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. What are the most commonly reported side effects by those who received Spikevax (COVID-19 Vaccine mRNA)? The Spikevax Prescribing Information includes a warning about these risks. Information is not yet available about potential long-term health outcomes. However, some individuals required intensive care support. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. 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. In an additional analysis, Spikevax was 98% effective in preventing severe COVID-19. 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. How safe and effective is Spikevax (COVID-19 Vaccine mRNA)? 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. The updated safety analyses included 15,184 Spikevax recipients and 15,162 placebo recipients 18 years of age and older. 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 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 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 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 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 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. It is administered as a primary series of two-doses, one month apart. Español 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?įDA 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.
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