November 26, 2020

expert reaction to media report reporting AstraZeneca may run an additional study as part of the COVID-19 vaccine trial

It has been reported in the media that AstraZeneca could run an additional study as part of the COVID-19 vaccine trial.

Prof Helen Fletcher, Professor of Immunology at the London School of Hygiene & Tropical Medicine, a vaccines expert and UKRI’s Director of International Development, said:

“In my opinion this will not necessarily delay licensure as even the efficacy in the high dose vaccine group is greater than 50% which was the minimal level defined in the WHO Target Product Profile (TPP) and also the level defined by the US FDA.  It is not unusual to take a licensed vaccine and then – typically some years later – perform studies to alter the dose or schedule to try and optimise the performance of the vaccine.  In fact the Oxford Vaccine Group, headed by Andy Pollard, has done many studies like this in the past with licensed vaccines for children and infants.  It’s entirely possible AZ and Oxford could license the high dose and then quickly seek an amendment to use the low dose when they have sufficient data.  I think this is just another example of how vaccine development has accelerated to respond to COVID-19.”

* https://www.bloomberg.com/news/articles/2020-11-26/astra-likely-to-run-fresh-global-covid-vaccine-trial-ceo-says

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

Declared interests

Prof Helen Fletcher: “Director of International Development at UKRI.  Trustee of the Jenner Vaccine Foundation.”