Biden hailed the development as an example of industry coming together for the common good, in keeping with his frequent calls for a stronger emergency footing to combat the pandemic.
"Two of the largest pharmaceutical companies in the world who are usually competitors are working together on the vaccine," he said in remarks delivered at the White House. "This is the type of collaboration between companies we saw in World War II."
Biden's vow to produce enough vaccine for all U.S. adults by the end of May is two months faster than his previous goal of the end of July. But the Merck deal on its own is not expected to ramp up fast enough to impact vaccine supplies significantly in the next three months.
Biden officials have successfully pushed Johnson & Johnson in other ways: The company and its contract manufacturers are moving to round-the-clock production, posting full-time technicians in plants to immediately repair any machinery breakdowns, and accepting daily logistical help from the Department of Defense, the administration said.
"Among the things I learned when I came into office was that Johnson & Johnson was behind in manufacturing and production,'' Biden said. "We had the potential to have a highly effective vaccine to accompany the two existing vaccines. It simply wasn't coming fast enough."
Rather than a vastly accelerated timeline, Biden's revised May target reflects his administration's new confidence in the schedules set forth by all of the vaccine manufacturers. An administration official said Johnson & Johnson's latest goal is to produce 94 million doses of its single-shot vaccine by the end of May - that is about 7 million doses ahead of the schedule in its contract, which calls for delivery of 87 million doses by the end of May and the full 100 million by the end of June.
With Pfizer and Moderna already pledging to deliver 200 million doses each of their two-shot vaccines by late May, the total supply would be more than enough for the estimated 260 adults living in the United States currently eligible for a coronavirus vaccine.
The Merck deal is geared toward the second half of the year, an administration officials said. That's when the threat of variants could loom larger, requiring the manufacture of booster shots, and also when greater political attention will turn to supplying the developing world with vaccine.
The administration will pay $268.8 million to Merck to upgrade multiple plants to the necessary safety standards to produce Johnson & Johnson vaccine, from fermentation in vats to final finish and filling in vials. The Biden administration and the companies did not disclose the number of doses Merck would produce for Johnson & Johnson.
Biden's team began scouring the country for additional manufacturing capacity soon after taking office, according to administration officials who spoke on the condition of anonymity before Biden's announcement.They soon sought a deal with Merck, one of the world's largest vaccine makers, which had failed to develop its own coronavirus vaccine.
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 said.
Merck's participation sets up a race to see how quickly it can make an impact on Johnson & Johnson's rollout. 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.
Merck said Tuesday it would use the federal emergency money for vaccine-related upgrades as well as enhancements for production of unnamed drug treatments. After abandoning two vaccine candidates because they didn't work, Merck still has two potential covid 19 treatments in its clinical trial pipeline.
"This funding from [the U.S. government] will allow us to accelerate our efforts to scale up our manufacturing capacity to enable timely delivery of much needed medicines and vaccines for the pandemic," said Mike Nally, executive vice president, Human Health at Merck.
Johnson & Johnson said Merck's involvement would permit it to go beyond the 100 million doses it has pledged to provide the United States under a $1 billion contract, but it did not provide any specifics.
"We think it's going to add considerably to our capabilities, both near and long term," Johnson & Johnson CEO Alex Gorsky told CNBC on Tuesday.
Biden is wielding 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 ofmachinery, 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 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.
Its 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.
After the FDA on Saturday authorized the Johnson & Johnson vaccinefor 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.
Most of Johnson & Johnson's partnersdisclosed to date are contract manufacturing companies, but now it is moving to team with larger drug companies that have seen their own vaccine projects delayed or fizzled.
Sanofi - which had to reboot its clinical trials of a vaccine candidate after early stumbles - announced last week that it would help Johnson & Johnson with final production steps and bottling in vials in Europe. Projected capacity from a Sanofi plant in France is 12 million doses per month.
BioNTech, Pfizer's German partner on its mRNA vaccine, also announced deals in January for rivals Sanofi and Novartis to fill and finish vaccine vials in Europe.
The manufacturing process is time-consuming: Johnson and Johnson ferments large batches of its vaccine in vats at a contract manufacturing facility in Baltimore operated by Emergent, as well as locations in the Netherlands and India. That brewing step takes two months.
Emergent received commitments of $628 million from the Trump administration in June to expand capacity at its Baltimore plant for coronavirus vaccine production. It then received contracts worth $615 from Johnson & Johnson in July.
But eight months later, the undisclosed number of J&J vaccine doses produced at Emergent are not available for public distribution. Emergent still has not been authorized to produce Johnson & Johnson's vaccine under the FDA emergency use authorization, the New York Times first reported Tuesday. An administration official said Emergent's Baltimore production line is expected to be approved in the next few weeks.
After fermenting in vats, the vaccine needs to be put into its final formulation and packaged into vials for shipping, which takes another five to six weeks, including testing for purity. In the United States and Europe, that final "fill-finish" process for vaccines has created bottlenecks across the industry, as manufacturers have flooded the supply chain with demand to finish hundreds of millions of doses.
Johnson & Johnson has agreements for fill-finish work to be done by two companies in the United States: Grand River Aseptic, with plants in Michigan, and Catalent, at a plant in Indiana. Catalent also isperforming fill-finish operations for Moderna, which is obligated to deliver 300 million doses of its mRNA vaccine to the government by the end of July.
In Italy, Catalent also is helping Johnson & Johnson and AstraZeneca manufacture their vaccines.
Catalent said Tuesday that it had sufficient, dedicated capacity at its Bloomington, Ind., plant to handle the vaccine volume for both companies.
"Catalent is on track to deliver on our commitments for Johnson & Johnson coronavirus vaccine deliveries as soon as we are approved to begin shipments by the FDA, which we anticipate in the coming weeks. Catalent is also on schedule to meet our commitment to Moderna to produce 100 million doses by the end of March 2021," company spokesman Chris Halling said in an email.
Published : March 03, 2021
By : The Washington Post · Laurie McGinley, Christopher Rowland