US drug manufacturer Emergent BioSolutions began accelerating drug stock purchases early last year, when the coronavirus outbreak broke out in China. In addition to manufacturing drugs such as the opioid overdose-reversing Narcan nasal spray, the company develops vaccines and antibody drugs and has scored lucrative contracts for key biologically defensive drugs over the decades.
During the Obama administration, the Centers for Disease Control and Prevention awarded the Maryland-based company a contract worth nearly $ 1 billion worth of anthrax vaccines in 2016.
In late January last year, company executives presented a white paper to federal health officials showing the Trump administration how to turn on 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 staffing a handful of Centers for Innovation in Advanced Development and Manufacturing (CIADMs) across the country.
Emergent was selected for such a CIADM award in 2012 and was soon commissioned to build a site in Maryland designed to rapidly ramp up vaccine production in the event of another, potentially deadlier, pandemic.
“H1N1 showed that even some of the world’s largest vaccine companies lacked the capacity to produce vaccines for pandemics at a population scale,” Gary Disbrow, director of the Biomedical Advanced Research and Development Authority (BARDA), told CBS News.
Federal officials say vaccine manufacturing capacity in the country has reached its limits in response to the COVID-19 pandemic as companies have sought to expand production for the roughly 800 million vaccine doses ordered by the Trump administration last year .
Pfizer relied on expanding several manufacturing sites in the US and abroad to produce doses of its COVID-19 vaccine. Although much smaller than Pfizer, Moderna struck a deal with Swiss multinational Lonza last year to make the key ingredient in its vaccine.
And with Americans clamoring for COVID-19 shots that can’t seem to be produced fast enough, BARDA-approved Emergent will face for his first test.
While it awaits a hoped-for emergency use approval from the Food and Drug Administration (FDA) by the end of the month, Johnson & Johnson says the major first step in vaccine manufacturing will take place in just three locations: its own facility in The Netherlands, a manufacturing subcontractor in India, and at Emergent’s Baltimore facility.
How Emergent Makes the Johnson & Johnson COVID-19 Vaccine
Producing Johnson & Johnson’s COVID-19 uptake begins in live tissue cultures grown by Emergent, a troublesome process in which cells are replicated after they are infected with a carefully engineered adenovirus, a type of cold virus that contains the signature spike protein of SARS. CoV-2.
The vaccine is then frozen and disposed of to “fill-finish” facilities. There it is thawed, diluted and divided into vials, ready to be divided.
Johnson & Johnson claims that making a batch of their COVID-19 vaccine, from the first step through to packaging, generally takes only 60 to 70 days. In comparison, Pfizer recently said it was working to cut the time to produce its vaccine from 110 to 60 days.
Besieged by overwhelming demand, public health officials earlier this month welcomed news of a possible infusion of vaccine offerings from Johnson & Johnson’s single-dose immunization.
The doses have another advantage over Pfizer and Moderna: Johnson & Johnson’s vaccine can be stored at standard refrigerator temperatures for three months, solving logistical challenges that have forced some vaccination centers to dispose of tainted 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 freezing temperatures for long-term storage.
Clinical Trial Results touted last week by Johnson & Johnson claim it was vaccine 72% effective for the prevention of moderate and severe COVID-19 infection among US subjects.
In addition to manufacturing doses for Johnson & Johnson, Emergent has also produced the lead ingredient for millions of doses of AstraZeneca’s COVID-19 vaccine. And Novavax relied on Emergent’s production lines for doses used in early clinical trials with its COVID-19 vaccine candidate.
But officials at the Biden administration last week acknowledged that they remain concerned about production delays in Johnson & Johnson, which first emerged during the closing months of the Trump administration, which initially reached 10 million in late February. doses of the vaccine had been promised.
“You’re right, as is the case with other vaccines, we haven’t found that the level of production allows us to get as much vaccine as we need to get out of the gate,” said Andy Slavitt, a senior White House adviser, at one point. press conference on February 5.
“Every option is on the table to find out how to speed up production should the FDA approve the Johnson & Johnson vaccine,” Slavitt added.
Emergent admitted to having encountered obstacles in ramping up production, but said they remained confident that they would be able to fulfill the Johnson & Johnson order.
“We’ve taken a timeline of over two years, you know, typical timeline and compressed to seven months, so of course we’re going to 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 caused the production delays.
“This is not making cornflakes”
Both government officials and Emergent say the company has taken advantage of aggressive contract maneuvers like the Defense Production Act, which can speed up production by forcing suppliers to prioritize orders from the vaccine manufacturers.
The effort now dominates the work of many in the supply chain, right down to companies like Grand River Aseptic Manufacturing in Michigan, who will fill and finish Johnson & Johnson’s vaccine vials. The company’s capacity has been fully reserved by BARDA and the Ministry of Defense through August.
However, some caution that the Biden administration may already be close to maximizing what the Defense Production Act can accomplish as it strives to squeeze more doses out of a complex, specialized manufacturing effort.
“Sometimes assigning priorities for the fill-and-finish lines for manufacturers, which is now crucial, has pushed products into those finishing lines that were destined for other patients with some very critical illnesses. So it’s just not a definitive solution,” said former Biden. COVID-19 advisor Luciana Borio told a House hearing last week.
Disbrow said the agency was “closely monitoring the impact” on other critical drugs and working with pharmaceutical developers “to try to eliminate negative effects.”
Both Emergent and Johnson & Johnson declined to provide specific figures on how many doses have been produced to date. A report from the Government Accountability Office last month said Janssen, the Johnson & Johnson subsidiary that developed the vaccine, was estimated to deliver only 2 million doses at the time of FDA approval for emergency use.
Six days after receiving emergency use clearance on Dec. 11, a Pfizer press release said the company had shipped “all 2.9 million doses requested for shipment” and an unspecified “millions more” at its warehouse. had.
And over that same time frame, General Gustav Perna, chief operating officer of the Trump administration’s COVID vaccination, said Moderna shipped “a little less than 6 million doses” in the first week.
Kirk says the attempt to scale up Emergent’s vaccine production was “unprecedented.”
“This isn’t making cereal,” he said. “This is an extremely difficult and extremely complicated process, and it must be so because it is a highly regulated, appropriate manufacturing process that requires a high degree of control.”
He added that while the manufacturing process can be compressed, “it is something that cannot be so rushed that one would be forced to take turns.”