The Food and Drug Administration on Tuesday (Dec 15) found Moderna’s coronavirus vaccine to be safe and “highly effective,” setting the stage for the vaccine to become the second one authorized for emergency use, The Wall Street Journal reported.
The FDA released a 54-page report, prepared by its staff and by Moderna, analyzing the safety and effectiveness of the vaccine in a large clinical study.
According to the report, the vaccine developed by Massachusetts biotech firm’s product is 94 percent effective at preventing the disease associated with the coronavirus. However, in people older than 65, Moderna’s vaccine had only an 86.4 percent rate of immunization success, according to the report.
The analysis posted by the FDA, also included new data suggesting that the first dose of its vaccine can reduce infections that don’t cause symptoms. If further analysis conforms this, it could mean that the vaccine not only protects individuals from disease, but also curbs transmission of the virus from person to person.
The analysis by FDA found that the Moderna vaccine was effective “across age groups, genders, racial and ethnic groups, and participants with medical comorbidities [underlying conditions] associated with high risk of severe Covid-19.”
As the next step, the FDA’s Vaccines and Related Biological Products Advisory Committee is set to convene on Thursday (Dec 17) and recommend that the Moderna vaccine be approved for emergency use. The FDA is likely to authorize emergency use of the Moderna vaccine Friday, The same panel reviewed the Pfizer data at an all-day meeting last week, after which it voted 17-4, with one abstention, in favor of .
Late last week, the FDA granted emergency-use authorization for drug-maker Pfizer’s coronavirus vaccine, developed with BioNTech, the first vaccine to be cleared for widespread use by the public. The first vaccinations outside of clinical trials were given on Monday, and a nurse in Long Island became the first to receive the shot in the United States.
Doses of Moderna’s vaccine could be shipped this weekend, with vaccinations starting early next week.
More than 300,700 people have died in the U.S. from the coronavirus since the pandemic began, according to data from Johns Hopkins University, and more than 16.5 million people have tested positive across the country.
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