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Rutgers professor discusses drug manufacturers' safety pledge for coronavirus vaccine

Michael Gusmano, a professor in the Department of Health Behavior, Society and Policy and director of the Health Systems and Policy Concentration, said the safety pledge states that drug manufacturers must make the safety of vaccinated individuals top priority, and must continue to follow both scientific and ethical standards through thorough clinical trials and manufacturing processes. – Photo by NIH via Flickr

In an effort to combat the coronavirus disease (COVID-19) pandemic, scientists around the world are working toward a vaccine.

Michael Gusmano, a professor in the Department of Health Behavior, Society and Policy and director of the Health Systems and Policy Concentration, discussed the pledge taken by drug manufacturers to uphold ethical standards and scientific principles in the global quest for a COVID-19 vaccine.

“The safety pledge is a document signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi in which they develop and seek approvals for the first COVID-19 vaccines,” Gusmano said. 

He said the pledge states that these companies will make the safety of vaccinated individuals top priority, continue to follow scientific and ethical standards concerning thorough clinical trials and manufacturing processes, only submit for approval after illustrating safety and efficacy through a phase 3 clinical study that has met requirements of regulatory agencies and work to make certain an adequate supply and range of vaccine options are available, including those that are globally acceptable. 

“The CEOs of these companies felt the need to issue this pledge because it appears that the (President Donald J.) Trump administration is placing pressure on the Food and Drug Administration (FDA) to approve a new vaccine, or to issue (an) emergency use authorization, before the presidential election in November,” Gusmano said. 

This pressure could potentially cause ethical concerns if companies were to release a vaccine before it completed the approval process, he said. 

“If the FDA were to (approve a vaccine) before data from phase 3 human clinical trials have been evaluated, (it) could be dangerous and counterproductive,” he said. “It is crucial to follow existing protocols so we have sufficient evidence that any new vaccine is both safe and effective.”

While following these protocols is supposed to be the role of the FDA and other agencies worldwide, the current circumstances called for an additional pledge to be made, Gusmano said.

“ ... because the Trump administration has threatened to politicize the regulatory process in an unprecedented fashion, these companies have taken the unusual step to make this pledge and engage in a form of self-regulation,” he said. 

Gusmano said the typical process of vaccine development involves several stages and takes years to complete.

The first step, the exploratory stage, involves basic lab research to identify antigens that could help treat or prevent a disease, Gusmano said.

Next, in the pre-clinical stage, scientists run tests to evaluate the safety and ability of the candidate. If the vaccine makes it past this stage, then the company has to apply to the FDA for permission to test an investigational new drug (IND), he said.

“The application has to specify all of the details of the research and must include (institutional review board) IRB approval at the site where the vaccine will be tested,” Gusmano said. “If the FDA issues an IND, the vaccine has to make it through three phases of clinical trials.” 

Gusmano said that each of the three clinical phase trials can take one to two years, and the candidates are more likely to fail at each stage than not. If the vaccine makes it through this entire process, and there is strong evidence it is safe and effective, it can still take another year or two to get approved by regulatory agencies, under normal circumstances, he said.

“In total, the usual process can take at least 10 years ... so the speed with which we are trying to develop a vaccine for COVID-19 is extraordinary,” Gusmano said. 

He said that if a vaccine were to be released prematurely, it could cause serious side effects and/or be ineffective against COVID-19. Also, trust in drug companies and science has been going down for years, so this could further diminish that trust, Gusmano said.

“In addition to the direct harm that could result from such a situation, this could have the unfortunate side-effect of further eroding public trust in other vaccines, which are safe, effective and crucial to maintain public health,” he said. 

Scientists have established this careful and extensive process in order to protect the public, so releasing an under-tested vaccine would be unethical and run the risk for harm, Gusmano said. 

“It is an upside-down scenario in which private companies are pledging to protect the public against elected officials who may be pressuring regulators to issue approvals without sufficient evidence,” Gusmano said.

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