The European Medicines Agency (EMA) has launched a rolling review process of the Covid-19 vaccine candidate being developed by BioNTech in collaboration with Pfizer.
What is a rolling review? According to the EMA, “a rolling review is one of the regulatory tools that the agency uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.”
This means that instead of evaluating all the data on the vaccine after it is completed, the agency will evaluate the data as it becomes available, in order to speed up its potential approval, if all the safety and effectiveness criteria are met.
“The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data),” the EMA said in a statement on Tuesday.
The EMA added that this does not mean that a conclusion on the vaccine’s safety and effectiveness can be reached yet, with much of the evidence still to be submitted.
Last week the agency started its first review process of a Covid-19 vaccine, when it began a rolling review on the candidate being developed by AstraZeneca in collaboration with the University of Oxford.
In September, BioNTech CEO and co-founder Ugur Sahin told CNN they are confident they can have a vaccine against the novel coronavirus ready for regulatory approval by the middle of October or early November.
“It has an excellent profile and I consider this vaccine … near perfect, and which has a near perfect profile,” Sahin said.