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Moderna Files for USFDA Authorization After Achieving 94.1% Vaccine Efficacy

by Ruchi Jhonsa
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November 30, 2020 – Moderna released the final results of its 30,000 participants vaccine trial in a press release today. The company said that its vaccine showed similarly high efficacy of 94.1%, as it observed at the first interim analysis. But this time, the data is from 196 COVID-19 infected individuals, slightly more than double the number tested in the interim analysis, which boosts the confidence in the vaccine. Now that Moderna has the final data, it will file for emergency authorization with the USFDA and conditional approval from the European medicines agency. This makes Moderna the second company to file for emergency authorization after Pfizer submitted its application to the USFDA on November 20th.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death,” said Stéphane Bancel, Chief Executive Officer of Moderna.

Of the 196 COVID-19 cases in the trial, 185 were in the placebo group, and only 11 were infected in the vaccine arm. Topping that, the vaccine protected against severe COVID-19 infection as 30 of 30 cases of the severe infection reported were from the placebo group. This means 100% protection against severe diseases. Efficacy from the trial was consistent across different age groups and different ethnical backgrounds. Besides the efficacy, the vaccine did not cause any serious side effects, but many recipients experienced headaches, mild fever, fatigue, joint and muscle aches, and sore arms for a day or two.

According to the statement, the USFDA’s Vaccines and Related Biological Products Advisory Committee will be conducting a meeting on December 17th to discuss this data. It is expected that the vaccine could get a green signal shortly after. Moderna expects to release 20 million as soon as the emergency authorization is granted. Since this is a double dose vaccine, 20 million vaccines will be sufficient to protect 10 million individuals, which could include health care workers, essential workers like police officers, people in other critical industries, and employees and resident in nursing homes. This is still a speculation, and more details will be revealed on Tuesday when a panel of advisers to the Centers for Disease Control and Prevention will meet to determine who all will get the priority.

Moderna is currently neck-to-neck with Pfizer, who also filed emergency authorization with the USFDA a week ago. The USFDA’s vaccine advisory committee will convene on December 10th, a week before they are scheduled for reviewing Moderna’s vaccine and decide whether the vaccine is good enough for a public rollout. If Pfizer gets the FDA’s blessings, then it will roll out 50 million doses this year, half of which will go to the United States.

Even if the approval comes by the end of this year, the challenge remains to distribute them to 330 million people living in the U.S. While Moderna’s vaccine will be distributed by the U.S. government’s operation warp speed, Pfizer will be doing the distribution on its own. To ensure that the vaccination starts the next day after the approval, Pfizer has already started distributing its vaccines via United Airlines. The flight company began flying charter flights between Brussels International Airport and Chicago O’Hare to move doses of the vaccine.

By Ruchi Jhonsa. Ph.D.

Related Article: Russian Vaccine Makers Nudge AstraZeneca to Combine COVID-19 Vaccine, AZD1222 with Sputnik V

References
  1. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study
  2. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization
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