Btobioinnovation.com

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

COVID Vaccines in Germany

In a TV interview with the editorial staff of the Wiesbadener Kurier, Professor Ugur Sahin, CEO of the Mainz-based biotech company BioNtech, explains at length the status of BNT162b, the SARS-CoV-2 vaccine he discovered and is currently developing with Pfizer. Ugur Sahin reports that the efficacy results of the clinical study, which enrolled 44,000 patients, will be disclosed in the second half of November and that the safety results will be known one month later.

https://www.youtube.com/watch?v=3EuU9lZlycE&ab_channel=AllgemeineZeitung

BNT162b is a genetic vaccine which uses messenger RNA (mRNA) to induce cells to produce the spike protein of the SARS-Cov2 virus and thus stimulate the immune system of the vaccinated subject. mRNAs are rather unstable molecules that do not easily cross cell membranes. In order for this type of molecule to penetrate the cytoplasm of human cells, it is delivered through a lipid nanoparticles formulation. The current formulation of BNT162b is not very stable and requires storage of the experimental vaccine at the very low temperature of – 80°C.

It is now very likely that the vaccines from Moderna (Cambridge, USA) and BioNTtech, both mRNA vaccines, will be the first for which final phase 3 clinical results will become available. In most countries, the  distribution and allocation plans of future SARS-CoV2 vaccines are far from being widely disclosed.  Germany is clearly anticipating its plan for BNT162b, if health authority approval is granted soon after the publication of the clinical results.

What do we know so far?

In Germany, as in most European countries, the pandemic is growing fast and Chancellor Angela Merkel has urged her fellow citizens to limit contacts: "Meet far fewer people, whether outside or at home. I ask you: give up any trips or celebrations that are not really necessary. Stay at home as much as possible” she said. For Germans, as for other countries, the success of BioNTech's BNT162b vaccine would be a light at the end of a long and dark tunnel.

A joint logistics plan between the German authorities and BioNTech has already been drawn up to ship, within a few hours, tens of thousands of doses of BNT162b to ultra-low temperature storage centres at 60 identified sites in different parts of Germany. This logistics plan is also considering the purchase of tens of millions of syringes, needles and other materials needed for massive vaccination. The storage of the vaccines already manufactured is currently carried out in a secret location under very high security. One of our sources indicates that the supervision of this logistics has been entrusted to the German army.

If BNT162b is approved by the European Medicines Agency (EMA), the German plan could be triggered immediately and the first vaccines available for selected subjects before year end. German Health Minister Jens Spahn said last week in the "Spiegel" that a coronavirus vaccine would probably be available in his country "early next year" in January, February or March 2021. According to him, it will take six to seven months to immunise the majority of people who wish to receive the new vaccine.

The German government is consulting experts from the Leopoldina Academy, from the ethics council and from the Robert Koch Institute in order to decide which population should be vaccinated first. The results of the consultation are expected this week and it is likely that the following categories will be selected :

– Health-care workers

– Law-enforcement people

– Subjects with high medical risks

– Subjects located in highly virulent clusters

– Elderly subjects

– People living in crowed environments

Leave it to the Germans for anticipation, planning and organisation. Their plan probably stands in sharp contrast to most other countries who wish to rapidly vaccinate a significant number of their own people.

Paris, 3 November 2020

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.