South San Francisco, CA September 16, 2022
WHO denounces GSK-VIR, Regeneron COVID drugs following Lancet Criticism
The Lancet Commission published a lengthy criticism of the World Health Organization’s COVID-19 pandemic response. The WHO, in turn, welcomed the Commission’s recommendations but offered a reply to a number of the complaints.
In addition, in updated guidelines for COVID-19 treatment, the WHO advised against using GlaxoSmithKline and Vir Biotechnology’s sotrovimab, Regeneron Pharmaceuticals’ REGEN-COV and recommended limited use of Gilead Sciences’ remdesivir.
The Lancet Commission issued a 57-page critique of the WHO’s response to the COVID-19 pandemic titled, “The Lancet Commission on lessons for the future from the COVID-19 pandemic.” The Commission comprises numerous public health experts worldwide, including Columbia University in New York, Simon Fraser University in British Columbia, Canada, Harvard, Parliamentarians for the Global Goals in Denmark, the Organization for Economic Cooperation and Development in France and numerous others.
The report detailed “multiple failures of international cooperation” in 10 categories:
- Slow notification of the initial outbreak
- Delays in acknowledging airborne exposure pathways
- Lack of coordination among countries
- Failure of governments to evaluate evidence and adopt best practices for controlling the pandemic
- Lack of global funding for low-income and middle-income countries
- Failure to ensure adequate global supplies and distribution of key commodities
- Poor data on infections, deaths, variants and other health factors
- Poor enforcement of biosafety regulations
- Failure to combat systematic disinformation
- Lack of global and national safety nets
The Commission concluded, “The COVID-19 crisis has exposed major weaknesses in the UN-based multilateral system, resulting from excessive nationalism, tensions among the major powers, chronic underfinancing of global public goods including the UN system itself, lack of flexibility of intellectual property regimes to ensure that global public goods are available to all…” and more.
At its core, the Commission said, “Our most basic recommendation is the strengthening of multilateralism in all crucial dimensions: political, cultural, institutional, and financial.”
WHO’s Detailed Response
The WHO welcomed the recommendations, “which align with our commitment to stronger global, regional and national pandemic preparedness, prevention, readiness and response.”
However, the agency took issue with several criticisms, calling them “omissions and misinterpretations … not least regarding the public health emergency of international concern (PHEIC) and the speed and scope of WHO’s actions.”
The agency also noted that many of the Commission’s recommendations were consistent with those previously received over the past two years from the WHO’s internal reviews, such as the Independent Panel for Pandemic Preparedness and Response and the IHR Review Committee.
The WHO then detailed 12 comprehensive rebuttals, as well as more detailed day-to-day responses the WHO took that they assert were glossed over by the Lancet Commission.
The rebuttals include:
• “On 30 December 2019, WHO received the first alerts of pneumonia of unknown cause in Wuhan, China, and notified the IHR focal point, seeking further information from Chinese health authorities the next day.”
• “Between 10 and 12 January 2020, WHO published a comprehensive package of technical guidance for countries….”
• “From 11 to 12 February 2020, WHO led a Global Research and Innovation Forum on the new virus, convening nearly 900 experts and funders from more than 40 countries, to take stock of what was known about the novel coronavirus and to set the agenda going forward.”
For the day-to-day steps, the WHO’s response included:
• “WHO repeatedly warned of the potential of asymptomatic human-to-human transmission, particularly presymptomatic transmission, including in late January in updated surveillance guidance…”
• “At the beginning of the pandemic, dramatic global supply constraints saw health workers around the world scrambling to find basic supplies to protect themselves. WHO’s early priority was getting access to masks for those most at-risk around the world….”
WHO concluded with a five-point plan for “laying a stronger foundation for the future.” The plan includes daily meetings of experts, WHO-supported research, assisting countries access vaccines, the launch of the intermediary financial fund for pandemic prevention, preparedness and response in September 2022, and an active investigation into the origins of the SARS-CoV-2 virus.
WHO Advises Against GSK-Vir and Regeneron’s COVID-19 Drugs
WHO also published updated guidelines in The BMJ on treatment recommendations for COVID-19, covering a broad range of therapeutics.
In the update, WHO recommended against using GSK and Vir’s sotrovimab and Regeneron Pharmaceuticals’ antibody cocktail REGEN-COV (cairivimab-imdevimab). The agency also made a conditional recommendation against using Gilead Sciences’ antiviral drug remdesivir in critical COVID-19 patients while approving its use in severe COVID-19.
The rationale for the antibodies is advisory, as the agency believes they are not effective for patients with non-severe COVID-19 at this point in the pandemic, which is dominated by various Omicron subvariants.
A GSK spokesperson told BioSpace, “Whilst we are disappointed with the WHO’s recommendation, GSK and Vir believe that sotrovimab continues to bring benefits to appropriate patients across the globe. We remain committed to gathering data, including real-world evidence on the effectiveness of sotrovimab to support clinical decision-making. We have been and will continue to share emerging data with regulators and work with them to support ongoing access to sotrovimab.”
The GSK spokesperson added, “As COVID-19 continues to evolve and new variants emerge, we expect that governments and health systems will continue to need a full and diverse arsenal of vaccine and therapeutic options to both prevent and treat patients with COVID-19, particularly for vulnerable groups who remain at high risk.”
A spokesperson for Regeneron also told BioSpace, “In January 2022, the FDA amended the REGEN-COV/Ronapreve (casirivimab and imdevimab) EUA to exclude its use in geographic regions where infection or exposure is likely due to variants such as Omicron that are not susceptible to the drug. Therefore, REGEN-COV has not been in use in any U.S. states, territories or jurisdictions for some time, and the new recommendations are consistent with the U.S. approach.”
Regeneron’s spokesperson added, “Separately, Regeneron has ‘next-generation’ COVID-19 antibodies currently in or entering Phase I evaluation, with the intention of progressing candidates that are safe and effective against currently circulating and future variants.”