US advisory panel endorses Pfizer/BioNTech vaccine, setting stage for approval
Washington, D.C. – A US government panel comprised of outside experts voted 17 to 4, with one abstention, to endorse an emergency use order for a Covid-19 vaccine produced by Pfizer and BioNTech.
The panel's non-binding recommendation is one of the last steps before the US Food and Drug Administration (FDA), can issue an emergency use authorization for the vaccine, which is now expected in the coming days.
During an hours-long public hearing the panel of experts questioned Pfizer officials on the safety of the vaccine and details of the vaccine trial implementation. Some experts expressed concern that there is not enough information on the efficacy of the vaccine on teenagers ages 16 and 17.
Capping off the hearing, the committee voted on whether the benefits of the vaccine "outweigh" the risk for use in individuals 16 years of age and older.
If approved by the FDA, tens of millions of Pfizer vaccine doses would be shipped throughout the country, beginning a mass inoculation program. The US has already been pre-ordered 100 million doses, which is enough to cover 50 million people since the vaccine must be administered in two stages.
"Our challenge now is to scale up manufacturing and distribution to distribute 100 million shots in the first 100 days of my administration," president-elect Joe Biden said in a statement following the panel vote.
The death toll continues to rise as vaccine approval reaches its final stages
The final hurdles of the vaccine approval process come as the US daily death toll continues to break records, topping 3,000 people on Wednesday. The nation is in the midst of a massive surge in cases with dwindling hospital beds across the country, renewed lockdown orders in many states and a total death toll approaching 300,000 Americans.
The vaccine, which was found to be 95 per cent effective according to a Pfizer trial, is already being distributed in the United Kingdom. Canada and Israel are also among the countries to green light the vaccine.
This week, the UK's drug regulator warned that people with serious allergies should not take the vaccine after two front-line health workers suffered allergic reactions.
The vaccine, developed Pfizer and its German partner BioNTech, must be stored at temperatures around minus 94 degrees Fahrenheit, posing a logistical challenge to distribution.
Cover photo: Alfredo Garcia Saz/123RF