Pfizer to supply UNICEF up to four million treatment courses of novel COVID-19 oral treatment for LMICs

Pfizer announced yesterday an agreement with UNICEF to supply up to four million treatment courses of its COVID-19 oral treatment, Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), to 95 Low-and Middle-Income Countries (LMICs), pending authorisation or approval. This includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the last five years, accounting for approximately 53 per cent of the world’s population.

Financial details of the agreement were not disclosed. Pfizer expects supply to be available to support orders in April 2022, and supply will continue throughout 2022, pending regulatory authorisation 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, the company said in a statement.

Paxlovid has not been approved, but has been authorised for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalisation or death, added the statement.

The emergency use of Paxlovid is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorisation revoked sooner, the statement concluded.