Pfizer/BioNTech has announced that it will submit a new crown vaccine EUA application for Phase 3 clinical end

Ten severe cases of COVID-19 were observed in the trial, 9 in the placebo group and 1 in the BNT162b2 vaccination group.
, the study's data monitoring committee has not reported any serious vaccine-related safety issues.
Review of the original data on the debunked response to the final analysis (including a random subset of at least 8,000 subjects aged 18 and over in phase 2/3 clinical studies) showed good vaccine tolerance, with most adverse events fading shortly after vaccination.
the first or second vaccination, the rate of ≥2% of level 3 adverse events was fatigue (3.8%) and headache (2.0%) after the second vaccination.
were consistent with earlier shared results, and older adults tended to report fewer and lighter adverse events after vaccination.
, Pfizer and BioNTech also announced that the FDA-required Emergency Use Authorization (EUA) security milestone had been reached.
plan to submit an EUA application to the FDA within days, based on all safety and ability data collected so far, as well as production data related to vaccine quality and consistency.
data will also be submitted to other regulators around the world.
"s findings mark an important step in this historic eight-month journey to come up with a vaccine that could help end this devastating pandemic.
continue to move forward at a scientific pace, sharing all data collected so far with regulators around the world.
," said Dr. Albert Bourla, Pfizer's chairman and chief executive.
with hundreds of thousands of people infected every day around the world, we urgently need to provide the world with a safe and effective vaccine," he said.
" We are pleased that the first global trial to achieve the final efficacy analysis mark has shown that the high protection rate of COVID-19 can be achieved very quickly after the first dose of the 30 g dose, highlighting the power of BNT162b2 in providing early protection," said Dr. Uur Sahin, CEO and co-founder of BioNTech.
" highlight the potential of mRNA as a new class of drugs.
our goal from the start was to design and develop a vaccine that is fast and powerful for COVID-19 and has good tolerance for all ages.
believe that our candidate vaccine, BNT162b2, has achieved this in all age groups studied to date and look forward to sharing more details with regulators.
" References: Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints. Retrieved 2020-11-18, from Source: Supplied