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Dec 19, 2020

Moderna shot cleared in U.S., boosting immunization effort

2021 is looking to be a good news year: Epidemiologist on vaccine roll-out

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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.

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.

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.

“I am proud of what the Moderna team has achieved in collaboration with our partners,” Stéphane Bancel, the company’s chief executive officer, said. “We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

Monitoring Reactions

Moderna’s vaccine, like the one from Pfizer, is administered in a two-dose regimen. Moderna said the most common adverse reactions after receiving its shots included injection site pain, swelling, and swollen lymph nodes. Most reactions were mild or moderate.

The FDA is investigating five allergic reactions related to Pfizer’s vaccine in the U.S., Peter Marks, director of the agency’s office that oversees vaccines, said Friday on a call with reporters. A few allergic reactions have also been reported in the U.K., 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 in Moderna’s shot, “could be a culprit here,” Marks said. The compound is “uncommonly associated” with allergic reactions, he said, though “those allergic reactions could be more common than the uncommon we thought.”

The FDA along with at least a handful of other federal programs are watching closely for vaccine side effects that weren’t seen in clinical trials. The agency has asked facilities that administer vaccines to have medication on hand to treat any allergic reactions.

Moderna’s vaccine doesn’t require special equipment to be kept cold. Pfizer’s 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 US$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. United Parcel Service Inc., under an agreement with McKesson, will begin to deliver Moderna’s vaccine, the cargo giant said in a statement Friday.

Moderna’s vaccine is 94.1 per cent 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 per cent effective. Both shots far exceed the minimum standard of 50 per cent efficacy the FDA set for clearing any potential 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 vast numbers of hospitalizations and deaths in the United States each 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 is how our country will begin to heal and move forward. ”

President-elect Joe Biden, in a statement, called the authorization “another milestone in our battle to overcome the crisis our country is facing today.”

Scaling Up

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 does 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, Moderna and 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.

Placebo Issue

Pfizer has already begun allowing health-care workers who participated in the trial and got the placebo to switch to the actual vaccine since they are eligible under U.S. guidelines currently to receive the shot.

Asked whether Moderna would follow a similar staggered approach, Marks declined to comment, saying that conversations are continuing between U.S. regulators and the company.

Moderna indicated at the meeting Thursday of FDA advisers it wants to give its vaccine to all volunteers who received the placebo and not wait. Bloomberg has previously reported that Moderna hopes to start offering the vaccine to those volunteers within one to two weeks of emergency authorization, according to a letter to some trial participants.

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 Dec. 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 per cent. But since the company began working on its vaccine, the shares have soared, leaping by more than eightfold.

--With assistance from Riley Griffin.