Will AstraZeneca vaccine be allowed to be used?
Despite all the assurances of AstraZeneca Pascal Soriot, CEO of AstraZeneca, that the additional study should not slow down obtaining regulatory approvals for the use of COVID-19 vaccine, a number of questions have arisen about the effectiveness of the drug being developed by the company together with Oxford University, Bloomberg writes.
In order to clarify the uncertainty and confusion surrounding the positive results of the current study, the vaccine will be sent to a new trial to confirm its stated 90 per cent effectiveness.
It should be noted that after Astra Zeneca admitted that the lower dosage level, which in fact proved to be even more effective, was the result of a mistake. A day after the release of the 90 percent vaccine efficacy data, the head of the American vaccine programme Operation Warp Speed said that the higher efficacy regime had been tested on younger, and therefore stronger, patients.
P. Soriot said: "I think there will be another global study, but it will go faster because we know that the effectiveness of the drug is high, so we need fewer patients".
Also, the UK Health Secretary, Matthew Hancock, has asked the regulator to issue a permit earlier than his EU colleague and to approve the delivery of AstraZeneca vaccine to speed up its introduction in the country before the end of the year, when the UK will end its transition period after Brexit.
The current rule allows the UK regulator to allow temporary deliveries of the vaccine even before the European Medicines Agency authorises it, if the data on the vaccine tests are sufficiently reliable. It is now up to the results of the tests alone.
With regard to authorising the vaccine in the USA, the Food and Drug Administration (FDA) may delay approval, firstly because the vaccine tests are not carried out in America, and secondly because there are questions about the results.
Astra shares fell 0.8 per cent on Friday morning on the London Stock Exchange, resulting in a fall of around 8 per cent this week.