Covered head to toe in sterile garments, workers inside a modern manufacturing plant in East Baltimore have been making coronavirus vaccine for months — tens of millions of doses that, for now, are being stockpiled with no date set for distribution.
None of the vaccines at the Emergent BioSolutions factory has yet been authorized for use. But among the pharmaceutical companies contracting with Emergent is Johnson & Johnson, which reported promising trial results Friday and is expected to submit data to federal regulators within a week for emergency authorization.
The vaccine hasn’t proven as effective as vaccines already in use, but it requires just one dose rather than two and could more easily cover millions of American beginning in a couple of months or even weeks.
If it is approved, the 100 million doses pledged by Johnson & Johnson by June could mean a significant boost to U.S. supplies that now rely on just two authorized vaccines. Democratic President Joe Biden recently increased the nation’s orders from the companies that make the already-authorized vaccines and expects enough doses to inoculate 300 million Americans by the end of summer.
Ultimately, the timeline for vaccinating the country will rely on many variables — including potential snafus in the complicated and time-consuming manufacturing process.
“Making vaccines is not just a matter of a day or a few hours here and there, put it together and box it up,” said Syed T. Husain, senior vice president at Emergent. ”But all eyes and effort are on trying to do that as aggressively and as accelerated as possible.”
There have been more than 48 million doses of the Pfizer and Moderna vaccines produced and distributed as of Friday in the United States, and more than 26 million doses administered. Much more is needed for the country to reach herd immunity.
The Emergent BioSolutions factory was built with the help of federal government dollars before the pandemic for just such an assignment, making large batches of complex vaccines and therapies.
Emergent, based in Gaithersburg, is an experienced vaccine maker, producing its own products such as a smallpox vaccine kept in U.S. stockpiles. It has nine facilities globally, including another facility in South Baltimore near the city’s professional sports stadiums, where it fills vials of vaccines and therapies.
The company has received millions in federal dollars to boost production of COVID-19 therapies and vaccines, including at the East Baltimore factory near Johns Hopkins Bayview Medical Center.
Emergent is now producing four vaccines, two of which are just for human trials.
It is producing large quantities of the other two for possible distribution to the public: Johnson & Johnson’s and an AstraZeneca vaccine. There is no date set for AstraZeneca to seek authorization for its vaccine.
Johnson & Johnson said in April it contracted with Emergent to get commercial supplies ready. Emergent’s Husain wouldn’t disclose how much Johnson & Johnson vaccine has already been made, but said the company added equipment and the scale of production was “unprecedented.”
Emergent grows cells to make vaccines in 2,000-liter bioreactors that resemble metal tanks in breweries. Depending on the vaccine, workers can brew tens to hundreds of millions of doses a year.
It can take 30 to 60 days to make a batch of vaccine using specifications from the vaccine developers, not including time to find and buy specific biological materials that are often in short supply. That also doesn’t include time to package and label doses, done in other facilities. Then, time is needed for shipping.
“We have set a high bar,” said Dr. Paul Stoffels, Johnson & Johnson chief scientific officer, said when the contract with Emergent was announced. “Johnson & Johnson has committed to rapidly produce and supply more than one billion doses of a safe and effective vaccine globally. Our collaboration with Emergent is proof that we are moving quickly to deliver on that promise.”
Johnson & Johnson has said it is also making vaccines in its own facility in Europe, helping boost the global supply.
Some of the doses could end up in poorer countries that have struggled to secure doses as richer countries buy up doses. With new support from the Biden administration and other world leaders, the World Health Organization and a vaccine alliance are preparing to send 1.8 billion doses to 92 developing countries this year.
The Johnson & Johnson vaccine has appeal logistically because it not only requires just one dose, but it can be refrigerated for long periods. The Pfizer and Moderna vaccines use a new technology called messenger RNA and require ultracold storage.
The deep freeze has added to the difficult rollout of doses to priority groups, including delays and some waste of defrosted vaccine, said Dr. Kathleen Neuzil, director of the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health.
But she said each type of vaccine has its own complex needs, including obtaining the specific biological materials to manufacturing to shipping. AstraZeneca has already reported manufacturing troubles in Europe.
Vaccines can’t be labeled and sent anywhere until they are given emergency authorization by the U.S. Food and Drug Administration, itself an involved process, said Neuzil. Her lab is conducting trials for three COVID-19 vaccines, including continued testing of the two already authorized for emergency use.
The vaccine candidates under study around the world use several different platforms, she said. But she said the federal government anticipated a need to make different vaccines as part of an influenza pandemic preparedness plan, in which Neuzil participated, and invested in facilities such as Emergent’s plant.
She said manufacturing plants can make a lot of the Pfizer and Moderna vaccines in a small space, if they can get enough raw materials.
Other vaccines, such as one from Novavax, require making a virus-related protein and thus take longer and need huge facilities.
The Johnson & Johnson type of vaccine delivers coronavirus genetic code to induce an immune response via an adenovirus, which normally causes the common cold. They are typically easier to make but haven’t been authorized for use.
“Each has a slightly different reason why they may be limited,” Neuzil said.
Each can run into problems along the way, including supply shortages, batches that don’t meet quality standards, and regulatory hurdles. She said Pfizer discovered there was enough in its vials to squeeze out another dose, but that requires special syringes that are in short supply.
“It would be really great to have at least one other vaccine, if not two, but we should be expecting problems along the way,” Neuzil said.
“We need more wins,” she said. “And a single-dose vaccine like Johnson & Johnson’s could be a game changer, so we’re all anxiously awaiting the results. We don’t know how effective it will be.”
Johnson & Johnson reported Friday that a final phase trial showed the vaccine was 72% effective in the United States, but only 57% effective against a variant first identified in South Africa.
That’s enough to satisfy a bar set by U.S. regulators, but lower efficacy than vaccines from Pfizer and Moderna, which both exceeded 90% efficacy.
The swift development and effectiveness of those vaccines, plus more promising vaccines in the pipeline, are bright spots during the pandemic. The results were possible because of substantial upfront public investment, said Dr. Georges C. Benjamin, executive director of the American Public Health Association and a former Maryland health secretary.
Benjamin said many hurdles remain to getting substantial stocks of the vaccines made and distributed. And then there is the last hurdle, which is proving extra difficult: getting the shots into people’s arms.
“Biological production is not the same as making cars,” he said.
“You need the right raw materials, right cook, right temperature” — and just as important, he said, is getting “a qualified and trusted vaccinator.”
The effort has been slow to vaccinate the first few priority groups, including frontline health care providers, first responders and those in nursing homes, and now, seniors and some other essential workers. National figures show Maryland got off to an especially slow start, but the pace has quickened somewhat.
There have been more than 852,000 doses distributed in the state as of Friday, and about 483,000 doses administered, according to the state health department.
“So far, we’ve spent money and time creating it,” Benjamin said of vaccines in the U.S., “and almost no money or time in the distribution of vaccination delivery.”