The Food and Drug Administration’s
Beginning Sunday morning, United Parcel Services will truck the vaccine from a Kentucky facility to a nearby airfield for flights across the U.S. Deliveries will begin Monday, said Wes Wheeler, chief of UPS’s healthcare unit.
FedEx, which like UPS delivered the first shipments of the Pfizer vaccine this week, said in a statement its “operations are in motion” to distribute the Moderna shot.
Developed with the National Institutes of Health, Moderna’s shot, like the one produced by
On Thursday, a group of outside advisers to the FDA
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
“I am proud of what the Moderna team has achieved in collaboration with our partners,”
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 $950 million available to Moderna to develop the vaccine. The U.S. has committed to spend billions to purchase
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.
Moderna’s vaccine is 94.1% 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.
“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
crisis our country is facing today.”
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
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
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%. But since the company began working on its vaccine, the shares have soared, leaping by more than eightfold.
(Updates with delivery information in paragraphs three and four.)
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