AstraZeneca pauses vaccine trials as pharma execs pledge to follow the science

0

The CEOs of nine pharmaceutical companies, including AstraZeneca announced a pledge, outlining a united commitment to follow the scientific process in developing a Covid-19 vaccine with Oxford University.

AstraZeneca has job sites in Delaware that employ 1,500.

AstraZeneca was in the news later in the day when a closely watched late-stage trial of its vaccine was suspended.

“A standard review process has been triggered, leading to the voluntarypause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial,” the company stated. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”

Pascal Soriot, CEO stated: “At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts. We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

Earlier, Soriot and other pharmaceutical company 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.

The companies that include Johnson & Johnson, Merck, Glaxo SmithKline, and Norvartis have collectively developed more than 70 novel Covid-19 vaccines.

Facebook Comments