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Will moving at “warp speed” to develop a vaccine impact efficacy or safety?
The rapid spread of the novel coronavirus is a reminder of the interconnected nature of global populations and economies. A few other realities also should be obvious. First, no single individual, company, or country can solve the pandemic crisis alone. Second, while getting a vaccine to patients quickly is crucial, decisions about quality and efficacy should be based on science, not political or public pressure.
The competition for vital medical resources in the early days of the pandemic illustrated how uncontrolled or misguided competition and anxiety can quickly overwhelm response to an emergency. Fortunately, collaborative efforts are shaping the development of treatments and vaccines. For example, the World Health Organization (WHO) is coordinating global efforts for vaccine development and clinical trials for treatment options.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership is a public-private effort to develop a framework to prioritize vaccine and drug candidates, streamline clinical trials, coordinate regulatory processes, and leverage assets to respond to the COVID-19 and future pandemics. More than a dozen biopharmaceutical companies have joined the National Institutes of Health (NIH), Foundation for the NIH, Health and Human Services Office of the Assistant Secretary for Preparedness and Response, FDA, Centers for Disease Control and Prevention, and the European Medicines Agency in an effort to advance the most promising vaccine and therapeutic candidates (1).
While groups are collaborating on development and clinical trial phases; the need for a coordinated manufacturing strategy cannot be overlooked.
For an industry used to development timelines counted in years, the COVID-19 vaccine and therapy development process is moving very fast. Sponsors of the leading vaccine candidates now in early clinical trials are expressing confidence that the product can reach patients by the end of 2020, months or years earlier than predicted by experts just one week ago.
To achieve that goal, manufacturing capacity for unproven vaccines must be created now, a risky prospect for the companies developing the capacity and for patients. Drug companies and contract manufacturers are accepting the challenge; governments and taxpayers may bear the financial risk.
In April 2020, AstraZeneca and the University of Oxford announced a development and manufacturing partnership. Johnson & Johnson announced manufacturing agreements with Catalent and Emergent BioSolutions for its vaccine candidate, as did Lonza with Moderna for its mRNA vaccine. Both Johnson & Johnson and Moderna have received funding from the Biomedical Advanced Research and Development Authority.
In late April, a Trump Administration plan-dubbed “Operation Warp Speed”-committed to make 300 million doses of coronavirus vaccine available by the end of 2020 (2). Details for this program-including which vaccines were going to be manufactured-were not available at press time.
After weeks of stay-at-home orders, social distancing, closed restaurants, high unemployment numbers, and bad economic news, optimism about the early arrival of a vaccine, as well as treatments such as Gilead Sciences’ remdesivir, offers some good news and excitement.
With anxiety for a resolution to the pandemic driving vaccine development activity, it is crucial that science-based information-from the global bio/pharma experts-should drive development, approval, and manufacturing decisions.<
1. NIH, “NIH to Launch Public-Private Partnership to Speed COVID-19 Vaccine and Treatment Options,” Press Release, April 17, 2020.
2. J. Jacobs and D. Armstrong, “Trump’s ‘Operation Warp Speed’ Aims to Rush Coronavirus Vaccine,” Bloomberg.com, April 29, 2020.
Vol. 33, No. 5
When referring to this article, please cite it as R. Peters, "How Fast Is Too Fast?" BioPharm International 33 (5) 2020.