Moderna seeks emergency FDA approval for its coronavirus vaccine

Drugmaker Moderna said it would ask the Food and Drug Administration on Monday to clear its coronavirus vaccine for emergency use.

The first injections can be done as early as December 21 if the process goes smoothly and approval is granted, Stéphane Bancel, chief executive of the company, said in an interview.

Moderna’s claim is based on data it also announced on Monday, showing that its vaccine is 94.1% effective and that its study of 30,000 people met the scientific criteria necessary to determine whether the vaccine works. The conclusion of the full data set is consistent with an analysis of earlier data released on November 16 that found the vaccine to be 94.5% effective.

The new data also showed the vaccine to be 100% effective in preventing serious illnesses caused by the coronavirus. The product was developed in collaboration with government researchers at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases.

Mr Bancel said the company was “on track” to produce 20 million doses by the end of December, and between 500 million and one billion in 2021. Each person needs two doses, given every month interval, so 20 million doses will suffice for 10 million people.

Moderna is the second vaccine manufacturer to apply for emergency use authorization; Pfizer submitted its request on November 20. Pfizer said it could produce up to 50 million doses this year, about half of which are in the United States. His vaccine also requires two doses per person.

The first shots of the two vaccines are likely to go to certain groups, including healthcare workers, essential workers like police officers, people from other critical industries, and nursing home employees and residents. . On Tuesday, a group of advisers from the Centers for Disease Control and Prevention will meet to determine how to allocate initial vaccine supplies.

The encouraging news comes at a particularly dark time in the US health crisis. Coronavirus cases have increased and overwhelmed hospitals in some areas, and health officials have warned the numbers could worsen further in the coming weeks due to Thanksgiving trips and gatherings. In November alone, there were more than four million new cases and 25,500 deaths in the United States.

In total, about 13.3 million Americans have contracted the virus and more than 265,900 have died. Globally, there have been nearly 62 million cases and nearly 1.5 million deaths.

More than 70 coronavirus vaccines are in development around the world, including 11 that, like the vaccines from Pfizer and Moderna, are in large-scale trials to assess their effectiveness.

One of these is made by AstraZeneca, which announced positive but baffling preliminary results on November 23: its vaccine was 90% effective in people given a half dose and then a full dose, but 62% in those who received two full doses. Researchers are waiting for more data.

Moderna’s emergency use authorization application will include data from its Phase 3 study of 30,000 people. The application, which is several hundred pages long, will also include several thousand pages of additional data.

FDA scientists will review the information and the application will likely go for a final review on Dec. 17 by a panel of expert advisers from the agency, Bancel said, adding that he expected the advisers make a decision within 24 to 72. hours. The FDA generally follows the recommendations of its advisory committees.

Officials for Operation Warp Speed, the government program to accelerate vaccine development, said vaccinations could begin within 24 hours of FDA clearance.

Mr Bancel said Moderna had not yet started shipping vaccines across the country and would not do so until emergency clearance was granted.

The government has made arrangements to purchase vaccines from both Moderna and Pfizer and provide them free to the public. Moderna has received a $ 955 million commitment from the US government’s Biomedical Advanced Research and Development Authority for research and development for its vaccine, and the United States has pledged $ 1.525 billion to purchase $ 100 million. of doses.

Moderna and Pfizer’s vaccines use a synthetic form of coronavirus genetic material called messenger RNA, or mRNA, to program a person’s cells to make many copies of part of the virus. This viral fragment sets off alarms in the immune system and trains it to recognize and attack if the real virus tries to invade.

No mRNA vaccine has yet arrived on the market, and Pfizer and Moderna’s candidates have faced considerable skepticism from scientists and a suspicious public.

But the good results of the two vaccines began to dispel doubts.

Neither vaccine has had serious side effects so far, but many recipients have had headaches, mild fevers, fatigue, joint and muscle pain, and sore arms for a day. or two.

Of the 30,000 people in the Moderna study, half were vaccinated and the other half received placebo injections of salt water; neither the participants nor their doctors knew who had what. Then, the researchers monitored the participants to see who had contracted the coronavirus and watched for side effects.

To statistically determine whether the vaccine was effective, a total of 151 cases of Covid-19 were needed.

Because the coronavirus increased in the United States, Moderna ended up with 196 cases – 185 in the placebo group and 11 in the vaccinated group, meaning the vaccine was 94.1% effective in preventing Covid-19 .

Thirty participants had severe cases, all in the placebo group. One is dead.

Mr Bancel said he considered the statistics on the prevention of serious illnesses to be the most important data in the study.

“That’s why I think this vaccine will be a game-changer,” he said. The vaccine will reduce hospitalizations and deaths, he added, “and I hope to return this country to its pre-pandemic state.”

Moderna said she is also seeking approval to market her vaccine in Europe, Canada, Britain, Israel and Singapore.