Today, the WHO made a strong recommendation of nirmatrelvir and ritonavir, sold under the name Paxlovid, to mild and moderate COVID-19 patients at greatest risk of hospitalization, calling it the best therapeutic choice for high-risk patients to date. However, availability, lack of price transparency in bilateral agreements concluded by the manufacturer and the need for rapid and accurate testing before it is administered make this life-saving medicine 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 greatest risk of developing serious illness and hospitalization, such as unvaccinated, elderly or immunosuppressed patients.
This recommendation is based on new data from two randomized controlled trials with 3078 patients. Data show that the risk of hospitalization is reduced by 85% after this treatment. In a high-risk group (over 10% risk of hospitalization), this means 84 fewer hospitalizations per 1000 patients.
The WHO suggests that it should not be used in patients at lower risk, as the benefits have been shown to be negligible.
An obstacle for low- and middle-income countries is that the medicine can only be administered while the disease is in the early stages; Fast and accurate testing is therefore crucial for a successful outcome with this therapy. Data collected by FIND shows that the average daily test rate in low-income countries is as low as 80% of the rate in high-income countries. Improving access to early testing and diagnosis in primary care will be the key to the global rollout of this treatment.
The WHO is extremely concerned that – as happened with COVID-19 vaccines – low- and middle-income countries will once again be pushed to the end of the queue when it comes to accessing this treatment.
Lack of transparency on the part of the original company makes it difficult for public health organizations to get an accurate picture of the availability of the medicine, which countries are involved in bilateral agreements and what they pay for. In addition, one license agreement made by Pfizer with Medicines Patent Pool limits the number of countries that can benefit from generic medicine production.
The original product, sold under the name Paxlovid, will today be on the WHO’s pre-qualification list, but generic products are not yet available from quality assured sources. Several generic companies (many of which are covered by the license agreement between Medicines Pool and Pfizer) are in discussion with WHO Prequalification, but it may take some time to comply with international standards so that they can deliver the medicine internationally.
The WHO therefore strongly recommends that Pfizer make its prices and agreements more transparent, and that it expand the geographical scope of its license with Medicines Patent Pool, so that more generic manufacturers can start producing the medicine and make it available more quickly at affordable prices.
Along with the strong recommendation for the use of nirmatrelvir and ritonavir, the WHO has also updated its recommendation on remdesivir, another antiviral drug.
Earlier, the WHO had suggested that it was not used in all COVID-19 patients regardless of the severity of the disease, due to the overall evidence at the time showing little or no effect on mortality. Following the publication of new data from a clinical trial looking at the outcome of hospitalization, the WHO has updated its recommendation. The WHO now proposes the use of strapsivir for mild or moderate COVID-19 patients who are at high risk of hospitalization.
The recommendation for the use of remdeivir in patients with severe or critical COVID-19 is currently under review.