The U.S. pharmaceutical regulator has allowed the emergency use of the Moderna Covid-19 vaccine, making second injections available and promoting products at an emergency facility as several states complain that they cannot view get enough.
The second emergency use authority for the Covid-19 vaccine will mean more than 5.9m Moderna shots will be delivered in the coming week.
Moderna said about 20m doses would be given to the US government by the end of the year. In the first quarter of next year, the company now expected between 100m and 125m doses to be available, of which 85m-100m will be in the US.
Stephen Hahn, commissioner of the Food and Drug Administration, said it was “another important step in the fight against this global pandemic that is causing large numbers of hospitalizations and deaths in the United States every day.” .
While Pfizer only took a pre-order from the U.S. government for the first U.S.-approved vaccine, Operation Warp Speed - the Trump administration’s sprawling vaccine effort – poured funding into Moderna’s injection, it raised up to $ 4.1bn towards testing and expanding manufacturing capacity.
The Boston-based biotech has promised to deliver 200m doses to the U.S., twice the size of Pfizer. Health secretary Alex Azar complained this week that Pfizer had kept the government at “arm’s length” while the drug dealer issued his vaccine and said he would like more gain visibility into the production.
On Friday Mr. Azar stressed how the U.S. government has helped Moderna, including setting the foundation in partnership with the Biomedical Research and Development Authority since 2016, and co. operation on the Covid-19 vaccine by the National Institutes of Health.
“It is amazing to have two vaccines against a novel virus authorized and distributed within a year, and one of those vaccines developed by scientists at the NIH should be no cause for pride, “he said.
Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, said his scientists were working with Moderna long before the novel coronavirus entered “public consciousness.”
The extra stores come at a critical time as Covid-19 levels and hospitals rise across the U.S., ahead of a holiday season that is expected to be worse than an already unavoidable situation. -optimistic.
Stéphane Bancel, chief executive of Moderna, said it was “a 10-year scientific, entrepreneurial and medical journey”. “We remain focused on scaling up manufacturing to help us protect as many people as possible from this terrible disease,” he said.
The Moderna vaccine will also be easier to circulate, as it can be kept at 2C to 8C, but the Pfizer vaccine, developed in partnership with BioNTech in Germany, must be stored at very cold temperatures.
The FDA issued the emergency use permit for people over the age of 18 and its decision comes a day after a group of outside experts met to discuss the Moderna vaccine, to which they supported, with 20 people voting that the benefits of Moderna vaccine outweighed the risks. There was one stop.
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The vaccine is similar to Pfizer / BioNTech’s, using the same technology and boasting a similar efficacy rate, at 94.1 percent. An FDA report published earlier in the week found that it was highly effective and did not present major safety concerns.
The FDA said it is investigating a severe allergic reaction suffered by a couple of people who received the vaccine in Alaska. One hypothesis is that polyethylene glycol, a very common pharmaceutical ingredient, may be associated with the reaction.
Individuals will be warned of a “remote chance” of a “true allergic reaction”, usually within a few minutes to an hour of receiving the vaccine. The FDA said people who have had an allergic reaction to the vaccine parts should not take it.
Investors are hoping that the Covid-19 vaccine will do well for other Moderna vaccines. No results were agreed with the loss of biofuels, and the pandemic may have carried out its first permit by three or four years.
Shares in Moderna rose 2.2 percent in after-hours trading to $ 143.37.