December 17, 2020
The United States Food and Drug Administration (FDA) authorized the emergency use of the Moderna COVID-19 vaccine, the second vaccine to receive such approval in the U.S. during the COVID-19 pandemic.
Silver Spring, United States | U.S. Food and Drug Administration
On December 17, 2020, the United States Food and Drug Administration (FDA) authorized the emergency use of the Moderna COVID-19 vaccine, marking a significant milestone in the fight against the COVID-19 pandemic. This authorization made Moderna’s vaccine the second COVID-19 vaccine to receive such approval in the United States, following the Pfizer-BioNTech vaccine, which had been authorized just a week earlier.
The COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, emerged in late 2019 and rapidly spread worldwide, leading to widespread illness, death, and significant disruptions to daily life and economies. In response, pharmaceutical companies and research institutions globally accelerated efforts to develop effective vaccines.
Moderna, a biotechnology company based in Cambridge, Massachusetts, developed its vaccine using messenger RNA (mRNA) technology. This innovative approach uses synthetic mRNA to instruct cells in the body to produce a protein similar to the spike protein found on the surface of the coronavirus, thereby eliciting an immune response without using the live virus that causes COVID-19.
Clinical Trials: Moderna conducted extensive clinical trials to evaluate the safety and efficacy of its vaccine. The Phase 3 trial, which began in July 2020, involved approximately 30,000 participants across the United States. The trial results demonstrated an efficacy rate of approximately 94.1% in preventing COVID-19 infection.
FDA Review Process: Following the successful trial results, Moderna submitted an application for Emergency Use Authorization (EUA) to the FDA. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened on December 17, 2020, to review the data and recommend whether the vaccine should be authorized for emergency use.
Authorization: After a thorough review of the data, the FDA granted EUA for the Moderna vaccine, allowing it to be distributed and administered to individuals 18 years and older in the United States.
Vaccine Rollout: The authorization of the Moderna vaccine significantly expanded the availability of COVID-19 vaccines in the U.S., aiding in the effort to curb the spread of the virus. The vaccine’s storage requirements, which are less stringent than those of the Pfizer-BioNTech vaccine, facilitated broader distribution, particularly in rural and underserved areas.
Public Health Impact: The introduction of the Moderna vaccine, alongside other vaccines, played a crucial role in reducing COVID-19 cases, hospitalizations, and deaths. It contributed to the gradual reopening of economies and the resumption of normal activities.
Ongoing Developments: Following the EUA, Moderna continued to monitor the vaccine’s effectiveness and safety, conducting further studies and trials. The vaccine later received full approval from the FDA and became a key component of global vaccination efforts.
The emergency use authorization of the Moderna COVID-19 vaccine was a pivotal moment in the pandemic response, underscoring the importance of scientific innovation and international collaboration in addressing global health crises.
Source: www.fda.gov