The United States Food and Drug Administration (FDA) on Friday granted emergency approval for Moderna’s coronavirus vaccine vaccine.
It is the second coronavirus vaccine to receive such approval in the United States. Last week, the FDA gave the green light to the Pfizer-BioNtech vaccine to be distributed in the United States.
The FDA’s approval came a day after an advisory panel to the agency voted 20-0 to endorse the vaccine. One committee member abstained.
The Moderna vaccine proved to be more than 90 percent effective in late-stage clinical trials and requires two doses giving few weeks apart.
Unlike the Pfizer-BioNtech vaccine, the Moderna vaccine does not require ultra-cold storage.
The vaccine however elicited non-serious adverse reactions such as muscle pain, joint pain, chills, fatigue and headaches. The side effects were characterized as mild to moderate.
Committee members answered yes to the following question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 vaccine outweigh its risk for for use in individuals 18 years of age and older?”
The committee members came from experts outside Moderna and included representatives from the FDA’s Center for Biologics Evaluation and Research advisory committee.
The committee noted that was not enough data to evaluate the duration of protection in relation to the vaccine.
In addition, there was not also enough data on how effective is the Moderna vaccine for high-risk populations such as immunocompromised individuals, or in individuals who have previously been infected with SARS-Cov-2. There was not also enough data on effectiveness in pediatric populations.
Committee members also carefully noted that there was not enough data also for them to evaluate future vaccine effectiveness in relation to changes in the virus, effectiveness against asymptomatic infection, and effectiveness against long-term effects of COVID-19, effectiveness against transmission of coronavirus, and effectiveness against mortality.
The other vaccine from Johnson & Johnson will require just one dose once it is approved. There is also another vaccine candidate from Oxford University and AstraZeneca that may also end up being approved.
The United States would need the combination of these vaccines to end the coronavirus pandemic that is now killing more than 3,000 people a day.