Kuwait City, 10th November 2020:
Kuwait said to sign contract for Pfizer Vaccine, iiQ8
Pfizer-BioNTech in vaccine success
■ Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
■ Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
■ Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; safety and additional efficacy data continue to be collected
■ Submission for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) planned soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
■ Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
NEW YORK / MAINZ, Germany, November 9, and KUNA:
Pfizer Inc (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on Nov 8, 2020 by an external, independent Data Monitoring.
Committee (DMC) from the Phase 3 clinical study. After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases.
Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90 percent, at seven days after the second dose.
This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned.
The data will be discussed with regulatory authorities worldwide. “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID- 19,” said Dr Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.
Sources disclosed the bureau has asked the Ministry of Health to take all the necessary measures to guarantee the availability of the vaccine on the agreed dates in order to fully benefit from this contract. Sources said the bureau informed the ministry about the need to set a timetable with the Pfizer to ensure that Kuwait will obtain the required quantities at the beginning of each quarter.
Source – Arab Times
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