New Therapy May be a COVID-19 Game Changer
Justice Department Approves Pharmaceutical Monopoly to Manufacture Anti-COVID Monoclonal Antibodies
The COVID-19 related collapse of the hospitals in Queens, New York is burnt into the minds of Americans. Who would be the next person chained to a ventilator? Shockingly, scores of physicians, nurses, EMTs, police, and fire, armed with courage and training, but short of equipment, died along with their patients. The randomness of outcomes made the terror of this viral Russian roulette worse.
Vaccines are the best long-term solution to COVID-19, but they will not be available soon, unless the FDA violates its own rules, which will destroy the faith in any vaccine. A vaccine turns a person into an antibody factory. Any exposure to the COVID-19 virus and we generate antibodies that attack the virus, reducing symptoms and improving the outcomes of COVID-19. Our immune system generates an early warning counterattack which will prevent serious infection.
We can also make antibodies in the lab. They don’t prevent infection. They don’t create long-term immunity to COVID-19. They cost many times more than a vaccine. But given at the right time in the infection, they can interrupt progression to hospitalization, intensive care, and death. They can reduce the randomness of outcomes such that coronavirus, while still unique, will no longer be the stuff of nightmares.
Monoclonal Antibodies are Established Therapy
Monoclonal antibodies have been in use since 1986 to prevent transplant rejections, cure cancers, and treat connective tissue diseases. 2018 marked the first use against a virus. This was not any infection, but the Ebola virus, which kills two-thirds of its victims. Thousands of West Africans had died in three epidemics since 2008. The epidemic subsided spontaneously before significant numbers of patients could be treated. The handful of patients who were treated were cured. They had no significant side effects. But the data set was too small to make any conclusions. However, in the world viral warfare, nothing had ever slowed, let alone defeated Ebola.
When asked if monoclonal antibodies like those used for Ebola, could have a significant role in COVID-19, Anthony Fauci, MD, could only say the Ebola treatments were “very encouraging.” (Interview NIH press release 8/4/20). Dr Fauci, never one for overstatement, had his laboratory at NIH working with Eli Lilly almost since the beginning of the pandemic, to identify human antibodies on which to model a monoclonal drug.
Would Convalescent Plasma Work as Well?
The FDA approved emergency use of convalescent plasma transfusions from recovered COVID-19 patients to patients who are still sick. Obtaining plasma from volunteers, screening it, transporting it, and infusing is time consuming, expensive, associated with adverse reactions. Fauci find its use problematic.
“The difference between monoclonal antibodies and convalescent plasma is plasma has a lot of other things in it, which could lead to allergic and other reactions,” Fauci said. Plasma requires an intravenous infusion, which requires a medical infrastructure not found in many developing countries. Most monoclonal antibody treatments can be administered by a simple injection.
The NIH/Eli Lilly team had recovered the human antibody they had been seeking. Should it work anywhere near as well as the antibody treatment for Ebola, they could change the trajectory of the sickest of the COVID-19 patients. They had their seed corn for antibody production, but it would require the entire pharmaceutical industry. The plan was to produce monoclonal antibodies thousands of times more concentrated than convalescent serum. Fauci’s conclusion on the proposed monoclonal antibody:
“Using an antibody generated by the immune system of a recovered COVID-19 patient gives us a jump start on finding a safe and effective therapeutic.”
The Justice Department Leads Where the CDC and FDA Should Have
Dr. Fauci restricts his observations, with the exception of his critique of his Opening Day pitch at National Stadium, to medical issues, so I can’t say who initiated the request to the Justice Department. However, the history of the supply chain and capacity dilemmas that plagued the CDC’s development of a COVID-19 test were widely known. The consequences include most of the 180,000 COVID-19 related deaths.
The Justice Department took the opportunity to try to avoid a similar outcome with the antibody program. They granted six of the largest monoclonal antibody pharmaceutical companies an anti-trust exemption to jointly scale up manufacturing, supply chains, and share scientific information. The exemption can be expanded when more companies apply. It is likely any antibody medication will contain a “cocktail” of antibodies from multiple companies to attack a COVID virus at multiple areas. A virus can mutate and alter the antibody specific binding site and thereby become resistant. The monoclonal “cocktail” anticipates just such an event.
In practice, among 100 patients with symptoms (Fever, cough, shortness of breath, etc.) and a positive COVID-19 test, after evaluation, approximately 15% will have indications for hospitalization/observation. Most will get better on their own. Those with a worsening course will get an injection of monoclonal antibody. Based on prior studies, their clinical course would improve in a few days as the antibody attacks the virus. Most would be discharged from the hospital, and ICU admissions and deaths could plummet. Exactly how many will improve is being evaluated in clinical trials that are already underway and may have results as soon as Q4 2020. A monoclonal antibody will not end the pandemic, but it should relieve some of our darkest fears.
Press Release: Thursday, July 23, 2020
Department of Justice Issues Business Review Letter to Monoclonal Antibody Manufacturers To Expedite And Increase The Production Of Covid-19 Mab Treatments