American pharmaceutical company Emergent BioSolutions started accelerating its acquisition of drug supplies early last year, when the coronavirus outbreak was emerging in China. In addition to producing drugs like the Narcan opioid overdose nasal spray, the company develops vaccines and antibody therapies and has won lucrative contracts for essential biodefense drugs over the decades.
During the Obama administration, the Centers for Disease Control and Prevention awarded the Maryland-based company a contract of up to $ 1 billion in doses of anthrax vaccine in 2016.
In late January last year, company executives presented a white paper to federal health officials, which showed the Trump administration how it could enlist the pandemic vaccine factory funded by President Obama nearly a decade ago.
In the wake of the 2009 H1N1 “swine flu” pandemic, the Obama administration poured millions into building and contracting a handful of Advanced Development and Manufacturing Innovation Centers (CIADMs) across the country.
Emergent was selected for one of these 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 potentially more deadly pandemic.
“H1N1 demonstrated that even some of the largest vaccine companies in the world lacked the capacity to manufacture 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 country’s vaccine-making capacity has reached its limits in response to the COVID-19 pandemic, as companies sought to expand production of about 800 million doses of vaccines ordered by the Trump administration last year.
Pfizer has relied on expanding several of its factories in the United States and abroad to produce doses of its COVID-19 vaccine. Although much smaller than Pfizer, Moderna signed an agreement last year with Swiss multinational Lonza to manufacture the key ingredient in its vaccine.
And now, as Americans clamor for COVID-19 photos that don’t seem to be produced fast enough, the BARDA-approved Emergent will face its first test.
Pending the expected Food and Drug Administration (FDA) emergency authorization authorization by the end of the month, Johnson & Johnson says the first major stage of vaccine production will take place in only three locations: its own facilities in the Netherlands, a manufacturing subcontractor in India and at Emergent’s Baltimore facility.
How Emergent makes the Johnson & Johnson COVID-19 vaccine
Production of Johnson & Johnson’s COVID-19 injection begins in living tissue cultures grown by Emergent, a complicated process by which cells are replicated after being infected with a carefully designed adenovirus, a type of common cold virus that carries the spike protein characteristic of SARS-CoV-2.
The vaccine is then frozen and sent to “fill-finish” facilities. There, it is thawed, diluted and divided into vials for distribution.
Johnson & Johnson claims that making a batch of its COVID-19 vaccine, from the first stage to packaging, usually takes just 60 to 70 days. In comparison, Pfizer said recently that it is working to reduce its vaccine production time from 110 to 60 days.
Plagued by overwhelming demand, public health officials welcomed the news earlier this month of a potential vaccine infusion brought about by Johnson & Johnson’s single dose immunization.
Its doses have another advantage over Pfizer and Moderna – the Johnson & Johnson vaccine can be stored in standard refrigerator temperatures for three months, solving the logistical challenges that have forced some vaccination sites to destroy the spoiled doses of Pfizer and Moderna and complicated immunization efforts in more rural communities. Their vaccines, which rely on mRNA technology, are much more fragile and require sub-zero temperatures for long-term storage.
Clinical trial results praised last week by Johnson & Johnson claim that the vaccine was 72% effective in the prevention of moderate and severe COVID-19 infection among study participants in the USA.
In addition to manufacturing doses for Johnson & Johnson, Emergent has also produced 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 candidate vaccine COVID-19.
But Biden government officials acknowledged last week that they remain concerned about Johnson & Johnson’s production delays, first raised during the final months of the Trump administration, which initially promised 10 million doses of the vaccine by the end of February.
“You are correct, as is the case with other vaccines, we have not found that the level of manufacture allows us the amount of vaccine we need to leave the gate,” said Andy Slavitt, a senior consultant at the White House, at a news conference in February 5th.
“All options are on the table to find out how to speed up manufacturing in case the FDA approves the Johnson & Johnson vaccine,” added Slavitt.
Emergent admitted that it faced obstacles to increase production, although it said it was confident it would be able to comply with Johnson & Johnson’s order.
“We took more than two years, you know, a typical, compact schedule in seven months, so of course we will have challenges. But nothing that is or is impassable,” said Sean Kirk, executive vice president of manufacturing and technical operations at Emergent Biosolutions . Kirk did not say what was causing production delays, however.
“This is not making corn flakes”
Both government officials and Emergent say the company has benefited from aggressive hiring maneuvers, such as the Defense Production Act, which can speed up production by forcing suppliers to prioritize vaccine manufacturers’ orders.
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 vaccine bottles. The company’s capacity was fully reserved by BARDA and the Department of Defense until August.
However, some warn that the Biden government may already be close to maximizing what the Defense Production Act can achieve, as it seeks to extract more doses from a complex and specialized production effort.
“Sometimes, allocating priorities for the filling and finishing lines for manufacturers, which is critical at the moment, has hindered the products in these finishing lines that were intended for other patients with some very critical illnesses. , former Biden Luciana Borio, COVID-19 advisor said a hearing in the House Last week.
Disbrow said the agency is “closely monitoring the impact” on other essential drugs and working with pharmaceutical developers “to try to eliminate the negative impacts”.
Both Emergent and Johnson & Johnson declined to provide specific figures on how many doses have been produced so far. A report by the Government Accountability Office last month said that Janssen, the Johnson & Johnson subsidiary that developed the vaccine, estimated that only 2 million doses would be delivered at the time of 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 “all 2.9 million doses that were ordered for shipment” and had “millions more” not specified in your deposit.
And in the same period, General Gustav Perna, chief operating officer for the Trump administration’s COVID vaccination effort, said Moderna delivered “just under 6 million doses” in its first week.
Kirk says the effort to increase Emergent’s vaccine production was “unprecedented”.
“This is not making corn flakes,” he said. “This is an extremely difficult and extremely complicated process, and it has to be that way 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 of being forced to cut costs.”