Moderna to ask the FDA to greenlight its coronavirus vaccine

Small bottles labeled with a “Vaccine COVID-19” sticker and a medical syringe are seen in this illustration taken taken April 10, 2020. REUTERS/Dado Ruvic/Illustration

Biotechnology company Moderna, one of the leaders in the race for a coronavirus vaccine, announced it would file Monday, Nov. 30, 2020, for regulatory clearance – a critical milestone that brings the United States a step closer to having two coronavirus vaccines before the end of the year.

Moderna’s vaccine was 94 percent effective at preventing illness in a 30,000-person clinical trial, the company said – a performance that exceeds expectations and is on par with the best childhood vaccines. All 30 cases of severe covid-19, the illness caused by the virus, were in a group that received a placebo.

The application will arrive as public health experts gird for a blitz of coronavirus cases seeded by holiday travels and gatherings – a surge coming so soon that no vaccine can blunt it. But Moderna’s filing marks the fourth Monday in a row with good news about the vaccine effort and means the United States could have enough vaccine to treat 20 million people by year’s end, between doses of Moderna’s vaccine and those of another candidate that is about a week ahead from Pfizer and German firm BioNTech. The Food and Drug Administration could authorize the vaccines for emergency use by mid- to late December.

“You don’t want to get ahead of yourself and claim any victories, but this has the makings of a very, very important positive impact on ending this outbreak,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. “A vaccine that is highly efficacious, if taken by a very, very high percentage of people, could potentially crush this outbreak – similar to what was done with outbreaks of measles and polio and smallpox and other diseases.”

The coming weeks, while likely to strain an already overburdened health-care system as the virus runs rampant, will bring a whirlwind of vaccine news that could signal an eventual end to the pandemic.

The data have yet to be published or peer-reviewed, but they will be scrutinized closely by regulators and an outside committee of experts in coming weeks. On Tuesday, an advisory committee to the Centers for Disease Control and Prevention will make recommendations on which groups of people should receive the first doses, which will be in short supply for months. Pfizer and BioNTech’s vaccine will be debated by a group of expert advisers to the FDA on Dec. 10, and Moderna’s vaccine is expected to be considered a week later, on Dec. 17.

Both companies have said they would be ready to distribute a vaccine almost immediately after receiving a green light from the FDA. Results reported last week from a third coronavirus vaccine candidate, from AstraZeneca and the University of Oxford, were positive but confusing, and it is unclear yet whether that vaccine can move forward in the United States without more data.

The vaccines from Moderna and Pfizer and BioNTech are a major proof of concept for a flexible and fast medical technology, years in the making, that utilizes a snippet of genetic material called messenger RNA that teaches cells to build the spiky protein found on the surface of the coronavirus. The immune system learns to recognize and block the real virus.

In Moderna’s trial, volunteers were randomly assigned to two groups. One received two doses of the real vaccine and the other received two shots of salt water. Trial investigators then waited as people were exposed to the virus in their daily lives, to see if more cases occurred in the placebo group.

There were 196 cases of covid-19 in the study, 11 of which occurred in the vaccine group – a decisive signal that the vaccine protected people from illness. The 30 severe cases of covid-19 in the trial, including one death, all occurred in the group that got salt water shots.

The details of the data will be pored over by regulators. Major questions remain, including how long the protection will last and whether the vaccine will decrease transmission in addition to preventing illness. One worst-case scenario that has been debated by scientists is a vaccine that prevents symptoms and disease but doesn’t decrease the spread of the virus by asymptomatic people.

The company reported that the vaccine performance was consistent across all ages, races, ethnicities and genders. There were 33 cases of covid-19 in people over 65; 29 cases in people who identified as Hispanic; 6 cases in Black people; 4 cases among Asian Americans; and 3 in multiracial people.

Most reactions to the vaccine were mild or moderate, according to a previous news release from the company. The adverse events rated as “severe” in the trial were soreness at the injection site, tiredness, muscle aches, headache and pain.

“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,” Stéphane Bancel, Moderna’s chief executive, said in a statement.

Moderna will also file Monday for a green light from the European Medicines Agency and has an open application with regulators in the United Kingdom, Switzerland, Canada, Israel and Singapore.

The vaccine can be stored frozen at minus-20 degrees Celsius and lasts at refrigerator temperatures for up to a month, which would likely make it easier to deploy than the candidate from Pfizer and BioNTech, which requires ultracold storage conditions not typically found at pharmacies and doctors’ offices.




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