(只是先轉貼，來不及翻譯。下班後再翻譯重要的內容）
發稿單位：Paul Ehrlich Insititut
發稿時間：Updated: 22.04.2020
撰 稿 者：Updated: 22.04.2020
原文連結：
1.
新聞稿
https://reurl.cc/qdrOap
2.記者會投影片
https://reurl.cc/z8lMo7
3.BioNTech-BNT162投影片
https://reurl.cc/Kk4pDj
4.提問
https://reurl.cc/b5DkxE
5.Paul Ehrlich Insititut官網(德國聯邦疫苗藥物研究及授權機關)
https://reurl.cc/oLreqV
新聞稿原文
First Clinical Trial of a COVID-19 Vaccine Authorised in Germany
08 / 2020
The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines,
has authorised the first clinical trial of a vaccine against COVID-19 in
Germany. The authorisation of this trial is the result of a careful
assessment of the potential risk/benefit profile of the vaccine candidate.
Based on extensive scientific advice to the medicine developer, BioNTech, in
the preliminary phase, the Paul-Ehrlich-Institut was able to complete the
authorisation procedure within four days. Trials of vaccine candidates in
humans are an important milestone on the road to safe and efficacious
vaccines against COVID-19 for the population in Germany and internationally.
Spike-Protein SARS-CoV-2 (Source: Viaframe/Corbis/GettyImages)
The provision of authorised safe and efficacious COVID-19 vaccines is a
central aim in combating the rampant new SARS Coronavirus-2 (SARS-CoV-2).
First clinical trials aim at investigating the general tolerability of
vaccine candidates as well as their ability to induce a specific immune
response against the pathogen. The Paul-Ehrlich-Institut, which is
responsible for the authorisation of clinical trials as well as the
evaluation and authorisation of vaccines in Germany, supports the development
of COVID-19 with the highest priority. The early and extensive scientific
advice performed by the Paul-Ehrlich-Institut ensures that the development of
a vaccine is accelerated in a targeted manner while still fulfilling to the
necessary scientific requirements. This is because the Paul-Ehrlich-Institut
considers it as one of its central duties to provide its regulatory support
for the clinical development of COVID-19 vaccines for the prevention and of
biomedicines for the treatment of the disease to permit the availability of
such medicinal products in a timely manner. In doing so, it assures that the
required care is not impaired.
The vaccine candidate of the Biotechnology company BioNTech at Mainz is a
so-called RNA vaccine, which contains the genetic information for the
construction of the so-called spike protein of CoV-2 or parts thereof in the
form of ribonucleic acid (RNA). In the authorised first part of the
authorised clinical trial, 200 healthy volunteers aged between 18 and 55
years will be vaccinated in each case with one or more than one variants of
the vaccine, each of which is slightly modified. After an observational
waiting period, additional volunteers of the same age range will be
vaccinated in the second part of the clinical trial. The additional inclusion
of persons with an increased infection risk or an increased risk of a serious
course of a COVID-19 disease is planned for the second part of the clinical
trial, for which additional study data are required to be submitted in
advance.
In the authorised part of the clinical trial, different variants of the RNA
vaccine candidates are tested. In addition to their tolerability, their
ability to create an immune response to SARS-CoV-2 after a specific amount of
RNA (dose) is also tested (first dose finding). In this context, different
RNA types and different lengths and modifications of the spike protein are
tested, as well as the effect of a second vaccination.
This is the fifth authorised clinical trial world-wide in which a preventive
specific COVID-19 vaccine candidate is tested in humans. Considering the
serious consequences of the COVID-19 pandemic, this is a significant step
toward developing an efficacious and safe COVID-19 vaccine available in
Germany and making it available world-wide as soon as possible.
Based on the current state of knowledge, the Paul-Ehrlich-Institut assumes
that further clinical trials of COVID-19 vaccine candidates will start in
Germany in the next few months. To combat the pandemic, additional vaccine
products will be necessary to ensure a sufficient supply of the vaccines.
Background RNA Vaccine
During the vaccination with an RNA vaccine, the genetic information for the
construction of an innocuous component of the pathogen is administrated using
various methods, including injection into the muscle . The RNA is absorbed in
a number of body cells of the person vaccinated. These body cells use the
genetic information on the RNA for the construction of the pathogen
component. The pathogen components thus produced in the vaccinated person are
not infectious and do not induce disease either. The human immune system will
recognise the foreign pathogen component and will consider the cells which
have constructed this component of the pathogen as putatively infected cells.
It builds up a protective immune response against the pathogen which, in the
case of exposure, prevents the infection or at least the disease or mitigates
its seriousness.