Pharmaceutical giant Merck will help make Johnson & Johnson single shot coronavirus vaccine — an unusual pact between fierce competitors that could sharply boost the supply of the newly authorized vaccine, according to senior administration officials.
Under the arrangement, Merck will dedicate two facilities in the United States to Johnson & Johnson’s shots. One will provide “fill-finish” services, the last stage of the production process during which the vaccine substance is placed in vials and packaged for distribution. The other will make the vaccine, and has the potential to vastly increase supply, perhaps even doubling what Johnson & Johnson could make on its own.
The officials declined to provide details about how Merck’s involvement will affect the projected supply of the Johnson & Johnson vaccine and the timetable for distributing it. It could easily take two months to get the “fill-finish” plant ready and a few more months to equip the other facility to make the vaccine, according to a person familiar with the process who spoke on the condition of anonymity because he was not authorized to discuss the issue.
The Biden administration’s efforts to ramp up production of the Johnson & Johnson vaccine suggest that it sees the vaccine playing a bigger role in addressing the challenges ahead, such as the eventual need for children’s vaccines and possibly for boosters to counter virus variants, said a person familiar with the situation who spoke on the condition of anonymity because he was not authorized to discuss it. Johnson & Johnson is conducting a trial of a two-shot vaccine regimen, with the doses given two months apart; results are not expected until at least May.
The administration officials indicated Biden would wield the powers of the Defense Production Act, a Korean War era law, to give Merck priority in securing equipment it will need to upgrade its facilities for vaccine production, including the purchase of machinery, bags, tubing and filtration systems.
In teaming up with Merck, Johnson & Johnson has a partner with a century-long tradition of making vaccines. In the United States, Merck is the sole supplier of the combination childhood vaccine that protects against measles, mumps and rubella. It developed Gardasil, which protects against the human papillomavirus. And it won Food and Drug Administration approval for an Ebola vaccine in 2019.
But the company, which makes vaccines in North Carolina, Pennsylvania and elsewhere, encountered setbacks in its quest to develop a coronavirus vaccine. Merck announced on Jan. 25 that it was halting work on two experimental shots for the virus. The vaccine did not stimulate enough antibodies in Phase 1 human clinical trials to justify continuing, the company said.
Johnson & Johnson has been searching the world for manufacturing sites where it could produce doses of its vaccine on a global scale. It has publicly disclosed more than half a dozen manufacturing sites on four continents that it said were winnowed from more than 100 possibilities.
“While the science and the biology, the chemistry is certainly challenging … the engineering feat of actually producing it is just as challenging, and we’ve been working very, very closely with partners around the world,” Johnson & Johnson CEO Alex Gorsky said on Monday.
Johnson & Johnson’s vaccine uses an adenovirus vaccine as a vector — a harmless cold virus that does not replicate in the body — to deliver DNA instructions into a healthy human cell. The cell uses the genetic instructions to create a replica of a coronavirus spike protein that triggers an immune response that can recognize — and respond to — the real thing. The U.S. government paid the company $2 billion for development and clinical trials and preorders at a price of $10 per dose just days after it received emergency authorization from federal regulators.
The FDA on Saturday authorized the Johnson & Johnson vaccine for use in those 18 and older. The company said it would immediately ship nearly 4 million doses in the United States, and a total of 20 million by the end of March, which is 17 million less than expected under its government contract. Its current schedule calls for a recovery from those delays, with the company saying it is on track to deliver 100 million doses by the end of June. A top company executive told Congress last week that it has a goal of manufacturing 1 billion doses worldwide by year’s end.