WHO Recommends Highly Effective COVID-19 Therapy, Calls for Wide Geographic Distribution and Originator Transparency
Today, the WHO made a strong recommendation for nirmatrelvir and ritonavir, sold as Paxlovid, for mild and moderate COVID-19 patients at high risk of hospitalization, calling it the best treatment choice for high-risk patients to date. However, availability, the lack of price transparency in bilateral agreements made by the producer, and the need for rapid and accurate testing before administering it make this life-saving drug a major challenge for low- and middle-income countries.
Pfizer’s oral antiviral drug (a combination of nirmatrelvir and ritonavir tablets) is strongly recommended for patients with non-severe COVID-19 who are most at risk of developing severe illness and hospitalization, such as patients not vaccinated, elderly or immunocompromised.
This recommendation is based on new data from two randomized controlled trials involving 3078 patients. The data shows that the risk of hospitalization is reduced by 85% following this treatment. In a high-risk group (more than 10% risk of hospitalization), this means 84 fewer hospitalizations per 1,000 patients.
The WHO advises against its use in low-risk patients, as the benefits have been shown to be negligible.
A barrier for low- and middle-income countries is that the drug can only be given when the disease is in its early stages; rapid and accurate tests are therefore essential for a positive result with this therapy. Data collected by TO FIND show that the average daily testing rate in low-income countries is as low as one-eightieth the rate in high-income countries. Improving access to early screening and diagnosis in primary health care settings will be essential for the global rollout of this treatment.
WHO is extremely concerned that – as happened with COVID-19 vaccines – low- and middle-income countries will again be pushed to the end of the queue when it comes to vaccines. to access this treatment.
The lack of transparency from the originating company makes it difficult for public health organizations to get an accurate picture of the availability of the drug, the countries involved in bilateral agreements and what they pay. Moreover license agreement made by Pfizer with the Medicines Patent Pool limits the number of countries that can benefit from generic production of the drug.
The originator product, sold as Paxlovid, will be included in the WHO prequalification list today, but generic products are not yet available from quality-assured sources. Several generic companies (many of which are covered by the licensing agreement between the Medicines Pool and Pfizer) are in discussion with WHO prequalification but may take some time to comply with international standards so that they can supply the drug internationally.
The WHO therefore strongly recommends that Pfizer make its pricing and agreements more transparent and expand the geographical scope of its license with the Medicines Patent Pool so that more generic manufacturers can start producing the drug and make it available more quickly at affordable prices.
Along with the strong recommendation for the use of nirmatrelvir and ritonavir, the WHO also updated its recommendation on remdesivir, another antiviral drug.
Previously, the WHO suggested against using it in all patients with COVID-19, regardless of disease severity, due to the totality of evidence at the time showing little or no effect. on mortality. Following the publication of new data from a clinical trial on the outcome of hospital admission, WHO has updated its recommendation. The WHO now suggests the use of remdesivir in mild or moderate COVID-19 patients who are at high risk of hospitalization.
The recommendation for the use of remdesivir in patients with severe or critical COVID-19 is currently under review.