Moderna said on Monday that it will require the emergency removal of the coronavirus vaccine in its food after new data confirms that the vaccine is effective in preventing Covid-19 and is more than 94% safe.
On November 20, another front-runner of the Covid-19 vaccine competition, Pfizer, applied for the same authorization on November 20. It is the second drugmaker to seek emergency use by the FDA. Get the vaccine within a few weeks.
The new analysis from Moderna evaluated 196 confirmed Covid infections out of the 30,000 participants in the late trial. The company said that 185 cases of Covid were observed in the placebo group and 11 cases were observed in the vaccine group. The company said this estimates that the vaccine̵
The company released an early analysis of the Phase III trial based on only 95 Covid-19 cases on November 16, and the results showed that its vaccine is at least 94% effective. Monday’s data provided a more comprehensive illustration of the vaccine’s effectiveness.
It also seems to prevent volunteers from becoming seriously ill from the virus. Moderna said that of the 30 severe Covid-19 cases tested, none received the vaccine. In addition, according to the company, one Covid-19-related death occurred in the placebo group in this study.
In pre-market trading on Monday, Moderna’s stock price rose more than 12%.
“This positive preliminary analysis confirmed that our vaccine has a 94.1% ability to prevent COVID-19 disease. Importantly, it can prevent severe COVID-19 disease. We believe that our vaccine will provide a new powerful tool. , May change the course of this epidemic and help prevent serious illness, hospitalization and death,” Moderna CEO Stephane Bancel said in a statement.
Moderna said that the effectiveness of the vaccine is consistent across age, race and gender. The 196 confirmed cases include 33 adults over the age of 65 and 42 people from black, Latino and other “diverse” communities. The company said the vaccine is also well tolerated, and the most common side effects are fatigue at the injection site, muscle pain, headaches and pain.
According to data collected by Johns Hopkins University, Moderna achieved this result as drugmakers and public health officials scramble to provide safe and effective vaccines to end the pandemic. As of Sunday night, the pandemic has killed at least 1.45 million people worldwide. After the virus wreaked havoc in almost every country, investors also saw vaccines as a way to get the global economy back on track.
The FDA’s review of the Moderna vaccine is expected to take several weeks. The agency may schedule an advisory committee meeting on December 17 to review the vaccine. It has started rolling submissions with multiple regulatory agencies around the world, including the European Medicines Agency.
Federal agencies are already sending out vaccination plans to employees. A person with first-hand knowledge of these plans told CNBC on November 20 that five organizations have begun telling employees that they can receive the Covid-19 vaccine from Pfizer or Moderna in just eight weeks.
The Secretary of Health and Human Services, Alex Azar, told CNBC on November 16 that the FDA will take action “as soon as possible” to remove emergency vaccines from Pfizer and Moderna. Azar said at the time that between Moderna and Pfizer, by the end of this year, Azar told about 40 million doses of vaccines. Since both vaccines require two injections, it is enough to vaccinate about 20 million people.
Moderna’s preliminary results released earlier this month are based on the first interim efficacy analysis of Phase III clinical trials conducted by an external and independent data monitoring committee. An independent panel of experts is responsible for overseeing clinical trials in the United States to ensure the safety of participants.
Public health officials and medical experts pointed out that it is not clear how long the vaccine will provide immunity, and whether or how long people need regular booster injections. Like Pfizer, Moderna’s vaccine also uses messenger RNA or mRNA technology. This is a new vaccine method that uses genetic material to stimulate an immune response.
Moderna, based in Cambridge, Massachusetts, said its vaccines are stable for up to 30 days at 36 to 46 degrees Fahrenheit (the temperature of a standard household or medical refrigerator). It can be stored for up to six months at minus 4 degrees Fahrenheit. In contrast, the storage temperature of Pfizer’s vaccine is 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 the late-stage trial a week ago. In August of this year, Moderna stated that it charges between US$32 and US$37 per dose for certain customers, which is a lower price. The company said it is discussing a lower-priced high-volume agreement.
This is a developing story. Please check for updates.