Pfizer makes strong pitch for vaccine as US regulators debate emergency approval
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.
Pfizer’s coronavirus vaccine is poised to become the first of several shots to get US Food and Drug Administration authorization as the US gets crushed with record deaths during a pandemic winter surge.
A 17-member independent Vaccines and Related Biological Products Advisory Committee is in the thick of picking apart data in a day-long session on Thursday to discuss whether data from the Pfizer and BioNTech vaccine is strong enough to merit emergency use authorisation.
The FDA is not required to follow the committee’s advice but all indications point towards a swift greenlighting. The US government’s vaccine czar Moncef Slaoui is confident about shipping millions of doses to states within 24 hours of FDA’s okay,
Plenty of questions have been raised in the first half of the day’s livestream, mostly relating to efficacy of the vaccine in older teens since the emergency use authorisation request covers those about 16, and indications for use in people with already low immunity.
Some of the big question marks that have been swirling ahead of Thursday’s meeting relate to the kind of protection the vaccine offers and testing scale in subsets of vulnerable populations. Could vaccinated people still spread the virus while staying asymptomatic? Were the shots adequately tested in communities of colour? What should pregnant women be told about vaccination, since they were either not tested in the Pfizer study or studies are just beginning.