Special Report: Vaccines in Development Part 2: Moderna vaccine second to receive emergency use authorization

Section 2: Moderna Vaccine Second to Receive Emergency Use Authorization

The FDA Advisory Committee met on December 17, 2020, ultimately recommending the Moderna vaccine’s approval for emergency use in the prevention of COVID-19. After hospitals across the U.S. began to receive batches of the Pfizer/BioNTech vaccine, Moderna has become the second to receive FDA approval. This candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein,1 which is similar in mechanism to the Pfizer/BioNTech vaccine previously approved. This vaccine, specifically, uses the mRNA platform with the stabilized SARS-CoV-2 spike immunogen (S-2P), which was developed by NIAID scientists.2 This Phase 1, dose-escalation, open-label trial was published on July 14, 2020.3 The study recruited 45 healthy adults between the ages of 18 and 55 years to receive two intramuscular injections 28 days apart with an equal number of participants in the 25μg, 100μg, and 250μg dose groups. Antibody responses were assessed after the first vaccination and were shown to be dose-dependent with day 29 enzyme-linked immunosorbent assay anti-S2P antibody geometric mean titer (GMT) of 40,227(25μg), 109,209 (100μg), and 213,526 (250μg). Day 57 GMT, following the second vaccination, titers increased further to 299,751(25μg), 782,719(100μg), and 1,192,154(250μg). Serum-neutralizing activity was detected in all participants via two methods. Fatigue, myalgia, chills, headache, and pain at injection site were reported in ≥50% of participants. Three participants (21%) in the 250μg dose group reported at least one severe adverse event. Overall, no trial-limiting safety concerns arose, such that development has been able to continue. On November 30, 2020, Moderna reported final results of their efficacy trial of 30,000 participants, demonstrating that only 11 participants who received two doses of the vaccine developed COVID-19 symptoms, compared to 185 participants in the placebo group, boasting 94% effectiveness. More importantly, no serious COVID-19 cases arose among any participants who received two doses of Moderna’s vaccine.4,5 The U.S. has already purchased 200 million shots of the Moderna vaccine, which will assist in ensuring that enough Americans can be vaccinated by mid-2021.6 While vaccines often take decades to develop and distribute, the speed with which COVID-19 vaccines have been developed is not a cause for concern – it is attributable to advances in computational biology, protein engineering, gene synthesis, and structure-based antigen design.7 Scientific advancement has allowed for rapid development and emergency distribution.

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