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Oxford vaccine gets government’s vote of confidence despite concerns over trial data

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Britain gave AstraZeneca’s Covid-19 vaccine a vote of confidence on Friday (Nov 27) when it asked its regulator to assess it for a rollout after experts raised questions about trial data and the company said it may run another study to gauge the shot’s efficacy.

The UK government has secured 100 million doses of the vaccine, developed by AstraZeneca and Oxford University, the most supplies it has ordered of any shot to fight the pandemic.

Chief executive of the Pharmaceutical Services Negotiating Committee Simon Dukes indicated at the Pharmacy Business Conference on Tuesday that community pharmacy could play a big part in a national roll-out of the Covid-19 vaccine. The vaccine candidate developed by the British drugmaker could be an easier one for a nation-wide rollout because it is much cheaper that Pfizer’s and Moderna’s vaccines and it doesn’t require supercold temperature for storage.

AstraZeneca expects four million doses to be available in the UK by the end of next month, and health secretary Matt Hancock aims for a rollout to begin before Christmas.

“We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards,” Hancock said.

“This letter is an important step towards deploying a vaccine as quickly as safely possible.”

The Medicines and Healthcare products Regulatory Agency has started an accelerated “rolling review” of the vaccine at the start of this month as data comes in on safety and efficacy.

AstraZeneca had released trial data on Nov 23 that showed its experimental vaccine prevented on average 70 per cent of Covid-19 cases in late-stage trials in Britain and Brazil.

While the success rate was 90 per cent in the sub-group, some experts said the relatively small number of participants made it harder to be confident in the findings.

AstraZeneca said the administering of the half dose in the trial had been reviewed and approved by independent data safety monitors and the UK regulator, adding that the regulator publicly confirmed there was “no concern”.

CEO Pascal Soriot said on Thursday, though, that the drugmaker was likely to run an additional global trial to assess the efficacy of its vaccine using the lower dosage.

Confusion ‘problematic’

Pauline Londeix, co-founder of French drug transparency group OT-Med, said the apparent confusion over the trial results was “very problematic for public confidence in vaccines”.

“It has largely to do with the race drugmakers are engaged in currently, which leads them to present vaccine candidates in the best possible way and not release full protocols and results. It is the opposite of what is needed in our view.”

Nonetheless, government’s top science adviser said on Nov 26 that the interim results showed the AstraZeneca vaccine was successful.

“The headline result is the vaccine works and that’s very exciting,” Patrick Vallance said during a news conference with Prime Minister Boris Johnson.

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