AstraZeneca coronavirus vaccine to face deeper scrutiny by US regulator

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AstraZeneca PLC’s (LON:AZN) coronavirus vaccine development with Oxford University is to come under closer scrutiny in the US to address any possible safety concerns, according to reports overnight.


A trial of the vaccine has been halted in the US after one of the people taking the drug in Britain was affected by a rare spinal inflammatory disorder.


While the drug has restarted elsewhere, the US study remains suspended and Reuters reported last night that an investigation was underway into data surrounding other vaccines developed by the Oxford University unit.


The AstraZeneca/Oxford is seen as one of the most promising of the numerous vaccines currently under development, but this additional investigation will likely push back the schedule, suggested Reuters.


US drug regulator the Food and Drug Administration wants more time to look at the information available and was just being ‘thorough’ said the report.


“We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial,” AstraZeneca said in a statement.


CEPI to compares ‘apples with apples’


Meanwhile, a new network of global laboratories has been set up to monitor and assess the efficacy of the various different vaccines under development.


The Coalition for Epidemic Preparedness Innovations (CEPI) is a not-for-profit organisation that will bring all samples from trials of COVID-19 candidates being developed in Europe, Asia and North America under one roof.


“When you start off (with developing potential new vaccines) especially with a new disease, everyone develops their own assays, they all use different protocols and different reagents – so while you get a readout, the ability to compare between different candidates is very difficult,” Melanie Saville, director of vaccine R&D at CEPI told Reuters.


“By taking the centralised lab approach … it will give us a chance to really make sure we are comparing apples with apples.”


The CEPI network will initially involve six labs: In Canada, Britain, Italy, the Netherlands, Bangladesh and India.


At present, there are 320 potential COVID-19 vaccines under development, of which six are in late stage trials.


Saville said intially, CEPI will assess samples from early-stage vaccine candidate testing and first and second stage human trials but eventually will expand to phase III trials.


CEPI is co-funding nine of the potential COVID-19 vaccines including those under development by Moderna, AstraZeneca, Novavax and CureVac.

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