FDA Issues EUA for Moderna COVID-19 Vaccine
On Sunday, ACIP voted to recommend frontline workers and those ages 75 years and older be included in next phase of vaccine distribution
MONDAY, Dec. 21, 2020 (HealthDay News) -- A second COVID-19 vaccine is poised to be administered in the coming weeks after the U.S. Food and Drug Administration granted emergency use authorization (EUA) to the Moderna COVID-19 vaccine on Friday.
The EUA allows for the vaccine to be administered to adults 18 years and older in two doses one month apart. On Sunday, the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted to recommend that adults 75 years and older and frontline essential workers, including first responders, teachers, and grocery store workers, be the next in line to receive vaccines against COVID-19 in what is considered phase 1b of the distribution. The committee also voted to recommend that Phase 1c includes people 65 to 74 years old and those 16 to 64 years old with high-risk medical conditions, in addition to other essential workers.
The EUA decision was based on safety data from 30,351 participants in an ongoing randomized, placebo-controlled study; 15,185 individuals received the vaccine and 15,166 received saline placebo. Participants were then followed for more than two months after the second dose. Side effects that were most commonly reported included pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the arm injected, nausea, vomiting, and fever. These side effects lasted several days, and similar to the Pfizer vaccine, they were more common after the second dose.
The efficacy data for the EUA were from 28,207 participants in the ongoing randomized, placebo-controlled study; 14,134 were administered the vaccine and 14,073 received placebo. Researchers reported 11 COVID-19 cases in the vaccine group and 185 in the placebo group -- yielding a 94.1 percent efficacy rate. None of the cases in the vaccine group were classified as severe, while 30 in the placebo group were severe. The FDA noted that after evaluation of these data, one severe case was identified in the vaccine group and is awaiting confirmation. "At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person," the FDA writes in a press release.
The EUA was administered to ModernaTX Inc. The company submitted a pharmacovigilance plan to monitor the vaccine's safety and complete longer-term follow-up and is required to report all vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that lead to hospitalization or death.
"With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic," FDA Commissioner Stephen M. Hahn, M.D., said in an agency news release. "Through the FDA's open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization."