U.S. drugmaker Emergent BioSolutions began speeding up drug supply early last year as the coronavirus outbreak broke out in China. In addition to manufacturing drugs such as the opioid-reversing Narcan nasal spray, the company also develops vaccines and antibody therapies and has won lucrative contracts for key bioprotective drugs over the decades.
During the Obama administration, the Centers for Disease Control and Prevention awarded the company in Maryland a contract worth up to $ 1 billion in anthrax vaccine doses in 2016.
At the end of January last year, the company’s executives presented a white paper to federal health officials that showed the Trump administration how they can recall the pandemic vaccine factory that was funded by President Obama nearly a decade ago.
In the wake of the 2009 H1N1 “swine flu” pandemic, the Obama administration has poured millions of dollars into staffing a handful of Advanced Development and Manufacturing Centers (CIADMs) across the country.
Emergent was selected for such a CIADM award in 2012, and was soon tasked with building a site in Maryland designed to rapidly increase vaccine production in the event of another, potentially deadly pandemic.
“H1N1 has shown that even some of the largest vaccine companies in the world have not been able to produce population-scale vaccines for pandemics,” Gary Disbrow, director of the Biomedical Advanced Research and Development Authority (BARDA), told CBS News.
Federal officials say the country’s vaccine production capacity has reached its limits in response to the COVID-19 pandemic as companies try to expand production for the approximately 800 million doses of vaccine ordered by the Trump administration last year has.
Pfizer is relying on the expansion of 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 entered into an agreement with Swiss multinational Lonza last year to make the main ingredient in its vaccine.
And now, as Americans beat COVID-19 shots that apparently cannot be produced fast enough, the BARDA-approved Emergent will face its first test.
While awaiting a hopeful authorization from the Food and Drug Administration (FDA) for emergency use by the end of the month, Johnson & Johnson says the most important first step of vaccine production will take place in only three areas: its own facility in the Netherlands, a manufacturing subcontractor in India, and at Emergent’s plant in Baltimore.
How Emergent Makes the Johnson & Johnson COVID-19 Vaccine
The production of Johnson & Johnson’s COVID-19 recording begins in living tissue cultures grown by Emergent, a difficult process in which cells are replicated after being infected with a carefully designed adenovirus, a type of cold virus that SARS -CoV-2 carries characteristic vein protein. .
The vaccine is then frozen and sent to “fill-off” facilities. There it is thawed, diluted and divided into vials ready to be dispensed.
Johnson & Johnson claims that the production of a group of COVID-19 vaccines, from the first step through packaging, usually takes only 60 to 70 days. By comparison, Pfizer recently said it was working to reduce the time it takes to produce the vaccine from 110 days to 60 days.
Overwhelming demand officials, public health officials welcomed news earlier this month about a possible administration of vaccine brought by Johnson & Johnson’s single-dose vaccination.
Its doses have another advantage over Pfizer’s and Moderna’s – Johnson & Johnson’s vaccine can be stored for three months at standard refrigerator temperatures, solving logistical challenges that have forced some vaccination sites to remove spoiled doses of Pfizer and Moderna and complicated immunization efforts in rural communities. Their vaccines, which rely on mRNA technology, are much more brittle and require temperatures below zero for long-term storage.
Results of clinical trials presented last week by Johnson & Johnson claims the vaccine was 72% effective to prevent moderate and severe COVID-19 infection among U.S. participants in the trial.
In addition to the manufacturing doses for Johnson & Johnson, Emergent also cost the most important ingredient for millions of doses of ASTZENECA’s COVID-19 vaccine. And Novavax relies on Emergent’s production lines for doses used in early clinical trials of the COVID-19 vaccine candidate.
But Biden administration officials admitted last week that they remain concerned about the delays in the production of Johnson & Johnson, which was only raised during the last months of the Trump administration, which initially received 10 million doses of the vaccine is promised.
“You are right, as is the case with other vaccines, we have not found that the level of manufacture allows us as much vaccine as we need to get to the gate,” said Andy Slavitt, senior adviser to the White House. , said press release on February 5.
“Every option is on the table to figure out how to speed up manufacturing if the FDA approves the Johnson & Johnson vaccine,” Slavitt added.
Emergent acknowledged that it had faced obstacles to increase production, but said they remained confident they would be able to carry out Johnson & Johnson’s commission.
“We took a more than two years, you know, a typical timeline and compressed it into 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. Kirk, however, did not say what caused production delays.
“It does not make wheat flakes”
Both administration officials and Emergent say the company has benefited from aggressive contracting maneuvers such as the Defense Production Act, which could speed up production by forcing suppliers to prioritize orders from vaccine manufacturers.
The effort now dominates the work of many people in the supply chain, through companies like Grand River Aseptic Manufacturing in Michigan, which fills and finishes Johnson & Johnson’s vaccination scales. BARDA and the Department of Defense maintained the company’s capacity until August.
However, some people warn that the Biden government may already be approaching the maximum performance of the Defense Production Act, as it seeks to extract more doses from a complex, specialized production effort.
“Sometimes the allocation of priorities for the fill-and-finish lines for manufacturers, which is currently critical, has pushed products into the finish lines that were destined for other patients with very critical illnesses, so this is just not a final solution. , “said former Biden. COVID-19 Advisor Luciana Borio said at a hearing in the house last week.
Disbrow said the agency is closely monitoring the impact on other critical medicines and is 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 so far. According to a report from the Government Responsibility Office, Janssen, the Johnson & Johnson subsidiary that developed the vaccine, estimated last month that only 2 million doses would be delivered during the FDA’s authorization for emergency use.
Six days after receiving its consent for emergency use on December 11, a Pfizer press release said the company had sent ‘all 2.9 million doses requested to be shipped’ and an unspecified ‘millions more’ in its warehouse had.
And at the same time, General Gustav Perna, chief operating officer of the Trump administration’s COVID vaccination effort, said Moderna had sent out a little less than 6 million doses in the first week.
Kirk says the attempt to boost Emergent’s vaccine production was ‘unprecedented’.
“It does not make wheat flakes,” he said. “It’s an extremely difficult and extremely complicated process, and it has to be so, because it’s a very regulated, appropriately so, manufacturing process that requires a high level of control.”
He added that although the manufacturing process could be compressed, “it is something that cannot be rushed to the extent that one would be forced to cut.”