Military metaphors for US government initiatives are often misplaced, but in the case of the development of a vaccine for a global pandemic, use of that language in nationalism’s service is so morally and practically wrong as to defy any notion of rationality. Pandemics spread; they do not observe borders, and by definition they cry out for cooperation. Many countries in the world understand this, but the United States, which has distinguished itself for the sheer numbers of cases and deaths it has seen, intends to go it alone.
In the realm of vaccine development, where the number and diversity of approaches matter to the speed and accuracy of the outcome, as does sharing data in real time, the United States has taken the tack of least possible cooperation. It is not participating in global coalitions, and internally, the strategy is to pit pharmaceutical companies against one another in a competitive race where the prize is the profit to be made.
What’s Happened to Date
The US government has abjectly failed to protect the nation from the ravages of COVID-19, racking up over 5 million cases and more than 160,000 deaths. In excess of 1000 people are still dying each day, even six months into the crisis. Inadequate resources and carelessness around procedures have delayed testing and the receipt of testing results, left medical personnel without proper personal protective equipment (PPE), and allowed the virus to become so rampant that the economy remains in a coma and much of the country’s schools can’t reopen safely.
But there’s one place where the federal government has a strategy, however ill-conceived: vaccine development. With a $10 billion budget, Operation Warp Speed is funding biotech firms to research, develop, and manufacture millions of vaccine doses by year’s end—sooner, if possible. These firms are under a tremendous amount of pressure from political and market forces, raising concerns about whether vaccine candidates will be safe and affordable when they are ready for distribution.
Vaccine Development
According to the Guardian vaccine tracker, 140 candidates for a COVID vaccine are in various stages of research and development. Among these, six have begun Phase 3 clinical trials, where the vaccine is given to tens of thousands of people and rates of infection are compared over time to a control group that has received a placebo.
Among the top candidates being funded by the US government are those being developed by Moderna in partnership with the National Institute of Allergy and Infectious Disease (NIAID); AstraZeneca, in partnership with University of Oxford; and Pfizer, which is partnering with BioNTech. Billions of dollars have also gone to Sanofi and GlaxoSmithKline, Johnson and Johnson, and Novavax, all of which are still in earlier stages of development. Alex Azar, Secretary of Health and Human Services, has already indicated the price of these vaccines—assuming they are successful—will be determined by the pharmaceutical industry.
While funding these private, for-profit efforts, the US has refused to join the World Health Organization’s COVID-19 Vaccines Global Access Facility (COVAX), a nonprofit partnership intended to speed vaccine development and ensure equitable global distribution. WHO has gotten 70 nations to commit to contributing $18 billion to this effort, which would coordinate vaccine development and then distribution to ensure those most in need—for example, frontline healthcare workers—get access first.
The questionable morality of all this was revealed in the big hacking scare into which much of this country’s media fell head first, writes Joshua Cho of FAIR:
The New York Times’ report, “Russia Is Trying to Steal Virus Vaccine Data, Western Nations Say,” levied the accusations of US, British and Canadian governments that “the Kremlin” is “opening a new front in its spy battles with the West amid the worldwide competition to contain the pandemic.”
The Times story, by national security reporter Julian Barnes, takes it for granted that individual countries around the world are engaged in a ruthless struggle to gain geopolitical advantage by being the first to develop an effective vaccine. That ignores projects like the Inclusive Vaccine Alliance, formed by the German, French, Dutch and Italian governments to speed up development of a vaccine through joint research and investments…
But focusing too much on whether or not Russian and Chinese hackers actually did try to hack US coronavirus vaccine research would be missing the point. Corporate media reports accuse China of stealing “American” intellectual property, even though the vast majority of Americans don’t own any, and would likely benefit from China not respecting the intellectual property of corporations like Microsoft and Pfizer (FAIR.org, 5/23/18, 8/27/19). Why anyone should care more about the potential inability of US corporations to profit off a coronavirus vaccine—as opposed to getting an effective vaccine as soon as possible, no matter where the source is—is never explained in these reports.
Add inadequate outreach and deep distrust to the lack of cooperation, and you get a formula unlikely to yield desired results.
As they enter Phase 3 clinical trials, vaccine researchers are trying to answer multiple questions:
- Does the vaccine confer sufficient immunity to prevent contagion or to lessen the impact of disease?
- How long does immunity endure?
- Are there short-term or long-term side effects?
These questions can only be answered if the vaccine is tested across diverse populations and the results are tracked over a sufficient period of time to determine the outcomes. The political and market pressures to bring a vaccine to market by fall 2020 could easily compromise this process.
Among the biggest challenges vaccine researchers face is ensuring a diverse pool of participants in Phase 3 trials. A vaccine primarily tested among healthy, white, young populations tells us little about the effectiveness of the vaccine among people of color, older people, or people with chronic conditions. Researchers acknowledge, for example, that vaccines are often less effective for older people, who are most at risk for complications and death from COVID-19. Also, vaccines are known to be less effective among people who are obese, a chronic condition for about 40 percent of US adults.
According to Kaiser Health News, on average, Black people, who make up 13 percent of the population, and a wildly disproportionate number of those infected with COVID-19, comprise only five percent of participants in clinical trials. Only one percent of participants are Latinx, despite making up 18 percent of the population and being disproportionately at risk. Old people are often excluded from drug trials, making medication use particularly dangerous for them.
A history of unethical medical experimentation—such as the Tuskegee experiments in which African American men were not treated for syphilis despite penicillin being known to cure the disease—has made people of color rightfully distrustful of medical authorities. Combine that distrust with poor access to health care, information barriers, and racial bias—it’s no wonder that people of color are underrepresented in clinical trials, writes Carolyn Y. Johnson in the Washington Post.
To draw more diverse populations into clinical trials requires widespread community partnerships that often take years to develop. Jeanne Marrazzo, an infectious diseases physician at the University of Alabama at Birmingham, worries that the aggressive timelines could undermine diversity. “It’s much faster to take the path of least resistance and sign up the people who have access to health care and everything—they have cars, they can pay for parking,” Marrazzo tells the Post.
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The Food and Drug Administration (FDA), which regulates vaccines, “encourages” diverse trials but doesn’t require pharmaceutical companies to have any particular demographic mix to accept the results as valid. Thus far, worries that diversity will be sacrificed for speed seem to be realistic.
The Moderna trial, for example, is supposed to be enrolling 30,000 people in different US communities. It wasn’t until mid-July, when the firm was about to launch its Phase 3 trial, that Moderna sat down with the National Black Church Initiative (NBCI) to discuss how NBCI could partner to supply African American participants. According to NBCI president Rev. Anthony Evan, “It’s not that the industry came to me. I went to the industry.”
Moderna has also engaged partners such as Anthony Johnson, a community affairs specialist at the University of Illinois at Chicago, to recruit participants, but he too feels unprepared. He told the Post, “I don’t even have a script yet. It’s about education, and I don’t want to call people and say we have a study that’s upcoming soon and blah blah blah—I need to have a concrete plan.”
The community education that goes into finding trial participants is also key to educating communities about the safety and efficacy of a vaccine, so that once it is available, people are inclined to get vaccinated. Gary Puckrein, head of the National Minority Quality Forum, a nonprofit focused on healthcare disparities, told Politico, “The groundwork has not been laid to persuade minority populations that they need to accept those vaccines.”
Ignored by the healthcare system and subject to substandard care, people of color are skeptical when rich, white pharmaceutical executives and philanthropists suddenly tell them they must get vaccinated. COVID-19 has devastated their communities, laying bare the true impact of racial inequities in health care and throughout our society.
Roshon Green of Lawrenceville, Georgia, told Johnson from the Post, she doesn’t plan to be first in line for a new vaccine. A diversity educator for a health plan, she knows that the black community is denied adequate health care every day. She explained her decision, “Now, all of a sudden, you come up with the vaccination and it’s supposed to work, and work well, and you want to try it on us? You haven’t paid attention to us for years. You never care about us, and all of a sudden, you have a vaccination and you want to save us? No way.”
Roshon would like to see the rich and powerful try the vaccine first. “If there’s this great vaccination, something that can remotely help someone, and you’re secure in it, why are you seeking out the African American community?” she asks. “Why aren’t you getting more of the 1-percenters? Give it to Bill Gates. Give it to Donald Trump. Someone like me…every-day-trying-to-make-it people…will wait.”
Despite the obvious need, thus far, there is no national strategy for outreach and education to communities of color to ready these communities for a vaccine. Public health experts who spoke with Politico recommended strategies that have been used for HIV-treatment testing and education. These include:
- Ensure clinical trials are diverse.
- Engage communities of color in conversation to understand their attitude toward vaccines and address their concerns.
- Engage local groups with deep relationships in the community to deliver resources and information.
None of this has come together for COVID-19. “I feel already behind,” said Nancy Messonnier, head of the Center for Disease Control and Prevention (CDC) respiratory disease center, calling for “greater engagement with local organizations in at-risk communities.”
The CDC is beginning to conduct focus groups with at-risk communities and the National Academies of Sciences, Engineering and Medicine is developing plans for vaccine distribution, particularly in terms of reaching high-risk communities. But there is much more to do to ensure the vaccine is safe and effective for those who the health care system fails over and over again.
How Much Will It Cost?
If a safe and effective vaccine is developed this year, what will it cost? The pharmaceutical industry isn’t known for its generosity. In recent years, the cost of life-sustaining medications like insulin have become so inflated that people are dying from rationing their drugs. Pharmaceutical companies have begun to price medications not in terms of what it costs to develop and manufacture the drug, but what its “value” is for society. New medications for Hepatitis C, for example, cost $100,000 for 90 days—i.e., more than $1,000 per pill. Certainly less than the cost of a liver transplant, but extraordinarily expensive when considering that much of the research and development costs for medications is paid for by taxpayers, as is the case here.
To head off extraordinary pricing of vaccines and treatments for COVID-19, Democratic congressional representatives Jan Schakowsky (IL), Peter DeFazio (OR), Rosa DeLauro (CT), and Lloyd Doggett (TX), in mid-April laid out basic principles that should be adhered to by the pharmaceutical industry:
- Therapies and vaccines should be priced “reasonably.”
- Costs of research and manufacturing should be made public.
- Companies should not be able to profit exclusively from lifesaving drugs.
“Exclusivity determines who has access, who can manufacture, and how we scale up production to meet the need,” they wrote in a press release. “We cannot leave these decisions up to a single, profit-motivated private company.”
These principles were attacked in May by a group of conservative organizations, many of which receive funding from PhRMA, the pharmaceutical trade association. They called the proposed protections “dangerous, disruptive, and unacceptable.” The principles set forth by the Democratic legislators have yet to be codified into law, and neither Moderna nor Pfizer would commit to pricing their vaccines at cost, during a Congressional hearing in July.
Moderna has recently announced that it plans to set the price of its vaccine between $32 and $37 per dose. Pfizer announced $19.50 per dose. The Serum Institute in India, however, plans to manufacture and distribute 100 million doses of COVID-19 vaccine for $3 per dose.
To Americans, $37.50 may not sound expensive, but remember, US taxpayers have thus far financed Moderna’s entire vaccine program and, assuming yearly vaccines are needed, the firm is looking at annual revenues of $10 billion. Already, its executives and board members are making millions selling the high-flying stock, but “every-day-trying-to-make-it people” are likely to see insurance companies recouping their costs through higher premiums. Will the vaccine be free for those without insurance? Will the taxpayers pick up those costs as well?
The Democracy Collaborative proposes a publicly owned pharmaceutical industry, the purpose of which would be to develop lifesaving medication for all rather than maximizing shareholder profits. Decisions that put people first would make sure medications were developed to treat rare diseases and that all communities were engaged in the process of developing and distributing a something as vital as a vaccine that could stop a global pandemic. With all our eggs in the basket of Operation Warp Speed, it’s best to continue best public health practices: wear a mask and keep your social distance.
As we publish this article, Russia has declared to much skepticism that it has bested the US and the rest of the world in producing a vaccine it has named Sputnik V. We wish we were kidding.
