A Change in Priorities – How COVID-19 Has Changed the Public and Private Sector
By Ines Dieringer, Associate Consultant
The COVID-19 crisis has altered the way in which vaccines and drugs are developed and approved. In the private sector, we see unprecedented partnerships arise, while the public sector has experienced a policy shift towards a system of rapid approvals.
Exemplary of the private sector, GlaxoSmithKline (GSK) and Sanofi have announced a unique partnership to develop a COVID-19 vaccine. Both companies hold a key piece of the puzzle necessary to develop an effective vaccine. By combining Sanofi’s S-protein COVID-19 antigen, the main ingredient, and GSK’s H1N1 pandemic adjuvant, which is needed to boost the effectiveness of the vaccine, the partnership aims to start Phase I clinical trials in the second half of this year, targeting a mid-2021 commercial release date1.
GSK and Sanofi are not the only companies racing to develop a COVID-19 vaccine. Both Chinese and American companies are making fast progress in early testing for vaccines, with China’s CanSino Biologics in its second phase of testing, closely followed by the American company Moderna. Furthermore, the WHO has identified over 60 vaccine candidates in earlier development stages that are being investigated globally2. Clearly, the private sector is undertaking radical steps to ensure the timely development of a COVID-19 treatment.
While many resources are being dedicated to the development of a vaccine, experts predict the first COVID-19 vaccine will not be publicly available until at least a year to 18 months from now – even this timeline is considered incredibly short, as most vaccines may take decades to develop3. Even in this unprecedented scenario, it remains important to ensure that the safety and efficacy of the vaccine is properly established.
In the public sector, the COVID-19 pandemic is testing our ability to quickly deal with a novel disease and deploy medications in a timely and efficient manner. It has caused significant pressure on both healthcare systems and regulatory bodies, with the latter suffering under pressures to speed up approval of possible treatments. However, while it is important that treatments and vaccines are approved promptly, to stop the spread of the disease, these approvals must remain evidence based4.
Hydroxychloroquine, an agent commonly used to treat malaria, was endorsed as a possible treatment for the pandemic by the FDA. However, this endorsement preceded any form of evidence reflecting its efficacy against COVID-19. The treatment is known for having serious heart-related side effects, which, in addition to its dubious efficacy profile, raises significant doubts on whether hydroxychloroquine should have been endorsed in the first place.
Brazil has recently halted a COVID-19 clinical trial with chloroquine, a very similar agent to hydroxychloroquine, due to several deaths that occurred in the higher-dose patient group5. Seeing as there are no known concrete benefits for patients suffering from COVID-19, subjecting patients to this treatment may be considered clinically unjustifiable4.
Widening access to these experimental therapies, without solid efficacy and safety bases, may have significant consequences. While it is important to develop and approve an effective treatment in a timely manner for the COVID-19 pandemic, it is also of the utmost importance to maintain the standards of evidence-based efficacy and safety profiles. Through this pandemic, two roles have emerged: the private sector must position itself to decrease development times, while the public sector must ensure that efficacy and safety standards are met.
Naturally, this raises some key questions:
- Can we find a balance between accelerating therapy approvals and ensuring these therapies have enough supporting data?
- Can we increase the efficiency of current safety and efficacy testing?
- How will partnerships between different pharmaceutical companies impact future therapy development?
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