US panel endorses emergency use of Pfizer vaccine; over to FDA now (Ld)

A high powered vaccine advisory panel, after a marathon 9 hour debate on safety and efficacy data, has endorsed emergency use approval of the Pfizer and BioNTech’s Covid-19 vaccine for mass vaccinations of Americans.

The vaccine advisory group, in a 17-4 vote, decided that Pfizer’s shot is safe in people aged 16 and older.

The US Food and Drug Administration is expected to follow the recommendation and set the ball rolling for an epic vaccination drive in America.

Before the final vote, which came just before 6 pm EST, regulators boiled down all of their findings into a single question: Do the benefits of the Pfizer vaccine outweigh its risks for vaccination in people aged 16 and older?

The sticking point for the last one hour of the debate was around the issue of whether or not to recommend the Pfizer vaccine for 16 year olds. “The data is thinnest in this age group,” said one of the vaccine advisory members. At least three members said they would prefer vaccinations only for people older than 18.

Pfizer made a strong pitch for its vaccine for “prevention of Covid-19 in individuals 16 years and older, with or without evidence of prior infection”.

Pfizer said its overall vaccine efficacy of 95 per cent was observed in both younger and older adults as well as in diverse demographics.

“In addition, we have demonstrated a favourable safety and tolerability profile in more than 40,000 individuals,” Kathrin Jansen, Head of Vaccine research at Pfizer, told US regulators in a historic science court-style meeting Thursday.

Responding to multiple questions on efficacy in 16 and 17 year olds (the EUA has been requested for vaccinating people 16 and older), Pfizer and the FDA both suggested that efficacy in older populations could be extrapolated for older pediatric 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,” Jansen told members of FDA’s Vaccines and Related Biological Products Advisory Committee.

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.A In virology, generating neutralizing antibodies is a good surrogate of our bodiesae ability to protect from sickness.

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.

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 were raised Thursday, 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.

On December 17, the FDA is scheduled to meet to decide on another vaccine, developed by Moderna and the National Institutes of Health, that has shown efficacy on the lines of the Pfizer candidate. Johnson & Johnson and AstraZeneca vaccines are also in the pipeline.

The initial supplies from Pfizer and Moderna will be limited and reserved primarily for health care workers and nursing home patients.

The virus has killed 290,000 people in the US.

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