The great pivot of vaccines: Merck hesitates over Covid-19 shots, then makes one for Rival J&J
Weeks after Merck MRK -0.33%
& Co. scrapped development of its Covid-19 vaccines in January, one of its senior manufacturing officials began calling its deputies, telling them their work on a pandemic shot was not actually finished.
“We are doing it,” John McGrath told his Merck employees. “And we’re doing it with J&J.”
The Johnson & Johnson-Merck partnership, announced by the companies in March, is now paying off in expanding the global vaccine supply. After a rampant ramp-up that involved sourcing raw materials, purchasing equipment, and upgrading factories at the same time, the first Merck-made snapshots were shipped on Friday.
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Merck produces over 500,000 doses per day for use outside the United States, including in countries desperate for injections.
J & J’s unusual collaboration with a rival and the rapid rise in manufacturing at Merck reflects one of the greatest challenges of the pandemic: to manufacture enough Covid-19 vaccines to meet high demand.
Even in the United States, early supplies were limited as drug makers increased their production lines. To date, many countries are struggling with a shortage of supplies.
At a sprawling plant in West Point, Pa., Merck is helping J&J in the final stages of its vaccine production, known as fill-finish, which involves thawing frozen doses made by J&J, adding stabilizer to maintain their activity during storage, then put them in vials for shipping.
Merck, one of the world’s largest drugmakers by sales, said it upgraded its manufacturing facilities in about three months, saving nearly a year of the time normally required to set up a factory.
“We’ve broken all kinds of records on construction, on technology transfers, just on product preparation,” McGrath said. The federal government, which has given Merck at least $ 105 million to modernize factories, also helped by quickly getting needed supplies through Customs.
Johnson & Johnson’s Covid-19 vaccine has not been adopted by people and health authorities as much as initially expected, in part because of concerns about a rare blood clotting disease. Manufacturing issues have also played a role in limiting its use.
Yet, if enough doses are produced, the vaccine can still play an important role in the pandemic, as many poor countries do not have access to other vaccines and J & J’s vaccine is easier to handle and store, according to public health advocates and Wall Street analysts.
The J&J vaccine does not require a special freezer to keep it cool, unlike messenger RNA vaccines, and the primary series is one dose, not two.
âOur vaccine is ideally positioned for use around the world,â said Remo Colarusso, J&J global pharmaceutical manufacturing manager. “The world is not completely vaccinated by a long shot.”
J&J and Merck, their headquarters approximately 30 miles apart in New Jersey, are normally competitors in areas such as cancer and cardiovascular disease. Last December, at the request of the federal government, rivals began discussing the possibility of Merck helping manufacture J & J’s Covid-19 vaccine.
J&J chief scientist Paul Stoffels was initially reluctant to work with another company, people familiar with the matter said. He was concerned that his staff would be overextended due to existing manufacturing partnerships, but agreed after a call from National Institutes of Health director Francis Collins, the people said.
In a Jan. 4 call between U.S. officials, Dr Stoffels, and then Merck chief executive Ken Frazier, the companies agreed to assess whether Merck’s factories could adapt to manufacture the shot. from J&J, the people said.
At the time, Merck was seeking a role in the pandemic response. He had started clinical trials of two Covid-19 vaccines, but they ultimately failed, with Merck halting the programs at the end of January. Its Covid-19 antiviral, molnupiravir, was still being tested.
Merck was a partner because of its decades of vaccine manufacturing, Colarusso said.
Another key: Merck’s production line at West Point was idle after the failure of the Covid-19 vaccines. Merck was also not using a freshly built 4,000 square foot cold room with 18 specialty freezers the company had built for its Covid-19 shots. Each freezer could hold 5.5 million doses of J&J.
The West Point factories are on a leafy campus 30 miles outside of Philadelphia. It is Merck’s largest workplace, in terms of space and number of workers, and has its own postcode. Despite the rooms and equipment available, Merck needed to upgrade its facilities, as J & J’s vaccine uses smaller vials than Merck’s failed Covid-19 vaccines, as well as newer vaccine technology.
âOur problem then became what equipment do we need, where can we get it, how fast can we get it, is it available, and if not, what are our alternatives? Said Mr. McGrath, an industry veteran who joined Merck in 2019.
Merck discovered that it needed to secure equipment and raw materials quickly, even though other drug makers needed them for their own products. Merck needed around 200 chemicals and devices such as filters. It usually takes two to three months to get such items, but Merck needed them within a few weeks.
Merck has relied on its relationships with its suppliers, such as Thermo Fisher Scientific Inc.,
who provided specialized plastic bags used to purify and filter the vaccine. Merck has also suspended production of some non-Covid-19 products, which could have generated sales to competitors but freed up equipment and materials, McGrath said.
In April, workers discovered that a screw used to hold vials steady as they rolled down the production line was not working. The bottles wobbled and some fell, blocking the production line. Merck worked with a supplier in Japan to redesign the screws.
In May, Merck employees discovered another problem with the vials while testing the production line using water. They became very heavy with water when filled. To solve the problem, a machinist at Merck designed a plate that held the containers securely, said Kim Dezura, manager of the West Point plant.
âThese are the types of little things that you come across,â she said. âWe want to resolve these issues quickly so that they don’t create bigger issues later. “
Once filled, the vials should be transferred from the trays to the cardboard boxes for shipment without damage and before they get too hot. J&J did not specify how to do this, so their rival refined their own system.
Initially, Merck tried to move the vials one by one, but it took too long and was too physically difficult for the workers. Using 3D printers, Merck built workstations that allowed workers to release vials from a tray, sort them into rows, remove containers, and transfer them 39 at a time.
In August, Merck began manufacturing commercial doses, Ms. Dezura said. It took companies until recently to receive regulatory approvals for the clearance of shipments. J&J then obtained the doses at its distribution center in the Netherlands and released the doses on Friday for worldwide distribution.
Merck plans to dose with J&J at its North Carolina plant, a more difficult process that takes longer to complete.
Write to Jared S. Hopkins at [email protected]
Corrections and amplifications
Remo Colarusso is the global pharmaceutical manufacturing manager of Johnson & Johnson. An earlier version of this article misspelled his last name as Remo Colaruso. (Corrected December 11)
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