The regulator’s briefing document, published yesterday [December 15], comes ahead of the public meeting tomorrow of the advisory group, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), aimed at discussing the benefits and the risks of the investigational vaccine, mRNA-1273, the final step before regulators decide on granting EUA.
That committee will also determine what additional studies should be conducted by the vaccine manufacturer following issuance of the EUA to gather further data on the safety and effectiveness of this vaccine.
On November 30, Moderna submitted an EUA request to FDA, based on the interim analyses of its Phase 3 study, for use of mRNA-1273 to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The Pfizer/BioNTech COVID-19 vaccine, the first to be federally authorized and given to healthcare workers and other priority members of the US population in a vaccination campaign that started on Monday, is targeted at those aged 16 years and older.
The FDA’s review found Moderna’s vaccine safe and efficacious – the analysis affirmed the company’s assessment that mRNA-1273 had an efficacy rate of 94.1% in a trial including a cohort of 30,000 people.
The vaccine is less effective in people older than 65 years of age, the FDA analysis found.
The most common side effects linked to inoculation with the Moderna vaccine were fatigue, headache and muscle pain. Nausea and facial swelling, while rare, were also reported, as per the FDA analysis.
Pathway to approval
According to the US media, it is widely anticipated that the Moderna vaccine's path to authorization will be similar to Pfizer's. Positive approval from the US regulator could come as soon as Friday.
Officials with US vaccine development and distribution initiative, Operation Warp Speed, are already planning for widespread delivery of the Moderna vaccine, reported NBC News.
On December 3, Moderna re-affirmed its expectation of having around 20 million doses available in the US by the end of 2020.
Additionally, the company said then it expected to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the US and 15-25 million of those available outside of the US. "These expected first quarter doses are inclusive within the 500 million to up to 1 billion doses that the company expects to manufacture globally in 2021."