Since the start of the pandemic, America’s biopharmaceutical companies have worked around the clock to research, develop and manufacture treatments and vaccines to fight COVID-19. Already, we’ve made unprecedented progress; three vaccines are currently available for protection against COVID-19 in the U.S, one of which was recently approved by the U.S. Food and Drug Administration (FDA) for use in certain populations.
On the recent approval, acting FDA Commissioner Janet Woodcock, M.D., noted, “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”
The COVID-19 vaccines are safe, and to date, over 370 million doses have been administered in the U.S. alone, and billions around the world. As of today, one antiviral is also currently approved by the FDA 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. Monoclonal antibodies are helping patients stay out of the hospital and recover as well.
Globally, vaccine manufacturers are also estimated to produce more than 11 billion doses of COVID-19 vaccines by the end of 2021 and have already delivered more than 5 billion doses around the globe.
But as an industry committed to science, our work is not over. As viruses are constantly changing, variants have emerged, bringing with them the need for additional research and genomic surveillance. Companies are continuing to pursue research around the duration of vaccine efficacy as the need for boosters is currently being explored. Some COVID-19 infections have also led to what is being commonly referred to as long-term COVID, defined by the CDC as a wide range of persistent symptoms that can last weeks or months after first being diagnosed with COVID-19, even if the illness was mild or asymptomatic.
Biopharmaceutical companies remain committed to addressing these and other challenges by:
Continuing to research and develop vaccines: Already, two mRNA vaccines and one viral vector vaccine have been authorized for emergency use by the FDA and are being administered globally, along with others. On Monday, August 23, the FDA approved one of the mRNA vaccines for adults 16 years of age and above, which had previously been authorized for emergency use.
Further safety and efficacy testing is ongoing for patients younger than 12. At the same time, biopharmaceutical research companies are continuing to develop different scientific approaches to vaccines, such as protein or DNA-based vaccines, as well as modifications to the storage and distribution mechanisms of existing vaccines that may help further global access. Companies are also investigating whether adjustments or boosters are needed to guard against emerging variants, which may have different characteristics.
Further investigating potential treatments: Although safe and effective vaccines remain the best defense against COVID-19, treatments such as monoclonal antibodies or antivirals can help support patients who become infected. Monoclonal antibodies are a type of biologic medicine that play a central role in advancing our ability to treat a range of diseases, including cancer and autoimmune conditions.
Monoclonal antibodies are synthetic versions of the body’s antibodies produced in a laboratory and are designed to restore, mimic, inhibit or enhance immune system functions. By building on vast stores of knowledge and information about how these treatments interact with the immune system and can be used to counteract disease, America’s biopharmaceutical researchers have been able to rapidly research and develop monoclonal antibodies that are targeted treatments against the novel coronavirus that causes COVID-19. Hundreds of unique therapeutics are still under investigation for COVID-19 and COVID-19-related complications, such as pneumonia. Lastly, researchers are investigating the underlying causes of long COVID conditions to learn more about short- and long-term health effects after the virus is no longer detected in patients, including who is most susceptible to developing long COVID and how these conditions might be treated.
Forging a global network of partnerships to expand equal access to vaccines: Armed with experience garnered from previous outbreaks and decades of knowledge about infectious diseases, America’s biopharmaceutical companies have been working with one goal in mind, and that is to fight COVID-19. Companies are leading by collaborating with each other and key health stakeholders on efforts to address the global health crisis through developing diagnostics, treatments and vaccines and by scaling up manufacturing and addressing access issues.
However, meeting the capacity need is far beyond the reach of any one group or company, and despite significant cross-sector and multi-stakeholder efforts such as COVAX, a coalition of governments, global health organizations, manufacturers, scientists, the private sector, civil society and philanthropy, we are still seeing vaccine access and distribution challenges across many regions of the world due to trade barriers and a lack of local infrastructure, among other hurdles. Biopharmaceutical companies are working with governments to call out harmful trade and regulatory barriers, as well as address last-mile challenges. This includes supporting partnerships that allow for dose sharing among low- and middle-income countries and countries that have a larger supply of vaccines than needed.
Since the start of the pandemic, America’s biopharmaceutical companies have focused on saving lives. At the same time, the incredible progress we’ve made in fighting COVID-19 would not have been possible without the rich history of policies that encourage innovation, protect novel ideas, enable critical partnerships and incentivize continued progress against deadly diseases.
These policies have helped the United States play a leading role in not only the development of treatments and vaccines to help fight COVID-19, but also in medicines that address a wide range of conditions, from cancer to rare diseases. As conversations continue to evolve around how the health care system can better help patients, it is important that we continue to pursue a policy framework that supports the fight against COVID-19 and allows for further innovation to benefit patients, both today and long into the future.
Learn more at PhRMA.org/Coronavirus
Topics: Research and Development, Vaccines, Coronavirus