EU's heath regulator reviewing Pfizer-BioNTech COVID-19 vaccine in real-time

Following the assessment process for AstraZeneca’s COVID-19 vaccine candidate, the European health regulator is currently reviewing the potential vaccine being developed by Pfizer and BioNTech in real-time. As per reports, the European Medicines Agency (EMA) said on October 6 that its human medicines committee was evaluating the first batch of data on COVID-19 vaccine and would keep doing so until enough data is collected to conclude with a final decision. 

Pfizer and BioNTech have said in a joint statement that the start of the review is based on data derived from labs (non-clinical), animal and human testing. It added further that they would continue to submit data as it emerged. Moreover, in a bid to finish the review process swiftly, EMA is reportedly using “rolling reviews”, that is, by studying the data as it is submitted instead of waiting for all data to be made available. 

Just last week, EMA had started reviewing the COVID-19 vaccine candidate developed by AstraZeneca and Oxford University, AZD1222 or ChAdOx1 nCoV-19. This has also increased the chances of British vaccine to become the first one that is approved in the region for COVID-19 while the global infections have continued to soar. Pfizer and BioNTech’s vaccine is called BNT162b2. And while AZD1222 uses a diluted version of a chimpanzee common cold virus against the novel coronavirus, BNT162b2 uses ribonucleic acid which acts as a chemical messenger.

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 Trials for kids should begin, says Oxford study

Meanwhile, a recent study published by Oxford has said that the coronavirus vaccine trials for children should ‘begin now’, given their susceptibility to the virus. While COVID-19 vaccine trials for adults have moved to Phase III, they are yet to start for children. The researchers have said that the direct coronavirus impact upon children is ‘greater’ than what has already been observed. They also believe that the role of children in the transmission of coronavirus is under-appreciated. 

The authors of the study speculated that delaying Phase II vaccine clinical trials in children will delay the recovery from the COVID-19 and unnecessarily prolong its impact upon children’s education, health and emotional well-being. Given the potential direct and indirect benefits of paediatric vaccination, the authors said that the implementation of Phase II clinical trials for Covid-19 vaccines should ‘begin now’. 

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