The World Health Organisation (WHO) has announced that it strongly recommended use of nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at the highest risk of hospital admission.
WHO, in a statement from Geneva, said the oral antiretroviral drug was developed by Pfizer and is the best therapeutic choice for high-risk patients to date.
The UN health agency said a highly successful COVID-19 therapy should be made available to more people, calling for wider distribution and greater transparency surrounding its pricing.
It, however, noted that availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, were turning this life-saving medicine into a major challenge for low- and middle-income countries.
Paxlovid is strongly recommended for patients with non-severe COVID-19 who were at the highest risk of developing severe disease and hospitalisation, such as unvaccinated, older, or immunosuppressed persons.
The recommendation was based on new data from two randomised controlled trials involving more than 3,000 patients.
Risk of hospitalisation was reduced by 85 per cent and in a high-risk group, that means 84 fewer hospitalisations per 1,000 patients.
Use for patients at lower risk was not recommended as the benefits were found to be negligible.
One obstacle for low- and middle-income countries was that the medicine could only be administered while the disease was at its early stages, making prompt and accurate testing essential for successful outcomes.
“Improving access to early testing and diagnosis in primary health care settings will be key for the global rollout of this treatment,” WHO said.
The UN agency also feared that when it came to access, poorer countries “will again be pushed to the end of the queue”, as occurred with COVID-19 vaccines.
Furthermore, lack of transparency on the part of the originator was making it difficult for public health organisations to obtain an accurate picture of the medicine’s availability, as well as which countries were involved in bilateral deals and what they were paying.
Additionally, a licensing agreement between Pfizer and the UN-backed Medicines Patent Pool (MPP) limited the number of countries that could benefit from generic production of the medicine.
Paxlovid would be included in the WHO prequalification list as of Friday, but generic products were not yet available from quality-assured sources.
Prequalification meant that WHO had assessed a medication and it met international standards, thus making it eligible for procurement by national health authorities.
Several companies, many of which were covered by the licensing agreement, were in discussions with WHO Prequalification but might take some time to comply with international standards so that they could supply the medicine internationally.