Latest News - 28 July 2021
WHO Collaborating Centre for the Quality Assurance of Blood Products and in vitro Diagnostic Devices (IVD) designated for the fifth time
28 July is World Hepatitis Day
COVID-19 Vaccine for childen
The Committee for Medicinal Products for Human Use (CHMP) at the EMA recommends extending authorization of Moderna's COVID-19 vaccine Spikevax for those aged 12 to 17 years.
The European Commission decided to follow the CHMP recommendation at the same day.
Rolling Review Process for the COVID-19 Vaccine Vidprevtyn
Our announcement at the start of the Rolling Review of the Sanofi Pasteur vaccine candidate:
12th safety report on COVID-19 vaccines published up to and including 30 June 2021
See the safety report overview page for a brief summary and link to the full report:
Go directly to the report:
www.pei.de/sicherheitsbericht (German only)
All subscribers to our press newsletter will be notified automatically – including the link - when the safety report is published. You can subscribe to the press newsletter at:
Biennial report 2019/2020 of the Paul-Ehrlich-Institut published
Very Rare Cases of Thrombosis with Thrombozytopenia (TTS) after Vaccination
Current scientific evidence indicates that thrombosis with thrombocytopenia (thrombosis-with-thrombocytopenia syndrome, TTS) is causally related to Vaxzevria and the Janssen COVID-19 vaccine.
Most TTS reports are related to cerebral/sinus vein thrombosis.
The currently available figures on suspected cases are now published in the safety reports on suspected cases of vaccine adverse events and vaccine complications.
www.pei.de/sicherheitsbericht (German only)
Proof of vaccination as defined in the COVID-19 Protective Measures Exemption Directive and the Directive on Coronavirus Entry Regulations – including new list of vaccine product names in third countries
Information and the most important questions and answers on the new regulations at:
STIKO Decision the 8th update of the COVID-19 Vaccination Recommendation
125 Years of the Paul-Ehrlich-Institut
On 1 June 1896 the Paul-Ehrlich-Institut was founded in Steglitz near Berlin then still known as the "Institute for Serum Research and Serum Testing". We use this occasion to take a look at important milestones in our history in text and pictures (video).
Additional Monoclonal Antibody against COVID-19
In addition to the neutralising monoclonal antibodies Bamlanivimab (Eli Lilly) and Casirivimab/Imdevimab (Roche/Regeneron), which are already available in Germany, another monoclonal antibody from the US pharmaceutical company Eli Lilly, Etesevimab, is expected to be available in Germany in June 2021 for use in combination therapy together with Bamlanivimab.
EU Commission Authorises Indication Extension of COVID-19 Vaccine Comirnaty for 12- to 15-year-olds
On Monday, 31 May 2021, the EU Commission approved the marketing authorisation extension for BioNTech/Pfizer's COVID-19 vaccine Comirnaty.
Haemovigilance Report 2019 published
With the haemovigilance report, the Paul-Ehrlich-Institut offers a series of publications that provides more transparency with regard to reports and measures on blood products and their application.
Now, the report for 2019 is available, covering the assessment of the Reports of Serious Adverse Transfusion Reactions pursuant to section 63 i AMG (German Medicines Act).
Two new infographics – COVID-19 vaccination and vaccines at a glance
- Overview: the four COVID-19 vaccines (currently) authorised in the EU with information on efficacy, vaccination interval, duration and onset of protection.
- Overview: COVID-19 vaccination protects against severe disease with information on common symptoms and complications
Easier reporting of suspected side effects after COVID-19 vaccination
The Paul-Ehrlich-Institut now offers a new form at www.nebenwirkungen.bund.de that can be used specifically to report suspected adverse events following vaccination with one of the approved COVID-19 vaccines. For example, the EU-authorised COVID-19 vaccines are stored here and can be selected by drop-down.
Procedure for positive allergy history prior to COVID-19 vaccination (mRNA vaccines)
We provide a flow chart at www.pei.de/flussdiagramm-covid-19-allergieanamnese (German only).
Rolling Review Process for the First COVID-19 VLP (Virus-Like Particle) Vaccine
Our announcement on the start of the rolling review of the VLP vaccine:
Important Short Links for Your Research
- COVID-19 safety reports:
- COVID-19 vaccines (with link to product information):
- SafeVac 2.0 App observational study information:
- COVID-19 biomedical drugs (vaccines, monoclonal antibodies):
- Corona FAQ (including approval and development, efficacy and safety, or for batch testing):
- Corona dossier with all information releated to COVID-19:
- Explainer videos as well as recordings of press briefings: