European Union regulator starts review of BioNTech-Pfizer vaccine


Swiss drug authority Swissmedic has begun evaluating the so-called "Covid-19 Vaccine AstraZeneca".

"However, no decision on authorisation can be taken until all the data needed to assess the safety, quality and efficacy of the vaccine have been submitted".

Pfizer Inc. and BioNTech S.E. said Tuesday that the European Medicines Agency will review data on the duo's lead Covid-19 vaccine candidate on a rolling basis, as it becomes available from trials.

The EMA defines a "rolling review" as a tool it uses to "speed up the assessment of a promising medicine or vaccine during a public health emergency".

"That will help us to open the world together, or for the world to recover together".

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). Its goal is to develop vaccine development, production and reach everyone.

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In normal times, pharma companies would complete their tests and compile all their findings first before submitting them for review.

Scientists around the world are racing to develop a safe and efficient Covid-19 jab to end a pandemic that has killed more than a million people and devastated the global economy.

The novel coronavirus has infected over 35 million people worldwide, resulting in more than 1 million deaths as of Tuesday according to the WHO. Currently, two indigenously developed vaccine candidates, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila Ltd, are in the phase 2 of the human clinical trials. More than 28,000 have recently received their second shot, the statement said.

Brazil's Paraná and Bahia states, which have testing and production or distribution agreements for the Russian vaccine, have not yet filed requests for clinical trials in Brazil, a spokeswoman for Anvisa said.

In late September, Regional Director for Europe at the WHO Hans Kluge thanked Russian Federation for "its excellent efforts to create a safe and effective vaccine".

"All the data obtained in this trial support the safety and immunogenicity of this inactivated vaccine and are encouraging with regard to further studies of its efficacy in the future", the paper said.