The Twist: Merck will be manufacturing the vaccine from an arch rival.
“We’re doing it,” John McGrath told his workers at Merck. “And we are doing it with J&K.”
The Johnson & Johnson-Merck partnership, which the companies announced in March, is now bearing fruit in expanding the world’s vaccine supply. After a frantic ramp-up that included scouting for raw materials, buying equipment and upgrading plants all at the same time, the first Merck-made shots shipped on Friday.
Merck is churning out more than 500,000 doses daily for use outside the US, including countries desperate for shots.
J&J’s unusual collaboration with a rival, and Merck’s rapid manufacturing run-up, reflects one of the biggest challenges of the pandemic: creating enough COVID-19 vaccines to meet high demand.
Even early supplies in the US were limited as drug makers extended production lines. Even today many countries are struggling with short supply.
At a massive plant in West Point, Pa., Merck is helping J&J with the final phase of vaccine production, known as Fill-Finish, which involves thawing frozen doses made by J&J , adding a stabilizer to maintain their potency during storage, then pouring them into vials for shipment.
Merck, one of the world’s largest drugmakers by sales, said it has revamped its manufacturing facilities in about three months, which is about a year longer than it would normally take to build a plant. makes savings.
“We broke all kinds of records on manufacturing, on technology transfer, when the product was ready,” said Mr. McGrath. The federal government, which gave Merck at least $105 million to retrofit the plants, also contributed by quickly moving essential supplies. Custom.
Johnson & Johnson’s COVID-19 vaccine has not been received as well by people and health officials as initially hoped, partly because of concerns about a rare blood-clotting condition. Manufacturing issues have also played a role in limiting its use.
Yet even if adequate doses are given, the vaccine could still play an important role in the pandemic as many poorer countries lack access to other shots and the J&J vaccine is easier to handle and store, public-health advocates and Wallace said. Street analysts say.
Unlike messenger-RNA vaccines, the J&J vaccine does not require a special freezer to keep cold, and the primary series is one dose, not two.
“Our vaccine is uniquely positioned to be used in the world,” said Remo Colaruso, J&J’s global head of pharmaceuticals manufacturing. “The world is not completely vaccinated by a long shot.”
J&J and Merck, headquartered about 18 miles from New Jersey, are typically competitors in areas such as cancer and heart disease. Last December, at the insistence of the federal government, rivals began discussing whether Merck could help J&K develop a COVID-19 vaccine.
J&J Chief Scientific Officer Paul Stoffels was initially reluctant to work with another company, people familiar with the matter said. People said they were concerned it would thin their workforce too much because of existing manufacturing partnerships, but the director of the National Institutes of Health, Francis Collins, agreed after an appeal.
People said that during a January 4 call between US officials, Dr. Stoffels, and then-Merck chief executive Ken Frazier, the companies agreed to assess whether Merck’s plants were suited for the J&J shot. Maybe, people said.
At the time, Merck was looking for a role in the pandemic response. It had begun clinical trials of two COVID-19 vaccines, but they ultimately failed, with Merck halting the programs in late January. Its COVID-19 antiviral, molnupirvir, was still being tested.
Merck is fit as a partner because of its decades of manufacturing vaccines, Mr. Collaruso said.
Another key: Merck’s production line at West Point sat idle after a Covid-19 vaccine flop. Merck was also not using the 4,000-square-foot cold-storage room with 18 special freezers that the company had built for its COVID-19 shots. Each freezer can hold 5.5 million J&J doses.
West Point’s plants sit on a leafy campus 30 miles outside of Philadelphia. It is Merck’s largest workplace in terms of location and number of workers and has its own ZIP code. Despite the available rooms and equipment, Merck needed to upgrade its facilities, as J&J’s vaccine uses smaller vials than Merck’s failed COVID-19 shots, as well as a new vaccine technology.
“Our issue then became what equipment do we need, where can we get it, how quickly can we get it, is it available, and if not, what are our options?” said industry veteran Mr McGrath, who joined Merck. 2019
Merck found it needed to secure equipment and raw materials quickly, even as other drugmakers needed them for their products. Merck needed about 200 chemicals and equipment like filters. It usually takes two to three months to receive such items, but Merck needs them in weeks.
Merck relied on its relationships with suppliers, such as Thermo Fisher Scientific Inc., which provided special plastic bags used to purify and filter vaccines. Merck also halted production of some non-Covid-19 products, which could have sold competitors, but freed up equipment and materials, Mr McGraw said.
In April, workers discovered that a screw used to hold vials steady as they went down the production line was not working. Vials rattled, and some fell down, jamming the production line. Merck worked with a vendor in Japan to redesign the screw.
In May, Merck workers discovered another problem with the vials while doing a test-run of a production line using water. On filling the water, they became heavy from above. To address the issue, a Merck machinist designed a plate in which to secure the containers, said West Point plant manager Kim DeJura.
She said, “They’re the kind of little things you encounter. We want to solve them quickly so they don’t cause big issues later on.”
Once filled, the vials must be transferred from the tray to the cardboard box for shipment without damage and before becoming too hot. J&J didn’t specify how to do this, so its rival respected its own system.
Initially, Merck tried to shake the vials one by one, but this took too long and was too physically difficult for the workers. Using a 3-D printer, Merck built workstations for workers to drop vials from a tray, sort them into rows, take out containers, and move them 39 at a time.
In August, Merck began manufacturing commercial supplements, Ms Dzura said. It took companies recently to get regulatory approval to approve shipments. J&J then received the doses at its distribution center in the Netherlands, and released the doses on Friday for global distribution.
Merck plans to build supplements with J&J at its plant in North Carolina, a more difficult process that is taking longer to finish.
This story has been published without modification in text from a wire agency feed
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