Biopharmaceutical industry strives to build confidence in Covid-19 vaccines



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OIn recent weeks, the United States has passed 100,000 cases of Covid-19 per day and hit a staggering 10 million cases. It is both disappointing and humiliating.

While there has been encouraging news regarding progress in the development of Covid-19 vaccines, it is essential to ensure that Americans have confidence in these vaccines to help bend the infection curve and bring us back to a semblance of normality.

According to researchers writing in The Lancet, we will need a majority of Americans to have the confidence to get vaccinated against Covid-19 vaccines to be effective in moving the United States forward towards control at the level of the population of viral spread. As Anthony Fauci noted, “If you have a very effective vaccine and too few people get vaccinated, you will not fully realize the important effect of having a vaccine.”

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Widely reported opinion polls have suggested that a significant portion of the public is waiting to be 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 that companies use to research and develop Covid-19 vaccines. This includes testing each 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 reluctance to immunize. Here are three steps taken by the biopharmaceutical industry to ensure the safety and integrity of the development of the Covid-19 vaccine.

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Meet the highest standards

Covid-19 vaccine candidates must meet the same clinical trial standards as other vaccines, including testing in very large phase III clinical trials. We wouldn’t have it any other way.

Pfizer and Moderna’s vaccine candidates have enrolled more than 40,000 and 30,000 participants, respectively, and AstraZeneca plans to enroll up to 60,000 participants worldwide in trials of its vaccine under development. Today, more than 30 unique vaccines are in clinical trials, several of them already in phase 3 with promising results. Additionally, many candidate vaccines are currently being manufactured in large numbers and pose a financial risk to the companies developing them – before they are submitted to the FDA for review – so if they are given the green light, they will be ready. to be shipped. as quickly as possible.

Researchers closely monitor data, including adverse event reports, throughout the clinical trial process to understand the safety profile of each vaccine. For all vaccine candidates determined to be safe and effective that receive FDA approval or emergency use clearance, the biopharmaceutical companies that develop them will continue to take steps to help ensure product safety, including manufacturing controls that help ensure quality and ongoing monitoring and evaluation. adverse events.

Since vaccines are administered to healthy individuals, industry sponsors must have confidence in the safety and efficacy of any new vaccine based on data from large and rigorous clinical trials conducted with populations before submitting their data to the FDA and other national regulatory agencies around the world for review.

Ensure transparency

The biopharmaceutical industry is working at a breakneck 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 recruitment updates as close to real time as possible. They share data with each other, as well as with public institutions and universities. And information on clinical trials conducted in the United States is also readily available to the public at ClinicalTrials.gov.

The industry is supporting the FDA’s efforts to provide clarifying advice, including recent guidance on standards for emergency use authorization for Covid-19 vaccines.

The FDA’s efforts to instill confidence in the safety of these potential vaccines have been remarkable. He recently took steps to ensure a rigorous review process for vaccine candidates by engaging the Advisory Committee on Vaccines and Related Biologics (VRBPAC). This body provides independent review and advice to support the role of the FDA in regulating vaccines for Americans. Its first public meeting was broadcast on YouTube for the world to see. The FDA said additional VRBPAC meetings will be held to provide information and advice for the FDA’s review of planned applications of the Covid-19 vaccine.

The industry I represent is committed to ensuring that the highest standards in research, clinical trials, and manufacturing are met throughout the vaccine research and development process. To put this in context and help instill greater confidence in these vaccine candidates, leading biopharmaceutical companies working on Covid-19 vaccines have pledged to “make the safety and well-being of those vaccinated the top priority in development of the first Covid vaccine19. ”This commitment to safety is not new – it is what the industry is doing day in and day out.

Advancing 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 because of the historic harms they have been caused.

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 with, the industry is working with the FDA, patient advocacy organizations, healthcare providers, and other stakeholders in the research ecosystem to collaborate and use strategies to encourage greater participation in all clinical trials, with an emphasis on Covid-19 trials. PhRMA, the organization I lead, recently released Industry First Principles on Diversity in Clinical Trials, which represent an important step towards greater equity in health.

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 United States as a whole . ” Pfizer has also expanded its clinical trial from an initial population of 30,000 to over 40,000 to increase participant diversity.

Looking to 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 people with the disease. Given the urgent need to deal with the pandemic, as well as the complexity of the human immune system and how it responds to this disease, a wide range of approaches are being tested with the aim of improving the chances that ‘one or more vaccines and drug candidates are successful.

At the same time, companies continue to work on treatments for heart disease, cancer and many other diseases.

In the fight against Covid-19, prioritizing safety, 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 will continue to adopt.

We are not out of the woods yet, but I am convinced that science can bring us back to normal.

Stephen J. Ubl is President and CEO of PhRMA, a trade association representing US biopharmaceutical companies.



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