4 Ways COVID-19 Vaccine Makers Pledged to Ensure Safety

Nine major biopharmaceutical companies pledged on Tuesday to only seek approval for COVID-19 vaccines that are proven to be safe and effective. The move comes on the heels of mounting concerns that the push for a quickly developed COVID-19 vaccine is politically motivated.

CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, signed the pledge. The rival companies include the three leading COVID-19 vaccine efforts that have advanced into late-stage clinical trials.

“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 pledge reads.

Their statement says that the safety and efficacy of vaccines—including a vaccine for COVID-19—is reviewed and determined by regulatory agencies around the world, including the 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,” the pledge says. “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."

The pledge goes on to explain the FDA's requirements for regulatory approval:

• Scientific evidence must come from large, high-quality clinical trials.
• Trials must be observer-blinded and randomized.
• There must be a significant number of participants, pulled from diverse populations.

Based on guidance from the FDA, the drug companies say they will do the following:

• Always make the safety and well-being of vaccinated individuals 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 distribution.

The Reason for the Pledge

The biopharmaceutical companies stated they believe this pledge will help ensure public confidence in the COVID-19 vaccines currently undergoing rigorous, scientific evaluation processes. Their response came quickly after President Donald Trump made promises to have a vaccine ready before the presidential election in November.

“You could have a very big surprise coming up. I’m sure you’ll be very happy. But the people will be happy. The people of the world will be happy,” President Donald Trump told reporters, per ABC News. “We’re going to have a vaccine very soon, maybe even before a very special date. You know what date I’m talking about.”

But senior public health officials have said that’s highly unlikely. Moncef Slaoui, PhD, the chief scientific officer overseeing Operation Warp Speed—the Trump administration’s effort to fast-track a vaccine—told NPR last week that having a vaccine available before the election is "extremely unlikely, but not impossible.” Slaoui also said that there is a “very, very low chance” that clinical trials for a vaccine will be completed before the end of October and that there would be an emergency use authorization from the FDA in time. 

Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, recently told reporters at the Research! America 2020 National Health Research Forum that it’s “unlikely we’ll have a definitive answer” on a vaccine by the election in early November. Instead, he said, a vaccine will likely be ready by “the end of the year.”

Reactions from the Public Have Been Mixed

A new poll from the nonpartisan Kaiser Family Foundation found that 62% of American respondents are worried that political pressure from the Trump administration will lead the FDA to rush to approve a coronavirus vaccine without making sure that it is safe and effective.

Many people have expressed on social media that the pledge seems unnecessary. “Is this necessary for any reason? An obvious responsibility that pharmaceutical companies should abide by without having to say it?” one person wrote on Twitter. “This is kind of a no brainer. No company wants to be that company that puts out a vaccine that causes more problems than it solves,” another said.

“It is bizarre that waiting for evidence of safety is being presented as new or beyond reasonable expectations. Why are you misleading the public?” one wrote. “Wow. This is good, but also sad,” was the response from another tweeter.

Where Vaccine Trials Stand Now

There are currently at least 93 preclinical vaccines under active investigation in animals, and 38 vaccines that are in human trials, according to The New York Times’ coronavirus vaccine tracker.

Nine of those vaccines are in Phase 3 of clinical trials, which involve large-scale testing on humans. Three of the vaccines have been approved for early or limited use, including two from Chinese companies and one from a research institute in Russia.

AstraZeneca’s Phase 3 COVID-19 vaccine trials were recently halted after a woman participating in the trial developed neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, a company spokesperson told ABC News. AstraZeneca previously said that it decided to “pause” its trial to “allow review of safety data.” At the time, the company provided few details except to say that a participant had an “unexplained illness.” There is no word on when the vaccine trial will resume.

The pharmaceutical pledge ended on one last call for confidence from the public: “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 information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.