US drugmaker Emergent BioSolutions has begun accelerating its procurement of drugs since early last year as the coronavirus outbreak erupted in China. In addition to producing drugs such as Narcan opioid overdose nasal spray, the company develops vaccines and antibody therapies and has won lucrative contracts for key biodefense drugs over the decades.
During the Obama administration, the Centers for Disease Control and Prevention awarded the Maryland-based company a contract worth up to $ 1 billion in anthrax vaccine doses 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 enroll President Obama-funded pandemic vaccine factories nearly a decade ago.
Following the 2009 swine flu pandemic H1N1, the Obama administration has invested millions in building and staffing a handful of Advanced Development and Production Innovation 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 more lethal, pandemic.
“H1N1 has shown that none of the world’s largest vaccine companies have the capacity to produce pandemic vaccines on a large scale,” 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 sought to expand production to the approximately 800 million doses of vaccine ordered by the Trump administration last year. .
Pfizer has relied on the expansion of several factories in the US and abroad to produce doses of the COVID-19 vaccine. Although much smaller than Pfizer, Moderna struck a deal last year with Swiss multinational Lonza last year to make it the key ingredient in its vaccine.
And now, as Americans shout for COVID-19 photos that don’t seem to be produced fast enough, BARDA-approved Emergent will face its first test.
While awaiting an emergency use authorization 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 in only three locations: its own unit in the United States. Downstairs, a production subcontractor in India and at Emergent’s Baltimore headquarters.
How Emergent produces the Johnson & Johnson COVID-19 vaccine
Johnson & Johnson’s COVID-19 stroke begins in Emergent’s cultured living tissue cultures, a difficult process by which cells reproduce after being infected with a carefully designed adenovirus, a common type of cold virus that carries top of SARS-CoV-2 signature.
The vaccine is then frozen and shipped to the “filling-finishing” facilities. There, it is thawed, diluted and divided into vials ready for distribution.
Johnson & Johnson claims that the manufacture of a batch of COVID-19 vaccine, from the first step to packaging, generally lasts only 60 to 70 days. By comparison, Pfizer recently said it is working to reduce vaccine production time from 110 days to 60 days.
Besieged by overwhelming demand, public health officials welcomed news earlier this month of a potential vaccine supply infusion from Johnson & Johnson’s single-dose immunization.
Its doses have another advantage over Pfizer and Moderna – Johnson & Johnson vaccine can be kept at standard refrigerator temperature for three months, solving logistical challenges that have forced some vaccination sites to throw altered doses of Pfizer and Moderna and complicated efforts immunization in more rural communities. Their vaccines, which are based 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% efficient in the prevention of moderate and severe COVID-19 infection among US study participants.
In addition to manufacturing dosages for Johnson & Johnson, Emergent has also produced the key ingredient for millions of doses of AstraZeneca COVID-19 vaccine. Novavax also relied on Emergent’s production lines for the doses used in the early clinical trials of its COVID-19 vaccine candidate.
But Biden officials acknowledged last week that they remain concerned about Johnson & Johnson’s production delays, which were first lifted in the last 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, a senior White House adviser. press briefing on February 5th.
“Every option is on the table to find out how to speed up production if the FDA approves the Johnson & Johnson vaccine,” Slavitt added.
The emergent admitted that he faces obstacles in intensifying production, although he said he remained confident that he would be able to fulfill Johnson & Johnson’s order.
“We’ve taken a two-year, you know, a typical, compressed calendar in seven months, so of course we’re going to have challenges. But none of that has been or isn’t insurmountable,” said Sean Kirk, executive vice president of production and technical operations at Emergent Biosolutions. However, Kirk did not say what caused the delays in production.
“It doesn’t make cornflakes”
Both government officials and Emergent say the company has benefited from aggressive contracting 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 Michigan-based companies such as Grand River Aseptic Manufacturing, which will fill and finish Johnson & Johnson vaccine vials. The company’s capacity was fully reserved by BARDA and the Department of Defense until August.
However, some warn that the Biden administration may already be close to maximizing what the Defense Production Act can accomplish as it seeks to eliminate more doses from a complex, specialized production effort.
“Sometimes the allocation of priorities for filling and finishing lines for manufacturers, critical at this time, hit the products in those finishing lines that were intended for other patients with some very critical diseases. So it’s not just a final solution,” the former Biden COVID-19 counselor Luciana Borio said a Chamber hearing last week.
Disbrow said the agency is “closely monitoring the impact” of other critical drugs and is 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 Janssen, the Johnson & Johnson subsidiary that developed the vaccine, estimated that only 2 million doses would be given at the time of the FDA’s emergency clearance.
Six days after receiving the emergency use permit on December 11, a Pfizer press release stated that the company had delivered “all of the 2.9 million doses that were requested to be shipped” and that it had ” millions more ”not specified in its repository.
At the same time, General Gustav Perna, the operational director of the Trump administration’s COVID vaccination effort, said Moderna shipped “just under 6 million doses” in the first week.
Kirk says the effort to expand Emergent vaccine production has been “unprecedented.”
“It doesn’t make cornflakes,” he said. “This is an extremely difficult and extremely complicated process and it must be so, because it is a highly regulated manufacturing process, appropriately, which needs 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 someone would be forced to cut corners.”