A rolling review of one more potential COVID-19 vaccine has started
A rolling review of one more potential COVID-19 vaccine has been started by the European Medicines Agency, EMA. This happens only five days after the EMA started the same process for AstraZeneca’s potential COVID-19 vaccine.
To accelerate the assessment and possible authorisation of potential COVID-19 vaccines, the EMA evaluates prospective vaccines in a rolling review as part of its emergency procedure. Last week, the EMA started a rolling review of AstraZeneca’s COVID-19 vaccine, and today the EMA begins yet another rolling review of a potential COVID-19 vaccine – this time a vaccine from BioNTech/Pfizer.
In a rolling review, the data from the different phases of vaccine development are assessed when generated instead of following the normal procedure of waiting for all data to become available.
The data currently being reviewed by the EMA are data from the first laboratory tests of BioNTech/Pfizer’s prospective vaccine. These data cannot alone form the basis for drawing conclusions on the vaccine’s efficacy and safety. When all data from the final phases of vaccine development, including tests of the vaccine in human subjects, are ready and have been reviewed thoroughly, the EMA will announce its conclusion on the vaccine.
The EMA’s decision to start a rolling review of BioNTech/Pfizer’s potential vaccine is based on interim results from non-clinical studies, i.e. laboratory studies and animal testing, and from early clinical trials, i.e. trials in human subjects, so far indicating that the vaccine triggers the production of antibodies and T cells (cells in the immune system, the body’s defence against infection) targeting the virus.
Vaccine is now being tested in comprehensive trials with human subjects
Major clinical trials with several thousands of trial subjects are being conducted right now to test the vaccine, and the results of these trials are expected to become available in the coming weeks and months.
All available data on the safety of the vaccine coming from these trials as well as data on the vaccine’s quality, such as active substances and excipients and the way they are produced, will also be thoroughly reviewed.
The EMA’s assessment of data on COVID-19 vaccines will follow the usual high standards for assessing quality, safety and efficacy.
EMA’s press release: EMA starts second rolling review of a COVID-19 vaccine.
News on the DKMA website, 1 October: EMA starts rolling review of a potential COVID-19 vaccine
News on the DKMA website, 5 October: EMA:Transparency and scientific independence – the basis for authorising COVID-19 vaccines in the EU.
Theme on the DKMA website: Vaccines and medicines for treatment of COVID-19.