The CEO of Gaithersburg’s Novavax Inc. (NASDAQ: NVAX) has joined with several other biopharmaceutical executives in a global pledge to prioritize safety over speed in the race to find a viable Covid-19 vaccine.
Stanley Erck, who leads the Maryland biotech, signed the pledge alongside the chiefs of eight other companies that are advancing their own coronavirus vaccine candidates: British-based AstraZeneca PLC (NYSE: AZN) and GlaxoSmithKline PLC (NYSE: GSK), both of which have D.C.-area presences; Cambridge, Massachusetts-based Moderna Inc. (NASDAQ: MRNA), which has local clinical trial sites; New Brunswick, New Jersey-based Johnson & Johnson (NYS: JNJ); New York-based Pfizer Inc. (NYSE: PFE); Kenilworth, New Jersey-based Merck (NYSE: MRK); Paris-based Sanofi (NASDAQ: SNY); and Cambridge, Massachusetts-based BioNTech (NASDAQ: BNTX).
In a letter released Tuesday, the CEOs said they are jointly establishing their commitment to developing vaccine candidates “in accordance with high ethical standards and sound scientific principles,” as well as the Food and Drug Administration’s protocols for clearing safe, effective vaccines — a process that requires scientific evidence from large, high-quality clinical trials that meet specific criteria.
The pledge comes as the pandemic approaches the six-month mark, and the Trump administration indicated potential attempts to deliver a vaccine as early as November. The Centers for Disease Control and Prevention had notified the states and District to ready for a potential vaccine in the days and weeks leading up to the presidential election, raising concerns about the potential for political pressure or interference in the scientific process — which administration leaders have refuted. Still others have voiced concerns about whether enough members of the public would embrace a new coronavirus vaccine to significantly cut down on its spread. The pledge also comes as the FDA considers the prospect of emergency use authorization, which if used, would greenlight a vaccine early, before late-stage trials finish.
“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,” it reads.
Per the letter, the companies vow to:
- Always make the safety and well-being of vaccinated individuals their 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 final, phase 3 clinical study that is designed and conducted to meet FDA requirements.
- Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
Novavax’s phase 2 clinical trial for its Covid-19 candidate is now underway and enrolling patients, with sites in the U.S., Australia and South Africa. After a successful early-stage study, the candidate will need to perform well in those trials — and in a subsequent phase 3 study — to be considered for final approval by the FDA.
The local company’s stock was trading down slightly, at about 2%, by Tuesday afternoon to $91.25, a slide from the $170 per-share price it saw this time last month.
