Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, expect annual manufacturing capacity for BNT162b2, their COVID-19 vaccine, to reach three billion doses by the end of 2021 and up to four billion doses in 2022. BioNTech provided the update as part of its second-quarter 2021 earnings results released this week (August 9, 2021).

As of July 21, 2021, BioNTech and Pfizer had shipped approximately one billion doses of BNT162b2 to more than 100 countries or territories. The companies have signed orders of more than 2.2 billion doses for delivery in 2021 and more than one billion doses for 2022 and beyond as of July 21, 2021. Further discussions for additional dose commitments are ongoing, and the companies expect order bookings to further grow, reported BioNTech.

Key supply pacts in place

Key recent order commitments include the US government purchasing an additional 200 million doses of the vaccine in late July to bring the total number of doses under an existing US supply agreement to 500 million. The companies expect to deliver 110 million of the additional doses by December 31, 2021, and the remaining 90 million doses no later than April 20, 2022. The US government also has the option to acquire an updated version of the vaccine that includes new formulations or addresses potential viral variants, if available and authorized. The 500 million doses under the existing supply agreement includes 200 million doses in 2021 and 300 million doses in the first half of 2022. The US government will donate the 500 million vaccine doses to low- and lower middle-income countries and organizations that support them. These doses are part of BioNTech’s and Pfizer’s previously announced pledge to provide two billion doses of the COVID-19 vaccine to low- and middle-income countries over the next 18 months.

In addition, in May (May 2021), BioNTech and Pfizer announced an agreement with the European Commission (EC) to supply 900 million doses to the European Union, with an option for the EC to request up to an additional 900 million doses. This brings the total number of potential doses delivered to the EC, inclusive of all agreements, to up to 2.4 billion. The EC also has the option to purchase an updated version of the vaccine that includes new formulations or addresses potential viral variants, if available and approved. All doses for the EC are planned to be manufactured in the European Union.

Key manufacturing updates

In its second-quarter earnings release, BioNTech also summarized recent updates to its manufacturing activity. In the second quarter of 2021, the European Medicines Agency approved the manufacturing of the COVID-19 vaccine drug product at BioNTech’s facility in Marburg, Germany. This manufacturing facility has annual production capacity of up to one billion doses of the COVID-19 vaccine, once fully operational. The first batches of vaccines manufactured at the Marburg facility were delivered in mid-April 2021.

In addition, in May (May 2021), BioNTech announced plans to establish an integrated mRNA manufacturing facility in Singapore with support from the Singapore Economic Development Board, as well as plans to establish its first regional headquarters for Southeast Asia. The new facility will produce a range of mRNA vaccines and therapeutics and will have estimated annual capacity of several hundred million doses to provide regional and global supply capacity.

In addition, last month (July 2021), BioNTech and Pfizer announced the signing of a letter of intent with Biovac, a Cape Town-based, South African bio/pharmaceutical company, for the manufacture of vaccine for distribution within the African Union. Biovac will perform fill–finish manufacturing and distribution activities within BioNTech’s and Pfizer’s global COVID-19 vaccine supply chain and manufacturing network. Biovac’s Cape Town facility is expected to be incorporated into the vaccine supply chain by the end of 2021. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55-member states that make up the African Union.

Source: BioNTech