On Apr. 22, 2022, the World Health Organization (WHO) made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission, calling it the best therapeutic choice for high-risk patients to date. Pfizer’s oral antiviral drug (a combination of nirmatrelvir and ritonavir tablets) is strongly recommended for patients with non-severe COVID-19 who are at highest risk of developing severe disease and hospitalization, such as unvaccinated, older, or immunosuppressed patients.

This recommendation was based on new data from two randomized controlled trials involving 3078 patients. The data show that the risk of hospitalization is reduced by 85% following this treatment. In a high-risk group (over 10% risk of hospitalization), that means 84 fewer hospitalizations per 1000 patients. WHO is extremely concerned that – as occurred with COVID-19 vaccines – low- and middle-income countries will again be pushed to the end of the queue when it comes to accessing this treatment.

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. In addition, a licensing agreement made by Pfizer with the Medicines Patent Pool limits the number of countries that can benefit from generic production of the medicine.

The originator product, sold under the name 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 medicine internationally.

WHO therefore strongly recommends that Pfizer make its pricing and deals more transparent and that it enlarge the geographical scope of its licence with the Medicines Patent Pool so that more generic manufacturers may start to produce the medicine and make it available faster at affordable prices.