How did FDA arrive at the decision to approve Spikevax (COVID-19 Vaccine mRNA)? What is different now when compared to the December 2020 authorization of Moderna COVID-19 Vaccine?

FDA conducted a thorough evaluation of the data and information submitted in the Biologics License Application (BLA) for Spikevax before making a determination that the vaccine is safe and effective in preventing COVID-19 in individuals 18 years of age and older.  It is administered as a primary series of two-doses, one month apart.

The EUA for the Moderna COVID-19 Vaccine for individuals 18 years of age and older was based on safety and effectiveness data from a randomized, placebo-controlled, blinded ongoing clinical trial in 14,134 individuals who received the vaccine and 14,073 who received a placebo and who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine. The vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 COVID-19 cases in the vaccine group and 185 in the placebo group.  The safety of Moderna COVID-19 Vaccine was assessed in 15,185 vaccine recipients and 15,166 placebo recipients who were followed for a median of more than two months after receiving the second dose.

The approval of Spikevax is based on FDA’s evaluation and analyses of follow-up data from the ongoing clinical trial that supported the EUA and information from post emergency use authorization experience to further inform safety and effectiveness. The updated analysis to determine effectiveness for individuals 18 years of age and older included 14,287 Spikevax recipients and 14,164 placebo recipients who did not have evidence of SARS-CoV-2 infection prior to receiving the first dose.  The vaccine was 93% effective, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group.

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

How safe and effective is Spikevax (COVID-19 Vaccine mRNA)? 

In the clinical trial, the vaccine was 93% effective in preventing COVID-19 disease, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group. In an additional analysis, Spikevax was 98% effective in preventing severe COVID-19.

The most commonly reported side effects by those clinical trial participants who received the vaccine 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.

In addition, 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.

What are the most commonly reported side effects by those who received Spikevax (COVID-19 Vaccine mRNA)?

The most commonly reported side effects by those clinical trial participants who received the vaccine 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.

How long will Spikevax provide protection?

Data are not yet available to inform about the duration of protection that the vaccine will provide. 

Can people who have already had COVID-19 get Spikevax?

Yes. Available data suggest that individuals previously infected with SARS-CoV-2, including individuals who have had COVID-19, are at risk of reinfection and developing COVID-19 again and could benefit from vaccination.

Does Spikevax protect against asymptomatic SARS-CoV-2 infection (i.e. the individual is infected with SARS-CoV-2, but does not have signs or symptoms of COVID-19)?

It is not known if Spikevax protects against asymptomatic SARS-CoV-2 infection. In an exploratory analysis, among 14,287 Spikevax recipients and 14,164 placebo recipients enrolled in the clinical trial, there were 180 cases of asymptomatic SARS-CoV-2 infection in the Spikevax group compared with 399 cases in the placebo group. However, it is likely that not all cases of asymptomatic infection were captured during the study.

If a person has received Spikevax, will the vaccine protect against transmission of SARS-CoV-2 from individuals who are infected despite vaccination?

Most vaccines that protect from viral illnesses also reduce transmission of the virus that causes the disease by those who are vaccinated. While it is hoped this will be the case, the scientific community does not yet know if Spikevax will reduce such transmission.

Can Spikevax cause infertility in women?

There is no scientific evidence to suggest that the vaccine could cause infertility in women. In addition, infertility is not known to occur as a result of natural COVID-19 disease, further demonstrating that immune responses to the virus, whether induced by infection or a vaccine, are not a cause of infertility. Reports on social media have falsely asserted that the vaccine could cause infertility in women and the FDA is concerned that this misinformation may cause women to avoid vaccination to prevent COVID-19, which is a potentially serious and life-threatening disease. SARS-CoV-2 is the virus that causes COVID-19. The symptoms of COVID-19 vary and are unpredictable; many people have no symptoms or only mild disease, while some have severe respiratory disease including pneumonia and acute respiratory distress syndrome (ARDS), leading to multi-organ failure and death. Spikevax is a mRNA vaccine. It contains a piece of the SARS-CoV-2 virus’s genetic material that instructs cells in the body to make the virus’s distinctive “spike” protein. After a person is vaccinated, their body produces copies of the spike protein, which does not cause disease, and triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. Contrary to false reports on social media, this protein is not the same as any involved in the formation of the placenta.

After FDA granted the emergency use authorization of the Moderna COVID-19 Vaccine were clinical trial participants unblinded so that the placebo recipients could be offered the vaccine?

Yes. After issuance of the EUA, clinical trial participants were unblinded in a phased manner over a period of months to offer the authorized Moderna COVID-19 Vaccine to placebo participants.  These participants were followed for safety outcomes.  Overall, in blinded and unblinded follow-up, approximately 7,500 Moderna COVID-19 Vaccine recipients have been followed for at least 6 months.

Does the emergency use authorization (EUA) for Moderna COVID-19 Vaccine remain in effect after the approval?

Yes. Moderna COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two dose primary series in 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 5 months after completing a primary series of the Moderna COVID-19 Vaccine or Spikevax.

The Moderna COVID-19 Vaccine 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 authorized or approved COVID-19 vaccine.

How is Spikevax (COVID-19 Vaccine, mRNA) related to the Moderna COVID-19 Vaccine authorized for emergency use?  Can the vaccines be used interchangeably?

The FDA-approved Spikevax and the EUA Moderna COVID-19 Vaccine have the same formulation and can be used interchangeably without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA for use in individuals 18 years of age and older are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccines.