Drug Companies Release Blueprints for Coronavirus Vaccine Trials
In an unprecedented show of transparency, two companies revealed their blueprints for their coronavirus vaccine trials in an effort to garner public trust.
Drug companies Moderna and Pfizer released the details of their vaccine trials on Thursday, detailing how participants will be selected and monitored, what would cause a trial to be discontinued, and evidence researchers will use to determine if the vaccine effectively protected trial participants from COVID-19.
To provide additional transparency in context of pandemic, the protocol for the Phase 3 COVE study of mRNA-1273 being conducted in collaboration with the NIH and BARDA is now available: https://t.co/ToJWTwNyYa #mRNA pic.twitter.com/hYaGi1iohK— Moderna (@moderna_tx) September 17, 2020
“Companies typically share these documents after their studies are complete,” according to The New York Times. “The disclosures while the trials are underway, a rare move, are aimed at addressing growing suspicion among Americans that President Trump’s drive to produce a vaccine before the election on November 3 could result in a product that was unsafe.”
The decision to release their plans came at a moment when U.S. adults are divided on whether they will get a vaccine should one be released. A recent survey by the Pew Research Center found that 49 percent of U.S. adults would “definitely or probably would not” get vaccinated today if a vaccine were available. Pew also found that intent to get a COVID-19 vaccine had fallen from 72 percent in May, a 21 percentage point drop.
“There are widespread public concerns about aspects of the vaccine development process,” Pew explained. “On the heels of a pledge from nine pharmaceutical companies to ensure that a potential vaccine would meet rigorous standards, the Center survey finds three-quarters of Americans (77 percent) think it’s very or somewhat likely a COVID-19 vaccine will be approved in the United States before its safety and effectiveness are fully understood. And when asked about the pace of the vaccine approval process, 78 percent say their greater concern is that it will move too fast, without fully establishing safety and effectiveness, compared with just 20 percent who are more concerned approval will move too slowly, creating unnecessary delays.”
The pledge—signed by AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi—was a commitment for the companies to hold themselves to “high ethical standards and sound scientific principles” in the development of a vaccine for COVID-19.
The companies specifically committed to making the safety and well-being of vaccinated individuals their top priority, continuing to adhere to high scientific and ethical standards for conducting clinical trials and manufacturing a vaccine, only submitting for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that meets regulatory authority requirements, and working to ensure a sufficient supply and range of vaccine options.
“An important feature of the pledge is that firms are saying that they will not be pressured into submitting bad data, or into submitting data that does not show evidence of vaccines’ safety and efficacy, to the [Food and Drug Administration],” said Herschel Nachlis, PhD, a research assistant professor of government and a policy fellow in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences at Dartmouth College, in an interview with Healthline.
Drug manufacturers are under immense pressure to create an effective vaccine for COVID-19 as the number of confirmed cases across the globe neared 30 million and almost 1 million deaths on Thursday night, with 90 percent of countries experiencing disruptions to essential health services due to the pandemic, according to the World Health Organization (WHO).
Ahead of the 75th United Nations General Assembly—held virtually—the WHO released several messages for leaders to consider. The first was a call for support for the Access to COVID-19 Tools (ACT)-Accelerator, an international collaboration to fast-track the development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
The #UNGA75 starts today. @WHO calls on world leaders to:— Tedros Adhanom Ghebreyesus (@DrTedros) September 16, 2020
1⃣ Support the #COVID19 ACT-Accelerator
2⃣ Maintain the momentum to deliver promises on @GlobalGoalsUN & #HealthForAll
3⃣ Invest more in preparedness for future pandemicshttps://t.co/yqJ3vp1eyC
“The ACT-Accelerator needs $35 billion to fast-track the development, procurement, and distribution of 2 billion vaccine doses, 245 million treatments, and 500 million tests over the next year,” according to a WHO press release.
The WHO also called for support to prepare for the next pandemic following the release of the independent Global Preparedness Monitoring Board’s (GPMB's) 2020 report World in Disorder on the world’s response to COVID-19.
“Never before has the world been so clearly forewarned of the dangers of a devastating pandemic, nor previously had the knowledge, resources, and technologies to deal with such a threat,” wrote the report’s authors. “Yet, never before has the world witness a pandemic of such widespread and destructive social and economic impact.
“The COVID-19 pandemic has revealed a collective failure to take pandemic prevention, preparedness, and response seriously and prioritize it accordingly. IT has demonstrated the fragility of highly interconnected economies and social systems, and the fragility of trust. It has exploited and exacerbated the fissures within societies and among nations. It has exploited inequalities, reminding us in no uncertain terms that there is no health security without social security. COVID-19 has taken advantage of a world in disorder.”
To bring order, the GPMB recommended world leaders engage in responsible leadership; develop engaged citizenship; create strong and agile systems for health security; sustain investment; and engage in robust global governance of preparedness.
“We have already learned many crucial lessons that demand immediate action if we are to say with any confidence, ‘never again,’” the authors wrote. “But learning without action is pointless, and unsustainable commitment is futile. As we warned in our last report, ‘For too long, we have allowed a cycle of panic and neglect when it comes to pandemics: we ramp up efforts when there is a serious threat, then quickly forget about them when the threat subsides.”
For more COVID-19 information and resources, visit ASIS International’s Disease Outbreak: Security Resources page.