Source : 'The Pink Sheet'
The US government has invested about four and a half times as much money in the development and manufacturing of potential COVID-19 vaccines to prevent the disease as it has on therapeutics to treat the coronavirus, and experts say President-elect Joe Biden’s team should work to close this gap, though few recommend spending on treatments at the same level as vaccines.
The Biomedical Advanced Research and Development Authority has provided more than $12.6bn to vaccines, more than $2.77bn to therapeutics and $308m to diagnostics as of 4 November, the Health and Human Services Department told the Pink Sheet. (Story continues after chart.)
HHS told the Pink Sheet that the BARDA numbers account for the total Operation Warp Speed investment in vaccines and therapeutics thus far.
HHS and the US Office of Management and Budget did not respond to requests for whether there was other significant government spending on these areas not coming from BARDA, but outside experts said they were not aware of any other US government organization putting nearly this level of money into the COVID-19 effort and believed the emphasis towards more spending on vaccines would hold even if some additional money was being allocated towards therapeutics outside of BARDA. For example, the Defense Advanced Research Projects Agency said it is using $93m in addition to some previous investments to work on therapeutics for COVID-19, but it is not working on vaccine efforts. That small sum of money towards therapeutics does little to make up the overall gap.
Health policy and economics experts said that while there are good reasons the governments might need to put more money towards vaccines, additional money should be going towards therapeutics. Some said significantly more taxpayer money needs to be going towards both categories of spending. Even with the promising vaccination news from the past few weeks (see sidebar), most places are a year or more away from mass scale vaccination and even then, there will likely be a continued need for COVID-19 treatments.
“I would like to see a more balanced approach from BARDA,” said Craig Garthwaite of Northwestern’s Kellogg School of Management. “I don't think that is equality in spending, because these are different products that need different incentives. But I do think we have paid less attention to therapeutics compared to vaccines.”
Vaccines require more government funding because ideally nearly the entire population will receive the vaccine, whereas only sick people and sometimes only even a subset of those who get sick will need to receive COVID-19 therapeutics, Garthwaite said. There’s also a significantly larger manufacturing and distribution investment that must go into the vaccines.
Indeed, “one of the major differences between the funds obligated to date for therapeutics and vaccines is that HHS is working with companies to manufacture hundreds of thousands of doses of therapeutics and hundreds of millions of vaccines,” an HHS spokesperson said.
People who are sick are typically willing to take and pay for treatments, Garthwaite added, but vaccinating healthier people is more challenging. Because of the growing vaccine hesitancy trends in the US population there is more of a need for the government to assure companies a market exists for a vaccine, he said.
Furthermore, part of the reason for a heavier government investment in vaccines is also because that gives the government control over distribution in a way they don’t necessarily want or need for therapeutics, he added.
Still, Garthwaite said more attention could have been put towards treatments, particularly manufacturing of monoclonal antibodies. The country’s 300,000 dose supply of Lilly’s bamlanivimab is tiny given that it’s for people with mild disease and the US has been recording about 100,000 to 150,000 virus cases each day recently. ()
Biotechnology Innovation Organization’s Phyllis Arthur said the government needs to take a more diverse approach to developing therapeutics.
“There was not as much government investment early on in the pandemic in trying multiple approaches to either attack the virus, or treat the more serious symptoms,” in the same way the government invested in multiple types of vaccine platforms, she said, saying the government seemed to focus on just testing one mechanism of action for therapeutics at a time.
“There’s no question when you're in the middle of an outbreak, or a pandemic, that’s the time you try multiple different approaches to see what happens, especially in a disease that you're still trying to understand,” said Arthur, BIO’s vice president of infectious diseases and diagnostic policy.
But Dan Mendelson, an advisor at Avalere Health and a operating partner at private equity firm Welsh Carson, argues that at least for small molecule drugs, companies don’t need the same government push to get into the space as they do for vaccines, noting their scale up and manufacturing is much easier.
Many of the drugs being looked at for COVID-19 are also repurposed products so a lot of the initial development work has been de-risked whereas vaccines are starting from scratch, he added.
Mendelson argues that most therapeutics will have other uses besides COVID-19 and will offer “a very strong economic return.” He says its hard for him to imagine there would have more activity in the therapeutics space if the government had thrown more money to that area.
Rena Conti of Boston University, however, argued there is a role for more government involvement in the therapeutic space, both in terms of funding and management of resources.
For starters, she said the typical market demand doesn’t always exist in a pandemic situation, because governments are intervening in ways that aren’t letting companies charge normal monopoly prices for COVID-19 treatments. And some potential COVID-19 treatments are off-patent molecules where there is little industry incentive to invest in trials or increased manufacturing needs.
There have been shortages of older generic drugs during this crisis as news indicated they might be useful for the virus. ()
Plus, Conti said more government investment in therapeutics would allow it to take on an “air traffic control,” type role that could level the playing field between companies that have private interests and the public interests. For example, one of the scarcest resources right now is the limited number of patients that can participate in trials, and she said she has heard stories about hospitals being encouraged to enroll patients in certain COVID-19 trials based on high fees from drug developers at the expense of other trials. This could lead to a focus on products that are on-patent or likely to be the most profitable instead of necessarily the best products scientifically, Conti said.
The US could better test a range of therapeutics and put all therapeutics on more of an equal playing field if it invested in the type of master protocol trials being embraced by Europe, she added.()
There’s also a more bang for your buck argument with therapeutics.
“A small amount of resources would go a long way in terms of a phase two or three trials for a couple of products to see if they worked. There were opportunities to try more things,” BIO’s Arthur said.
Conti said that equity concerns with regard to the developing world, including lessons from HIV, motivated funders like the Gates Foundation to focus solely on vaccines for COVID-19 and helped shaped how the US government has operated, but “all else equal vaccines are way more expensive and way more risky than therapeutic areas.”
Anti-infectives investment portfolios more generally tend have more of a 20-80 split or 30-70 split measured by product type, where 30 percent of money is put in preventatives versus 70 percent to therapeutics, she said.
Some health economists suggested more taxpayer money should be spent in each of the categories: vaccines, therapeutics and diagnostics.
“We are spending far too little fighting the virus on any front – vaccines, testing or therapeutics,” said Alex Tabarrok of George Mason University. “The pandemic is costing the US economy $16 trillion in lost GDP and lives. The paltry $13 billion that we have spent on Operation Warp Speed has been money very well spent as illustrated by the tremendous jump in the stock market when Pfizer announced interim results proving that their vaccine is highly efficacious.”
“Fighting the pandemic is the world’s easiest cost benefit test,” Tabbarok added, saying Nobel Prize winning economists Paul Romer and Michael Kramer have argued it would be worth spending upwards of a $100 billion on testing and a similar amount on vaccines to end the crisis more quickly.
By Sarah Karlin-Smith