Photographer: Adam Glanzman / Bloomberg
Photographer: Adam Glanzman / Bloomberg
The Covid-19 vaccine from Moderna Inc. was eliminated by U.S. regulators, the second vaccine to get emergency clearance this month, as a historic mass vaccination effort increases across the country.
The Food and Drug Administration the decision to grant permission Friday for the use of the shot between adults means that two of the six vaccine candidates identified by Operation Warp Speed are now available to the public, a feat achieved in less than a year. Shots from AstraZeneca Plc i Johnson & Johnson, which have also received support from the U.S. government, are expected to undergo review next year.
Developed with the National Institutes of Health, the feature of Modern, as produced by Pfizer Inc. i BioNTech SE, which was deleted last week, is based on messenger RNA technology that had not previously been used in vaccines. For Moderna, whose symbol is MRNA, it is also the company’s first product that regulators authorize to use.
Thursday, a group of FDA external advisors voted 20-0, with one abstention, to support the shot, which has not yet been approved in any other country and has not yet been used by anyone outside of a clinical trial.
Delivery of the vaccine to the U.S. government will begin immediately and a request for full approval is expected next year, Moderna said in a statement.
“I am proud of what the Moderna team has achieved in collaboration with our partners,” said Stéphane Bancel, CEO of the company. “We continue to focus on increasing manufacturing to help protect as many people as we can from this terrible disease.”
Follow-up reactions
Moderna’s vaccine, like Pfizer’s, is given in a two-dose regimen. Modern said the most common adverse reactions after receiving her shots included pain at the injection site, swelling and swollen lymph nodes. Most reactions were mild or moderate.
The FDA is investigating five allergic reactions related to the Pfizer vaccine in the United States, Peter Marks, director of the agency’s office that monitors vaccines, said Friday in a call to reporters. Some allergic reactions were also reported in the UK, where Pfizer’s shot was approved earlier this month, including two that were a serious reaction called anaphylaxis.
An ingredient in the vaccine called polyethylene glycol, which is also Moderna’s shot, “could be a culprit here,” Marks said. The compound is “rarely associated” with allergic reactions, he said, although “these allergic reactions could be more common than we thought.”
The FDA along with at least a handful of other federal programs are closely monitoring the side effects of the vaccine that were not seen in clinical trials. The agency has asked the facilities that administer vaccines to have medicines on hand to treat any allergic reactions.
The Moderna vaccine does not require special equipment to stay cold. Pfizer should be stored in deep-frozen freezers, but those from Moderna can be stored in a standard freezer like those found in most domestic kitchens. This is expected to be easier to distribute and manageable in many pharmacies.
Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development, made more than $ 950 million available to Modern to develop the vaccine. The United States has pledged to spend billions on buying 200 million doses, enough to vaccinate 100 million people, and you have the option to buy 300 million more.
The option of securing more doses could be especially crucial for the deployment of vaccines in the United States, one of the most comprehensive mass vaccination campaigns ever conducted. United Parcel Service Inc., according to an agreement with McKesson, will begin administering Moderna’s vaccine, the cargo giant said in a statement Friday.
The Moderna vaccine is 94.1% effective in preventing symptomatic cases of Covid-19 and was able to prevent the most serious infections, according to FDA analysis of the results of clinical trials. The Pfizer and BioNTech vaccine is 95% effective. Both shots far exceed the minimum 50% efficacy standard set by the FDA to eliminate any possible coronavirus vaccine.
“With the availability of two vaccines now for the prevention of 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 the United States every day, ”FDA Commissioner Stephen Hahn said in a statement.
Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, said in a statement that he hopes that “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 described the authorization as “another milestone in our battle to overcome the
crisis facing our country today “.
Extension
When it comes to launching a new product on a large scale, Moderna, as a young company, is not tested. However, it may account for half or more of the initial U.S. vaccine inventory. This is because while the United States bought 100 million doses from Pfizer last summer, enough for 50 million people, they initially passed up 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, a maker of some of the best-selling pharmaceuticals of all time, such as cholesterol fighter Lipitor and erectile dysfunction drug Viagra, has said it should meet orders from other countries before meeting new demand from USA of more features.
Secretary of Health and Human Services Alex Azar said on Wednesday that 5.9 million Moderna vaccines would be shipped quickly across the country after authorization. He said 2.9 million doses of Pfizer vaccine have already been shut down and another 2 million doses of Pfizer’s shot will come out next week.
Modern expects to be able to produce 20 million doses for the United States by the end of the year and another 85 to 100 million doses in the U.S. in the first quarter.
In general, Modern and manufacturing partner Lonza Group AG plans to produce between 500 and 1 billion total doses of its vaccine by 2021. The European Union, Canada and Japan also have major purchase agreements with the company and the UK has secured 7 million doses.
Problem with placebo
Pfizer has already begun allowing health workers who participated in the trial and got the placebo to switch to the actual vaccine, as they are eligible under U.S. guidelines to receive the vaccine.
Asked if Modern would follow a similar step-by-step approach, Marks declined to comment, saying talks continue between U.S. regulators and the company.
Moderna indicated at Thursday’s meeting of FDA advisers that she wants to administer her vaccine to all volunteers who received the placebo and did not wait. Bloomberg has previously reported that Moderna hopes to begin offering the vaccine to those volunteers within a week or two after the emergency clearance, according to a letter addressed to some trial participants.
Headquartered in Cambridge, Massachusetts, Moderna became one of the wealthiest private biotechnology companies before selling shares to the public for the first time in December 2018. Although since its inception it had been working to develop numerous vaccines, the potential personalized cancer vaccine caught more attention.
Investors were initially skeptical about the shares, as the company had no portfolio of approved products for a reliable revenue stream and, between its debut and the beginning of this year, had declined by about 15%. But since the company started working on its vaccine, shares have risen and jumped more than eight times.
– With the assistance of Riley Griffin
(Updates to Biden’s statement, in paragraph 17.)