The FDA Says Moderna's Vaccine Is Safe and Effective, and Could Be Approved This Week
After approving the COVID-19 vaccine from Pfizer-BioNTech , the United States Food and Drug Administration (FDA) reported that the vaccine from the American pharmaceutical company Moderna is safe and effective. The drug could receive authorization for distribution this week, when experts meet to discuss its emergency approval.
The FDA confirmed that Moderna's vaccine does not show "specific safety concerns" in adults 18 years of age and older that "prevent the issuance" of an emergency use authorization.
"The FDA has determined that the manufacturer has provided adequate information to guarantee the quality and consistency of the vaccine for product authorization , " reads the document delivered by the US agency .
The reported efficacy among study participants was 94.5%, and 100% for those over 65 years of age. That is, none of the 3,527 volunteers in this age group had contagion. Among the 10,407 people aged 18 to 65 studied, there were 5 positives. None of them developed a severe COVID-19 picture.
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Moderna Vaccine Has "Mild" Side Effects
The formula, called mRNA-1273 , presented some side effects such as pain at the injection site (90% of cases), fatigue (70%), headache (60%), muscle pain (60%), pain joint (45%) and chills (45%). Few of these effects were "serious" and occurred more in the young than in older adults. Lymphadenopathy , or swollen lymph nodes, occurred in 1.1% of those vaccinated, in contrast to 0.6% of the group that received the placebo.
1.5% of the vaccinated population presented "hypersensitivity" , that is, allergic or inflammatory reactions of the immune system. In comparison, 1.1% of the unvaccinated reported such a reaction.
The FDA report is part of the documents released for Thursday's meeting, where experts will debate whether to approve an emergency use authorization for Moderna's vaccine.
The Pfizer and BioNTech vaccine was approved on Friday night, after the committee approved the formula by broad consensus the day before, which began to be applied this Monday in the United States.
The FDA issued the first emergency use authorization for a vaccine for the prevention of COVID-19 disease caused by SARS-CoV-2 in people 16 years of age and older. https://t.co/lEPJX5eMn1 pic.twitter.com/w8Wfxx47zI
- US FDA in Spanish (@FDAenEspanol) December 14, 2020
The United States plans to supply 40 million doses of vaccine this month, enough to inoculate 20 million people. That includes both the Pfizer-BioNTech and Moderna vaccines, which would be the second available formula to fight the SARS-CoV-2 virus in that country.
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