On Sept. 8, 2020, nine pharmaceutical companies working on COVID-19 vaccines signed a pledge saying they would not submit their experimental vaccines to the U.S. Food and Drug Administration (FDA) unless they were shown to be both safe and efficacious in the Phase 3 human clinical trials.1 2 3 4 5
The pledge, signed by the CEOs of AstraZeneca plc, BioNTech SE, GlaxoSmithKline plc, Johnson & Johnson, Inc., Merck & Co., Inc., Moderna, Inc., Novavax, Inc., Pfizer Inc. and Sanofi SA expressed the companies’ “on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles” and promised that they would “always make the safety and well-being of vaccinated individuals our top priority.”1 2 3 4 5
The pledge was signed just two days after the results of a CBS News/YouGov poll of 2,493 registered U.S. voters were published showing that 65 percent of them were skeptical about the safety of any COVID-19 vaccine made available this year due to concerns about it being “rushed through without enough testing.” Pfizer’s CEO, Albert Bourla, indirectly referenced the poll (and other similar polls) as a reason for the pledge.5 6 7 Bourla said:
With increasing public concerns about the processes that we are using to develop these vaccines and even more importantly the processes that will be used to evaluate the vaccines, we thought it was critical to come out and reiterate our commitment.2
The CEOs said they believe the 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.”1
Public Trust in Pharma is Very Low
But how far, really, will the pledge go toward allaying public fears? Particularly given the appearance it was made out of self interest specifically to counteract plummeting public confidence. Also, it’s not like the American public’s trust and confidence in the pharmaceutical industry and government agency regulation and oversight is exactly stellar. In fact, a recent Gallup poll shows that public trust in biopharmaceutical companies is at an all-time low.8 9
According to the Gallup poll:
The pharmaceutical industry is now the most poorly regarded industry in Americans’ eyes, ranking last on a list of 25 industries that Gallup tests annually. Americans are more than twice as likely to rate the pharmaceutical industry negatively (58%) as positively (27%).9
Referencing the poll, an article in Biopharma Dive noted “the public sees the drug industry as falling short of its responsibility to society—a shortcoming severe and persistent enough to sap the public’s trust.”8
So why take the word of nine pharma CEOs whose companies stand to make billions of dollars in sales for years to come if their COVID-19 vaccines, which have been heavily subsidized by taxpayer dollars, are approved by the FDA and sold in the U.S.? Clearly, there is a huge financial incentive to say and do everything possible to encourage the American people to get over their fears and get vaccinated with these vaccines as soon as they become available.
Billions of Dollars at Stake With COVID-19 Vaccines
Analysts at investment bank SVB Leerink of Boston, Massachusetts are projecting that Pfizer alone may earn $3.5 billion in sales from its COVID-19 vaccine in 2021 and $1.4 billion annually after that. SVB Leerink analysts said they “expect the virus to become endemic in the human population” and that their “current assumption is that vaccinees will need to be revaccinated every two years or so to maintain protective immunity.” They added, “We assumed high operating margin around 75%-80% initially, with minimal sales and marketing expense, which is different from other pharmaceutical products.”
Industry news website Fierce Pharma reported that profits for Pfizer from its COVID-19 vaccine (BNT162b2) could be significant “given the urgency among politicians and the general populous to put an end to the pandemic.10
The headline of a recent article in The New York Times reads “COVID-19 Vaccines Offer Drug Makers Chance at Salvation, Financial and Beyond.” The article opens, “Big profits beckon for pharmaceutical companies, which are already using their work on vaccines to fight efforts in Washington to curb drug prices.” It cites a sales estimate of $20 billion for COVID-19 vaccines in the first year they are introduced.11 The article continues:
For a long time, drug makers have been the most hated industry in America. Companies are blamed for gouging prices on lifesaving drugs and enriching themselves through the opioid crisis, among other sins. Now, with pharmaceutical companies racing to find vaccines to end the coronavirus pandemic, the industry is hoping to redeem itself in the public’s mind.11
This reads more like a plea and cautionary warning than a glowing vote of confidence in the moral integrity of a wealthy and politically powerful industry that is pledging it will abide by “high ethical standards and sound scientific principles” in its development of COVID-19 vaccines. So it is not unreasonable to say that this sudden statement committing to ethical behavior rings a little hollow.
1 Biopharma Leaders Unite to Stand with Science. Business Wire Sept. 8, 2020.
2 Chappell B. 9 Drugmakers Sign Safety Pledge In Rush To Develop Coronavirus Vaccine. NPR Sept. 8, 2020.
3 Sullivan P. Drug companies issue rare joint pledge on vaccine safety amid political fears. The Hill Sept. 8, 2020.
4 Thomas K, Weiland N, LaFraniere S. Pharma Companies Plan Joint Pledge on Vaccine Safety. The New York Times. Sept. 4, 2020.
5 Voytko L. Pharma CEOs Counter Trump By Promising Safety Over Shortcuts In Coronavirus Vaccine Development. Forbes Sept. 8, 2020.
6 De Pinto J. Voters Skeptical About Potential COVID-19 Vaccine And Say That One This Year Would Be Rushed – CBS News Poll. CBS News Sept. 6, 2020.
7 Raines K. Polls Find Many Americans Do Not Want COVID-19 Vaccine as Soon as It’s Licensed. The Vaccine Reaction Sept. 14, 2020.
8 Dunn A. Public trust in drugmakers is at an all-time low. Can biopharma recover? Biopharma Dive Sept. 11, 2020.
9 McCarthy J. Big Pharma Sinks to the Bottom of U.S. Industry Rankings. Gallup Sept. 3, 2020.
10 Weintraub A. Pfizer could haul in $3.5B in 2021 from COVID-19 vaccine: analyst. Fierce Pharma Oct. 21, 2020.
11 McCaDrucker J, Gelles D, Katier T. COVID-19 Vaccines Offer Drug Makers Chance at Salvation, Financial and Beyond. The New York Times Oct. 13, 2020.