Multinational drugmaker Pfizer came in for the carrot and stick treatment from the World Health Organization over its anti-viral Paxlovid, given to mild and moderate Covid-19 patients with the highest risk of hospitalisation.

The UN health agency made a strong recommendation for nirmatrelvir and ritonavir, sold as Paxlovid by Pfizer, calling it “the best therapeutic choice for high-risk patients to date.”

However, the WHO said, “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.”

Prequalified list

Paxlovid will now be on WHO’s prequalified list, making it easy for countries to adopt the drug. 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 Ppequalification but may take some time to comply with international standards,” WHO added.

At least 19 Indian companies are part of the sub-licensing deal with medicines patent pool to make the drug. The WHO has called on Pfizer “to make its pricing and deals more transparent and to enlarge the geographical scope of its licence with the medicines patent pool so that more generic manufacturers may start to produce the medicine, making and make it available faster and at affordable prices.” Paxlovid is being recommended for patients with non-severe Covid-19 who are at highest risk of developing severe disease and hospitalisation, such as the unvaccinated, older, or immunosuppressed patients. The WHO recommendation comes on the back of 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. In a high-risk group (over 10 per cent risk of hospitalisation), that means 84 fewer hospitalisations per 1,000 patients,” the WHO said.

The agency did not suggest its use in patients at lower risk, as the benefits were found to be negligible.

BusinessLine reached out to Pfizer on concerns raised by the WHO, a response is awaited.

End of the queue

Fearing a repeat of inequities, WHO said it was “extremely concerned that — as 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 by 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, the WHO said. Further, it added, the licensing agreement made by Pfizer with the medicines patent pool limited the number of countries that can benefit from generic production of the medicine.

WHO on remdesivir

WHO also updated its recommendation on remdesivir, another antiviral medicine. Following publication of new data from a clinical trial looking at the outcome of admission to hospital, WHO now suggests the use of remdesivir in mild or moderate Covid-19 patients who are at high risk of hospitalisation, the agency said. It had earlier advised against its use in Covid patients.

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