“The Pfizer vaccine is based on RNA, small snips of genetic material with the instructions to make coronavirus spike proteins once injected into a body,” said Paula Cannon, Distinguished Professor of Molecular Microbiology & Immunology at the Keck School of Medicine of USC. “But RNA is very unstable, and the vaccine needs to be at extremely low temperatures all the time.
“This creates a problem both for transportation, as well as storage in a pharmacy or doctor’s office. Initial rollout may well be restricted to large centers that can provide this temperature capability. Hoped-for advances in the chemistry of RNA may provide a version in the future that is stable under less extreme temperatures.”
Any vaccine must be assessed for safety and efficacy
“The company would likely seek an Emergency Use Authorization from the U.S. Food and Drug Administration based on the results of the interim analysis,” said Eunjoo Pacifici, an associate professor and chair of the department of regulatory and quality sciences at the USC School of Pharmacy. “According to the FDA guidance document, the agency expects to convene an open session of its advisory committee meeting to discuss the adequacy of available safety and effectiveness data to support the authorization.”
“The FDA has provided the industry with clear guidance outlining the requirements for safety and effectiveness before a vaccine is authorized for emergency use. It is important to keep in mind that the only way to ensure long term safety efficacy of a product is to assess safety and efficacy long term.”
Pfizer’s was a ‘high risk, high reward effort’
“Unlike other drug companies contracting with the United States under Operation Warp Speed for the development of a COVID-19 vaccine, Pfizer (and its German partner BioNTech SE) took no money for R&D,” said Shon Hiatt, an associate professor at the USC Marshall School of Business who researches entrepreneurship, strategy, regulatory affairs, and business sustainability.
“This has freed the company from not only bureaucratic red tape during its Phase 1-3 trials that could have slowed the process, but also reduces the potential for future litigation against ownership issues and application of IP developed from the vaccine. Under Operation Warp Speed, Pfizer signed a $1.95 billion contract with U.S. government for distribution of 100 million doses, and can negotiate a contract for another 500 million more doses.
“So far, Pfizer has invested over $1.5 billion in the development of the vaccine. This was a high risk, high reward effort with an extremely quick drug development time period. If the high efficacy stands, this could be a financial win for Pfizer and even a greater reputational win for the company.”
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