The human medicines committee (CHMP) at the European Medicines Agency (EMA) has started the first ‘rolling review’ of a vaccine against COVID-19 that is being developed by AstraZeneca in collaboration with the University of Oxford.
Immunization currently prevents millions of deaths every year from several diseases. In particular, there are now vaccines to prevent more than 20 life-threatening diseases and a huge work is ongoing at unprecedented speed to make also available a vaccine to prevent COVID-19 disease.
However, no vaccine against COVID-19 will be deployed before the competent authorities have evidences of efficacy and safety!
Speeding up the development of a vaccine for COVID-19 is now a priority, but we always need to bear in mind the safety of patients. A lot of clinical trials (see our page to keep you up to date) are currently evaluating candidate vaccines on humans with the aim to gather as many reliable data as possible that will be assessed by the regulators.
The CHMP’s decision to start the rolling review of the AstraZeneca vaccine is based on preliminary results from non-clinical and early clinical studies suggesting that the vaccine triggers the production of antibodies and T cells that target the virus.
All the available data on the safety of the vaccine emerging from ongoing large-scale clinical trials, as well as data on its quality, will be also reviewed.
If you are interested in discovering more about this topic you cannot miss the XIII Foresight Training Course, organised by Fondazione Gianni Benzi that will be held on 23rd October 2020. Research and development of new medicines and vaccines will be deeply discussed during a dedicated session of the course. Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at EMA, will take part in the event by giving an overview on the EMA regulatory framework.
Professor Andrea Gambotto from University of Pittsburgh, who is studying a candidate vaccine against COVID-19, will provide with the academia perspective on the development of COVID-19 vaccine while a representative from Janssen-Cilag SpA, Roberta Termini, will present the company point of view. Martine Dehlinger-Kremer, President of the European CRO Federation, will offer an insight on what has changed within the trials’ procedures during the pandemic.
You can register for the course here and stay tuned for further updates!