Moderna Vaccine Cleared in U.S., Boosting Immunization EffortDecember 18, 2020
Moderna Inc.’s COVID-19 vaccine was cleared by U.S. regulators, the second vaccine to gain emergency authorization this month as a historic mass immunization effort ramps up across the country.
The Food and Drug Administration’s decision to grant the authorization Friday for the shot’s use among adults means that two of the six vaccine candidates identified by Operation Warp Speed are now available to the public, a feat accomplished in less than one year. Shots from AstraZeneca Plc and Johnson & Johnson that have also received U.S. government support are expected to be submitted for review next year.
Developed with the National Institutes of Health, Moderna’s shot, like the one produced by Pfizer Inc. and BioNTech SE that was cleared last week, is based on messenger RNA technology that previously hadn’t been used in vaccines. For Moderna, whose stock-market ticker symbol is ‘MRNA,’ it is also the first product from the company to be cleared by regulators for use. An application for full approval is expected next year.
“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 vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen Hahn said in a statement.
On Thursday, a group of outside advisers to the FDA voted 20-0, with one abstention, to back the shot, which isn’t yet approved in any other countries and hasn’t yet been used on anyone outside of a clinical trial.
Moderna’s vaccine is 94.1 percent effective at preventing symptomatic cases of COVID-19 and was able to prevent the most severe infections, according to the FDA’s analysis of clinical trial results. Pfizer and BioNTech’s vaccine is 95% effective. Both shots far exceed the minimum standard of 50% efficacy the FDA set for clearing any potential coronavirus vaccine.
Like the Pfizer shot, Moderna’s is administered in a two-dose regimen. However, it doesn’t require special equipment to be kept cold. Pfizer’s vaccine must be stored in ultracold freezers, but Moderna’s can be kept in a standard freezer like those found in most home kitchens. That is expected to make it easier to distribute and for many pharmacies to handle.
Operation Warp Speed, the Trump administration’s effort to speed vaccine development, made more than $950 million available to Moderna to develop the vaccine. The U.S. has committed to spend billions to purchase 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 crucial to the vaccine rollout in the U.S., one of the most far-reaching mass immunization campaigns ever undertaken, a massive logistics endeavor that the U.S. Army general in charge of Operation Warp Speed has likened to the D-Day invasion.
When it comes to rolling out a new product at enormous scale, Moderna, as a young company, is untested. However, it may account for half or more of the early U.S. vaccine inventory. That’s because while the U.S. purchased 100 million doses from Pfizer last summer — enough for 50 million people — it initially passed on the opportunity to acquire more. On Thursday, Moncef Slaoui, chief scientific adviser to Operation Warp Speed, said the U.S. is close to a deal for another 100 million Pfizer doses.
Pfizer, maker of some of the biggest-selling drug products of all time, like cholesterol fighter Lipitor and erectile-dysfunction drug Viagra, has said it would need to fulfill orders from other countries before satisfying any new U.S. demand for more shots.
Health and Human Services Secretary Alex Azar said on Wednesday that 5.9 million doses of Moderna’s vaccine would be sent out nationwide rapidly after the authorization. He said that 2.9 million doses of Pfizer’s vaccine have already gone out and another 2 million doses of the Pfizer shot will go out next week.
Moderna expects to be able to produce 20 million doses for the U.S. by the end of the year, and another 85 million to 100 million doses in the U.S. in the first quarter.
Overall, it and its manufacturing partner Lonza Group AG plan to produce 500 million to 1 billion total doses of its vaccine in 2021. The European Union, Canada, and Japan also have large purchase agreements with the company, and the U.K. has secured 7 million doses.
Based in Cambridge, Massachusetts, Moderna became one of the most richly valued private biotechnology companies before selling shares to the public for the first time in December 2018. Though it had been working to develop numerous vaccines from its early days, its work on a potential personalized cancer vaccine drew the most attention.
Investors were initially skeptical of the stock, given the company had no portfolio of approved products from which to draw a reliable stream of revenue, and between its debut and the start of this year it had declined roughly 15%. But since the company began working on its vaccine, the shares have soared, leaping by more than eightfold.
Moderna’s victory is likely to increase hopes for other pharmaceutical products based on the mRNA technology. According to BioNTech Chief Executive Officer Ugur Sahin, the first such drugs for cancer may be approved in two to three years. A Moderna vaccine combined with Merck & Co.’s immuno-oncology drug Keytruda helped shrink tumors in five 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 flu vaccines, as well as treatments for heart failure and cystic fibrosis. Messenger RNA vaccines may help produce immunizations for viruses that have evaded more conventional shots. For example, Moderna is working on a shot for cytomegalovirus, which can cause birth defects when passed from pregnant mother to unborn child and has eluded researchers for 50 years.
*Originally published in Crain’s Detroit Business.