Pfizer Inc and its partner
BioNTech on Monday said their experimental vaccine has proven more than 90%
effective in preventing COVID-19 based on initial data from a large study.
The announcement represents a
major victory in the fight against a pandemic that has killed over 1.2 million
people, roiled the world’s economy and upended daily life.
Pfizer and the German partner
BioNTech SE are the first drugmakers to show successful data from a large-scale
clinical trial of a coronavirus vaccine.
The companies said they have so
far found no serious safety concerns and expect to seek U.S. emergency use
authorisation later this month.
If authorised, the number of
vaccine doses will initially be limited.
Many questions also remain
including how long the vaccine will provide protection.
However the news provides hope
that other vaccines in development against the novel coronavirus may also prove
effective.
“Today is a great day for science
and humanity,” Albert Bourla, Pfizer’s chairman and chief executive, said in a
statement.
“We are reaching this critical
milestone in our vaccine development program at a time when the world needs it
most with infection rates setting new records, hospitals nearing over-capacity
and economies struggling to reopen.”
Pfizer expects to seek broad U.S.
emergency use authorisation of the vaccine for people aged 16 to 85. To do so,
it will need to have collected two months of safety data on around half of the
study’s roughly 44,000 participants, expected in late November.
“I’m near ecstatic,” Bill Gruber,
one of Pfizer’s top vaccine scientists, said in an interview.
“This is a great day for public
health and for the potential to get us all out of the circumstances we’re now
in.”
Pfizer said the interim analysis
was conducted after 94 participants in the trial developed COVID-19, examining
how many of them received the vaccine versus a placebo.
The company did not break down
exactly how many of those who fell ill received the vaccine.
Still, over 90% effectiveness
implies that no more than 8 of the 94 people who caught COVID-19 had been given
the vaccine, which was administered in two shots about three weeks apart.
The efficacy rate is well above
the 50% effectiveness required by the U.S. Food and Drug Administration for a
coronavirus vaccine.
To confirm its efficacy rate,
Pfizer said it will continue the trial until there are 164 COVID-19 cases among
participants.
Given the recent spike in U.S.
infection rates, that number could be reached by early December, Gruber said.
The data have yet to be
peer-reviewed or published in a medical journal. Pfizer said it would do so
once it has results from the entire trial.
Pfizer and BioNTech have a $1.95
billion contract with the U.S. government to deliver 100 million vaccine doses
beginning this year.
They have also reached supply
agreements with the European Union, the UK, Canada and Japan.
To save time, the companies began
manufacturing the vaccine before they knew whether it would be effective. They
now expect to produce up to 50 million doses or enough vaccine to protect 25
million people this year.
Pfizer said it expects to produce
up to 1.3 billion doses of the vaccine in 2021.
The global race for a vaccine has
seen wealthier countries forge multibillion-dollar supply deals with drugmakers
like Pfizer, AstraZeneca Plc and Johnson & Johnson Inc, raising questions
over when middle income and poorer nations will get access to inoculations.
The U.S. quest for a vaccine has
been the Trump administration’s central response to the pandemic.
The United States has the world’s
highest known number of COVID-19 cases and deaths with more than 10 million
infections and more than 237,000 fatalities.
President Donald Trump repeatedly
assured the public that his administration would likely identify a successful
vaccine in time for the presidential election, held last Tuesday.
On Saturday, Democratic rival Joe
Biden was declared the winner.
Reported by Reuters/NAN
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