Pfizer Inc on Monday said itsexperimental vaccine was more than 90% effective in preventingCOVID-19 based on initial data from a large study, a majorvictory in the fight against a pandemic that has killed over 1million people, roiled the world’s economy and upended dailylife.
Pfizer and German partner BioNTech SE are the firstdrugmakers to show successful data from a large-scale clinicaltrial of a coronavirus vaccine. The companies said they have sofar found no serious safety concerns and expect to seek U.S.emergency use authorization later this month.
If authorized, the number of vaccine doses will initially belimited. Many questions also remain including how long thevaccine will provide protection. However the news provides hopethat other vaccines in development against the novel coronavirusmay also prove effective.
“Today is a great day for science and humanity,” AlbertBourla, Pfizer’s chairman and chief executive, said in astatement. “We are reaching this critical milestone in ourvaccine development program at a time when the world needs itmost with infection rates setting new records, hospitals nearingover-capacity and economies struggling to reopen.”
Pfizer expects to seek broad U.S. emergency useauthorization of the vaccine for people aged 16 to 85. To do so,it will need to have collected two months of safety data onaround half of the study’s roughly 44,000 participants, expectedin late November.
“I’m near ecstatic,” Bill Gruber, one of Pfizer’s topvaccine scientists, said in an interview. “This is a great dayfor public health and for the potential to get us all out of thecircumstances we’re now in.”
Pfizer said the interim analysis was conducted after 94participants in the trial developed COVID-19, examining how manyof them received the vaccine versus a placebo.
The company did not break down exactly how many of those whofell ill received the vaccine. Still, over 90% effectivenessimplies that no more than 8 of the 94 people who caught COVID-19had been given the vaccine, which was administered in two shotsabout three weeks apart.
The efficacy rate is well above the 50% effectivenessrequired by the U.S. Food and Drug Administration for acoronavirus vaccine.
To confirm its efficacy rate, Pfizer said it will continuethe trial until there are 164 COVID-19 cases among participants.Given the recent spike in U.S. infection rates, that numbercould be reached by early December, Gruber said.
The data have yet to be peer-reviewed or published in amedical journal. Pfizer said it would do so once it has resultsfrom the entire trial.
Pfizer and BioNTech have a $1.95 billion contract with theU.S. government to deliver 100 million vaccine doses beginningthis year. They have also reached supply agreements with theEuropean Union, the UK, Canada and Japan.
To save time, the companies began manufacturing the vaccinebefore they knew whether it would be effective. They now expectto produce up to 50 million doses or enough vaccine to protect25 million people this year.
Pfizer said it expects to produce up to 1.3 billion doses ofthe vaccine in 2021.
The global race for a vaccine has seen wealthier countriesforge multibillion-dollar supply deals with drugmakers likePfizer, AstraZeneca Plc and Johnson & Johnson Inc, raising questions over when middle income and poorernations will get access to inoculations.
The U.S. quest for a vaccine has been the Trumpadministration’s central response to the pandemic. The UnitedStates has the world’s highest known number of COVID-19 casesand deaths with more than 10 million infections and more than237,000 fatalities.
President Donald Trump repeatedly assured the public thathis administration would likely identify a successful vaccine intime for the presidential election, held last Tuesday. OnSaturday, Democratic rival Joe Biden was declared the winner.
Vaccines are seen as essential tools to help end the healthcrisis that has shuttered businesses and left millions out ofwork. Millions of children whose schools were closed in Marchremain in remote learning programs.
Dozens of drugmakers and research groups around the globehave been racing to develop vaccines against COVID-19, which onSunday exceeded 50 million infections since the novelcoronavirus first emerged late last year in China.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA)technology, which relies on synthetic genes that can begenerated and manufactured in weeks, and produced at scale morerapidly than conventional vaccines.
Moderna Inc, whose vaccine candidate employssimilar technology, is expected to report results from itslarge-scale trial later this month. The mRNAtechnology is designed to trigger an immune response withoutusing pathogens, such as actual virus particles.
Pfizer alone will not have the capacity to immediatelyprovide enough vaccines for the entire United States. The Trumpadministration has said it will have enough supply for all ofthe 330 million U.S. residents who wish to be vaccinated by themiddle of 2021.
The U.S. government has said the vaccines will be providedfor free to Americans, including the insured, uninsured andthose in government health programs such as Medicare