Moderna announced Monday that the Food and Drug Administration will request an emergency clearance for its coronavirus vaccine after new data confirms that the vaccine is more than 94% effective in preventing Covid-19 and is safe.
Moderna is the second drug company to file an emergency application with the FDA after Pfizer, another front runner in the Covid-19 vaccine race, filed for the same approval on November 20. The announcement means some Americans could get their first doses of Moderna’s two-dose vaccine within a few weeks.
Moderna’s new analysis assessed 196 confirmed Covid infections among the 30,000 participants in the late-stage study. The company said 185 cases of Covid were seen in the placebo group, up from 11 cases in the group that received the vaccine. This resulted in an estimated vaccine effectiveness of 94.1%, the company said.
The company released an early analysis of its Phase 3 study on Nov. 16, which was based on just 95 Covid-19 cases, and showed the vaccine was at least 94% effective. Monday’s data provides a more complete picture of the vaccine’s effectiveness.
It also appears to prevent volunteers from getting seriously ill with the virus. Of the 30 severe cases of Covid-19 in the study, none were in the group that received the vaccine, Moderna said. Additionally, there was one Covid-19 death in the placebo group in the study, the company said.
Moderna shares rose more than 12% on the Monday leading up to trading.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% effectiveness, and most importantly its ability to prevent serious COVID-19 disease. We believe our vaccine is a new and powerful tool that will track the course of this pandemic and help prevent serious illness, hospitalization and death, “said Stephane Bancel, CEO of Moderna, in a statement.
Moderna said the vaccine’s effectiveness was consistent across age, race, and gender. The 196 confirmed cases included 33 adults over 65 years of age and 42 people from Black, Latino and other “diverse” communities. The vaccine was also well tolerated. The most common side effects were fatigue, muscle pain, headache, and pain at the injection site.
Bancel told CNBC Monday that the company expects to test the vaccine on children between the ages of 11 and 17 later this year. However, testing on children under 11 won’t begin until next year, he added. “For younger children, the age has to go down very slowly and you have to start with a lower dose to make sure it’s safe,” he said during an interview on Squawk Box.
Emergency clearance means the FDA will allow some adults to receive the vaccine while the agency continues to evaluate data. This is not the same as a full approval, which can typically take months. The FDA granted emergency approval for Gilead Sciences’ remdesivir in May before granting full approval in late October.
Moderna’s findings come as drug makers and public health officials battle for a safe and effective vaccine to end the pandemic that killed at least 1.45 million people worldwide on Sunday evening, according to Johns Hopkins University came. A vaccine is also seen by investors as a way to get the global economy going again after the virus wreaked havoc in almost every country.
The FDA review of the Moderna vaccine is expected to take a few weeks. The agency will likely schedule a meeting of the advisory committee to review the vaccine on Dec. 17, Moderna said. It has already initiated ongoing filings with several regulatory agencies around the world, including the European Medicines Agency.
Federal agencies are already sending vaccination schedules to employees. Five agencies have told their employees that they could get the Covid-19 vaccine from Pfizer or Moderna in just eight weeks, a person who knows these plans firsthand told CNBC on Nov. 20.
Alex Azar, secretary for health and human services, told CNBC on Nov. 16 that the FDA would act “as soon as possible” to clear Pfizer and Moderna vaccines for emergency use. Between Moderna and Pfizer, Azar told CNBC that about 40 million vaccine doses will be available by the end of this year, which is enough to vaccinate about 20 million people, as both vaccines require two vaccinations, he said at the time.
Moderna’s first results, released earlier this month, are based on the first preliminary efficacy analysis conducted by an external and independent data monitoring committee from the Phase 3 clinical trial. The independent group of experts monitors clinical studies in the USA to ensure the safety of the participants.
Public health officials and medical experts note that it remains unclear how long the vaccines provide immunity and whether or how often people will need regular booster vaccinations. Moderna’s vaccine, like Pfizer’s, uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response.
Moderna, of Cambridge, Massachusetts, announced that its vaccine would stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a regular household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. For comparison: Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.
Moderna announced on Oct. 29 that it was “actively preparing” for its potential vaccine launch worldwide, having completed late-stage registration a week earlier. In August, Moderna announced that some customers were being charged between $ 32 and $ 37 per dose for their vaccine at lower “pandemic prices”. The company said it was under discussion for larger volume agreements that will come at a lower price.
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