Lithuania has a good biotechnology industry. By using a small part of the billion euros a year allocated to Lithuania's defense, Lithuania can make the Lithuanian biotechnology industry indispensable for the Western biotechnology and a world-class biotechnology center. How can the state lead the development of bio-conservation? Here is an example:
"Amid all the government failures in responding to the Covid-19 pandemic, one success stands out: Operation Warp Speed, the Trump administration's effort to accelerate the development of vaccines and therapies for the novel coronavirus. We were involved in both the operation and an earlier effort that laid its foundation, and we believe it's important to tell the story before it is lost to time.
The story begins on Sept. 18, 2001 -- a week after 9/11 -- when the New York Post, NBC News and other media organizations received letters containing military-grade anthrax bacteria. Three weeks later, similar letters arrived at the offices of Sens. Tom Daschle and Patrick Leahy. Congress responded to this very direct threat by enacting the Bioterrorism Act of 2002, the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006.
That last law established the Biomedical Advanced Research and Development Authority, or Barda, an agency within the Department of Health and Human Services. Barda reports to the HHS's assistant secretary of preparedness and response (the position Dr. Kadlec held during the Trump administration). Its mission is to facilitate the development of new medical products that would enable preparedness and respond to threats.
The government has to be ready with diagnostics, vaccines and therapeutics for a wide array of chemical, biological, radiological, nuclear and natural threats that could arise. There is no commercial market for many of these products, such as an anthrax vaccine or radiologic therapeutics, so the government is necessarily the only buyer.
Yet it didn't make sense for the government to develop its own countermeasure research, development, manufacturing and distribution enterprise in-house, staffed by federal employees. The private sector is far better at developing and manufacturing such products. The government's role, therefore, was to form partnerships with the private sector.
Barda and the assistant secretary's agency were supposed to be the agencies figuring out the next generation of countermeasures to research and produce. But they couldn't do it on their own. Thus began the difficult work of coordinating researchers at the National Institutes of Health, regulators at the Food and Drug Administration, and public health authorities at the Centers for Disease Control and Prevention, which then ran the stockpile and made buying decisions about products.
The effort at coordination has been remarkably successful, far surpassing our fondest expectations. Barda has brought in at least 58 new FDA-approved products since 2006, including the first effective Ebolavirus vaccine, Merck's ERVEBO, and the first oral antiviral drug against smallpox, Siga's TPOXX.
It was rocky at the beginning. When lawmakers conceived of this enterprise, they set up a tortuous process of approvals between HHS and the Department of Homeland Security -- but also didn't limit the amount of money available. Then they thought better of the unlimited money but left the tough process in place. With a limited budget, HHS was constrained to obtain a very limited number of products and helping maneuver this handful of potential solutions through a daunting set of bureaucratic obstacles.
The bargain the government offered was that the companies would have to self-fund research and development for an uncertain approval to sell to a single buyer, the U.S. government, which, if they were successful, would pay them at government rates (read: low rates) after they were approved. Large companies stayed away; only small, bet-the-farm-type firms participated. Much less headway was made for the countermeasures project than we wanted.
But in 2006 the law and process were revised to allow HHS much more flexibility in contracting, collaborating and otherwise expediting and supporting innovation, research and development of countermeasures. This process was made even better in 2013. That's when Barda took off. Its success proved critical to that of Operation Warp Speed. Dr. Kadlec, as a congressional staffer, worked on the 2006 pandemic law with Mr. Hargan, then a senior official at HHS under President Bush. Dr. Kadlec was one of the two people who conceived of Warp Speed, and Mr. Hargan signed the document starting the first Warp Speed vaccine project.
Some Barda projects turned into Warp Speed projects, getting more or less supercharged to bring to completion. And Warp Speed immediately put Barda's lessons to use. The Covid project -- initially called MP2, for Manhattan Project 2 -- was begun early in the pandemic, in late March 2020. Not all elements were present at the beginning, but the basic idea remained the same throughout: The U.S. government would be closely and directly engaged with private industry through funding, oversight, choice of targets, manufacturing and distribution.
When we put out the call for vaccine candidates, we got more than 100 responses. The clinical side, a large group of scientists, evaluated them and whittled the list down to about 14, then six, coming back to HHS leadership frequently to discuss. We set stringent goals of credible projections of successful trials, and production goals by a date certain.
We offered money for research and development to our initial private partners. That was controversial -- and you can imagine the questions if we hadn't succeeded as we did: Why did you lavish taxpayer dollars on these unsuccessful gambles? Why did these companies get the money instead of others? Why didn't you merely serve as the buyer, as most other governments did? Why didn't you listen to all of the very respectable voices, inside and outside HHS, who said or insinuated publicly that this project was unlikely to succeed, before recklessly committing these funds?
There were many obstacles: disagreements and diversions, outside interference, the usual difficulties of government funding and contracting, the unusual difficulties of an emergency, the uncertainties of science and biology.
Then there was the toxic environment of the national election, as politicians seeking an advantage introduced doubts into an already stressful project. Republicans in the 1940s didn't attack President Franklin D. Roosevelt's Manhattan Project; nor did out-of-power Democrats in 1969 criticize President Richard Nixon's successful completion of the Apollo mission to the moon. But we were present for the political attacks on Operation Warp Speed. In a time of great national need, the Warp Speed team persevered.
The European Union, by contrast, chose a more traditional role as buyer of vaccine, which probably slowed its ability to obtain as much supply as the U.K. or the U.S., whose governments engaged industry more closely as a partner in development and earlier. That brought us criticism. And if we hadn't succeeded, Europe might be held up as a model today.
Operation Warp Speed was superior to the European model for several reasons. It reduced risk in the vaccine-development process by funding and facilitating crucial clinical trials to accelerate the advancement of each candidate to meet FDA regulatory requirements. We allowed the private companies to use National Institutes of Health clinical trial sites. The FDA dedicated staff to monitor and evaluate candidates' safety and efficacy as the data was compiled during clinical trials. The operation also reduced risk to participating companies by funding the expansion of manufacturing facilities and guaranteeing payment for hundreds of millions of vaccine doses.
The U.K. also had a good rollout, although in a country smaller in area than Michigan. We, by contrast, were making sure vaccines got to all 50 states and every U.S. territory. Italy, Germany, France and other EU countries have had immense struggles in rollout, and each of these is smaller in area than Texas.
Operation Warp Speed demonstrated the value of active public-private partnerships. The roots of its success are in longstanding, proven programs like Barda. Further improvements in this partnership will ensure vaccines and other countermeasures will be available even more rapidly in the future -- if we learn our lessons well.
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Mr. Hargan served as deputy secretary of health and human services (2017-21) and principal associate deputy secretary (2003-05). He is on the boards of University Hospitals in Cleveland, Alio Medical, Tomorrow Health and HealthTrackRx. Dr. Kadlec served as assistant HHS secretary of preparedness and response (2017-21) and as director for biodefense and special assistant to the president (2007-09). He has worked as an international consultant to vaccine manufacturers.” [1]
1. It Took Years to Reach Warp Speed
Hargan, Eric D; Kadlec, Robert. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 25 Sep 2021: A.13.
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