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ORIn recent weeks, the United States has surpassed 100,000 cases of Covid-19 per day and has reached the incredible milestone of 10 million cases. This is sobering and humiliating at the same time.
While there has been encouraging news about advances in Covid-19 vaccine development, making sure Americans have confidence in these vaccines is critical to helping bend the infection curve and bring us back to some semblance of normalcy.
According to researchers writing in The Lancet, we will need the majority of Americans to have the confidence to get vaccinated for Covid-19 vaccines to be effective in moving the United States towards population-level control of viral spread. As Anthony Fauci noted, “If you have a vaccine that is highly effective and not enough people are vaccinated, you will not realize the full and important effect of having a vaccine.”
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Widely reported public opinion polls have suggested that a sizable portion of the public is in a waiting mode to get vaccinated against Covid-19. My colleagues and I in the biopharmaceutical industry, a science-based industry, recognize that one of our duties in the Covid-19 pandemic is to lift the veil on the processes 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 being sent to the Food and Drug Administration for regulatory review.
Information and transparency help reduce uncertainty and hesitation about vaccines. Here are three things the biopharmaceutical industry is doing to ensure the safety and integrity of Covid-19 vaccine development.
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Meet 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 no other way.
Vaccine candidates from Pfizer and Moderna have enrolled more than 40,000 and 30,000 participants, respectively, and AstraZeneca plans to enroll up to 60,000 participants globally in trials of its developing vaccine. Today, more than 30 unique vaccines are in clinical trials, many of them already in phase 3 studies with promising results. In addition, many of the candidate vaccines are currently in production in large numbers and at financial risk to the companies that develop them – before they have undergone FDA review – so if they get the green light they will be ready to ship as quickly as possible.
Researchers are closely monitoring the data, including any adverse event reports, during the clinical trial process to understand the safety profile of each vaccine. For all candidate vaccines deemed safe and effective that receive approval or authorization for emergency use by the FDA, the biopharmaceutical companies that develop them will continue to take steps to ensure product safety, including manufacturing controls that help ensure quality and ongoing surveillance and evaluation of adverse events.
Because vaccines are administered to healthy individuals, industry sponsors need to be confident in the safety and efficacy of any new vaccine based on data from large and rigorous clinical trials conducted across different populations before submitting their data to the FDA and other other national regulatory agencies around the world for review.
Provide transparency
The biopharmaceutical industry has been working at a fast pace to provide as much timely, accurate and transparent data as possible. Companies have taken unprecedented steps to share vaccine clinical trial protocols and study recruitment updates as close to real-time as possible. They share data with each other, as well as with public institutions and universities. Additionally, information on clinical trials conducted in the United States is readily available to the public at ClinicalTrials.gov.
The industry supports the FDA’s efforts to provide clarifying guidance, including recent guidelines on standards for authorizing emergency use of Covid-19 vaccines.
The FDA’s efforts to instill confidence in the safety of these potential vaccines have been noteworthy. It recently took steps to ensure a robust review process for candidate vaccines by involving the Advisory Committee on Vaccines and Related Biological Products (VRBPAC). This body provides independent review and guidance to support the FDA’s role in vaccine regulation for Americans. His first public meeting was broadcast on YouTube to be seen around the world. The FDA said additional VRBPAC meetings will be held to provide input and guidance for the FDA’s review of planned Covid-19 vaccine applications.
The industry I represent is committed to ensuring that the highest standards of research, clinical testing and manufacturing are met throughout the vaccine research and development process. To contextualize this and help instill greater confidence in these candidate vaccines, leading biopharmaceutical companies working on vaccines for Covid-19 have promised “to make the safety and well-being of vaccinated individuals the top priority in developing the first vaccines against. the covid19. ” This commitment to safety is not new: it is what the industry does day after day.
Promote diversity
The industry is also working to address the systemic challenges and skepticism that have traditionally prevented people of color from participating in clinical trials due to historical wrongs committed to them.
Clinical trials can give people access to potentially life-saving drugs and high-quality care. Improving the diversity of people participating in clinical trials will lead to evidence that better reflects patients who will use approved vaccines.
To begin, the industry is working with the FDA, patient advocacy organizations, healthcare providers and other stakeholders in the research ecosystem to collaborate and employ strategies to encourage greater participation in all clinical trials, with particular attention to Covid-19 studies. PhRMA, the organization I lead, recently published the first ever industry-wide principles on the diversity of clinical trials, which represent an important step towards greater equity in health.
These efforts are working. Moderna’s vaccine trial clinical trial “includes more than 11,000 participants from communities of color, representing 37 percent of the study population, which is similar to the diversity of the United States in general.” Pfizer also expanded its clinical trial from an initial population of 30,000 to more than 40,000 to increase participant diversity.
Looking at the future
Biopharmaceutical companies are working tirelessly to identify and develop safe and effective vaccines to prevent Covid-19 and research and develop new therapies to treat the sick. Given the urgent need to address the pandemic, coupled 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 likelihood that one or more vaccines and candidate drugs will make it successful.
At the same time, companies are continuing their work on treatments for heart disease, cancer and many other diseases.
In the fight against 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 are not out of the woods yet, but I am confident that science can bring us back to normal.
Stephen J. Ubl is the president and CEO of PhRMA, a trade association representing US biopharmaceutical companies.
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