Mar 02, 2021
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About this Deal
The pharmaceutical giant Merck & Co will help manufacture the new Johnson & Johnson coronavirus vaccine under an unusual deal, brokered by the White House, that could substantially increase the supply of the new vaccine and ramp up the pace of vaccination just as worrisome new variants of the virus have been found in the United States.
President Biden is expected to announced the arrangement, first reported by The Washington Post, on Tuesday, according to two senior administration officials, who confirmed the arrangement on condition of anonymity to discuss a matter that has not yet been made public. It comes just days after the Food and Drug Administration granted emergency authorization to the Johnson & Johnson vaccine.
Merck is an experienced vaccine manufacturer whose own attempt at making a coronavirus vaccine was unsuccessful. Officials described the partnership between the two competitors as “historic,” and said it harks back to Mr. Biden’s vision of a wartime effort to fight the coronavirus, similar to the manufacturing campaigns waged during World War II.
Officials in both the Trump and Biden administrations had considered enlisting Merck’s help in manufacturing vaccines developed by Pfizer and Johnson & Johnson. Johnson & Johnson has been running behind on its mass production, though company officials have publicly said they expect to catch up in the coming months. But just how quickly Merck will be able to ramp up is unclear. It will take time, possibly as long as two months or more, for the company to be able to convert its facilities to manufacture and package a vaccine that it did not invent.
Under the agreement, Merck will dedicate two of its facilities to production of the Johnson & Johnson vaccine, which unlike the other two vaccines that have U.S. emergency authorization requires only one shot.
One facility will provide “fill-finish,” the final phase of the manufacturing process during which the vaccine is placed in vials and packaged for shipping. The other will make the “drug substance” — the vaccine itself. Officials hope that by the end of the year, the arrangement will double the capacity of what Johnson & Johnson could manufacture on its own — perhaps bringing the total number of doses to as many as one billion.
Officials are not identifying the facilities involved for security reasons, one said.
The Johnson & Johnson vaccine joins two others — one made by Pfizer-BioNTech, the other by Moderna — that already have emergency authorization from the Food and Drug Administration. The Centers for Disease Control and Prevention on Monday said about 50.7 million people have received at least one dose of a Covid-19 vaccine, including about 25.5 million people who have been fully vaccinated. While the Pfizer and Moderna vaccines performed slightly better in clinical trials, all are considered safe and effective and the Johnson & Johnson vaccine has some advantages: It requires only one shot, and studies show it may curb spread of the virus.
Those earlier vaccines use a new technology called mRNA. Although vaccines can be designed and tested much faster using that method than with more traditional technologies, both Pfizer and Moderna’s doses require more stringent storage conditions. Johnson & Johnson’s vaccine, which uses viruses to deliver genes into cells, can keep for three months at normal refrigeration temperatures, making it easier to distribute and easier for pharmacies and clinics to stock. At $10 a dose, it is also cheaper than the other two.
Johnson & Johnson’s $1 billion federal contract, signed last year when the vaccine was still in development, called for it to deliver 37 million doses by the end of March. The company has said it can only deliver 20 million doses, and senior administration officials have said the bulk of those will be delivered toward the end of the month.
This week states will receive 3.9 million doses that were manufactured at a Dutch plant and bottled in Grand Rapids, Mich. But the bulk of Johnson & Johnson’s production is expected to come from a new plant in Baltimore, Md. operated by a company called Emergent BioSolutions, with the vaccine bottled by Catalent.
The F.D.A.’s authorization for emergency use, granted late Saturday, covered the Dutch production lines and the Grand Rapids bottling operation. In about two weeks, federal regulators are expected to decide whether to amend that authorization to include the plants in Baltimore and Indiana, according to two people familiar with Johnson and Johnson’s operations who were not authorized to speak publicly. Until then, they said, supply will be uneven and limited.
For nearly a year, Merck has been searching for a way to play a key role in the nation’s vaccination program. But while its partnership with Johnson & Johnson should significantly increase supply, retooling plants is expected to take a few months. At that point, the demand for shots may have waned.
By the end of May, Pfizer, Moderna and Johnson & Johnson together have pledged enough doses to inoculate at least 220 million of the roughly 260 million eligible adults in the United States. Pfizer and Moderna, whose vaccines take two doses, have pledged to make available enough doses to cover another 100 million people by the end of July.
On the other hand, the emergence of even more worrisome variants of the virus could require booster shots for those who have already been vaccinated. And federal health officials are hoping that ongoing tests will show the vaccines are safe for children, which will mean tens of millions of more shots are needed. If the United States ends up with a surplus of vaccine, it could sell or even give away doses to other countries.