Photographer: Adam Glanzman / Bloomberg
Photographer: Adam Glanzman / Bloomberg
Moderna Inc.’s Covid-19 vaccine was approved by US regulators, the second vaccine to receive an emergency permit this month, as a historic mass immunization effort ramps up across the country.
The Food and Drug Administration Friday’s decision to grant permission to use the shot in 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 and Johnson & Johnson, which have also received support from the US government, are expected to be submitted for review next year.
Developed in conjunction with the National Institutes of Health, Moderna’s shot, such as the shot of Pfizer Inc. and BioNTech SE released last week is based on messenger RNA technology not previously used in vaccines. For Moderna, whose stock market symbol is MRNA, it is also the company’s first product to be released for use by regulators.
On Thursday, a group of outside advisers joined the FDA voted 20-0, with one abstention, to support the shot, which has not yet been approved in other countries and has not yet been used on anyone outside of a clinical trial.
Delivery of the vaccine to the U.S. government will begin immediately, and an application 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 CEO. “We remain focused on scaling up production to help us protect as many people as possible from this terrible disease.”
Follow responses
Moderna’s vaccine, like that from Pfizer, is administered in a two-dose regimen. Moderna said the most common side effects after receiving the injections were pain at the injection site, swelling, and swollen lymph nodes. Most responses were mild or moderate.
The FDA is investigating five allergic reactions related to Pfizer’s vaccine in the US, Peter Marks, director of the vaccine oversight agency, said Friday during a phone call with reporters. A few allergic reactions have also been reported in the UK, where Pfizer’s injection 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 in Moderna’s shot, “could be a culprit here,” Marks said. The compound is “unusually associated” with allergic reactions, he said, although “those allergic reactions could be more common than the unusual one we thought.”
The FDA, along with at least a handful of other federal programs, is closely watching for side effects from vaccines not seen in clinical trials. The agency has asked facilities that administer vaccines to have medicines on hand to treat any allergic reactions.
Moderna’s vaccine does not require any special equipment to be kept cold. Pfizer’s should be kept in ultra-cold freezers, but Modernas can be kept in a standard freezer, like those found in most home kitchens. This is expected to make distribution easier and manageable for many pharmacies.
Operation Warp Speed, the Trump administration’s attempt to accelerate vaccine development, made more than $ 950 million available to Moderna to develop the vaccine. The US has pledged to spend billions to buy 200 million doses, enough to immunize 100 million people, and has the option to purchase another 300 million.
The option to secure more doses could be especially critical to the introduction of vaccines in the US, one of the most far-reaching mass immunization campaigns ever. United Parcel Service Inc. will, under an agreement with McKesson, deliver Moderna’s vaccine, the cargo giant said in a statement Friday.
Moderna’s vaccine is 94.1% effective in preventing symptomatic cases of Covid-19 and was able to prevent the most serious infections, according to the FDA’s analysis of clinical trial results. The Pfizer and BioNTech vaccine is 95% effective. Both shots by far exceed the minimum standard of 50% efficacy that the FDA has set for cleaning up every possible coronavirus vaccine.
“With the availability of two vaccines for the prevention of Covid-19, the FDA has taken another critical step in the fight against this global pandemic that is causing massive numbers of hospitalizations and deaths in the US. 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 becomes available to them. That’s how our country will start to heal and move forward. “
President-elect Joe Biden in a statement called the authorization “another milestone in our struggle for the
crisis facing our country today. “
Scaling up
When it comes to rolling out a new product on a massive scale, Moderna as a young company has not yet been tested. However, it can make up half or more of the early vaccination rate in the US. That’s because, while the US bought 100 million doses of Pfizer last summer – enough for 50 million people – it initially passed on the opportunity to acquire more. On Thursday, Moncef Slaoui, chief scientific advisor to Operation Warp Speed, said the US is close to a deal for an additional 100 million Pfizer doses.
Pfizer, maker of some of the best-selling drugs of all time, such as cholesterol fighter Lipitor and erectile dysfunction Viagra, has said it would have to fulfill orders from other countries before a new US demand for more shots can be met.
Health and Human Services minister Alex Azar said on Wednesday that 5.9 million of Moderna’s vaccine will be shipped nationwide soon after approval. He said 2.9 million doses of Pfizer’s vaccine have already been issued and another 2 million doses of the Pfizer vaccine will go out next week.
Moderna expects to be able to produce 20 million doses for the US by the end of the year and an additional 85 million to 100 million doses in the US in the first quarter.
Generally Moderna and production partner Lonza Group AG plans to produce a total of 500 million to 1 billion doses of its vaccine by 2021. The European Union, Canada and Japan also have major purchase deals with the company, and the UK has secured 7 million doses.
Placebo issue
Pfizer has already begun allowing health professionals who took part in the trial and received the placebo to switch to the actual vaccine, as they are currently eligible to receive the injection under US guidelines.
When asked if Moderna would take a similar, staggered approach, Marks declined to comment, saying talks are ongoing between US regulators and the company.
Moderna said at Thursday’s meeting of FDA advisers that it would give her vaccine to all volunteers who received the placebo and not wait. Bloomberg has previously reported that Moderna hopes to offer the vaccine to those volunteers within one to two weeks of the emergency permit, said a letter to some trial participants.
Based in Cambridge, Massachusetts, Moderna became one of the most highly regarded private biotechnology companies before selling shares to the public for the first time in December 2018. potentially personalized cancer vaccine attracted most of the attention.
Investors were initially skeptical of the stock as the company lacked a portfolio of approved products from which to derive a reliable income stream, and was down about 15% between its debut and the beginning of this year. But since the company started working on its vaccine, shares have soared, more than eightfold.
– With the help of Riley Griffin
(Updates with Biden statement, in 17th paragraph.)