Photographer: Adam Glanzman / Bloomberg
Photographer: Adam Glanzman / Bloomberg
Covid-19 vaccine from Moderna Inc. was eliminated by US regulators, the second vaccine to get emergency clearance this month, as a historic mass immunization effort grows across the country.
Food and Drug Administration Friday’s decision to grant permission for the use of the shot to adults means that two of the six vaccine candidates identified by Operation Warp Speed are now available to the public, a fact accomplished in less than a year. Pictures from AstraZeneca Plc and Johnson & Johnson, which also received US government support, are expected to be reviewed next year.
Developed in conjunction with the National Institutes of Health, Moderna’s film, as produced by Pfizer Inc. and BioNTech SE, which was phased out last week, is based on RNA messenger technology that has not been used in vaccines before. For Moderna, whose stock symbol is MRNA, it is also the first product from the company to be authorized by regulators for use.
On Thursday, a group of FDA external advisors voted 20-0, with one abstention, to support the shooting, which is not yet approved in other countries and has not yet been used by anyone outside of a clinical trial.
Delivery of the vaccine to the US government will begin immediately and a request for full approval is expected next year, Moderna said in a statement. statement.
“I am proud of what the Moderna team has achieved in collaboration with our partners,” said Stéphane Bancel, the company’s executive director. “We remain focused on expanding production to help protect as many people as possible from this terrible disease.”
Monitoring reactions
The Moderna vaccine, like the Pfizer vaccine, is given in a two-dose regimen. Moderna said the most common side effects after vaccines included pain at the injection site, swelling and swelling of the lymph nodes. Most reactions were mild or moderate.
The FDA is investigating five allergic reactions to the Pfizer vaccine in the United States, Peter Marks, director of the agency that oversees the vaccines, said Friday in a call with reporters. Several allergic reactions have also been reported in the UK, where Pfizer’s shot was approved earlier this month, including two that were a severe reaction called anaphylaxis.
An ingredient in the vaccine called polyethylene glycol, which is also being shot by Moderna, “could be to blame here,” Marks said. The compound is “unusually associated” with allergic reactions, he said, although “those allergic reactions may be more common than the unusual ones I thought.”
The FDA along with at least a handful of other federal programs are closely following the side effects of the vaccine that have not been observed in clinical trials. The agency has asked vaccine facilities to have medicines on hand to treat any allergic reactions.
The Moderna vaccine does not require special equipment to be kept cold. Pfizer should be stored in ultracold freezers, but Moderna can be stored in a standard freezer, like those found in most home kitchens. This is expected to ease distribution and take care of many pharmacies.
Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development, provided Moderna with more than $ 950 million to develop the vaccine. The US has pledged to spend billions on the purchase 200 million doses, enough to immunize 100 million people and has the option to buy another 300 million.
The option to provide more doses could be especially important for the launch of the vaccine in the US, one of the largest mass immunization campaigns ever undertaken. United Parcel Service Inc., under an agreement with McKesson, will begin delivering the Moderna vaccine, the cargo giant said in a statement. statement Friday.
The Modern Vaccine is 94.1% effective in preventing symptomatic cases of Covid-19 and has been able to prevent the most severe infections, according to the FDA’s analysis of clinical trial results. The Pfizer and BioNTech vaccine is 95% effective. Both photographs far exceed the minimum 50% efficacy standard set by the FDA for the elimination of any potential coronavirus vaccine.
“With the availability of two vaccines now to prevent Covid-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing a large number of hospitalizations and deaths in Covid-19. United States every day, “FDA Commissioner Stephen Hahn said in a statement.
Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said in a statement that he hopes “all Americans will protect themselves by getting vaccinated when the vaccine is available to them.” This is how our country will begin to heal and move forward. “
President-elect Joe Biden, in a statement, called the authorization “another important step in our battle to overcome
crisis that our country is facing today. “
Climb up
When it comes to launching a new product on a huge scale, Moderna, as a young company, is not tested. However, it may account for half or more of the early US vaccine inventory. That’s because while the US bought 100 million doses from Pfizer last summer – enough for 50 million people – they initially gave the opportunity to purchase more. On Thursday, Moncef Slaoui, chief scientific adviser to Operation Warp Speed, said the United States is close to a deal for another 100 million doses of Pfizer.
Pfizer, the maker of some of the best-selling drugs of all time, such as the cholesterol-lowering leech Lipitor and the erectile dysfunction drug Viagra, said it will have to fulfill orders from other countries before meeting any new US demand for more. many photos.
Secretary for Health and Human Services Alex Azar said on Wednesday that 5.9 million Moderna vaccines will be shipped quickly nationwide after authorization. He said 2.9 million doses of the Pfizer vaccine had already gone out and another 2 million doses of the Pfizer vaccine would disappear next week.
Moderna expects to be able to produce 20 million doses for the US by the end of the year and another 85 million to 100 million doses in the US in the first quarter.
In general, Moderna and the production partner Lonza Group AG plans to produce between 500 and 1 billion total vaccine doses in 2021. The European Union, Canada and Japan also have large purchase agreements with the company, and the United Kingdom has provided 7 million doses.
Placebo problem
Pfizer has already begun allowing health workers who participated in the trial and received placebo to switch to the vaccine itself, as they are eligible under current US guidelines to receive the vaccine.
Asked if Moderna would follow a similar staggered approach, Marks declined to comment, saying talks were continuing between US regulators and the company.
Moderna said at a meeting of FDA advisers on Thursday that she wants to give the vaccine to all volunteers who received a placebo and not wait. Bloomberg previously reported that Moderna hopes to start offering the vaccine to those volunteers within one to two weeks of the emergency clearance, according to a letter to study participants.
Based in Cambridge, Massachusetts, Moderna became one of the richest private biotechnology companies, before selling shares to the public for the first time in December 2018. Although it has worked to develop numerous vaccines since its inception, its work on a potential personalized cancer vaccine attracted the most attention.
Investors were initially skeptical about the shares, given that the company did not have a portfolio of approved products from which to obtain a reliable income stream, and between its inception and the beginning of this year it decreased by about 15%. But since the company started working on its vaccine, shares have risen more than eightfold.
– With the assistance of Riley Griffin
(Updates to the Biden statement, paragraph 17.)