In­for­ma­tion on the De­vel­op­ment Sta­tus of COVID-19 Vac­cines

BioNTech and Pfizer announced first indications of efficacy of the COVID-19 vaccine BNT162b2 in a press release on 9 November 2020. They are the result of a first interim analysis of a large phase 3 clinical trial. An analysis of the data collected by BioNTech/Pfizer had not been published in a scientific journal or submitted to the European Medicines Agency at the time of the press release. The press release is encouraging, but an in-depth assessment by independent regulatory authorities cannot yet be made.

According to the companies, the first data on vaccine efficacy of BioNTech/Pfizer's COVID-19 vaccine candidate point to a more than 90% efficacy in laboratory-confirmed diseases after analysis of the first 94 cases. Further data from the ongoing phase 3 trial with approximately 44,000 subjects worldwide are required to evaluate the vaccine candidate. The Paul-Ehrlich-Institut will evaluate the detailed data on the observation presented in the press release as part of the evaluation procedure launched as described below. Vaccine safety data will also be included in the benefit-risk assessment as soon as they are submitted.

A proven high efficacy in vaccinated patients will be another milestone on the way to providing safe and effective COVID-19 vaccines. Evidence of potential efficacy in several COVID vaccine candidates has been shown to date by (i) demonstrating protection in animal models against lower respiratory and pulmonary infection and (ii) generating a specific immune response to SARS-CoV-2 with titers of neutralising antibodies comparable to those in COVID-19 genesis at tolerable doses.

Status of COVID-19 Vaccine BNT162b2 - European Rolling Review

In order to make COVID-19 vaccines available to all citizens in Europe, they are evaluated and approved through a centralised procedure. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has already started two evaluation procedures for COVID-19 vaccines. One of these vaccines is the BioNTech vaccine candidate BNT162b2, which is being evaluated in a so-called "rolling review". This procedure is designed to accelerate the process towards COVID-19 vaccine approval by successively evaluating data packages on the quality and manufacturing, the non-clinical and parts of the clinical development of a vaccine candidate before all the data required for a marketing authorisation application is fully collected and submitted.

Experts from the national drug authorities of the EU member states, including experts from the Paul-Ehrlich-Institut, evaluate the data on the efficacy and safety of the vaccines. The decision on the recommendation for authorisation is made by the Committee for Medicinal Products for Human Use (CHMP) of the EMA based on this evaluation. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, is represented in the CHMP.

The Paul-Ehrlich-Institut welcomes the fact that a number of COVID-19 vaccine candidates are already in clinical trials. It is expected that further companies will also publish interim evaluations of their clinical trials.

Updated: 13.11.2020