U.S. drug maker Emergent BioSolutions began accelerating the acquisition of drug supplies early last year as the coronavirus outbreak was erupting in China. In addition to producing drugs such as Narcan nasal spray that reverses opioid overdose, the company develops vaccines and antibody therapies and had secured lucrative contracts for key drugs for biodefense defense over the decades.
During the Obama administration, the Centers for Disease Control and Prevention awarded the Maryland-based company a contract worth up to nearly $ 1 billion in anthrax vaccine doses 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 hire the pandemic-funded vaccine factory funded by President Obama almost a decade.
Following the 2009 “swine flu” H1N1 pandemic, the Obama administration invested millions in the creation and staffing of a handful of advanced development and manufacturing innovation centers (CIADMs) across the country. .
Emergent was selected for a CIADM award in 2012 and was soon commissioned to build a site in Maryland designed to rapidly increase vaccine production in the event of another potentially more deadly pandemic.
“H1N1 showed that even some of the world’s largest vaccine companies did not have the capacity to manufacture pandemic vaccines on a population scale,” Gary Disbrow, director of the Biomedical Authority for Advanced Research and Development, told CBS News. (BARDA).
Federal officials say the country’s vaccine manufacturing capacity has reached its limits in response to the COVID-19 pandemic, as companies have tried to expand production of the 800 million doses of vaccine ordered by the Trump administration. last year.
Pfizer has relied on expanding several of its manufacturing sites in the U.S. and abroad to produce doses of its COVID-19 vaccine. Although much smaller than Pfizer, Moderna reached an agreement last year with Swiss multinational Lonza last year to manufacture the key ingredient in its vaccine.
And now, as Americans claim shots of COVID-19 that appear to be unlikely to occur quickly enough, BARDA-approved Emergent will face its first test.
While awaiting the Food and Drug Administration’s (FDA) emergency use authorization expected later this month, Johnson & Johnson says the first key step in vaccine production will be in just three locations. : its own facility in the Netherlands, manufacturing subcontractor in India, and Emergent facilities in Baltimore.
Com Emergent manufactures the Johnson & Johnson COVID-19 vaccine
Production of the Johnson & Johnson COVID-19 trait begins in cultures of living tissue cultured by Emergent, a complicated process in which cells replicate after being infected with a carefully designed adenovirus, a type of virus. of the common cold carried by the SARS-CoV-2 flagship protein. .
The vaccine is then frozen and sent to the “completion” facility. There it is thawed, diluted and divided into vials ready for distribution.
Johnson & Johnson claims that manufacturing a batch of its COVID-19 vaccine, from the first step to packaging, usually takes between 60 and 70 days. In comparison, Pfizer recently said it was working to reduce the time to produce its vaccine from 110 days to 60.
Harassed by an overwhelming lawsuit, public health officials welcomed earlier this month about a possible infusion of vaccine supply caused by Johnson & Johnson’s single-dose vaccination.
Their doses have another advantage over Pfizer and Moderna: the Johnson & Johnson vaccine can be stored at the standard refrigerator temperature for three months, solving logistical challenges that had forced some vaccination sites to eliminate Pfizer doses and Modern damaged and complicated vaccination 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.
Results of clinical trials promoted last week by Johnson & Johnson claim that the vaccine was 72% effective in the prevention of moderate and severe COVID-19 infection among trial participants in the United States.
In addition to manufacturing doses for Johnson & Johnson, Emergent has also been developing 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 its candidate COVID-19 vaccine’s first clinical trials.
But Biden administration officials acknowledged last week that they remain concerned about delays in Johnson & Johnson’s production, first raised during the last months of the Trump administration, which was initially promised 10 million doses of the vaccine in late February.
“You’re right, as with other vaccines, we haven’t found that the level of manufacturing allows us as many vaccines as we need to get out the door,” said Andy Slavitt, a senior White House adviser. press conference on February 5th.
“There are all the options on the table to figure out how to speed up manufacturing in case the FDA approves the Johnson & Johnson vaccine,” Slavitt added.
Emergents admitted they faced obstacles to increasing production, although they said they were confident they could comply with Johnson & Johnson’s order.
“It took us another two years, you know, on a typical timeline and it was reduced to seven months, so of course we’ll have challenges. But nothing that was or was insurmountable,” said Sean Kirk, vice president. manufacturing and technical operations executive at Emergents Biosolutions. Kirk did not say, however, what was causing delays in production.
“This is not making cornflakes”
Both government officials and Emergent say the company has benefited from aggressive recruitment maneuvers such as the Defense Production Act, which can speed up 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. BARDA and the Department of Defense have fully reserved the company’s capacity until August.
However, some warn that the Biden administration may already be close to maximizing what the Defense Production Act can achieve as it tries to pull more doses out of a complex and specialized production effort.
“Sometimes the prioritization of filling and finishing lines for manufacturers, which is fundamental right now, has led to products being destined for those destination lines for other patients with some very critical diseases. , is not a final solution, “said former Biden Luciana Borio, COVID-19 adviser said an audience in the house last week.
Disbrow said the agency was “closely monitoring the impact” on other critical 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 from 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 the use of the vaccine. FDA Emergency.
Six days after receiving the emergency use permit on Dec. 11, a Pfizer press release said the company had sent “all 2.9 million doses that were requested to be sent” and that it had “millions more” unspecified in your warehouse.
And in that same period of time, General Gustav Perna, head of operations for the Trump administration’s COVID vaccine effort, said Moderna sent “just under 6 million doses” during his first week.
Kirk says the effort to increase Emergent vaccine production was “unprecedented.”
“This is not about making cornflakes,” he said. “This is an extremely difficult and extremely complicated process, and it has to be that way because it is a highly regulated and appropriate manufacturing process that needs a high level of control.”
He added that while the manufacturing process can be compressed, “it’s something that can’t be rushed to the extent that it would be forced to cut corners.”