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Latest results of Phase 3 clinical trials of your vaccine for the disease COVID-19, BNT162b1, are published by Pfizer / BioNTech, according to which it is observed 95% efficiency versus SARS-CoV-2.
This new data paves the way for an urgent authorization request to the US Food and Drug Administration (FDA) in the coming days.
Remember that only on Monday Moderna announced 94.5% efficacy of its own vaccine.
Based on the latest clinical data from the Pfizer / BioNTech Phase 3 clinical trials, BNT162b1 appears to protect all age groups without significant safety concerns in the total of 44,000 volunteers participating in clinical trials.
A week ago Pfizer / BioNTech had reported that in a sample of 94 confirmed cases of COVID-19 infection, the vaccine was 90% effective. Now they report data from 170 confirmed COVID-19 cases: only eight participants who were vaccinated got sick, while in the placebo group 162 volunteers got sick.
BNT162b1 prevented the onset of severe COVID-19 disease, and nine out of ten severe cases affected the control group.
The vaccine is more than 94% effective in people older than 65, who are often more seriously ill, according to Pfizer / BioNTech.
In the majority of volunteers, the vaccine was well tolerated and fatigue was observed in 3.7% of those vaccinated after the second dose. However, this was the only adverse reaction reported in more than 2% of the sample.
According to the announcement of the two partners, in the next few days they will submit an urgent license application to the FDA. On Tuesday, Pfizer President Dr. Albert Mockery Speaking at a conference, he said there is now evidence of the vaccine’s safety over a two-month period, as required by the FDA, to consider applying for approval of each COVID-19 vaccine.
“The final analysis of the clinical data reinforces the positive results of the medium-term efficacy analysis announced on November 9,” BioNTech CEO Ugur Sahin said in a written statement.
He adds: “The data shows that our vaccine can provide a high level of protection against COVID-19, only 29 days after the first injection. Furthermore, the vaccine was observed to be well tolerated in all age groups with mainly side effects. mild to moderate, which may be due in part to the relatively low dose given to the volunteers.
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