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Technology Federal vaccine development sites ill-suited to counter covid-19 epidemic

21:20  15 march  2020
21:20  15 march  2020 Source:   washingtonpost.com

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Facilities built years ago to rapidly develop vaccines and life-saving medicines. Light is reflected through a window onto vials in a lab at Protein Sciences on March 12 in Meriden, Conn. The biotech company is currently researching a vaccine for covid - 19 . (Jessica Hill/AP).

Figure 3. Epidemic curve of COVID - 19 cases (n=1402) identified outside of China, by date of report and likely exposure location options, and accelerate the development of diagnostics, therapeutics and vaccines ; • Communicate critical risk and event information to all communities and counter

Nearly a decade ago, the U.S. government invested heavily in four sprawling facilities that officials said could rapidly make vaccines and other lifesaving medicines if America were struck by an outbreak of infectious disease or a biological attack.

But as the nation confronts the coronavirus pandemic, none of the sites — located in Florida, Maryland, North Carolina and Texas — have developed or are close to delivering medicines to counter the outbreak, according to records, government officials and others familiar with the facilities.

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COVID - 19 vaccine development . Date: February 26, 2020. "More generally, our work is part of a global effort seeking to capitalize on data for COVID - 19 , made available and rapidly shared by the scientific community, to understand this new virus and come up with effective interventions."

Instead of leading the rush to find and mass manufacture a vaccine or lifesaving treatment, two of the sites are taking no role, while the other two expect to conduct small-scale testing of potential coronavirus vaccines.

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At a cost to date of nearly $670 million, the Department of Health and Human Services and the Pentagon awarded contracts beginning in 2012 and 2013 to build or expand the four manufacturing complexes. Proponents said the sites would work with three private companies and one university to deliver emergency medicines and treatments, including flu vaccine, for both the military and civilians.

A Defense Department statement on Sept. 1, 2011, said its plant, which was eventually located in Alachua, Fla., would provide medical countermeasures and meet the military’s needs with “capabilities to rapidly respond” to “emerging and genetically engineered infectious disease outbreaks.’’

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Figure 3. Epidemic curve of COVID - 19 cases (n=2918) identified outside of China, by date of report and likely exposure location options, and accelerate the development of diagnostics, therapeutics and vaccines ; • Communicate critical risk and event information to all communities and counter

For COVID - 19 , the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. People can fight stigma and help, not hurt, others by providing social support. Counter stigma by learning and sharing facts.

The three new HHS-backed sites, in Baltimore, College Station, Tex., and Holly Springs, N.C., would use modern “vaccine technologies that have the potential to produce vaccines for not only pandemic influenza but also other threats more quickly and in a more affordable way,’’ according to an agency news release on June 18, 2012.

The facilities, HHS said, “will provide the first major domestic infrastructure in the United States capable of producing medical countermeasures to protect Americans from the health impacts of bioterrorism’’ and disease epidemics.

When the projects were first proposed, some medical and biodefense specialists warned about the expense and impracticality of rapidly producing such medicines at federally sponsored facilities.

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COVID - 19 is the name given to the disease associated with the virus. SARS-CoV-2 is a new strain of coronavirus that has not been previously The development of vaccines takes time. Several pharmaceutical companies are working on vaccine candidates. It will, however, take months or years

• The Global COVID - 19 Clinical Data Platform continues to collect core clinical data from COVID - 19 courses can be found here. Specifically, WHO has developed online courses on the For most people, COVID - 19 infection will cause mild illness however, it can make some people very ill and, in

The facilities were structured to handle laboratory tasks for both government and commercial clients. A steady flow of work at the sites, proponents said, would keep the sensitive lab equipment in ready condition for a crisis while maintaining the availability of skilled technicians.

Despite the federal spending commitments, the results have fallen short, according to an examination by The Washington Post.

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The overall performance of the four manufacturing sites has been criticized by government and independent biodefense specialists as recently as late last year.

Some of that concern came from Robert Kadlec, HHS Assistant Secretary for Preparedness and Response, who is at the forefront of federal efforts to combat the coronavirus. In his HHS role since 2017, Kadlec has initiated two reviews that found problems at the four sites.

Kadlec, a retired Air Force colonel and flight surgeon who has helped lead national biodefense planning since the 1991 Persian Gulf War, prompted the reviews well before the coronavirus, or covid-19, emerged as a global threat.

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No vaccine or specific treatment for COVID - 19 is available; care is supportive. The CDC clinical criteria for a COVID - 19 person under investigation (PUI) have been developed based on what is known about COVID - 19 and are subject to change as additional information becomes available.

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A “tiger team’’ of HHS and Pentagon officials, formed at Kadlec’s behest, identified shortcomings with the four sites, according to an October 2018 presentation at a Washington conference with biomedical industry counterparts.

The “operational capability has not been adequately developed and must be’’ improved at the four sites “to meet biodefense MCM [medical countermeasures] mission requirements,’’ the team said.

The team also concluded that year-to-year “sustainment’’ of the centers — with both government and commercially driven tasks — “has not been successful under the current architecture.’’

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The second review Kadlec initiated was completed in late 2019 by Mitre Corp., a nonprofit company that examines federal programs. It found similar deficiencies, according to people familiar with the findings who spoke anonymously because they were not authorized to do so publicly. A spokesman for Mitre declined to comment.

The Post requested interviews with Kadlec and Rick A. Bright, the head of HHS’s Biomedical Advanced Research and Development Authority; the agency declined.

Administration officials in recent weeks have begun to reorganize government oversight of the drug-manufacturing activities at the four centers.

This includes a new “National Biopharmaceutical Manufacturing Partnership’’ between HHS and the Defense Department “to provide joint oversight and management’’ of the centers, the Pentagon and HHS told The Post in response to questions.

The health agency also defended the performance of its three sites, which it said were established with “lessons learned” from 2009 H1N1 flu pandemic, when the U.S. faced a shortage of seasonal vaccine.

“In a national security or public health emergency, these existing partnerships will assist HHS in developing and manufacturing medical countermeasures more rapidly than we could otherwise,’’ said the agency’s statement. “If funding is received for COVID-19, we envision a role” for the three sites.

The Defense Department said its plant in Florida provides the military with ongoing development of medical countermeasures and the ability to provide “rapid response’’ to an outbreak.

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Yet as America faces a crisis of unknown dimensions with covid-19, the promise of breakthrough medicines and treatments appears to rest with private companies, not the federally sponsored manufacturing sites established with that intent.

“When this current pandemic subsides, and we can catch our breath, we need to ask: Why are we so vulnerable?’’ said Michael T. Osterholm, who is director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

'It may take even longer'

The imperative for large-scale manufacturing capacity was stressed at a Senate hearing on March 3 featuring Kadlec and two of the government’s other top health officials.

One of them, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases at NIH, estimated that developing and delivering a vaccine — if it were proved effective in human testing — would take 12 to 18 months, adding: “If you don’t have the production capacity to make tens and tens of millions of doses, it may take even longer.’’

Fauci’s comments prompted Sen. Mitt Romney, R-Utah, to ask: “Do we have that capacity in the United States? … We should have that capacity in the U.S. and have it ready, at the go.’’

Following the Senate testimony, two of the four government-sponsored manufacturing centers joined the efforts to develop a medicine against covid-19.

On Tuesday, Emergent BioSolutions, Inc., which in 2017 completed a 112,000-square-foot expansion of its plant in Baltimore with $163 million from HHS, announced that it has contracted with another Maryland-based company, Novavax, Inc., to produce material for an experimental covid-19 vaccine. Emergent will provide “small scale’’ manufacturing for that testing, according to Sean Kirk, a company executive. Novavax hopes to begin testing in humans this spring, according to a company news release.

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And on Wednesday, a Defense Department official said he expects the plant in Alachua, outside Gainesville, to begin making an experimental vaccine within six months for small-scale, initial human testing. Douglas W. Bryce, the department’s executive officer for countering chemical, biological, radiological and nuclear threats, said the effort will be carried out in partnership with HHS and the Defense Advanced Research Projects Agency.

“These are very difficult challenges,’’ Bryce said in an interview, referring to making a safe and effective vaccine. “You have multiple attempts at it, and some will succeed, and some will fail.’’

As of now there is no FDA-approved treatment or vaccine to counter covid-19, which scientists suspect jumped from an animal species to humans in Wuhan, China. The first deaths caused by the virus emerged there in January.

The challenges with the four federally sponsored sites underscore the government’s long struggle to obtain medicines for threat scenarios that, while seemingly improbable, pose grave potential consequences.

In 2006, for example, the Defense Threat Reduction Agency began its “Transformational Medical Technologies Initiative,’’ a $1.5 billion plan to fast-track the development of antidotes to protect the military against biological threats. Five years later, the initiative was shut down with no products delivered.

The four manufacturing sites were launched despite serious doubts.

a large building: A logo sign outside of a facility occupied by Emergent BioSolutions in Baltimore on March 8. © Tripplaar Kristoffer/Sipa USA /AP A logo sign outside of a facility occupied by Emergent BioSolutions in Baltimore on March 8.

In April 2008, Maj. Gen. Stephen V. Reeves told the House Appropriations Subcommittee on Defense that the Pentagon, before determining whether to sponsor its own medical manufacturing capacity, should conduct an “analysis of alternatives’’ to identify the most cost-effective approach.

He said, for example, the Pentagon was saving money by buying doses of anthrax and smallpox vaccines from the nation’s civilian stockpile instead of trying to produce products in-house. He also testified that the Pentagon and HHS were coordinating “research and development programs” to eliminate duplication.

The White House of President George W. Bush ordered the Pentagon and HHS to conduct the analysis that Reeves suggested.

The 112-page “Analysis of Alternatives,’’ by consultants affiliated with the Tufts Center for the Study of Drug Development, recommended that HHS and the Defense Department forego direct involvement with manufacturing medical countermeasures. The analysis said that doing so would save money and yield products faster.

The analysis, finalized in June 2009 and stamped “for official only,” concluded “there is no need for a dedicated USG-run, multi-product facility.”

But officials in President Obama’s administration differed. In 2012, the HHS awarded contracts to establish centers in Baltimore, College Station and Holly Springs.

The next year, the Pentagon launched its own site in Alachua — backed by a written recommendation from President Obama’s top assistant for counterterrorism and homeland security, John O. Brennan. He said it was needed to “respond faster and more effectively to bioterrorism and an infectious disease.”

In an interview on Friday, Brennan said the Obama administration had aimed to collaborate with companies “to very quickly get up to speed as far as the mass production’’ of vaccines, anti-viral treatments and other emergency countermeasures.

“Just because there’s not a pandemic every month or every year doesn’t mean that you can let those capabilities and those processes atrophy,’’ said Brennan, who also served from 2013 to 2017 as CIA director. “Too often throughout the course of our history if something is not blinking red, we tend to ignore it.’’

A senior Defense Department official, Arthur T. Hopkins, told a House Armed Services subcommittee in February 2016 that the military “needs the facility to rapidly develop and produce vaccines.’’

That year, at an initial cost of $204 million in public funds, the 180,000-square-foot facility opened in Alachua in partnership with a private company now called Ology Bioservices, Inc. Since then, the Defense Department has spent about $66 million to maintain the readiness of equipment there, federal records show.

The plant, including biocontainment lab facilities suitable for handling deadly pathogens, initially struggled to lure government or commercial contracts.

A draft of a memo prepared by an aide to Bryce, the Defense Department executive officer, warned that limited use of the plant was “creating a cash flow problem’’ for Ology. The memo, which was obtained by The Post, recommended taking steps to “maximize use’’ of the plant.

In an interview, Bryce said he and other federal officials have steered as many biodefense projects as possible to Ology, work that he said addressed the initial financial pressures.

“We started off slowly and the concern was the small business, [that] if we don’t keep them occupied and working that they would not be successful,” Bryce said. “Our goal was to ensure that they were successful … and they have turned out to be successful.’’

Peter H. Khoury, Ology’s chief executive officer, said the company provides its government and commercial clients access to the latest technology and production methods, along with qualified on-site staff.

“We do our best to fulfill our commitments to the USG [U.S. government], and especially the warfighters and their families,’’ Khoury said by email.

Waiting for a car, hoping for a Mercedes

Maintaining a stream of revenue-generating projects also has challenged the College Station site at Texas A&M University, where HHS initially invested $176 million to build a Center for Innovation in Advanced Development and Manufacturing.

In October 2013, the university’s chief executive for the center, Brett Giroir, told a House Armed Services subcommittee the Texas facility would be “fully capable of performing the advanced development and manufacturing’’ for medicines sought by both HHS and the military.

Giroir said he wanted the center “to be the cornerstone for an emergency response to genetically modified … organisms, as well as other unexpected agents that we believe are a growing, real threat to our national security and public health.’’ The center, he testified, would have “the capabilities to manufacture, at scale, vaccines or biological therapeutics required for an outbreak … as requested by the federal government.’’

Giroir, a physician, now serves as the Trump administration’s assistant secretary for health and is helping Kadlec with government-wide responses to the coronavirus. The health agency did not make Giroir available for comment.

The Texas A&M center was also touted by then-Texas Gov. Rick Perry, who said in September 2014 that the “anchor’’ of the center would be its partnership with a leading pharmaceutical company, GlaxoSmithKline, to develop and make flu vaccine at the campus complex. (In 2017, President Trump appointed Perry secretary of energy; he resigned in December and could not be reached for comment.)

The 100,000-square-foot HHS-supported manufacturing facility was completed in 2015 at Texas A&M to produce flu vaccine. However, the partnership with GlaxoSmithKline dissolved before a single dose was made.

“The expectations were that the government was going to put more products through there,’’ recalled Scott Lillibridge, who served as the university’s chief scientist for the manufacturing complex until 2017. “We were the garage waiting for the car, hoping for a Mercedes.’’

a group of people standing around a computer: Texas Gov. Rick Perry speaks with biotechnology gradate student Deepa Vijaykomar, right, during a tour at Texas A&M University in College Station, where the federal government had funded a center for advanced development and manufacturing, on Oct. 22, 2014. © Sam Craft/Bryan-College Station Eagle/AP Texas Gov. Rick Perry speaks with biotechnology gradate student Deepa Vijaykomar, right, during a tour at Texas A&M University in College Station, where the federal government had funded a center for advanced development and manufacturing, on Oct. 22, 2014.

The Texas center’s current executive director, Daniel J. Williams, declined through an aide to be interviewed.

In response to written questions, a university spokesman, Laylan Copelin, said Texas A&M and a commercial partner now at the site are “obligated to manufacture vaccines at the order of the federal government,” adding, “We have not received that order.”

The manufacturing site in North Carolina, completed in 2018 with $59 million from HHS and now operated by Seqirus, a subsidiary of an Australian company, makes an FDA-approved, seasonal flu vaccine.

A spokeswoman for Seqirus, Sharon McHale, said by email that the company is “not under any contracts related’’ to covid-19. If a vaccine against the virus becomes available for use, she said, “we have offered our full assistance to the U.S. Government.’’

In Washington, HHS officials have primarily turned to the private sector for help with covid-19.

On Feb. 18, HHS announced that the government is “particularly interested in identifying products and technologies’’ whose backers “have established large-scale commercial … manufacturing capability.”

The agency said it would work with two industry giants — Sanofi Pasteur and a subsidiary of Johnson & Johnson — to assist the companies’ efforts to develop coronavirus medicines. In its own announcement, Sanofi said it “has the potential to manufacture large quantities of the [coronavirus] vaccine candidate.’’ The J&J subsidiary declined through a spokesman to discuss its plans for manufacturing.

On Feb., 24, Moderna Inc., announced it manufactured vials of a candidate vaccine at its Norwood, Mass., plant and shipped them for testing in humans to the National Institutes of Allergy and Infectious Diseases in Bethesda.

Another company, Regeneron Pharmaceuticals, is working on its own treatment that would seek to stimulate a person’s growth of disease-fighting antibodies against covid-19. The firm plans to manufacture whatever quantities are needed at its plant near Albany, N.Y., according to Hala Mirza, a company spokeswoman.

Mirza said Regeneron hopes to make doses of the treatment for testing in humans by late August — and, eventually, if the results are successful — the general public. “If you don’t have in-house manufacturing, you have to find somebody to do it. And we’re able to scale that up here,” Mirza said.

David L. Danley, a biologist and retired Army colonel who helped oversee efforts to develop and acquire specialized vaccines after the 1991 Persian Gulf War and the 2001 anthrax letter attacks, said the government-sponsored plants appear poorly positioned to respond quickly to novel infectious threats, including covid-19.

The companies now working to develop the needed treatments can probably do it “better, faster and cheaper’’ than the four federally sponsored centers, he said.

“That they are having these kind of problems is not a surprise.”

Reeves, the retired Army major general, who years ago warned members of Congress about the pitfalls of pursuing the manufacturing sites, said he is not surprised that the nation was inadequately prepared for the pandemic.

It’s clear that the companies that are moving forward aren’t comfortable going with a government manufacturing facility,” said Reeves, who led the Pentagon’s defenses against biological and chemical threats for eight years.

david.willman@washpost.com

Alice Crites and Dalton Bennett contributed to this report.

UN health agency settles in for long fight with virus .
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