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Moderna said Monday he would seek emergency clearance from the Food and Drug Administration for his coronavirus vaccine after new data confirmed the vaccine is over 94% effective in preventing Covid-19 and that it was safe.
Moderna is the second drugmaker to seek emergency use from the FDA after Pfizer, another leader in the Covid-19 vaccine race, applied for the same clearance on November 20. This announcement means that some Americans could get the first doses of both Moderna. -dose of vaccine in a few weeks.
Moderna’s new analysis assessed 196 confirmed Covid infections among the 30,000 participants in the advanced stage trial. The company said 185 cases of Covid were seen in the placebo group compared to 11 cases seen in the group that received its vaccine. This resulted in an estimated vaccine efficacy of 94.1%, the company said.
The company on November 16 released an initial analysis of its phase three trial based on just 95 cases of Covid-19 which showed its vaccine to be at least 94% effective. Monday’s data provides a more complete picture of the vaccine’s effectiveness.
It also appears to prevent volunteers from being seriously ill from the virus. Of the 30 severe cases of Covid-19 in the trial, none were in the group that received the vaccine, Moderna said. Additionally, there was one death related to Covid-19 in the study that occurred in the placebo group, according to the company.
Moderna shares rose more than 12% on Monday in pre-market trading.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with an efficiency of 94.1% and, most importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a powerful new tool that could change the course of this pandemic and help prevent serious illness, hospitalization and death, ”Moderna CEO Stéphane Bancel said in a statement.
Moderna said the efficacy of the vaccine was consistent across age, race and gender. The 196 confirmed cases included 33 adults over 65 and 42 people from Black, Latin American and other “diverse” communities. The vaccine was also well tolerated, with the most common side effects being fatigue, muscle pain, headaches and pain at the injection site, the company said.
Moderna’s findings come as drugmakers and public health officials rush to deliver a safe and effective vaccine to help end the pandemic, which has killed at least 1.45 million people worldwide Sunday night, according to data compiled by Johns Hopkins University. A vaccine is also seen by investors as a way to get the global economy back on track after the virus wreaked havoc in nearly every country.
The review of Moderna’s vaccine by the FDA is expected to take a few weeks. The agency will likely hold an advisory committee meeting to review the vaccine on December 17, Moderna said. It has already initiated ongoing submissions to several regulatory agencies around the world, including the European Medicines Agency.
Federal agencies are already sending vaccination plans to staff. Five agencies have started telling their employees they could receive the Covid-19 vaccine from Pfizer or Moderna in as little as eight weeks, a person with first-hand knowledge of the plans told CNBC on November 20.
On November 16, Health and Human Services Secretary Alex Azar told CNBC that the FDA would act “as quickly as possible” to phase out Pfizer and Moderna’s vaccines for emergency use. Between Moderna and Pfizer, Azar told CNBC that there would be around 40 million doses of the vaccine available by the end of this year, enough to inoculate around 20 million people since both vaccines require two injections, he said. he stated at the time.
Moderna’s first results published earlier this month were based on the first interim efficacy analysis conducted by an external, independent data watchdog of the phase three clinical trial. The independent expert group oversees clinical trials in the United States to ensure the safety of participants.
Public health officials and medical experts note that it is not clear how long vaccines will provide immunity and whether or how often people may need periodic boosters. Moderna’s vaccine, like Pfizer’s, uses messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to elicit an immune response.
Moderna, based in Cambridge, Mass., Said her vaccine remained stable between 36 and 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at less than 4 degrees Fahrenheit. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.
Moderna told investors on October 29 that it was actively preparing for the global launch of its potential vaccine after completing registration for its advanced trial a week earlier. In August, Moderna said it was charging some customers between $ 32 and $ 37 per dose for its vaccine, under a cheaper “pandemic price”. The company said it was in talks for larger volume deals that will have a lower price.
This is a developing story. Please come back for updates.
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