Pfizer/BioNTech to Supply 40 Million Vaccine Doses to WHO’s COVAX Program

Pfizer and BioNTech have struck a supply deal with the World Health Organization (WHO)-backed COVAX program, pledging to ship up to 40 million doses of their COVID-19 vaccine this year for an undisclosed price.

“The urgent and equitable roll-out of vaccines is not just a moral imperative, it is also a strategic and economic imperative,” said WHO Director-General Tedros Adhanom Ghebreyesus. “We will only be safe anywhere if we are safe everywhere,” added Seth Berkley, CEO of Gavi, the Vaccine Alliance, which is responsible for administering the COVAX initiative.

COVAX previously secured supply agreements with other vaccine developers for a total of 2 billion doses of vaccines, with 1.3 billion doses specifically allocated for 92 lower-income nations. The contracts include 170 million doses of the AstraZeneca (AZ)/Oxford University vaccine and 500 million doses of a single-dose vaccine from Johnson & Johnson (DID, Dec. 21, 2020).

COVAX has had to lower its vaccination targets. It originally aimed to inoculate two-thirds of the world’s population by the end of 2021, but now says it hopes to vaccinate 20 percent of each participating nation’s population, with deliveries planned to start this quarter.

Given the logistical issues associated with its ultra-cold shipping and storage requirements, Pfizer and BioNTech said they are studying the supply chains in developing nations and working with international agencies to ensure that the doses reach vulnerable groups.

Also on Friday, COVAX said it would exercise its option with the Serum Institute of India for an initial 100 million doses of the AstraZeneca/Oxford University vaccine and anticipates getting 50 million further doses directly from AstraZeneca. The doses will be delivered early this year contingent upon the vaccine receiving a WHO Emergency Use Listing, which is expected by mid-February. The WHO granted the Pfizer/BioNTech vaccine an emergency listing earlier this month (DID, Jan. 4).

Russia and the U.S. are now the only major powers not participating in the COVAX program, but the Biden administration has announced plans to join and is seeking billions of dollars for the initiative in addition to the $4 billion Congress previously earmarked for Gavi (DID, Jan. 21).

Competition with wealthy countries for vaccine supplies is likely to be an ongoing challenge for COVAX, as will any interruptions in supply. Pfizer, for example, has temporarily reduced its shipments in Europe as it upgrades its Belgian product facility (DID, Jan. 22) and AstraZeneca has announced that it will cut its initial deliveries to Europe by 60 percent because of production issues.

“While there is no scheduled delay to the start of shipments of our vaccine should we receive approval in Europe, initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain,” an AZ spokesperson told FDAnews.

European regulators are expected to grant a conditional authorization for the AZ vaccine soon after a Jan. 29 expert panel meeting. And the company said it expects to be “supplying tens of millions of doses in February and March to the European Union.” ― Jason Scott