Sunday, November 29, 2020

Information on the state of development of COVID-19 vaccines


Biotech and Pfizer announced the first indications of the effectiveness of the COVID-19 vaccine BNT162b2 in a press release on November 9, 2020. They are the result of an initial interim analysis of a large phase 3 clinical trial. An analysis of the data collected by Biotech / Pfizer had not been published in a scientific journal or submitted to the European Medicines Agency at the time of the press release. The press release is encouraging, but an in-depth assessment by independent regulatory authorities is not yet possible.

The first data on the vaccine effectiveness of the COVID-19 vaccine candidate from Biotech / Pfizer from the interim analysis indicate, according to the company, after analyzing the first 94 cases, more than 90% effectiveness based on laboratory-confirmed COVID-19 diseases. Further data from the ongoing phase 3 trial with around 44,000 test subjects worldwide are required to evaluate the vaccine candidate. The Paul Ehrlich Institute will provide the detailed data for the observation presented in the press release in the context of the started. Assess the assessment process. Vaccine safety data will also be included in the risk-benefit assessment as soon as they are submitted.

A proven high level of efficacy in vaccinated people will be another milestone on the road to delivering safe and effective COVID-19 vaccines. So far, indications of possible effectiveness in several COVID vaccine candidates have emerged from the fact that protection against an infection of the lower respiratory tract and lungs could be shown in animal models and that a specific immune response to SARS-CoV-2 with titers neutralizing Antibodies comparable to those in those recovering from COVID-19 could be generated at a tolerable dose.

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