Paxlovid, Remdesivir Win New Recommendations from WHO
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The World Health Organization indicated support for Pfizer’s Paxlovid this week. It is also reversing a previous decision on using Gilead Sciences' antiviral remdesivir, now recommending the medication in cases of mild to moderate COVID-19 severity.
The WHO has long been a voice of authority over the pharmaceutical industry, setting standards and guiding the global population through difficult situations - such as the recent COVID-19 pandemic. The organization’s recommendations for standard of care in these situations hold immense gravity.
The U.S. Food and Drug Administration approved Paxlovid for emergency use against COVID-19, with Pfizer agreeing to philanthropic goals such as supplying 4 million treatments to UNICEF. Studies indicate potency- an 85% reduction in a patient’s chances of being hospitalized or dying of COVID-19.
The drug has now been recommended for global distribution and use by the WHO, despite reported adverse events that are gaining traction within the medical community. After following the regimen, patients are seen to fully recover before falling ill with a positive case of COVID-19 once again. One such case leaves Kathryn Stephenson of the Harvard Medical School pondering the implications of reinfection. “If you are testing positive on a rapid antigen test, then you have a decent amount of virus and likely an infectious amount of virus," she said.
Strategies for how to accommodate pricing and global availability have yet to be announced. The lack of plans is addressed in today’s press release: “WHO therefore strongly recommends that Pfizer make its pricing and deals more transparent and that it enlarge the geographical scope of its license with the Medicines Patent Pool so that more generic manufacturers may start to produce the medicine and make it available faster at affordable prices.”
An additional recommendation hints at developing a generic of Paxlovid to ease the global distribution process, citing how “lack of transparency on the part of the originator company is making it difficult for public health organizations to obtain an accurate picture of the availability of the medicine, which countries are involved in bilateral deals and what they are paying.”
A licensing agreement is in place between Pfizer and the Medicines Patent Pool, limiting the countries that can benefit from the generic production of the drug. Regardless, Paxlovid will make its way onto the WHO prequalification list along with other recommended treatments, such as nirmatrelvir and ritonavir.
The announced support of Paxlovid comes with a new stance on remdesivir, along with WHO encouragement to determine if the drug is appropriate for use in cases of severe or critical COVID-19 infections. The press release describes the reversal, indicating that the previous stance against the use of remdesivir stemmed from clinical studies demonstrating little to no effect on patient mortality. Now, with the support of hospital-derived data, the topic is being reexamined to extend treatment options.