Biopharma Leaders Including J&J Unite on Vaccine Safety Pledge

NEW BRUNSWICK, NJ—Nine drug company CEO’s including Johnson & Johnson’s Alex Gorsky signed a September 8 pledge to continue making the safety of vaccinated individuals the top priority as they develop the first COVID-19 vaccines, according to a media release.

In the pledge, consumer health products and pharmaceutical giant J&J said that “the safety and well-being of vaccinated individuals” would always be its top priority.

J&J, along with the other companies, also said it would keep following high scientific and ethical standards in clinical trials testing the COVID-19 vaccines, and in the “manufacturing processes.”  

Based in New Brunswick for well over a century, the corporation reportedly will start large trails of experimental vaccines in September 2020; the initial doses could be available in early 2021, or as soon as the end of 2020.

J&J also pledged to ensure a sufficient supply globally. It was announced in August that the federal government would pledge $1 billion to spend on 100 million doses of the corporation’s vaccine if it gets approved.

“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,” reads the safety pledge.

All nine CEO’s, following guidance from expert regulatory authorities such as FDA, pledged 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.

In a statement to mitigate concerns that mass vaccination is being rushed, J&J’s chief executive chimed in.

Johnson & Johnson Chairman and CEO Alex Gorsky

“The pandemic demands that we develop a Covid-19 vaccine, and, as an industry, we are guided by science and data in these efforts,” said Gorsky.

“With many vaccines now being tested in clinical trials, we believe it is important to affirm for people everywhere that we will only move forward with regulators to make a vaccine available to them when the data demonstrate it is safe and effective.”

Gorsky received $25 million in total pay in 2019, whereas the median employee pay at J&J was $76,000. In addition to CEO, he also functions as Chairman of the corporation’s Board of Directors.

Regulatory agencies throughout the world like the United States Food and Drug Administration (FDA), are tasked with expertly reviewing the safety and efficacy of COVID-19 vaccines.

“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” said the release. “[While] 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.”

FDA requires scientific evidence for regulatory approval to come from large, high quality clinical trials that are randomized and observer-blinded, said the release, citing an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Together, the nine companies have developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, said the release, noting their experience in clinical development and regulatory rigor.

Health experts believe that the first vaccine to be approved is unlikely to be the last. A handful of vaccines may, after properly passing clinical trials, be widely available, but not all at the same time.

“I think the general public maybe has the wrong impression that there will be a winner and only one winner and everybody else will be a loser,” Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, told the Wall Street Journal.

“That’s not the case at all. I think it’s quite conceivable, if not likely, that you’re going to have multiple candidates that’ll get over the finish line that will actually be good enough to be approved for production and use.”

All vaccine candidates must be at least 50% better than “a placebo-controlled efficacy trial,” according to COVID-19 industry approval guidance released in June by FDA.

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Dave is an award-winning business reporter who has authored over 200 articles for New Brunswick Today.