From Lab to Vaccine Vial: The Historic Manufacturing Journey of Johnson & Johnson's Janssen COVID-19 Vaccine
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etting COVID-19 vaccines to people around the world. It's hard to think of anything else right now, and it's something that's been top of mind at Johnson & Johnson since early last year, when the novel coronavirus was just beginning to spread.
As Johnson & Johnson begins shipping its Janssen COVID-19 Vaccine this week in the U.S., after receiving authorization for Emergency Use by the U.S. Food and Drug Administration (FDA)*, you may be wondering: What does it really take to get to this point?
The short answer: nearly a year of meticulous planning and preparation, which has included seeking out manufacturing partners to help boost capabilities, as well as repurposing existing distribution facilities and technologies.
“We have standard cold chain technologies that we’ve been using for more than 30 years to distribute other medications," says, Vice President, Janssen Supply Chain, LLC, Johnson & Johnson. "So we get to build on what we already have, which really helps us with transportation and distribution without the need for special temperatures.”
Add to that an announcement today from the U.S. government that Johnson & Johnson will partner with Merck to make its Janssen COVID-19 Vaccine. Through the agreement, Merck will use its facilities to produce drug substance, as well as formulate and fill vials of Johnson & Johnson’s vaccine.
This crucial work and such unprecedented partnerships speak to Our Credo, the company's guiding mission statement, which states that Johnson & Johnson's first responsibility is to the patients, doctors and nurses, mothers and fathers and all others who use the company's products.
Indeed, Johnson & Johnson is built for times like these. For well over a century, the company has played a leading role in helping to address epidemics and pandemics through innovation, dating as far back as the Spanish flu outbreak of 1918, when it began mass-producing epidemic masks.
“It’s a testament to the inspiring teamwork exemplified at our company,” Colarusso says.
If you're curious to see what this teamwork is like in action, here's a month-by-month look at our vaccine’s journey from single cells in the laboratory to vials stocked in a warehouse.
A Lead Investigational Janssen COVID-19 Vaccine Candidate Is Announced
As soon as news of SARS-CoV-2—the virus that causes COVID-19—hit early last year, Johnson & Johnson began to research potential investigational vaccine candidates in partnership with the Beth Israel Deaconess Medical Center, an affiliate of Harvard Medical School.
Based on this work, scientists were able to identify a lead investigational Janssen COVID-19 vaccine candidate in March. The company also announced a goal of making it available for potential emergency use in early 2021—and to supply doses for emergency pandemic use on a not-for-profit basis.
“Vaccine development and production typically takes five to seven years, but our R&D and supply chain teams didn’t have the luxury of time,” says Paul Lefebvre, Vice President, Strategic Initiatives, COVID-19 Vaccine Supply Chain, Janssen Pharmaceutical Companies of Johnson & Johnson. “We all knew that if we planned to get this investigational Janssen COVID-19 vaccine candidate out quickly, we would have to help get done in months what normally takes years.”
This unprecedented speed has been made possible due to extensive and unprecedented collaborations and partnerships with governments, regulatory authorities and the scientific community around the world, as well as the company's ability to streamline the production process based on past experience with vaccine development.Read More
Global Collaborations Spur Manufacturing
The first step in preparing to supply a vaccine worldwide: activating manufacturing capabilities.
Johnson & Johnson quickly prepared to produce the clinical trial supply of its investigational Janssen COVID-19 vaccine candidate at its vaccine launch facility in Leiden, the Netherlands, which was built in 2018 for the express purpose of large-scale production of vaccines for clinical trials and, pending regulatory approvals, the launch of new vaccines.
But the sheer scale of the pandemic quickly made it clear that more resources would be needed.
"We have a lot of experience," Colarusso says. "But we knew the scale here was so big that we couldn't do everything ourselves. It's essential to look to partners."
So, in April, the company announced a collaboration with its first manufacturing partner, Emergent BioSolutions, Inc., based in Maryland.
Between then and March 2021, Johnson & Johnson announced collaborations with four more U.S. partners—Catalent, Inc., in Indiana; Michigan-based Grand River Aseptic Manufacturing (GRAM); PCI and Merck in Pennsylvania—as well as Reig Jofre in Spain, a Catalent facility in Italy, Biological E Limited in India, ASPEN Pharmacare in South Africa and Sanofi Pasteur in France.
Johnson & Johnson hopes to have partnerships with a total of 10 manufacturing plants by the end of 2021.
“In addition to establishing a capable manufacturing network, it’s really important to have multiple manufacturing sites located in various regions to maintain the continuity of our supply chain,” Lefebvre explains. “So we have all-hands-on-deck in case of an emergency.”Read More
Drug Substance Manufacturing Begins
Johnson & Johnson began mass manufacturing its investigational Janssen COVID-19 vaccine candidate at the vaccine launch facility.
In the first step of the production process, cells are grown in a bioreactor. "Then we introduce our virus seed, which is our actual drug product," Colarusso says. "These cells then replicate to a very high degree so that we can make millions of doses of our investigational Janssen COVID-19 vaccine candidate from one batch. Then we purify that solution to make something called drug substance, which is an active ingredient."
The drug substance is then frozen and stored in bottles at -94° F.
This month, Johnson & Johnson also entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of its investigational Janssen COVID-19 vaccine candidate.Read More
It's Time to Fill, Finish and Package the Investigational Janssen COVID-19 Vaccine Candidate
Bottles of the investigational Janssen COVID-19 vaccine candidate from the vaccine launch facility in Leiden were shipped to a fill-finish site at GRAM, where the drug substance was thawed and diluted into the vaccine formulation that could potentially be administered to people.
The five-dose vials were then filled, finished with labels and packaged.Read More
An Equitable Distribution Pledge Is Signed
Johnson & Johnson announced an agreement in principle with Gavi, The Vaccine Alliance under which it would provide up to 500 million doses of its investigational Janssen COVID-19 vaccine candidate to lower-income countries. Gavi is an organization responsible for equitable access to vaccines and coordination of procurement and distribution of potential COVID-19 vaccines via the COVAX facility.
These potential doses would be distributed through 2022.
“This really is Our Credo in action—to make sure our products are accessible to people around the world,” Lefebvre says. “Our company exists to make lives better for everyone around the world."Read More
Process Performance Qualification in Leiden Is Complete
The vaccine launch facility in Leiden successfully completed its Process Performance Qualification, an FDA requirement for vaccine production, which shows that the manufacturing process is consistent, and that the facility can produce at least three consecutive batches of investigational Janssen COVID-19 vaccine candidate that induce the same immune response in people.
This is the last step before an investigational vaccine candidate may be submitted to the FDA for consideration for Emergency Use Authorization (EUA).
The investigational Janssen COVID-19 vaccine candidate itself is frozen at -4° F, and then transported from the fill-finish sites to Johnson & Johnson’s main distribution centers to be ready for immediate shipment.Read More
The U.S. Government Announces an Agreement Between Johnson & Johnson and Merck
Having received EUA from the FDA, Johnson & Johnson begins shipping its Janssen COVID-19 Vaccine to McKesson, the supplier in charge of distributing it to hospitals, pharmacies and other healthcare facilities in the U.S.
The vaccine can be frozen at -4° F for up to two years, and once it arrives at its final destination, can stay in a refrigerator at between 36 and 46° F for a maximum of three months.
Each pallet of the vaccine also includes 24/7 track-and-trace technologies that provide real-time location and other information needed to make sure each vaccine adheres to the highest quality standards.
This month, the U.S. government also announces a partnership between Johnson & Johnson and Merck, which will produce drug substance, as well as formulate and fill vials of the Janssen COVID-19 Vaccine.Read More
*The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by the FDA through an Emergency Use Authorization (EUA). The FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information are available here.