FDA takes key action by approving second COVID-19 vaccine

The U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.

Key points:

• Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval.

• Moderna COVID-19 Vaccine has been available under emergency use authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.

"The FDA's approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States," said Acting FDA Commissioner Janet Woodcock, M.D. "While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated."

Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series. Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. It is also authorized for use as a heterologous (or "mix and match") single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine.

"The FDA's medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax. This includes the agency's independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. "Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA's rigorous scientific standards."

FDA Evaluation of Effectiveness Data for Approval for Individuals 18 Years of Age and Older

The Spikevax biologics license application (BLA) builds upon the data and information that supported the EUA, such as preclinical and clinical data, as well as details of the manufacturing process and the sites where the vaccine is made. The FDA evaluates and conducts its own analyses of the data to determine whether the safety and effectiveness of the vaccine has been demonstrated and meets the standard for approval, and whether the manufacturing and facility information assure vaccine quality and consistency.

The approval of Spikevax is based on the FDA's evaluation and analysis of follow-up safety and effectiveness data from the ongoing randomized, placebo-controlled, blinded clinical trial that supported the December 2020 EUA for the Moderna COVID-19 Vaccine and information from post EUA experience to further inform safety and effectiveness.

The updated analyses to determine effectiveness of Spikevax included 14,287 vaccine recipients and 14,164 placebo recipients 18 years of age and older who did not have evidence of SARS-CoV-2 infection prior to receiving the first dose. The data used for the analyses were accrued before the Omicron variant emerged. These data demonstrated that Spikevax was 93% effective in preventing COVID-19, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group. The vaccine was also 98% effective in preventing severe disease.

FDA Evaluation of Safety Data for Approval for Individuals 18 Years of Age and Older

The FDA's safety analysis of Spikevax included approximately 15,184 vaccine recipients and 15,162 placebo recipients 18 years of age and older, more than half of these participants were followed for safety outcomes for at least four months after the second dose. Approximately 7,500 participants originally assigned to receive Spikevax in the blinded phase of the clinical trial completed safety follow-up for at least 6 months after the second dose.

The most commonly reported side effects by clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, nausea/vomiting, swollen lymph nodes under the arm and fever.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with the Moderna COVID-19 Vaccine and has determined that the data demonstrate increased risks particularly within seven days following the second dose, with the observed risk highest in males 18 through 24 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Spikevax Prescribing Information includes a warning about these risks.

The FDA conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in individuals 18 years of age and older would prevent versus the number of potential myocarditis/pericarditis cases, hospitalizations, ICU admissions and deaths that might be associated with the vaccine. FDA has determined that the benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older.

The FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Spikevax. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Spikevax. In addition, although not FDA requirements, the company has committed to conducting additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Spikevax during pregnancy.

The FDA granted this application Priority Review. The approval was granted to ModernaTX, Inc.