Biotech companies are working around the clock to develop safe and effective vaccines and treatments to combat and eradicate Covid-19. Thanks to this monumental push for innovation, there are well over 700 unique active compounds in the pipeline.
But speed cannot trump science nor safety. To reaffirm these priorities, nine biopharma companies (including several BIO members) stressed their commitment to upholding the integrity of science in their search for a COVID-19 vaccine.
In a joint statement, the nine company signatories -- AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi -- pledged “to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.”
They outlined the following principles:
- Always make the safety and well-being of vaccinated individuals our 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 the U.S. Food and Drug Administration (FDA).
- Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
Of note, these companies have collectively developed more than 70 novel vaccines—“underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.”
The pledge follows the example set by BIO leadership last week, when we released an open letter to the biopharmaceutical industry, articulating principles to ensure the “integrity, transparency, and objective assessment” of COVID-19 clinical data and secure public trust in new medical products developed in response to the pandemic.
The specifics from those recommendations:
- 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.
- Companies should disclose important clinical data via well-respected scientific meetings or rigorous, independent peer-review journals, and companies that need to release data in advance of publication should do so thoughtfully and not through press release alone.
- The FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence.
- The appropriate use and distribution of any new products should be data-driven, including through data collected during longer-term studies.
- Political considerations should be put aside by leaders in both parties and they should “reassure the public that politics will not influence the development and approval of new medicines.”
BIO’s board chair, Jeremy Levin, summed it up quite nicely: “We want the public to believe and to trust what we are doing.”