US drug maker Emergent BioSolutions began ramping up its procurement of drug supplies early last year, when the coronavirus outbreak was erupting in China. In addition to producing drugs like the Narcan nasal spray that reverses opioid overdoses, the company develops vaccines and antibody therapies and has won lucrative contracts for key biodefense drugs for decades.
During the Obama administration, the Centers for Disease Control and Prevention awarded the Maryland-based company a contract worth nearly $ 1 billion in doses of anthrax vaccine in 2016.
In late January of last year, company executives presented a white paper for federal health officials, showing the Trump administration how it could recruit the pandemic vaccine factory financed by President Obama nearly a decade ago.
In the wake of the 2009 H1N1 “swine flu” pandemic, the Obama administration invested millions in building and staffing a handful of Centers for Innovation in Advanced Development and Manufacturing (CIADM) across the country.
Emergent was selected for one of those CIADM awards in 2012, and was soon tasked with building a site in Maryland designed to rapidly increase vaccine production in the event of another life-threatening pandemic.
“H1N1 showed that even some of the largest vaccine companies in the world did not have the capacity to make pandemic vaccines on a population scale,” Gary Disbrow, director of the Advanced Biomedical Research and Development Authority (BARDA), told CBS. News.
Federal officials say the nation’s vaccine manufacturing capacity has reached its limits to respond to the COVID-19 pandemic as companies have sought to expand production of the roughly 800 million doses of vaccines ordered by the administration. Trump last year.
Pfizer has relied on the expansion of several of its manufacturing sites in the US and abroad to produce doses of its COVID-19 vaccine. Although it is much smaller than Pfizer, Moderna reached an agreement last year with the Swiss multinational Lonza to manufacture the key ingredient in its vaccine.
And now that Americans are clamoring for COVID-19 injections that don’t seem to come quickly enough, the BARDA-approved Emergent will face its first test.
While waiting for an expected emergency use authorization from the Food and Drug Administration (FDA) by the end of the month, Johnson & Johnson says the first key step of vaccine production will take place at just three sites: its own facility. in the Netherlands, a manufacturing subcontractor in India, and at Emergent’s facilities in Baltimore.
How Emergent makes the Johnson & Johnson COVID-19 vaccine
Production of Johnson & Johnson’s COVID-19 injection begins in Emergent-grown live tissue cultures, a complicated process by which cells replicate after being infected with a carefully engineered adenovirus, a type of common cold virus. carrying the characteristic peak protein of SARS-CoV-2.
The vaccine is then frozen and shipped to the “fill and finish” facility. There it is thawed, diluted and divided into vials ready to be distributed.
Johnson & Johnson claims that making a batch of its COVID-19 vaccine, from step one to packaging, typically takes only 60 to 70 days. By comparison, Pfizer recently said it was working to reduce the time to produce its vaccine from 110 days to 60 days.
Besieged by overwhelming demand, public health officials welcomed the news earlier this month of a possible vaccine supply infusion brought by Johnson & Johnson’s single-dose immunization.
Their doses have another advantage over those of Pfizer and Moderna: Johnson & Johnson’s vaccine can be stored at standard refrigerator temperatures for three months, solving logistical challenges that had forced some vaccination sites to dispose of spoiled Pfizer and Moderna doses. and complicated immunization efforts in more rural communities. Their vaccines, which rely on mRNA technology, are much more fragile and require subzero temperatures for longer-term storage.
Results of clinical trialsby Johnson & Johnson state that the vaccine was in preventing moderate and severe COVID-19 infection among trial participants in the US.
In addition to manufacturing doses for Johnson & Johnson, Emergent has also been producing the key ingredient for millions of doses of AstraZeneca’s COVID-19 vaccine. And Novavax relied on Emergent’s production lines for the doses used in the first clinical trials of its COVID-19 vaccine candidate.
But officials in the Biden administration acknowledged last week that they remain concerned about delays in Johnson & Johnson’s production, first raised during the final months of the Trump administration, which was initially promised 10 million doses. of the vaccine by the end of February.
“You are right, as is the case with other vaccines, we have not found that the level of manufacturing allows us as much vaccine as we need,” Andy Slavitt, a senior White House adviser, said at a February 5 news conference.
“All options are on the table to figure out how to speed up manufacturing should the FDA approve the Johnson & Johnson vaccine,” Slavitt added.
Emergent admitted facing obstacles to increasing production, although he said he remained confident that he could fulfill the Johnson & Johnson order.
“We took over two years, you know, a typical schedule and compressed it into seven months, so of course we will have challenges. But nothing that was or is insurmountable,” said Sean Kirk, executive vice president of manufacturing and technical operations. at Emergent Biosolutions. However, Kirk did not say what was causing production delays.
“This is not making corn flakes”
Both administration officials and Emergent say the company has benefited from aggressive contracting maneuvers like the Defense Production Act, which can speed production by forcing suppliers to prioritize orders from vaccine manufacturers.
The effort now dominates the work of many along the supply chain, through companies like Michigan-based Grand River Aseptic Manufacturing, which will fill and finish Johnson & Johnson’s vaccine vials. The company’s capacity has been fully reserved by BARDA and the Department of Defense until August.
However, some caution that the Biden administration may already be close to maximizing what the Defense Production Act can accomplish as it seeks to squeeze more doses out of a complex and specialized production effort.
“Sometimes the prioritization of filling and finishing lines for manufacturers, which is critical right now, has outpaced products on those finish lines that were intended for other patients with some very critical illnesses. So Therefore, it is simply not a final solution, “said former COVID-19 Advisor Biden Luciana Borio said at a House hearing In the past week.
Disbrow said the agency was “closely monitoring the impact” on other critical drugs and working with pharmaceutical developers “to try to eliminate negative impacts.”
Both Emergent and Johnson & Johnson declined to provide specific figures on how many doses have been produced so far. A report from the Government Accountability Office last month said Janssen, the Johnson & Johnson subsidiary that developed the vaccine, estimated that only 2 million doses would be delivered at the time of the FDA’s emergency use authorization.
Six days after receiving its emergency use authorization on December 11, a press release from Pfizer said the company had shipped “the 2.9 million doses requested to ship” and had “millions more” unspecified in your warehouse.
And in that same time frame, Gen. Gustav Perna, director of operations for the Trump administration’s COVID vaccination effort, said Moderna shipped “just under 6 million doses” in its first week.
Kirk says the effort to increase Emergent’s vaccine production was “unprecedented.”
“It’s not about making corn flakes,” he said. “This is an extremely difficult and extremely complicated process, and it has to be because it is a highly regulated manufacturing process, appropriately, that needs a high level of control.”
He added that while the manufacturing process can be compressed, “it is something that cannot be rushed to the point where you would be forced to cut corners.”