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- Moderna announced final results for its coronavirus vaccine, saying the overall efficacy is 94.1% and that the drug showed 100% efficacy against severe COVID-19.
- Moderna said it would seek emergency approvals in the US and Europe and provide up to 20 million doses for American patients this year.
- The FDA is expected to review the Moderna vaccine’s safety and efficacy data on December 17th and decide on emergency use authorization at that time.
Mondays in November continue to deliver good coronavirus vaccine news, with Moderna announcing the final results for its COVID-19 Phase 3 study. A few weeks ago, the company’s interim data said the mRNA vaccine it developed was 94% effective at preventing illness. At the time, the result was better than Pfizer’s interim efficacy of over 90%. Pfizer and BioNTech then announced final efficacy data, saying their mRNA vaccine is 95% effective at blocking the illness. Moderna has its own final results ready that confirm the drug’s efficacy rating stays at 94.1%. But the company said that the COVID-19 drug was 100% effective at blocking severe COVID-19.
Moderna plans to submit the paperwork for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) and Conditional Marketing Authorization (CMA) with the European Medicines Agency (EMA). If approved, Moderna will have up to 20 million vaccine doses ready for the US this year and plans to distribute between 500 million and 1 billion doses globally next year.
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Moderna’s interim data was based on 95 COVID-19 cases that occurred in the vaccine and placebo group. The new vaccine efficacy rating is based on 196 cases, 185 of which were observed in the placebo group. Only 11 cases were registered in the group that took the mRNA-1273 drug. This gave Moderna it’s 94.1% overall efficacy. “The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine,” the company said in a press release.
But the company said none of the 30 severe COVID-19 cases happened in the vaccine group. Furthermore, only 1 person from the placebo group died following complications. This prompted Moderna to announce that the drug was 100% effective against severe COVID-19. That might be a bold statement that could be revised down the road. But Pfizer/BioNtech did have a severe case in the vaccine group.
People who will get vaccinated for COVID-19 will still risk contracting the infection. The point of vaccines isn’t to block the infection but to prevent severe COVID-19, which can lead to death. Moderna said a few days ago that it’s yet to determine whether vaccinated people could still transmit the virus to others after a potential infection.
The company also addressed its volunteer group’s diversity in its announcement, saying that efficacy was “consistent across age, race and ethnicity, and gender demographics.”
“The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans, and 3 multiracial participants),” the company said.
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As for side-effects, the company said, “the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.” After the second dose, the reactions increased in frequency and severity in the vaccine group, the press release reads.
Moderna said that the study exceeded the two months of median follow-up post-vaccination required by the FDA.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data will likely be scheduled for December 17th, Moderna said. Shipping of the drug could follow after the EUA.
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