COVID-19 Vaccines – Development Standards/Regulatory Review/Commitments

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COVID-19 Vaccines – Development Standards/Regulatory Review/Commitments

Press Release
Biopharma Leaders Unite to Stand with Science
Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

NEW YORK–(BUSINESS WIRE)– Sep. 8, 2020 The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline plc), Johnson & Johnson, Merck, known as MSD outside the United States and Canada, Moderna, Inc., Novavax, Inc., Pfizer Inc., and Sanofi today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. All nine CEOs signed the following pledge:

“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

“The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

“ Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
:: Always make the safety and well-being of vaccinated individuals our top priority.
:: Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
:: Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
:: Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.”

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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FDA Voices 09/11/2020
The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health
By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
[Excerpt]
…The FDA’s career scientists and physicians are helping to facilitate the development and evaluation of safe and effective COVID-19 vaccines. These professionals have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of vaccines intended to prevent infectious diseases. They are experts in clinical trial design and analysis and synthesizing and evaluating tremendous amounts of data to determine whether a vaccine has been shown to be safe and effective. These experts are responsible for assessing the adequacy of manufacturing and the facilities where vaccines are made, which are critical to producing high-quality vaccines, and for post-marketing safety surveillance, using a wide variety of surveillance systems and data mining to continually review safety after a vaccine is approved.

The FDA is often held up as the “gold standard” of regulatory agencies around the globe. What’s at the core of these standards are the agency’s regulatory independence and science-based decision-making.  As with all products we regulate, we will follow the science and data in our decision making regarding COVID-19 vaccines. It is because the FDA is a science-based agency that we say this with the clarity of conviction. The dedicated career public health professionals who will be involved in evaluating the data submitted to the FDA in requests for Emergency Use Authorization (EUA) and in Biologics License Applications (BLAs) for COVID-19 vaccines are committed to decision making based on science and data. They are fathers, mothers, sisters, brothers, grandparents and more – and they (and their families) are directly impacted by the work they do. They are exactly who you want making decisions regarding vaccine safety and effectiveness.

No time in recent memory has shone as bright a light on the work of FDA review staff as the COVID-19 pandemic. We understand that a lot of people may not have information about vaccine development or how the FDA determines whether or not to approve a vaccine – and may not have given it much thought – at least until now.

With so much at stake, we understand the importance of being as transparent as possible about the work we do, including how we will make decisions regarding COVID-19 vaccines. The publication of our guidance was an important step – we firmly believe that transparency regarding the FDA’s thinking about the scientific data needed to support approval of safe and effective vaccines will help build public confidence in the FDA’s evaluation process, which will be critical in ensuring the use of COVID-19 vaccines once available.

An upcoming key milestone is the meeting of our Vaccines and Related Biological Products Advisory Committee on October 22, at which the committee will discuss publicly the general development of COVID-19 vaccines. While this meeting is not intended to discuss any particular vaccine candidates, the agency is also prepared to rapidly schedule additional meetings of this Committee upon submission of any BLAs or requests for EUAs to further ensure transparency.

The FDA has been asked what regulatory path will be used to make COVID-19 vaccines available (i.e., will there be an EUA, or will the FDA approve a BLA?). The short answer is, taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request or BLA to the FDA. The agency will review EUA requests and BLAs received and make appropriate determinations by looking at the totality of the available scientific evidence. For a vaccine for which there is adequate manufacturing information, issuance of an EUA may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine, but before the manufacturer has submitted all of the various data elements normally required and/or the FDA has completed its formal review of the BLA.

As we have said, these decisions will be firmly rooted in science. We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake….