发稿单位：(PEI)Paul Ehrlich Institut德国联邦疫苗生医药物机构
发稿时间：2020/04/01
撰 稿 者：PEI
原文连结：https://reurl.cc/KkeDMg
这是官方机构的新闻稿，想说顺便注意各国动态
(1)德国从日本进口 Pneumovax 23为 肺炎链球菌疫苗(?)
(2)卡介苗辅助 Trial
英文新闻原文:

Pneumococcal Vaccine Pneumovax 23 Imported from Japan
On 12 March 2020, The Paul-Ehrlich-Institut published some information on the
availability of pneumococcal vaccines on its website. A shortage for
Pneumovax 23 is claimed, while Prevenar 13 is available only to a limited
extent.
Probably from 3 April 2020, Pneumovax 23 vaccine imported from Japan labelled
in Japanese is available on the German market. Importing this vaccine is
possible based on an exceptional authorisation pursuant to the German
Medicines Act (AMG). The vaccine will be distributed by wholesalers
throughout Germany.
Details
The product, which is labelled in Japanese, is marketed in the country of
origin as "Pneumovax NP". Pneumovax NP is identical to Pneumovax 23
authorised in Germany.
The two batches imported are:
Pneumovax NP, Batch No.: R033352, expiry date: 11 June 2020
Pneumovax NP, Batch No.: R033353, expiry date: 13 June 2020
The assigned PZN is 16653218
A package leaflet in German is missing in the finished packed product. This
was not possible from the logistic point of view. A serialisation of the
product (i.e. providing features on the packaging which permit traceability
of each individual package from the pharmacy right back to the manufacturer)
could not be realised for technical reasons.
The German package leaflet and the summary of product characteristics are
provided as a download on this page
In contrast to the syringe presentation well known in Germany, these imported
lots are marketed in vials (single doses). This dosage form is also
authorised in Germany.
The Japanese tradename "PNEUMOVAX긠NP" printed in Latin letters is only on
the secondary packaging (outer carton) but not the primary container (vial).
Finished packed product
Finished packed product
Source: MSD Sharp & Dome GmbH
Vial
Vial
Source: MSD Sharp & Dome GmbH
How should the vaccines be used?
Special advice given by the German Advisory Committee for Immunisation
Practices (St鄚dige Impfkommission, STIKO) during the period of shortage
should be followed.
Background
The Coronavirus-2 pandemic has led to an increased demand for pneumococcal
vaccines, which has caused supply shortages for these products. The
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, is
the competent senior federal authority responsible for the quality, safety,
and efficacy, as well as the official batch release of vaccines in Germany.
In case the Federal Ministry of Health (BMG) publishes a supply shortage, the
use of special regulations laid down in the German Medicines Act (AMG)
permits the import of medicines under special conditions [AMG, Section 79
(5)]. These rules are applied in this case to import products available from
third countries, in this case, Japan, at short notice.
This website contains an overview of all current supply shortages of vaccines
for human use in Germany, which is regularly updated.
Our email newsletter “Safety and availability – information on medicines
safety, notes for action in the event of delivery shortages of vaccines for
human use" contains information on current availabilities and delivery
shortages on a regular basis.