The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has authorised another Phase-1 clinical trial of a vaccine against COVID-19 in Germany. The new vaccine candidate is a so-called vector vaccine. Trials on vaccine candidates in humans are a significant step in the direction of authorising safe and efficacious vaccines against COVID-19. This new vaccine is […]
BioNTech SE (Nasdaq: BNTX) and Pfizer Inc. (NYSE: PFE) today announced that preliminary, peer-reviewed data from their ongoing German Phase 1/2 Study of BNT162b1 were published online in the journal Nature. BNT162b1 is part of the companies’ mRNA-based vaccine development program Lightspeed against SARS-CoV-2. The preliminary clinical data from the German study of BNT162b1, a […]
BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that it will receive a grant of up to 375 million Euro from an initiative by the German Federal Ministry of Education and Research (BMBF) to support the accelerated development of SARS-CoV-2 vaccines. BioNTech will use the milestone-based BMBF funding to support its contribution to […]
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. Enrollment in […]
The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines started the annual batch release testing of influenza vaccines on 31 July 2020. In the meantime, the first 13,6 million doses have been released for German market. The batch testing is based on the strain adaptations approved by the Federal Institute or the EU Commission for the […]
The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has authorised another clinical trial of a vaccine against COVID-19 in Germany. The intensive preliminary scientific advice of the medicines developer CureVac, and the prioritisation of the regulatory activities at the Paul-Ehrlich-Institut for vaccines and biomedicines against COVID-19 have made it possible to complete the authorisation procedure […]
The European Investment Bank (EIB) and immunotherapy company BioNTech SE today signed a €100 million financing agreement to support the development of BNT162, the company’s COVID-19 vaccine programme. BioNTech is the first European company to enter clinical testing, having started a clinical trial in Germany in April and a further clinical trial in the United […]
Merck and Baylor College of Medicine, Houston, Texas, USA, today announced an extension of their ongoing collaboration to advance a manufacturing platform to fight Covid-19. • Company will focus on process development and improvements for manufacturing Baylor’s Covid-19 vaccine candidates Merck, a leading science and technology company, and Baylor College of Medicine, Houston, Texas, USA, […]
The first experimental covid-19 vaccine tested in humans, developed in record time by the U.S. company Moderna, has been shown to be “safe and generally well-tolerated” in an initial trial with 45 healthy volunteers, the company announced Monday. In the first eight participants, the prototype has generated levels of neutralizing antibodies – the body’s defenses […]
EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Public health, country knowledge, crisis managementCrisis management and preparedness in healthLuxembourg, 22 April 2020 Health Security CommitteeAudio meeting on the outbreak of COVID-19Summary Report The HSC received background information on vaccine development and EU activities. The WHO blueprint list of COVID-19 vaccines in development includes three candidates in […]
On 12 March 2020, the Paul-Ehrlich-Institut informed the public on supply problems with pneumococcal vaccines on its website. English labelled Prevenar 13 will be commercially available, as from 28 April 2020. These doses will supplement the regular deliveries. The importation of the product was supported by a permission pursuant to Section 79 (5) German Drug […]
The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, has authorised the first clinical trial of a vaccine against COVID-19 in Germany. Spike-Protein SARS-CoV-2 (Source: Viaframe/Corbis/GettyImages) 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, […]
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