“We heard last week that the FDA wanted to release those guidelines to give companies more information about what they needed to do to show that their vaccines were safe and effective.
“Yet that guidance has not yet been released.
“We urge Secretary Azar to release this as soon as possible and let our companies have all the tools that they need to produce the vaccine as quickly as they can,” said BIO president and CEO, Dr Michelle McMurry-Heath, in a video statement.
“We are hearing reports that morale at the FDA is at an all-time low… let the career scientists at FDA really do their jobs. Let them pursue the scientific questions around the COVID vaccine and have confidence in their decisions,” she stressed.
The scale and speed of the biopharma industry’s response to the novel coronavirus are unprecedented, said BIO. Currently, there are more than 180 experimental vaccines for COVID-19 in development, including 10 that now are in Phase 3 clinical trials.
Companies are working closely with scientists at the US Food and Drug Administration (FDA) and public health experts to achieve the shared commitment to testing and developing vaccines in strict accordance with sound scientific principles and with high ethical and safety standards, said a letter penned by BIO to US secretary of health and human services, Alex Azar, dated October 1.
However, the organization notes that there has been increasing political pressure in the US to deliver a vaccine as quickly as possible, and this has had repercussions on public opinion about science and a future COVID-19 vaccine.
The letter stated that all new FDA guidance should be finalized and communicated with those on the frontlines developing potential vaccines. “Just as importantly, it must also be shared more broadly with the American public. We cannot allow a lack of transparency to undermine confidence in the vaccine development process.”
Weighing in on that issue at the World Vaccine Congress last week were representatives from two leading pharmaceutical companies, Johnson & Johnson chief scientific officer, Paul Stoffels, and Julie Gerberding, executive vice president of Merck. The executives argued that the guidance should be released as a matter of public transparency, reported POLITICO.
“I think it is important that the guidance against which we will be judged will be available,” said Stoffels.
Transparency really matters right now, Gerberding said. "Even if the guidance isn’t shocking, we need to err on the side of transparency."