Pfizer makes strong pitch for vaccine as US regulators debate emergency approval

By Nikhila Natarajan New York, Dec 11 : Pfizer and BioNTech made a strong pitch for their Covid-19 vaccine candidate to get emergency use approval in the US, pointing federal regulators to zero risk of infection from their mRNA vaccine, ability to scale quickly and consistent safety results from an ongoing study which recruited nearly 44,000 participants.
“mRNA vaccine can be boosted repeatedly, an important consideration when persistence of vaccine immunity is not yet known. They can be developed and scaled up quickly,” Kathrin Jansen, Head of Vaccine research at Pfizer, told US regulators in a historic science court-style meeting on Thursday.
William Gruber, Pfizer’s Senior Vice President of Vaccine Clinical research, listed fever, chills and pain at the injection site as the most commonly reported effects after vaccination.
Pfizer’s dash to the finish line has broken all vaccine development speed records, and on a new mRNA technology platform. The coronavirus itself isn’t there inside the mRNA vaccine.
Instead, it is embedded with a piece of genetic code that trains our bodies to recognize imminent enemy action from the spike protein on the surface of the virus. When the mRNA enters our cells, it begins to spew copies of the coronavirus’ spike protein. That prompts the immune system to churn out antibodies against the virus. In virology, generating neutralizing antibodies is a good surrogate of our bodies’ ability to protect from sickness.
Pfizer and its German partner BioNTech have reported their shots are 95 per cent effective at preventing mild to severe Covid-19 disease. The efficacy results are based on 170 infections. Only eight of the infections were among volunteers who got the vaccine; the rest were among those who got dummy shots.