WHO recommends very successful COVID-19 therapy and calls for wide geographical distribution and transparency from originals

Today, the WHO gave a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, to mild and moderate patients with COVID-19 at the highest risk of hospital admission, calling them the best therapeutic choice for high-risk patients to date. However, availability, the lack of price transparency in bilateral agreements concluded by the manufacturer, and the need for rapid and accurate testing before its application, make this life-saving drug a major challenge for low- and middle-income countries.

Pfizer’s oral antiviral agent (a combination of nirmatrelvir and ritonavir tablets) is strongly recommended for patients with mild COVID-19 who are at highest risk of developing severe disease and hospitalization, such as unvaccinated, elderly or immunosuppressive patients.

This recommendation is based on new data from two randomized controlled trials involving 3,078 patients. The data show that the risk of hospitalization after this treatment is reduced by 85%. In the risk group (over 10% of the risk of hospitalization) this means 84 hospitalizations less per 1000 patients.

The WHO does not suggest its use in patients at lower risk, as the benefits have been found to be negligible.

One of the barriers for low- and middle-income countries is that the drug can only be given while the disease is at an early stage; rapid and accurate testing is therefore essential for a successful outcome of this therapy. Data collected by FIND show that the average daily testing rate in low-income countries is as much as one-eightieth rate in high-income countries. Improving access to early testing and diagnosis in primary care facilities will be key to the global introduction of this treatment.

The WHO is extremely concerned that – as has happened with the COVID-19 vaccines – low- and middle-income countries will once again be pushed to the end of the waiting list when it comes to access to this treatment.

The lack of transparency by the originator company makes it difficult for public health organizations to get an accurate picture of the availability of the drug, which countries are involved in bilateral affairs and what they pay for. In addition, a licensing agreement made by Pfizer with the Pool of Drug Patents limits the number of countries that can benefit from generic drug production.

The original product, sold under the name Paxlovid, will be included in the World Health Organization’s prequalification list today, but generic products are not yet available from a guaranteed quality source. Several generic companies (many of which are covered by a licensing agreement between Medicines Pool and Pfizer) are in discussion with the WHO for prequalification, but it may take some time to comply with international standards to be able to deliver the drug internationally.

The WHO therefore strongly recommends that Pfizer make its prices and operations more transparent and expand the geographical scope of its license with Half Patent Patents so that more generic manufacturers can start producing the drug and make it available faster at affordable prices.

In addition to strongly recommending the use of nirmatrelvir and ritonavir, the WHO has also updated its recommendation on remdesivir, another antiviral drug.

Previously, the WHO suggested against its use in all patients with COVID-19, regardless of the severity of the disease, due to the totality of evidence at the time showing little or no effect on mortality. Following the release of new data from a clinical trial observing hospital outcomes, the WHO updated its recommendation. The WHO is now proposing the use of remdesivir in mild or moderate patients with COVID-19 who are at high risk of hospitalization.

The recommendation for the use of remdesivir in patients with severe or critical COVID-19 is currently under revision.