WHO denounces GSK-VIR, Regeneron COVID drugs following Lancet criticism
The Lancet Commission published a long critical of the World Health Organizationof the response to the COVID-19 pandemic. The WHO, in turn, welcomed the Commission’s recommendations, but offered a Answer to a number of complaints.
Additionally, in the updated guidelines for the treatment of COVID-19, WHO informed against the use GlaxoSmithKline and Vir Biotechnologyis sotrovimab, Regeneron Pharmaceuticals‘REGEN-COV and recommended limited use of remdesivir from Gilead Sciences.
The Lancet Commission published 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 includes many public health experts from around the world, including Columbia University in New York, Simon Fraser University in British Columbia, Canada, Harvard, Parliamentarians for the Global Goals in Denmark, the Organization cooperation and economic development in France and many others.
The report details the “multiple failures of international cooperation” in 10 categories:
- Slow notification of initial outbreak
- Delays in recognition of airborne exposure pathways
- Lack of coordination between countries
- Failure of governments to assess the evidence and adopt best practices to control the pandemic
- Lack of global financing for low- and middle-income countries
- Inability to ensure adequate global supply and distribution of essential commodities
- Poor data on infections, deaths, variants and other health factors
- Poor application of biosafety regulations
- Failure in the fight against systematic misinformation
- Absence of global and national safety nets
At its heart, the Commission declared: “Our most fundamental recommendation is the strengthening of multilateralism in all the crucial dimensions: political, cultural, institutional and financial”.
Detailed response from WHO
The WHO welcomed the recommendations, “which align with our commitment to strengthen global, regional and national pandemic preparedness, prevention, preparedness and response”.
However, the agency disputed several criticisms, calling them “omissions and misinterpretations…particularly regarding the public health emergency of international concern (USPPI) and the speed and scope of the actions of the WHO”.
The agency also noted that many of the Commission’s recommendations were consistent with those received over the past two years from internal WHO reviews, such as the Independent Panel for Pandemic Preparedness and Response. and the IHR Review Committee.
The WHO went on to detail 12 full rebuttals, along with more detailed day-to-day responses that the WHO took and which it says were glossed over by the Lancet Commission.
Rebuttals include:
• “On December 30, 2019, WHO received the first alerts of pneumonia of unknown cause in Wuhan, China, and notified the IHR focal point, requesting additional information from Chinese health authorities the next day.”
- “Between 10 and 12 January 2020, WHO released a comprehensive set of technical guidance for countries….”
• “From February 11-12, 2020, WHO led a Global Research and Innovation Forum on the Novel Virus, bringing together nearly 900 experts and funders from more than 40 countries, to take stock of what we knew about the novel coronavirus and setting the agenda moving forward.
For daily steps, the WHO response included:
• “WHO has repeatedly warned of the potential for asymptomatic human-to-human transmission, particularly presymptomatic transmission, including late January in updated surveillance guidelines…”
• “At the start of the pandemic, dramatic global supply constraints caused health workers around the world to scramble to find basic supplies to protect themselves. The first priority for WHO was to have access to masks for those most at risk in the world…”.
The WHO concluded with a five-point plan to “lay a stronger foundation for the future”. The plan includes daily expert meetings, WHO-supported research, helping countries access vaccines, launching the interim 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 COVID-19 Drugs
WHO has also published updated guidelines in The BMJ on treatment recommendations for COVID-19, covering a wide range of therapies.
In the update, the WHO recommended against the use of sotrovimab from GSK and Vir and the antibody cocktail REGEN-COV (cairivimab-imdevimab) from Regeneron Pharmaceuticals. The agency also issued a conditional recommendation against the use of Gilead Sciences’ antiviral drug remdesivir in critical COVID-19 patients while approving its use in severe cases of 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 stage of the pandemic, which is dominated by various Omicron subvariants.
A GSK spokesperson said BioSpace, “While we are disappointed with the WHO recommendation, GSK and Vir believe that sotrovimab continues to provide benefit to appropriate patients worldwide. We remain committed to collecting data, including concrete evidence on the efficacy of sotrovimab to support clinical decision making. We have shared and will continue to share emerging data with regulators and work with them to support continued access to sotrovimab.
The GSK spokesperson added: “As COVID-19 continues to evolve and new variants emerge, we expect governments and healthcare systems will continue to need a comprehensive arsenal and diverse range of vaccines and treatment options to prevent and treat patients with COVID-19, especially for vulnerable groups who remain at high risk.
Sept 16, 2022
