« The potential of a vaccine like this is nothing short of a miracle, » Robin Feldman, a professor at the University of California Hastings College of the Law, who focuses on the pharmaceutical industry and pharmaceutical policy, wrote in an email to NPR. « The government, however, is spending the store – achieving critical short-term goals, but ignoring serious long-term costs. » « As a company founded in the heart of Europe, we look forward to supplying millions of people with the approval of the authorities. We would like to thank the Commission and the Member States for their support and confidence in our COVID 19 vaccines. Our goal is to develop a safe and effective vaccine that helps end this pandemic. It is only through collective efforts that we will be able to do so, » said Ugur Sahin, CEO and co-founder of BioNTech. Normally, federal funding contracts for the development of a bayh-dole drug or vaccine include rights that allow the government to adopt a drug or vaccine if the manufacturer that has received federal funding cannot or does not want to manufacture its product on reasonable terms. « We are committed to making the impossible possible by working tirelessly to develop and produce a safe and effective vaccine in record time to end this global health crisis, » said Dr. Albert Bourla, President and Chief Executive Officer of Pfizer, in a press release. « Pre-emption contracts were a way to acquire vaccines and counter-measures against certain threats that pharmaceutical companies have traditionally kept out of, » he said. Recently, two of the company`s four vaccine candidates (BNT162b1 and BNT162b2) were given the fast-track name of the U.S. Food and Drug Administration . This term was given on the basis of preliminary data from phase 1/2 studies currently underway in the United States and Germany, as well as on animal immunogenicity studies.
Further data from the ongoing Phase 1/2 clinical studies of the four vaccine candidates will be used to select a primary candidate and dose level for a large overall safety and efficacy study of Phase 2b/3 expected, which may begin this month until no marketing authorization is available. The New York Times first reported on Monday negotiations on other doses and said Pfizer was offering the U.S. government between 100 million and 500 million additional doses and warned that its vaccine could be rare given demand worldwide. As a result, a second allocation for the United States could not be available until June of next year. Baldassarre defended contract negotiations under Operation Warp Speed and argued that the Ministry of Defence had researched intellectual property prior to any agreement. « We are not aware of previous U.S. government funding of intellectual property, which is used by Pfizer and BioNTech. This contract was written to reflect this fact, not to repeal it. Nevertheless, the treaty seems to contradict itself.
While he says public funds are not used for research and development, he also says that the company will retain any technology it develops as part of the agreement and that these inventions will become trade secrets. Another description of risks and uncertainties is contained in Pfizer`s Management Report on Form 10-K for the year ended December 31, 2019 and in subsequent Reports on Form 10-Q, including « Risk Factors » and « Forward-Looking Information and Factors That May Future Future Results, » as well as in subsequent Reports on Form 8-K, which are presented to all United States.