna intends to submit its data for Emergency Use Authorisation (EUA) with the US Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least two months).

PremjiInvest, the private investment arm of Wipro founder Azim Premji, is reportedly an early investor in Moderna.

Study details

The study enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the NIH, among others.

The primary endpoint of the study was based on the analysis of Covid-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. “This first interim analysis was based on 95 cases, of which 90 cases of Covid-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5 per cent,” Moderna said.

Storage & distribution

In another note, Juan Andres, Moderna Chief Technical Operations and Quality Officer, said the company will also submit the extended stability conditions for mRNA-1273 to regulators for approval. “The ability to store our vaccine for up to six months at -20°C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the US and other parts of the world,” said Andres.

Interestingly, the vaccine will not require onsite dilution or special handling, which facilitates vaccination across a range of settings including pharmacies and physicians’ offices, the company said.

Published on November 16, 2020

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