On Jan. 31, the Food and Drug Administration (FDA) granted full approval to Moderna’s COVID-19 vaccine. Only a couple of days later, on Feb. 4, the Center for Diseases and Control endorsed a recommendation for the use of the vaccine on adults. The vaccine will now be marketed as Spikevax and used for the prevention of COVID-19 in individuals 18 years of age and older.
Studies demonstrate that Spikevax is 93% effective in preventing COVID-19 and 98% effective in preventing severe disease. The vaccine is also authorized for use as a “mix and match” single booster dose, meaning that individuals that completed their vaccination series with another vaccine can choose Spikevax as a booster. The full approval from the FDA came after the successful completion of a series of tests that verified its safety and effectiveness.
In December 2020, the Moderna COVID-19 vaccine was granted Emergency Use Authorization, a mechanism that facilitates the availability and use of medical countermeasures during public health emergencies.
To receive any kind of approval, clinical trials are conducted according to the rigorous standards set by the FDA. In phase one, the vaccine is given to a small number of mostly healthy people. The aim is to assess its safety at increasing doses and the first impressions on how well it works to induce an immune response in people.
If there are no safety concerns, the studies proceed to phase two. In this phase, different dosages and more people—from distinct demographic groups and with varying health statuses—are tested in randomized-controlled studies. This phase provides more information on common short-term side effects and risks, inspects the relationship between the dose given and the immune response, and may provide some information on the effectiveness of the vaccine.
Lastly, in phase three, the vaccine is broadly administered to thousands of people in wide-ranging demographic groups. This phase generates critical information on the effectiveness and the immune response in people who received the vaccine compared to those who received a placebo. Even after approval, the FDA continues to monitor effectiveness and safety.
Developing a vaccine in under one year is no small feat, therefore, it is normal to have some apprehension over its safety and effectiveness. Nonetheless, it is important to remember that researchers were not starting from scratch when scientists learned about the virus that causes COVID-19. SARS-CoV-2 is a member of the Coronavirus family and there are hundreds of them, including the one that caused the Severe Acute Respiratory Syndrome (SARS) epidemic in 2003.
Furthermore, a worldwide collaboration was essential for rapid development. Researchers from all around the globe mobilized to share their Coronavirus data, and billions of dollars were raised to fund the research. Additionally, the Moderna vaccine carries the mRNA technology, which uses the S protein’s genetic material of SARS-CoV-2 to train the immune system to recognize it and, thus, prepare it for a future attack. Full approval is granted when the FDA has accumulated even more scientific evidence to support the use of a drug, proving that its benefits are greater than its risks and that it can be manufactured reliably, safely and with constant quality.
