WHO backs Pfizer’s Paxlovid in high-risk COVID, raises concerns on drug access, pricing

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The World Health Organization (WHO) recommended the use of Pfizer’s (NYSE:PFE) antiviral pill Paxlovid to treat patients with mild and moderate COVID-19 who are at the highest risk of hospital admission.

The WHO suggested against not to use the drug in patients at lower risk, as the benefits were found to be negligible, the agency said in an April 22 press release.

The WHO called the drug ‘best therapeutic choice for high-risk patients to date’ but 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, are turning the therapy into a major challenge for low- and middle-income countries.

The agency said Paxlovid (a combination of nirmatrelvir and ritonavir) was recommended for patients with non-severe COVID-19 who are at highest risk of developing severe disease and hospitalization, such those not vaccinated, older or immunosuppressed patients.

The recommendation was backed by new data from two trials involving 3,078 patients. The data showed that the risk of hospitalization reduced by 85% after taking the drug.

The WHO, however, noted that it was concerned that — as occurred with COVID-19 vaccines — low- and middle-income countries will again be pushed to the end of the line when in terms of access to the therapy.

Lack of transparency on the part of the originator company was making it difficult for public health organizations to get accurate information on the availability of the drug, which countries are involved in bilateral deals and the price they are are paying for the drug, the agency added.

In addition, the WHO noted that a licensing agreement made by Pfizer with the Medicines Patent Pool has limited the number of countries that can benefit from generic production of the drug.

The agency said Paxlovid, will be included in the WHO prequalification list but its generic is not yet available. Several generic companies (several of which are covered by the licensing deal between Pfizer and Medicines Pool) are in discussion with WHO Prequalification but may take time to comply with international standards to supply the drug internationally.

WHO urged Pfizer to make its pricing and deals more transparent and to enlarge the geographical scope of the license with the Medicines Patent Pool so that more generic drugmakers may start to produce the therapy and make it available at affordable prices.

In March, it was reported that Pfizer (PFE) was expected to provide ~10M courses of Paxlovid to low and middle-income nations in 2022. Separately, Pfizer had agreed to supply Paxlovid to Africa Centres for Disease Control and Prevention.

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