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Modern Covid-19 vaccine has been cleared by US regulators, the second vaccine to win emergency clearance this month as a historic mass vaccination effort intensifies across the country.
The Food and Drug Administration’s decision to grant clearance for the vaccine’s use in adults on Friday means that two of the six vaccine candidates identified by Operation Warp Speed ​​are now accessible to the public, a feat accomplished in less than a year. Photos of AstraZeneca Plc and Johnson & johnson which also received support from the US government are expected to be submitted for consideration next year.
Developed with the National Institutes of Health, the Moderna photo, like the one produced by Pfizer Inc. and BioNTech SE, which was licensed last week, is based on messenger RNA technology that had previously not been used in vaccines. For Moderna, whose stock symbol is “MRNA”, it is also the company’s first product to be cleared by regulators. A full approval request is expected next year.
“With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken a new crucial step in the fight against this global pandemic which is causing a large number of hospitalizations and deaths every day in the United States”, said Stephen, commissioner of the FDA. Hahn said in a statement.
On Thursday, a group of outside FDA advisersvoted 20-0, with one abstention, to support the shot, which is not yet approved in any other country and has not yet been used on anyone outside of a clinical trial.
Moderna’s vaccine is 94.1% effective at preventing symptomatic cases of Covid-19 and may have prevented the most serious infections, according to the analysis of clinical trial results from the FDA. The Pfizer and BioNTech vaccine is 95% effective. Both shots far exceed the minimum 50% effectiveness standard set by the FDA to eliminate any potential coronavirus vaccine.
Shipping and storage
Like the Pfizer vaccine, Moderna is given in two doses. However, it does not require special equipment to be kept cold. Pfizer’s vaccine should be stored in ultra-cold freezers, but Moderna’s vaccine can be stored in a standard freezer like those found in most home kitchens. This should facilitate the distribution and management of many pharmacies.
Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development, made more than $ 950 million available to Moderna to develop the vaccine. The United States has pledged to spend billions to buy200 million doses, enough to immunize 100 million people, and has the potential to purchase an additional 300 million.
The option of getting more doses could be particularly crucial for the vaccine rollout in the United States, one of the most ambitious mass vaccination campaigns ever undertaken, a massive logistics undertaking that the US Army General in charge of Operation Warp Speed ​​compared to the D-Day Invasion.
When it comes to deploying a new product on a large scale, Moderna, as a young company, has not been tested. However, it can represent half or more of the initial inventory of American vaccines. Indeed, while the United States bought 100 million doses from Pfizer last summer – enough for 50 million people – it initially missed the opportunity to acquire more. On Thursday, Moncef Slaoui, chief scientific adviser to Operation Warp Speed, said the United States was close to a deal for 100 million more doses of Pfizer.
Pfizer, maker of some of the best-selling drug products of all time, like the cholesterol-fighter Lipitor and the erectile dysfunction drug Viagra, said it would have to fulfill orders from other countries before it could meet any news. US demand for more doses.
Health and Human Services Secretary Alex Azar said Wednesday that 5.9 million Moderna vaccines would be sent nationwide soon after clearance. He said 2.9 million doses of the Pfizer vaccine have already been distributed and a further 2 million doses of the Pfizer vaccine will be distributed next week.
Moderna expects to be able to produce 20 million doses in the United States by the end of the year, and an additional 85 to 100 million doses in the United States in the first quarter.
Overall, it and its manufacturing partner Lonza Group AG plan to produce between 500 million and 1 billion total doses of its vaccine by 2021. The European Union, Canada and Japan have also entered into major agreements to ‘purchase with the company, and the UK got 7 million doses.
Biotech darling
Headquartered in Cambridge, Massachusetts, Moderna grew into one of the most successful private biotech companies before selling shares to the public for the first time in December 2018. Although she has worked on the development of many vaccines since her birth In the early days, his work on a potential personalized cancer vaccine received the most attention.
Investors were initially skeptical of the stock, as the company did not have a portfolio of approved products from which to derive a reliable revenue stream, and between its debut and the start of this year it had declined. about 15%. But since the company began work on its vaccine, shares have skyrocketed, more than eight-fold.
Moderna’s victory is likely to raise hopes for other pharmaceuticals based on mRNA technology. According to BioNTech CEO Ugur Sahin, the first such cancer drugscan be approvedin two to three years. A Moderna vaccine associated with Merck & Co.’s immuno-oncology drug Keytruda has helped shrink tumors in 5 of 10 patients with advanced head and neck cancer, according to a study presented last month.
Companies are working to find ways to use mRNA for influenza vaccines, as well as for treatments for heart failure and cystic fibrosis. Messenger RNA vaccines can help produce immunizations against viruses that have escaped more conventional injections. For example, Moderna is working on a vaccine against cytomegalovirus, which can cause birth defects when passed from pregnant mother to unborn child and has eluded researchers for 50 years.
More health and Big Pharma coverage of Fortune:
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