Paul-Ehrlich-Institut

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

WHO Collaborating Centre Quality Blood IVD redesignated

28 July is World Hepatitis Day

World Hepatitis Day – Paul-Ehrlich-Institut is committed to protective Vaccines and safe Blood products

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.

Spikevax – marketing authorization extended for those aged 12 to 17

Rolling Review Process for the COVID-19 Vaccine Vidprevtyn

Our announcement at the start of the Rolling Review of the Sanofi Pasteur vaccine candidate:

Rolling Review begins for Protein Subunit Vaccine against COVID-19

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:

www.pei.de/safety-covid-19-vacines

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:

www.pei.de/newsletter-en

Biennial report 2019/2020 of the Paul-Ehrlich-Institut published

www.pei.de/biennial-report-2019-2020

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:

www.pei.de/impfstoffe/covid-19

STIKO Decision the 8th update of the COVID-19 Vaccination Recommendation

Current STIKO recommendation, dated 8 July 2021 (German only)

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).

125 Years of the Paul-Ehrlich-Institut

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.

Use of monoclonal antibodies against COVID-1

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.

Comirnaty - marketing authorisation extension for children

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).

www.pei.de/haemovigilance-report

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

Infographics

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:

CHMP starts Rolling Review for the first Virus-like Particle Vaccine against COVID-19

Important Short Links for Your Research

Updated: 28.07.2021