Expanding COVID-19 Manufacturing Efforts to Increase Global Vaccine Access
When the COVID-19 pandemic first began, the challenge for Pfizer and BioNTech wasn’t just developing an effective vaccine and securing regulatory authorization but figuring out how we were going to produce and deliver it by the billions of doses in record time. This was no small feat, but we proved that the impossible was in fact possible. To date, Pfizer has invested more than $2 billion at risk on our COVID-19 vaccine development program – $500 million of that went toward scaling up our manufacturing capabilities, so that we were ready to supply the Pfizer-BioNTech COVID-19 vaccine when it was authorized in December 2020. Pfizer successfully manufactured over 3 billion doses of the Pfizer-BioNTech COVID-19 vaccine in 2021, and we expect we can manufacture an additional 4 billion doses in 2022.
We have continued to find ways to scale up our manufacturing capabilities to increase global vaccine supply. This includes but isn’t limited to expanding our global network to include 11 of Pfizer-owned and contractor sites, reducing the production time for a batch from 110 to 60 days, and performing ongoing stability studies, improving storage and stability to provide pharmacies and other vaccination centers greater flexibility in storing and administering the vaccine. We are also proud to share that we had a 99 percent success rate in getting our vaccine deliveries to their destinations.
Thanks to the ongoing efforts of our colleagues and partners, as of December 31, 2021 we were able to deliver more than 2.6 billion vaccines to 166 countries and territories in every region of the world. The work does not stop here though; efforts are continuously underway to further increase global vaccine supply.
We also have worked to expand our capacity by leveraging new suppliers and contract manufacturers. Pfizer and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network now spans four continents and includes more than 20 contract manufacturing organizations (CMOs) who are or will be supporting the global Pfizer-BioNTech COVID-19 vaccine supply chain. Two such contract manufacturing agreements to further accelerate access around the world announced this year include:
- In July 2021, we announced a landmark agreement with the Biovac Institute in South Africa to manufacture the Pfizer-BioNTech COVID-19 vaccine exclusively for the 55 member states that make up the African Union.
- In August 2021, Pfizer and BioNTech also announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within Latin America.
From day one of the pandemic, Pfizer’s goal has been to provide equitable access of the Pfizer-BioNTech COVID-19 vaccine to people all over the world. These international collaborations are proof points of the tireless work being done to further accelerate vaccine access to countries that need it.
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.