Report: Public Citizen Identifies Key Biochemical Components, Manufacturing Specifications of Pfizer Vaccine

WASHINGTON, D.C. – Public Citizen has identified key manufacturing information about the Pfizer COVID-19 vaccine through analysis of a contract between the drugmaker and the European Commission. The information could help mRNA vaccine scientists as it illustrates the kinds of requirements needed to meet critical quality standards, ultimately contributing to the quest to bolster global vaccine production.

“This leaked contract teaches the world more about how to make mRNA vaccines than anything done by rich countries so far,” said Zain Rizvi, law and policy researcher at Public Citizen’s Access to Medicines program and author of the report. “The Biden administration should help the world produce more vaccines by sharing the rest of the vaccine recipe.”

In November 2020, the European Commission signed an agreement with Pfizer and BioNTech to purchase 100 million doses, which was published by the Italian broadcaster RAI. Public Citizen’s analysis of the contract found the vaccine’s manufacturing specifications, which include information about the molecular and biological characteristics that are useful for assessing product safety and efficacy, the tests required to analyze these characteristics, and the acceptance criteria for test results. For example, the contract lists that the RNA concentration must be between 2.00-2.50 mg/mL. This information can advance mRNA science and, together with the rest of the “recipe”, assist in mRNA vaccine production.

“Pfizer and Moderna endanger the world’s pandemic response by blocking access to the knowledge to make mRNA vaccines,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines program.  “Scientists worldwide, with the right tools and support, could help make many more vaccine doses – but not if basic manufacturing standards are held as corporate secrets.”

In the U.S., the Biomedical Advanced Research and Development Authority and the Department of Defense have access to the rest of the Pfizer vaccine recipe under vaccine development contracts. Public Citizen contends the government should release that information to ramp up COVID vaccine production globally in exchange for reasonable compensation. This knowledge can benefit more than a dozen countries in Africa, Asia and Latin America that have expressed interest in producing their own mRNA vaccines.

Read the report here.