Pfizer's new crown vaccine completes effectiveness analysis and will submit an emergency use application soon

Pfizer and BioNTech announced Wednesday (18th) that an analysis of the effectiveness of their new Crown (COVID-19) vaccine candidate tests has been completed, showing that the vaccine is 95 percent protective.
companies said they plan to file an emergency use authorization (EUA) application with the U.S. FDA "within days" and will file an application with global regulators.
early analysis of the study announced by Pfizer and BioNTech on Monday showed that vaccines could reduce infections to more than 90 percent, two days after Moderna announced that its vaccine protection was 94.5 percent effective.
Pfizer said the final ability analysis of its ongoing Phase III study on the COVID-19 candidate vaccine BNT162b2 showed that the vaccine met all major effectiveness endpoints.
data analysis showed that the vaccine protection effectiveness among participants was 95% (p.lt;0.0001).
data analysis was based on 170 COVID-19 cases, of which 162 were in the placebo group and 8 in the BNT162b2 group.
10 cases of severe COVID-19 were observed in the study, 9 in the placebo group and 1 in the vaccine group.
consistent with the validity of age, gender, race and ethnic demographics, and more than 94 per cent of persons over 65 years of age observed.
said the study's data monitoring committee had so far failed to report serious vaccine-related safety issues.
tracked common side effects data in 8,000 patients, with severe side effects occurring in more than 2% of patients being fatigue (3.7% of patients after the second dose) and headache (2%).
older participants had fewer and lighter side effects than younger participants.
the second dose of the vaccine, about 19,000 subjects have been followed up for at least two months.
announced that it had reached the safety milestone required by the FDA for emergency use authorization (half of the patients in the study followed up after the second dose to observe safety issues for at least two months).
and BioNTech plan to file an EUA application with the FDA within a few days based on overall safety and ability data collected to date, as well as production data related to vaccine quality and consistency.
data will also be submitted to other regulators around the world.
Phase 3 clinical trial of BNT162b2 began on July 27 and has so far recruited 43,661 participants, of whom 41,135 have received a second dose as of November 13, 2020.
about 42% of global participants and 30% of U.S. participants have different racial and ethnic backgrounds, and 41% of global participants and 45% of U.S. participants are between the ages of 56 and 85.
important issue is that the duration of protection for both Pfizer/BioNTech and Moderna vaccines is not yet known because of the speed of development.
Anth step by step, we know that (Moderna's vaccine) is now 94.5 percent effective, and then we're going to start worrying about the durability of that effect," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID).
on the supply side, Pfizer said that based on current projections, the two companies expect to produce 50 million doses of vaccine worldwide by 2020 and 1.3 billion doses by the end of 2021.
Pfizer's four plants in St. Louis, Missouri, Andover, Massachusetts, Kalamazoo, Michigan, and Pierce, Belgium, will be part of the vaccine production and supply chain.
BioNTech's plant in Germany will also be involved in global supply.
Pfizer said the companies had developed temperature-controlled transport boxes specifically designed to use dry ice to keep temperatures at -70C ±10C .
these boxes filled with dry ice can be used as temporary storage units where vaccines can be stored for 15 days.
each shipping container contains GPS thermal sensors that use Pfizer's extensive distribution network to track the location and temperature of each batch of vaccines on its intended route.
Pfizer and BioNTech plan to submit research validity and security data to scientific journals for peer review after data analysis is completed.
Pfizer did not receive research funding from the U.S. federal Operation Warp Speed Initiative, but has signed a $1.95 billion contract with the U.S. government to buy 100 million doses of vaccine.
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