The first shots could be given as early as Dec. 21, if authorization is granted.
I was wild and free cheap online levitra after a long time. Ginseng belongs to cheapest sildenafil 100mg the Araliaceae family of plants termed as Panax ginseng, the medicinal use of this herb help to increase testosterone and strengthen nerves. You need to have some preparation before you actually discount viagra make a purchase, it would be a real threat to men. This herbal pill is female viagra cheap developed using proven and tested herbal products.
By Nov. 30, 2020, 7:00 a.m. ET
The drugmaker Moderna said it would apply on Monday to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use.
The first injections may be given as early as Dec. 21 if the process goes smoothly and approval is granted, Stéphane Bancel, the company’s chief executive, said in an interview.
Moderna’s application is based on data that it also announced on Monday, showing that its vaccine is 94.1 percent effective, and that its study of 30,000 people has met the scientific criteria needed to determine whether the vaccine works. The finding from the complete set of data is in line with an analysis of earlier data released on Nov. 16 that found the vaccine to be 94.5 percent effective.
The new data also showed that the vaccine was 100 percent effective at preventing severe disease from the coronavirus. The product was developed in collaboration with government researchers from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.
Moderna is the second vaccine maker to apply for emergency use authorization; Pfizer submitted its application on Nov. 20. Pfizer has said it can produce up to 50 million doses this year, with about half going to the United States. Its vaccine also requires two doses per person.
The hopeful news arrives at a particularly grim moment in the U.S. health crisis. Coronavirus cases have surged and overwhelmed hospitals in some regions, and health officials have warned that the numbers may grow even worse in the coming weeks because of Thanksgiving travel and gatherings. In November alone, there have been more than four million new cases and 25,500 deaths in the United States.
Over all, about 13.3 million Americans have contracted the virus, and more than 265,900 have died. Worldwide, there have been nearly 62 million cases and almost 1.5 million deaths.
Moderna’s application for emergency use authorization will include data from its Phase 3 study of 30,000 people. The application, several hundred pages long, will also include several thousand pages of additional data.
F.D.A. scientists will examine the information, and the application is likely to undergo a final review on Dec. 17 by a panel of expert advisers to the agency, Mr. Bancel said, adding that he expected the advisers to make a decision within 24 to 72 hours. The F.D.A. usually follows the recommendations of its advisory panels.
Officials at Operation Warp Speed, the government’s program to accelerate vaccine development, have said vaccinations could begin within 24 hours after the F.D.A. grants authorization.
