A medical facility in Clayton, North Carolina, could be crucial to the development of a treatment for COVID-19.
Grifols, S.A., a multinational pharmaceutical and chemical manufacturer based in Barcelona, Spain, is collaborating with the U.S. Food and Drug Administration, U.S. Biomedical Advanced Research Development Authority and other federal health agencies on a development process for a COVID-19 treatment therapy in the company's Clayton facility. Grifols originally constructed the facility in 2014 to combat the outbreak of Ebola in West Africa.
Plasma fractionation, the process of separating various components of blood plasma, is the central component of the treatment, which is being studied in centers across the U.S. The Grifols-government partnership hopes to use antibodies extracted from the blood plasma of recovered COVID-19 patients to create a sterile solution known as immune globulin. This solution would then be given as a treatment to people diagnosed with the virus, if proven effective.
The exploration of this treatment will help preclinical and clinical studies determine whether the use of immune globulin can live up to its promise as a viable treatment option for COVID-19. With the opening of a new fractionation plant next year, Grifols in Clayton will be the world’s largest fractionation site, chief innovation officer David Bell said in an email to The Daily Tar Heel.
Grifols, which focuses predominantly on plasma-based medicines, is already a leading producer of these products worldwide. With more than 250 collection centers, Grifols runs the largest plasma donor center network in the United States, Bell said in the email.
Bell said the federal government will help identify consenting donors and refer them to Grifols. As of Monday, the company announced it has officially begun the process of identifying, screening and selecting such donors from a handful of cities that had a high number of COVID-19 cases earlier in the outbreak, including Chicago, Dallas, Los Angeles and Seattle.
The use of convalescent plasma to create immune globulin was also attempted during the outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 pandemic and the 2012 MERS-CoV epidemic.
Most notably, the hepatitis B immune globulin, HBIg, proved successful in providing immediate, short-term protection against the hepatitis B infection. The immune globulin does not have the power to fully prevent hepatitis B, however — that power remains with the vaccine.
Immunoglobulin therapy, while successful in fighting symptoms after infection, is not a preventative measure like vaccination.
This distinction becomes increasingly important when trying to determine treatment prices.
Stacie Dusetzina, an associate professor of health policy and cancer research at the Vanderbilt University School of Medicine, said new treatments such as the one being developed by Grifols generally face no limit on what prices could be set by drug makers.
“For COVID-19, there are a lot of partnerships between companies and the government to try to rapidly advance drug development, but that doesn’t necessarily mean that prices will account for those investments,” she said. “If drugmakers are allowed to set the price at what the market will bear, then it’s possible the price could be very high.”
Depending on how the development process plays out, Dusetzina said she expects most people will have access to a vaccine through their insurance without any out-of-pocket costs.
“I’d also expect the government to invest in getting uninsured individuals vaccinated,” she said. “They’re doing something similar now by paying hospitals to treat uninsured individuals through part of the recent stimulus bill.”
As part of the Affordable Care Act, vaccines are considered preventive services, Dusetzina said. That means they’re offered to people with private health insurance at no cost. The same applies to people on Medicare, Dusetzina said.
Although the government may help make a COVID-19 vaccine more affordable once it’s been created, immunoglobulin therapy doesn’t necessarily face the same fate.
“I don’t think that the IG therapy will be covered in the same way as the vaccine,” Dusetzina said. “The administration has indicated that treatment will be covered, but whether that is true after the first wave of the pandemic isn’t clear. I think it will be hard to say no to prices that companies set in this market.”
And since a treatment doesn’t do people much good if they can’t afford it, Dusetzina predicts much of the spending will be done by the government and private plans.
Affordability is especially important for people who may be incapable of getting the vaccine. Immunocompromised individuals and people who are allergic to certain components of the vaccine could be left with no other option than to pursue the potentially-expensive immune globulin treatment.
Britt Peterson, an adjunct assistant professor with the UNC School of Medicine, said the financial burden of these treatments will only increase mental health issues in what is already a stressful time.
“Everybody’s in survival mode,” he said. “And I think we’ll have to see how long that lasts before, you know, some of the mental health consequences, in particular, catch up to us.”
In the meantime, Peterson said he hopes the spirit of everybody recognizing that it’s okay to not be okay will continue.
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