Biontech Gets Green Light for German Covid Trials
27.04.2020 - Paul-Ehrlich-Institut (PEI), Germany’s federal institute for vaccines and biomedicines, has given the go-ahead for Germany’s first clinical trial of a vaccine candidate to prevent COVID-19.
The German trials will be conducted by Mainz-based German biotech BioNTech. The company is collaborating with US drugmaker Pfizer on a program to develop four vaccine candidates using the messenger-RNA (mRNA) technology.
In China, BioNTech awarded rights to its BNT162 vaccine program to Shanghai Fosun Pharmaceutical in March.
Only the fifth vaccine trial worldwide targeting the virus to date, Germany’s first clinical trial will combine phases 1 and 2 and will include 200 healthy people aged 18 to 55. Following analysis of the data, additional subjects, including some at higher risk, will be eligible to participate.
In the latter part of the first double phase, the age range of trial participantswill be extended to those 55–70 years old, then to those over 70, before progressing to Phase 3 evaluation in 5,000 volunteers aged 18 years and over.
Four vaccine candidates, which BioNtech will be responsible for supplying to Pfizer, will be tested. The US drugmaker said earlier that millions of doses could be tested by the end of 2020, given regulatory approvals.
Capacities could subsequently be scaled up to produce hundreds of millions of doses in 2021, Pfizer said.
BionTech and Pfizer plan to start trials in the US as soon regulatory approval for human testing is secured.
Though several more trials are likely to be conducted this year, PEI president, Klaus Cichutek, said it is unlikely that any vaccine will be approved and ready to be administered during 2020.
BioNtech is one of two German biotech firms working on a COVID-19 virus. Compatriot CureVac is collaborating with US pharma Eli Lilly.