Over the last few weeks, the United States has surpassed 100,000 Covid-19 cases a day and reached the staggering milestone of 10 million cases. This is both sobering and humbling.
While there has been encouraging news about progress in the development of Covid-19 vaccines, making sure that Americans have confidence in these vaccines is crucial to helping bend the curve of infections and getting us back to some semblance of normalcy.
According to researchers writing in The Lancet, we will need a majority of Americans to have the confidence to get vaccinated for Covid-19 vaccines to be effective in moving the U.S. toward population-level control of viral spread. As Anthony Fauci has noted, “If you have a vaccine that is highly effective and not enough people get vaccinated, you’re not going to realize the full, important effect of having a vaccine.”
Widely reported public opinion polls have suggested that a sizable portion of the public is in a wait-and-see mode for getting vaccinated against Covid-19. My colleagues and I in the biopharmaceutical industry, an industry built on science, recognize that one of our duties in the Covid-19 pandemic is to lift the veil on the processes that companies are using to research and develop Covid-19 vaccines. This includes testing every potential vaccine candidate among tens of thousands of people from all walks of life before they are sent to the Food and Drug Administration for regulatory review.
Information and transparency help reduce uncertainty and vaccine hesitancy. Here are three things the biopharmaceutical industry is doing to ensure the safety and integrity of Covid-19 vaccine development.
Meeting the highest standards
Covid-19 vaccine candidates must meet the same standards for clinical trials as other vaccines, including testing in very large Phase 3 clinical trials. We would have it no other way.
Vaccine candidates from Pfizer and Moderna have enrolled more than 40,000 and 30,000 participants, respectively, and AstraZeneca expects to enroll up to 60,000 participants globally in trials of its vaccine in development. Today, more than 30 unique vaccines are in clinical trials, with several of them already in Phase 3 trials with promising results. What’s more, many of the vaccine candidates are currently being manufactured in large numbers and at financial risk to the companies developing them — before they have been submitted to the FDA for review — so if they are given the green light they will be ready to ship as quickly as possible.
Researchers are closely monitoring data, including any reports of adverse events, throughout the clinical trial process to understand the safety profile of each vaccine. For any vaccine candidates found to be safe and effective that receive either approval or emergency use ization from the FDA, the biopharmaceutical companies developing them will continue to take steps to help ensure product safety, including manufacturing controls that help ensure quality and ongoing surveillance and assessment of adverse events.
Because vaccines are given to healthy individuals, industry sponsors must be confident in the safety and effectiveness of any new vaccine based on data from large, rigorous clinical trials conducted among diverse populations before submitting their data to FDA and other national regulatory agencies around the globe for review.
The biopharmaceutical industry has been working at a furious pace to provide as much timely, accurate, and transparent data as possible. Companies have taken unprecedented steps to share vaccine clinical trial protocols and trial recruiting updates in as close to real time as possible. They are sharing data with each other, as well as with public institutions and academia. And information on clinical trials being conducted in the U.S. is also readily available to the public on ClinicalTrials.gov.
The industry supports efforts by the FDA to provide clarifying guidance, including recent guidelines about the standards for emergency use ization of Covid-19 vaccines.
The FDA’s efforts to instill confidence in the safety of these potential vaccines has been noteworthy. It recently took steps to ensure a robust review process for candidate vaccines by engaging the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This body provides independent review and guidance to support the FDA’s role in regulating vaccines for Americans. Its first public meeting was broadcast on YouTube for the world to see. The FDA has said that additional VRBPAC meetings will be held to provide input and guidance for FDA review of anticipated Covid-19 vaccine applications.
The industry I represent is committed to ensuring that the highest of standards of research, clinical testing, and manufacturing are upheld throughout the vaccine research and development process. To put this in context and to help instill greater confidence in these candidate vaccines, the leading biopharmaceutical companies working on vaccines for Covid-19 issued a pledge “to make the safety and well-being of vaccinated individuals the top priority in development of the first Covid-19 vaccines.” This commitment to safety isn’t new — it’s what the industry does day in and day out.
The industry is also working to address the systemic challenges and skepticism that have traditionally kept people of color from participating in clinical trials because of historic wrongs done to them.
Clinical trials can give people access to potentially lifesaving medicines and high-quality care. Improving the diversity of people participating in clinical trials will lead to evidence that better reflects the patients who will use approved vaccines.
To start, the industry is working with the FDA, patient advocacy organizations, medical providers, and other stakeholders across the research ecosystem to collaborate and employ strategies to encourage greater participation in all clinical trials, with a focus on Covid-19 trials. PhRMA, the organization I lead, recently released the first-ever industry-wide principles on clinical trial diversity, which represent an important step toward greater health equity.
These efforts are working. The clinical trial for Moderna’s vaccine trial “includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large.” Pfizer also expanded its clinical trial from an initial population of 30,000 to more than 40,000 to increase the diversity of participants.
Looking to the future
Biopharmaceutical companies are working tirelessly to identify and develop safe and effective vaccines to prevent Covid-19 and researching and developing new therapies to treat those with the disease. Given the urgent need to address the pandemic, along with the complexity of the human immune system and how it responds to this disease, a wide range of approaches are being tested in an effort to improve the odds that one or more vaccine and drug candidates will be successful.
At the same time, companies are continuing their work on treatments for heart disease and cancer and so many other diseases.
In fighting Covid-19, putting safety first, being open and transparent, and working to ensure diverse representation in clinical trials is a model for the future of biopharmaceutical innovation that I hope all companies continue to embrace.
We aren’t out of the woods yet, but I’m confident science can get us back to normal.
Stephen J. Ubl is the president and CEO of PhRMA, a trade association representing U.S. biopharmaceutical companies.