A Food
and Drug Administration panel granted Pfizer an emergency
use authorization for its COVID-19 vaccine.
The
Vaccines and Related Biological Products Advisory Committee had been meeting
for hours before making its decision. It must now be approved
by the full FDA.
The
panel approval comes amid lingering questions surrounding the vaccine, including
the term of immunity and if there are any long-term side effects from it. The FDA insists that the review process has been
rigorous.
“The
American public demands and deserves a rigorous, comprehensive and independent
review of the data. And that's what FDA physicians
and scientists -- all of us career public health servants -- have been doing
over days, nights, weekends," says Dr. Doran Fink, the agency’s vaccine
deputy director.
Pfizer
says its vaccine works 95% of the time. So far, it's only resulted in minor
side effects.
Among
those pushing the hardest for approval are volunteers who tested the vaccine.
Evan Fein signed up as a participant at NYU Hospital, and said he “never felt
like a guinea pig.”
He
told the committee that withholding the vaccine would be
“immoral." He was asked if there were any long-term side effects from the
vaccine:
“It's
been more than five months now since my first shot, and I can happily
report that there are none,” he said.
Fein
was one of 43,000 people who either got the vaccine or a placebo. Some of them
were tested at Clinical Research Consulting in Milford.
But
Pfizer still doesn't know about long-term side effects. Doctors asked the FDA how the government will monitor
the vaccine for problems.
"It is one big human experiment,” says Kim Witczak, a drug
safety advocate. “The only ones that have 100% immunity in this will be the
pharmaceutical companies. They get all the benefits of sales without any of the
legal liability should something go wrong."
This
week, Great Britain warned severely allergic patients to avoid the Pfizer
vaccine for now after two patients developed serious reactions. But with
COVID-19 cases skyrocketing, the FDA knows
that time is running out.
Connecticut is expected to get 31,000 in its first batch.