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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #33

Will AstraZeneca-Oxford vaccine get U.K. approval before EU?

AstraZeneca and Oxford University COVID-19 vaccine AZD1222 is making headlines since Monday 23 November when its efficacy data were first disclosed. The results came in as a surprise when the interim data were showing different efficacy for different dosing regimens. The clinical vaccine candidate showed efficacy of 90% when given half a dose followed by a full dose but the efficacy rate was only of 62% when given in two full doses. Analysts were confused, raised questions with these unusual results and were wondering why half a dose was administered to some participants in the first place.  And even more so when Mene Pangalos, AstraZeneca’s executive vice president for biopharmaceuticals R&D said “I’m not going to pretend it is not an interesting result, because it is- but I definitely do not understand it and I don’t think any of us do”.  In addition, the most active dose regimen was not administered to any participants over age 55, according to Operation Warp Speed’s Moncef Slaoui. On November 25, one of the incoming news was that Oxford University had started vaccinating before the full protocol had been validated by AstraZeneca. But now it turns out that the error most probably arose from an error in the manufacturing process.

On Thursday AstraZeneca CEO Pascal Soriot told Blomberg News that “now that we have found what looks like a better efficacy (the lower dose) we have to validate this, so we need to do an additional study”.

In an email from an AstraZeneca spokesperson to MedNous on November 27 it said” there is a strong merit in continuing to further investigate the half-dose/full-dose regimen. We are further evaluating the data and will work with regulators on the best approach for further evaluation. This would add to data from existing trials which are currently being prepared for regulatory submission”.

Earlier today news was released that U.K. Health Secretary Matt Hancock has asked the Medicines and Healthcare Products Regulatory Agency (MHRA) to potentially bypass the European Medicines Agency and approve the vaccine for U.K. supply and use under regulation 174, although the U.K. is still an EU member until the end of the year. “We are dedicated to working with the MHRA and other regulatory agencies to bring our vaccine to people around the world as quickly as possible” the AstraZeneca spokesperson told MedNous. To many observers including us, Hancock’s action is considered as a political move, at a moment when the final Brexit negotiations are getting very tense between the U.K and the EU and thus make the point that Britain can act faster outside of the EU bureaucracy.

Paris November 27, 2020

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