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Regulatory Focus™ > News Articles > 2020 > 11 > NIH director: Efficacy for co-developed Moderna vaccine nears 95%

NIH director: Efficacy for co-developed Moderna vaccine nears 95%

Posted 16 November 2020 | By Kari Oakes 

NIH director: Efficacy for co-developed Moderna vaccine nears 95%

The director of the National Institutes of Health (NIH) reported favorable efficacy results after an interim analysis of data from the COVE Phase 3 efficacy trial of mRNA-1273, the messenger RNA vaccine candidate the agency co-developed with the biotechnology company Moderna.
In a NIH Director’s Blog post released on the same day Moderna issued a press release announcing interim efficacy figures topping 94% for its vaccine candidate, Francis Collins, MD, shared favorable top-line results from an interim analysis conducted by the trial’s oversight group: “This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults,” said Collins. The COVE trial has enrolled over 30,000 participants at 100 US research sites, said Collins.
The NIH director also reminded readers of the development history of the vaccine. Massachusetts-based Moderna developed the messenger RNA delivery platform for the vaccine, a technology which the company likens to “software” that provides instructions for cells to manufacture proteins, or “applications” according to the Moderna explanation of its platform. (RELATED: Building a vaccine at light speed: mRNA COVID vaccine development, Regulatory Focus 04 November 2020)
The molecular structure of the spike protein of SARS-CoV-2, the virus that causes COVID-19, was discovered by scientists at the National Institute of Allergy and Infectious Diseases (NIAID). Mapping out the structure of the spike protein – the means by which the virus fuses to and enters cells – allowed scientists to design a stabilized spike antigen that is delivered by Moderna’s mRNA technology.
After early development at NIAID, the mRNA vaccine came under the US government’s Operation Warp Speed umbrella with more development work at the Biomedical Advanced Research and Development Authority (BARDA). Both BARDA and NIAID continue to provide funding and technical support to Moderna, the vaccine’s sponsor; BARDA has provided nearly $1 billion in support to date, according to Moderna.
On 11 August 2020, Moderna announced that it had reached an agreement with the US government to provide 100 million doses for “up to” $1.525 billion. The government also retains the option to purchase up to 400 million additional doses of mRNA-1273.
Cold-chain issues are an important consideration both for the Moderna candidate and for the mRNA vaccine being trialed by Pfizer/BioNTech, which also reported interim efficacy results topping 90% in early November. However, here Moderna’s candidate has an apparent edge, since temperatures of -5° F are required for transport and storage of mRNA-1273, compared with temperatures of -94° F for Pfizer’s candidate.
Moderna is planning to submit an emergency use authorization (EUA) with FDA “in the coming weeks” after safety and efficacy data with a median duration of at least 2 months are available, said the firm. The vaccine is currently undergoing rolling review by the European Medicines Agency. (RELATED: CHMP starts rolling review of Pfizer/BioNTech COVID vaccine, Regulatory Focus 06 October 2020)
The efficacy point estimate of 94.5% was reached with an analysis of confirmed COVID-19 cases in those receiving the vaccine and in the placebo group, beginning two weeks after the second dose of vaccine. The report from Moderna is the first interim analysis; of 95 COVID-19 cases in participants, 90 were in the placebo group.
Moderna had earlier slowed Phase 3 enrollment to boost patients in diverse communities and older adults; 15 older adults and 20 participants identified as belonging to diverse communities were among the 95 cases.
Safety data were also reviewed in the interim data safety monitoring board analysis, with severe adverse events including injection site pain and redness, fatigue, muscle and joint aches and headaches. None of these were reported by more than 10% of participants and were “generally short-lived,” according to Moderna.
Of the COVID-19 cases detected at the first interim analysis, 11 cases were severe; all of these were in the placebo group.
“As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change,” said Moderna in the press release, adding that plans are underway to submit data from the full Phase 3 COVE study to a peer-reviewed publication.


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Tags: coronavirus, FDA, US

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