Throughout the COVID-19 pandemic, public health officials have focused their response into four main areas: 1) rapid and accurate testing: 2) contact tracing systems to monitor outbreaks; 3) prevention methods, such as vaccines and 4) effective treatments to aid recovery should a person become infected. For the last year and a half, biopharmaceutical companies have been working around the clock to help develop solutions, with emphasis on the latter two: the need for preventative vaccines and effective treatments.
Importantly, the best strategy to prevent infection against COVID-19 is to get vaccinated. Three vaccines are currently available for protection against COVID-19, one of which was recently approved by The U.S. Food and Drug Administration (FDA) for use in ages 16 and above. These vaccines are safe and effective and to date, more than 170 million Americans are fully vaccinated against the virus with billions of doses delivered globally. Additionally, new research suggests that for rare instances of breakthrough infections (where a person has been vaccinated against COVID-19), patients are significantly less likely to become hospitalized or to develop symptoms of long COVID-19.
Although the COVID-19 vaccines represent a historic success story, our industry is not done. As viruses are constantly changing, variants have emerged, bringing with them the need for additional research. Moreover, treatments that are effective in fighting infection across these variants – including antivirals and monoclonal antibodies – are a crucial tool to help aid recovery. By preventing the virus from replicating or clearing cells in which the virus has already entered, effective treatments can help slow the spread of a person’s infection, potentially reducing the length and severity of symptoms.
Treatments which target the SARS-CoV-2 virus generally fall into one of two categories:
- Monoclonal antibodies (mAb) are synthetic versions of the body’s antibodies produced in a laboratory and are designed to restore, mimic, inhibit or enhance immune system functions. They help by slowing the spread of the virus within the body, which is achieved by blocking the ability of the virus to enter cells. As of September 2021, three monoclonal antibodies have been authorized for emergency use by the FDA for the treatment of certain patients with COVID-19, and clinical trials continue for additional monoclonal antibody products.
- Antivirals are molecules specifically created to target the virus directly, disrupting or stopping its ability to replicate and spread. Thus far, the FDA has approved one antiviral for use in patients 12 years of age and older for the treatment of COVID-19, which has the ability to speed recovery time by up to 5 days. Hundreds of clinical trials are currently investigating antivirals for COVID-19, including more than a dozen newly developed antivirals specifically designed to target the SARS-CoV-2 virus.
Unlike bacteria, viruses cannot replicate on their own – they require a host, such as a human cell. Infection happens when a virus inserts its genetic code into the host cell, forcing it to replicate, which then spreads more viral material and usually leads to the death of the host cell. During a viral infection, this process can happen at enormous rates, which leads to harmful inflammation as the body’s immune system tries to seek out and destroy viral material.
Antivirals can directly block the ability of the virus to replicate, usually by inhibiting the specific proteins responsible for copying the virus’ genetic material. The virus’ ability to replicate is fundamental to how it spreads within the body and when that process is disrupted, the virus is stopped in its tracks, significantly reducing the length of infection.
Compared to monoclonal antibodies, which are modeled after natural antibodies found in patients who have been infected with the coronavirus, many antiviral treatments can require significantly more time to research and develop. In the earliest days of the pandemic, biopharmaceutical companies scrutinized research libraries of experimental medicines to identify potential antiviral treatments that may have already existed. Simultaneously, many companies began researching new compounds, building on prior knowledge around treatments for diseases like HIV, hepatitis C and Ebola.
As mentioned previously, the FDA has approved one antiviral treatment for some COVID-19 patients, which is delivered through infusion. Other potential treatments – including 10 treatments currently being investigated that can be taken orally early in during the course of infection, instead of through infusion, which may help reduce the burden on both patients and the health care system – have shown great promise in ongoing research.
Safe and effective antivirals are a crucial part of the pandemic response and our efforts to stem the tide against the virus’ impact. For these reasons, it’s imperative that we continue to support the R&D ecosystem that has allowed these treatments to be developed rapidly and safely. Research into antiviral treatments for COVID-19 was built on knowledge and experience fighting other infectious diseases. Recent news about one antiviral candidate is welcome news as we need all tools at our disposal to beat this virus. Undoubtedly, the progress made in our fight against the current pandemic will help lay the groundwork for future innovations as well.
Finally, while having treatment options available is crucial, vaccines continue to be the most powerful tool at our disposal to prevent infection in the first place. If you know someone who isn’t vaccinated, ask them if they have any questions or if you can help. Now is the time: do it for yourself and for your community.
To learn more, visit PhRMA.org/Coronavirus.
Richard Moscicki, M.D. Dr. Moscicki serves as executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA. He joined the organization in 2017 after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as the senior vice president and head of Clinical Development at Sanofi-Genzyme from 2011-2013.