Drug firms look to provide reassurance over Covid-19 vaccine safety
They have vowed, in a statement released today [September 8], to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first Covid-19 vaccines.
The CEOs that signed the “historic pledge” include those at the helm of Moderna, AstraZeneca, Pfizer and BioNTech, the companies deemed to be the frontrunners in the Covid-19 vaccine development race. The chief executives of Merck, GlaxoSmithKline, Johnson & Johnson, Sanofi, and Novavax were also signatories.
The biopharma leaders asserted that they will make the safety and well-being of vaccinated individuals their top priority, that they will continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
They vowed to only submit for approval or emergency use authorization (EUA) after demonstrating “safety and efficacy through a Phase 3 clinical study” designed and conducted to meet requirements of expert regulatory authorities such as the US Food and Drug Administration (FDA).
The executives also committed to work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
AstraZeneca CEO, Pascal Soriot, told this publication:
"We are putting science and the interest of society at the heart of our work. We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential Covid-19 vaccine. We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around world."
Restoring public confidence in process
The biopharmaceutical industry is at the center of the world’s fight against that coronavirus, leading the effort to develop new vaccines, therapeutic medicines and diagnostics but there are growing concerns that the FDA will come under political pressure to approve COVID-19 drugs and vaccines before seeing sufficient evidence of their safety and efficacy.
Late last month, the Financial Times reported US president Trump was considering pushing for an EUA for AstraZeneca’s AZD1222 to ensure a COVID-19 vaccine is available before the November election.
Political pressure was seen as the rational behind the FDA issuing an EUA for COVID-19 convalescent plasma on August 23, despite experts cautioning that data from randomized clinical trials are still lacking.
Trump, meanwhile, has been arguing on Twitter that the FDA is part of a “deep state” plot to delay the development of COVID-19 drugs and vaccines.
Against that background of mistrust, the CEOs stated: “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.”
Vaccine development should be ‘free from political influence’
The commitment made by those pharma leaders comes on the heels of an open letter to the global biopharma industry from biotech trade group, Biotechnology Innovation Organization (BIO), stressing that politics should not influence the development and approval of new medicines.
That communication stated that conclusions about both the safety and effectiveness of such medicines should be based on rigorous collection and assessment of data by all the appropriate bodies, and their distribution should be based on sound public health considerations. “This approach is all the more vital considering the unprecedented pace and scale of the effort to develop treatments and vaccines for Covid-19.”
The FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence, continued BIO.
Clinical trials should be conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects, said the organization.
“Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer review journals. The disclosure of key scientific and clinical data through meetings and journals is the gold standard. However, companies may need to release some clinical data in advance of publication. In these instances, companies should approach any pre-publication press activity thoughtfully, and data should not be released by press release alone.
“Sponsors should ensure that data included in any press statement are clear and include accurate descriptions of key data points while reinforcing that the full data will be submitted for peer review.”
Moreover, the trade group said the appropriate use of any new products should be data driven.
“Different sub-populations are likely to react differently to different medicines. These differences will begin to be revealed in larger long-term studies. The public should be assured that only rigorously considered data will dictate the subsequent use of any product. Distribution of any vaccines should be done with these considerations in mind.”
