Today, WHO (April 22) 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. However, availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, are turning this life-saving medicine into 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 at highest risk of developing severe disease and hospitalization, such as unvaccinated, older, or immunosuppressed patients.

This recommendation is 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 suggests against its use in patients at lower risk, as the benefits were found to be negligible.

One obstacle for low- and middle-income countries is that the medicine can only be administered while the disease is at its early stages; prompt and accurate testing is therefore essential for a successful outcome with this therapy. Data collected by 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 testing and diagnosis in primary health care settings will be key for the global rollout of this treatment.

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.

Along with the strong recommendation for the use of nirmatrelvir and ritonavir, WHO has also updated its recommendation on remdesivir, another antiviral medicine.

Previously, WHO had suggested against its use in all COVID-19 patients regardless of disease severity, due to the totality of the evidence at that time showing little or no effect on mortality. Following publication of new data from a clinical trial looking at the outcome of admission to hospital, WHO has updated its recommendation. WHO now suggests the use of remdesivir in mild or moderate COVID-19 patients who are at high risk of hospitalization.

The recommendation for use of remdesivir in patients with severe or critical COVID-19 is currently under review.