US FDA advisory panel gives green light to Pfizer Covid-19 vaccine; FDA considering its emergency use
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Washington/Canadian-Media: Pfizer’s Covid-19 vaccine has been recommended by a panel of experts composed of independent scientific experts, infectious disease doctors and statisticians to the United States (US) Food and Drug Administration (FDA) on Dec 10 to authorize the vaccine for use in the US, media reports said.
Pfizer-BioNTech's COVID-19 vaccine. Image credit: ContactPharma.com
There is a likelihood that within day FDA would also give a green light to Pfizer’s Covid-19 vaccine of use in the US and that the health care workers and nursing home residents would be prioritized in getting the first shots early next week.
The FDA is expected to grant an emergency use authorization on Saturday in an effort to slow the spread of the virus with infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday.
The initial shipment of 6.4 million doses will leave warehouses within 24 hours subject to the FDA approval according to federal officials.
“With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer, said at the meeting.
When asked the US federal officials about the adverse reactions of this vaccine, Pfizer officials said that in the trial of 44,000 participants, there were no cases of serious allergic reactions adding that people with a history of allergic reactions to vaccines were excluded from the study.
At the same time, the US health regulators were also evaluating an equally complex emergency authorization application submitted by Moderna, whose data will be examined publicly during another FDA outside advisory meeting next week.