WHO recommends Pfizer’s Paxlovid for wide geographical distribution

The World Health Organisation (WHO) has recently made a strong recommendation for Nirmatrelvir and Ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at the 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 (LMICs).

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 the highest risk of developing severe disease and hospitalisation, such as unvaccinated, older, or immunosuppressed patients, WHO said in a statement.

It also said that this recommendation is based on new data from two randomised controlled trials involving 3,078 patients. The data show that the risk of hospitalisation is reduced by 85 per cent following this treatment.

WHO suggests against its use in patients at lower risk, as the benefits were found to be negligible, according to the statement.

One obstacle for LMICs 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 healthcare settings will be key for the global rollout of this treatment, the statement added.

Further, as per the statement, WHO is concerned that — as occurred with COVID-19 vaccines — LMICs 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 organisations 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 (MPP) limits the number of countries that can benefit from generic production of the medicine.

Along with the strong recommendation for the use of Nirmatrelvir and Ritonavir, WHO has also updated its recommendation on Remdesivir, another anti-viral medicine, the statement further noted.

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 hospitalisation.

The recommendation for use of Remdesivir in patients with severe or critical COVID-19 is currently under review, the statement concluded.