[ad_1]
U.S. drug maker Emergent BioSolutions began ramping up drug procurement from early last year as the coronavirus epidemic erupted in China. In addition to producing drugs like the Narcan anti-opioid overdose nasal spray, the company develops therapeutic vaccines and antibodies, and has signed lucrative contracts for key biodefense drugs over the decades.
Under the Obama administration, the Centers for Disease Control and Prevention awarded the Maryland-based company a contract worth up to nearly $ 1 billion in doses of anthrax vaccine in 2016.
In late January last year, company executives presented a white paper to federal health officials that showed the Trump administration how it could enlist the President Obama-funded pandemic vaccine plant. almost ten years ago.
In the wake of the 2009 H1N1 swine flu pandemic, the Obama administration invested millions of dollars to build and staff a handful of Advanced Development and Manufacturing Innovation Centers (CIADMs) Across the country.
Emergent was shortlisted for one of these CIADM awards in 2012 and was quickly tasked with building a site in Maryland to quickly ramp up vaccine production in the event of another potentially deadlier pandemic.
“H1N1 has shown that even some of the world’s largest vaccine companies lack the capacity to manufacture population-wide pandemic vaccines,” said Gary Disbrow, director of the Biomedical Advanced Research and Development Authority (BARDA), at CBS News.
Federal officials say the country’s vaccine manufacturing capacity has reached its limits to respond to the COVID-19 pandemic, as companies have sought to increase production of the approximately 800 million doses of vaccine ordered by the administration Trump last year.
Pfizer has relied on the expansion of several of its manufacturing sites in the United States and abroad to produce doses of its COVID-19 vaccine. Although much smaller than Pfizer, Moderna struck a deal last year with Swiss multinational Lonza to manufacture the key ingredient in its vaccine.
And now that Americans are clamoring for COVID-19 snapshots that don’t appear to be produced quickly enough, BARDA-approved Emergent will face its first test.
Pending a hoped-for emergency use clearance from the Food and Drug Administration (FDA) by the end of the month, Johnson & Johnson says the first key step in vaccine production will take place at just three sites: its own facility in the Netherlands, a manufacturing subcontractor in India, and in the Emergent plant in Baltimore.
How Emergent is making the Johnson & Johnson COVID-19 vaccine
Johnson & Johnson’s COVID-19 vaccine production begins in live tissue cultures grown by Emergent, a delicate process, in which cells are replicated after being infected with a carefully crafted adenovirus, a type of common cold virus that carries the SARS-CoV-2 signature spike protein.
The vaccine is then frozen and shipped to “fill-finish” facilities. There it is thawed, diluted and divided into vials ready for dispensing.
Johnson & Johnson says it typically only takes 60 to 70 days to manufacture a batch of their COVID-19 vaccine, from step one to packaging. By comparison, Pfizer recently said it was working to cut its vaccine production time from 110 days to 60 days.
Besieged by overwhelming demand, public health officials earlier this month welcomed a possible shot of vaccines brought by the single-dose vaccination from Johnson & Johnson.
Its doses have another advantage over those of Pfizer and Moderna: Johnson & Johnson’s vaccine can be stored at standard refrigerator temperature for three months, solving the logistical problems that had forced some vaccination sites to destroy doses of Pfizer and Moderna spoiled and complicated vaccination efforts in more rural communities. Their vaccines, which are based on mRNA technology, are much more fragile and require sub-zero temperatures for longer-term storage.
Clinical trial results boasted last week by Johnson & Johnson claim that the vaccine was 72% effective in preventing moderate and severe COVID-19 infections among U.S. trial participants.
In addition to manufacturing doses for Johnson & Johnson, Emergent 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 COVID-19 vaccine candidate.
But officials in the Biden administration admitted last week that they remained concerned about delays in the production of Johnson & Johnson, first raised in the final months of the Trump administration, which were initially promised 10 million doses of vaccine by the end of February.
“You’re right, as is the case with other vaccines, we haven’t found that the level of manufacturing allows us as many vaccines as we need to get out of the gate,” said Andy Slavitt, senior advisor at the White House, during a press briefing on February 5.
“All options are on the table as to how to expedite manufacturing in the event the FDA approves the Johnson & Johnson vaccine,” Slavitt added.
Emergent admitted to encountering obstacles to ramping up production, while saying he remained confident he could honor the order from Johnson & Johnson.
“We’ve taken over two years, you know, a typical, compressed schedule in seven months, so of course we’re going to have challenges. But nothing insurmountable or insurmountable, ”said Sean Kirk, executive vice president of manufacturing and technical operations at Emergent Biosolutions. Kirk did not say what was causing the production delays, however.
“This is not making corn flakes”
Administration officials and Emergent say the company has benefited from aggressive contracting maneuvers like 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 players in the supply chain, including companies like Michigan-based Grand River Aseptic Manufacturing who will fill and complete Johnson & Johnson’s vaccine vials. The company’s capacity was fully booked by BARDA and the Department of Defense until August.
However, some warn that the Biden administration may already be on the cusp of maximizing what the Defense Production Act can accomplish, as it seeks to extract more doses from a complex and specialized production effort.
“Sometimes the prioritization of the filling and arrival lines to manufacturers, which is crucial at the moment, tipped products into those arrival lines that were intended for other patients with very critical illnesses. So it’s just not a final solution, ”former Biden COVID-19 Advisor Luciana Borio said at a House hearing last week.
Disbrow said the agency is “closely monitoring the impact” on other critical drugs and working with drug developers “to try to eliminate the negative impacts.”
Emergent and Johnson & Johnson declined to provide specific figures on the number of doses produced so far. A Government Accountability Office report 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 it was requested to ship” and had a “million more” unspecified in its warehouse.
And in the same time frame, General Gustav Perna, chief operating officer for the Trump administration’s COVID vaccination effort, said Moderna had shipped “just under 6 million doses” over the course of his first week.
Kirk says the effort to ramp up Emerging vaccine production was “unprecedented.”
“It’s not making corn flakes,” he says. “This is an extremely difficult and extremely complicated process, and it must be so because it is a highly regulated, appropriately regulated manufacturing process requiring a high level of control.”
He added that although the manufacturing process can be compressed, “it is something that cannot be rushed as you would have to cut costs.”
[ad_2]
Source link