Pfizer has announced an agreement with the United Nations Children's Fund (UNICEF) to supply up to 4m treatment courses of its Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), to 95 low- and middle-income countries, pending authorization or approval. The agreement covers all low- and lower-middle-income countries, some upper-middle-income countries in Sub-Saharan Africa, and countries that have transitioned from lower- to upper-middle-income sometime during the last five years—accounting for an estimated 53% of the world’s population.
Pfizer reportedly expects the supply of up to 4m treatment courses to be available to support orders in April 2022 and continue throughout the year, pending regulatory authorization or approval and according to country needs. All low- and lower-middle-income countries will be offered the treatment courses at the not-for-profit price, while upper-middle-income countries will pay the price defined in Pfizer’s tiered pricing approach.
Albert Bourla, Pfizer chairman and CEO, said, “We have seen the negative impacts of COVID-19 in every part of the world and know that we must work towards access for all people regardless of where they live or their circumstances. Supplying to UNICEF is an important part of our comprehensive strategy to accelerate access to PAXLOVID to treat COVID-19 infection as quickly as possible and at an affordable price in order to decrease the strain on healthcare systems and help save lives in low- and middle-income countries.”
According to Pfizer, the company has elevated its production projections from previous estimates to up to 120m courses of treatment total by the end of 2022, pending demand around the globe. Additionally, it has reached out to more than 100 countries around the world and entered into agreements with a number of them.
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. The company reportedly developed it as an orally administered treatment in order to allow it to be able to be prescribed at the first sign of infection or, pending clinical success of the rest of the EPIC development program and subject to regulatory authorization, at first awareness of an exposure.
Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir reportedly helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.
Paxlovid generally is administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice daily for five days. One carton contains five blister packs of the drug, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.