Pfizer Says Success of its COVID-19 Vaccine Trial Signals Breakthrough in Battle Against the Virus
Pfizer, Inc. announced on Monday its PFE.N experimental COVID-19 vaccine is more than 90-percent efficient based on preliminary trial results.
In a Reuters report, the drugmaker also said this is a major victory in the battle against a virus that has claimed the lives of more than 1.2 million people worldwide, not to mention battered the global economy.
Also, according to the report, scientists, public health officials, as well as investors welcomed the pioneering successful interim data from a "large-scale clinical trial as a watershed moment" that could aid turn the tide of the pandemic when the trail results get completed.
Nevertheless, mass roll-outs, which require regulatory approval, are reportedly not going to happen this year, and several vaccines are perceived as required to meet massive needs worldwide.
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A woman holds a small bottle labeled with a ‘Coronavirus COVID-19 Vaccine’ sticker and a medical syringe in front of the displayed Pfizer logo
To Seek EUA
Pfizer, together with BioNTech SE 22UAy.F, its German partner said, they did not find any "serious safety concerns yet," and that they are expecting to seek the United States emergency use authorization or EUA this month, increasing the chance "of a regulatory decision as soon as December."
If approved, the firms approximate that they can roll out a maximum of 50 million doses this year, adequate enough to shield about 25 million people, and then produce a maximum of 1.3 billion doses next year.
According to Albert Bourla, Pfizer Chief Executive, this data milestone comes with "infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen."
And, even though experts were saying they wanted to see the complete trial data, the initial results already looked encouraging.
The University of Oxford emerging infectious disease professor Peter Horby said, "It is a relief to see" such positive outcomes on this vaccine. It promises well, in general, for COVID-19 vaccines.
Pfizer is expecting to seek US EUA for people whose age ranges from 16 to 85. To be authorized, reports said it would need two months "of follow-up safety data" to guarantee no side effects would appear. Therefore, that's expected to be available in the third week of this month.
According to Alex Azar, the US Health and Human Services Secretary, it would take several weeks for regulators in the US to receive and process data prior to a probable approval.
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Vaccine for Up to 65 Percent of the Population Needed
In an interview, one of Pfizer's top vaccine researchers, Bill Gruber, said, "This is a great day for public health" and for the possibility of "getting us all out of the circumstances we're now in."
Meanwhile, Jens Spahn, health minister of Germany, said from 55 to 65 percent of the population would need vaccination to break the dynamic of the transmission of COVID-19. The official also added he was not expecting a "shot to be available before the first quarter of next year.
The European Union, on the other hand, said on Monday, it would soon be signing "a contract for a maximum of 300 million doses of Pfizer and BioNTech vaccine."
The firms, Reuters report indicates, have a contract worth $1.2 billion with the US government for the delivery of 100 million vaccine doses starting this year.
Furthermore, the drug manufacturers have reached supply agreements as well, with the United Kingdom, Canada, and Japan.
More Than 90 Percent Effective
The interim analysis, done after more than 90 participants in the trial, developed COVID-19, and examined the number of individuals who had been given the vaccine against a placebo.
Pfizer did not give any detail, although more than 90-percent efficient suggests that no more than eight of the 94 participants were given the vaccine, administered in two shots with an interval of about three weeks.
The efficiency rate, which could decline once complete results become available, is well more than 50 percent effectiveness, which the US Food and Drug Administration requires for a COVID-19 vaccine.
Shortly after the announcement of Pfizer, Russia also said it is the Sputnik V vaccine was more than 90-percent effective as well, based on data gathered from "inoculations of the public." Its initial Phase III trial data is due for publishing this month.
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Nov 10, 2020 06:00 AM EST
