Picture: REUTERS/DADO RUVIC
Picture: REUTERS/DADO RUVIC

Moderna’s Covid-19 vaccine has been cleared by US regulators, the second vaccine to gain emergency authorisation in December as a historic mass immunisation effort ramps up across the country.

The Food and Drug Administration’s (FDA) decision to grant the authorisation on 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 and Johnson & Johnson that have also received US government support are expected to be submitted for review in 2021.

Developed with the National Institutes of Health, Moderna’s shot, similar to the one produced by Pfizer and BioNTech 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 US government will begin immediately and an application for full approval is expected in 2021, Moderna said in a statement.

“I am proud of what the Moderna team has achieved in collaboration with our partners,” CEO Stéphane Bancel 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 US, Peter Marks, director of the agency’s office that oversees vaccines, said on Friday on a call with reporters. A few allergic reactions have also been reported in the UK, where Pfizer’s shot was approved earlier in December, 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 subzero freezers, but Moderna’s can be kept in a standard freezer such as  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 $950m available to Moderna to develop the vaccine. The US has committed to spend billions to purchase 200-million doses, enough to immunise 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 US, one of the most far-reaching mass immunisation campaigns ever undertaken. United Parcel Service, 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% 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 hospitalisations and deaths in the US 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 hoped “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 authorisation “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 US vaccine inventory. That’s because while the US purchased 100-million doses from Pfizer  — 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 US is close to a deal for another 100-million Pfizer doses.

Pfizer, maker of some of the biggest-selling drug products of all time, such as cholesterol fighter Lipitor and erectile-dysfunction drug Viagra, has said it would need to fulfil orders from other countries before satisfying any new US demand for more shots.

US 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 authorisation. 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 US by the end of the year, and another 85-million to 100-million doses in the US in the first quarter.

Overall, Moderna and manufacturing partner Lonza 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 UK 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 US 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 US regulators and the company.

Moderna indicated at the meeting on 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 authorisation, 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 personalised 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.

Bloomberg

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