Moderna vaccine has 'no specific safety concerns,' says US regulator
Moderna's COVID-19 vaccine has been found safe and effective, the United States Food and Drug Administration said in a report on Tuesday. The document was released two days before the US drug regulator would review the emergency use authorization (EUA) for Moderna's vaccine on December 17. Notably, the US has already granted emergency approval to Pfizer's vaccine and vaccinations with the shot have commenced.
'No specific safety concerns' preventing grant of EUA
The FDA's analysis has found that the vaccine has a "favorable safety profile," finding "no specific safety concerns" that would prevent the grant of EUA. The document also included new data from Moderna's 30,000-person clinical study of the vaccine. Serious infections were rare but side-effects were common - a majority of trial volunteers experienced pain at the injection site, fatigue, and headaches.
Moderna's vaccine is 94.1% effective
Further, the FDA's analysis observed that the vaccine was 94.1% effective at preventing symptomatic confirmed COVID-19 cases. It was 86.4% effective in people aged over 65, and 95.6% effective in those aged 18-65, the agency said in the report. The agency noted that the vaccine was similarly effective across racial and ethnic groups and those with underlying medical conditions.
Vaccine can prevent asymptomatic infections after first dose
Moderna's vaccine, mRNA-1273, involves two doses administered 28 days apart. The analysis found that "some asymptomatic infections start to be prevented after the first dose." This underlines the vaccine's ability to not only shield a person against symptomatic disease but an infection just after the first dose, which could help significantly slow the spread of the virus.
EUA grant to be reviewed this Thursday
The analysis report implies that Moderna's vaccine would be the second in the US to be granted emergency approval. The FDA's Vaccines and Related Biological Products Advisory Committee will review EUA for the vaccine on Thursday. The same panel had reviewed the data from Pfizer and BioNTech's COVID-19 vaccine last week. It had voted 17-4 (with one abstention) in favor of granting emergency approval.
US commenced vaccinations with Pfizer's shot yesterday
Meanwhile, vaccinations with Pfizer's shot had started on Monday. However, the distribution of the vaccine is challenging as the doses require low temperatures of -70°C to remain viable. However, Moderna's vaccine can be stored in a regular freezer. Pfizer's vaccine has been approved in several other countries including Bahrain, Canada, Mexico, Saudi Arabia, Singapore, and the United Kingdom.