AstraZenec Plc and the University of Oxford face several mounting questions about their trial results after acknowledging a manufacturing error. In an announcement made last week, they revealed their shot was 70 per cent effective on average in a late-stage study. However, details released by the UK partners have sparked worries about whether regulators would clear it.
In a later statement, Oxford said a difference in manufacturing processes led to some participants being given a half dose instead of a full one. Astra and Oxford said their vaccine was 90 per cent effective when a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62 per cent. However, they then said the dose showing the higher level of effectiveness was tested in a younger population and that the half-dose was given to some people because of an error in the quantity of vaccine put into some vials.
Fund manager at EdenTree Investment Management, Ketan Patel said, “Any time you have confusion in trials it's not a good thing because it effectively removes any kind of credibility you had. I think there will be a lot more scrutiny of Astra's product due to the manufacturing issue.”
Oxford said in a statement, that when it was apparent that a lower dose was used, it was discussed with regulators, and an agreement was reached to push ahead with the two regimens. “The methods for measuring the concentration are now established and we can ensure that all batches of vaccine are not equivalent,” it said.
In its statement, Oxford said that when it was apparent that a lower dose was used, it was discussed with regulators, and an agreement was reached to push ahead with the two regimens. “The methods for measuring the concentration are now established and we can ensure that all batches of vaccine are now equivalent,” according to the university.
New trial of vaccine
Oxford University and AstraZeneca said that they would go for an extra trials to satisfy regulators after US health officials revealed that nobody in the group with 90 per cent efficacy rates was above the age of 55. The revelation sparked widespread concern because the jabs will be targeted at the elderly first. However, scientists in the UK pointed out that previous trials suggest the vaccines are highly effective in the elderly.
Later, the UK government instructed regulators to start their formal assessment of the jabs, with hopes that vaccination rollout could start next month. AstraZeneca insisted that the extra trial would not delay the process of authorisation in Britain, but scientists have urged those involved in the trial to provide more information about their findings.
The head of AstraZeneca has said the company would run an extra study in order to validate the findings in the sub-group. While the study of those given two full doses involved 8,895 people, the 90 per cent efficacy was based on a dosing regime given to just 2,741 people.
AstraZeneca chief executive officer Pascal Soriot said: "Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study." He said he did not expect the additional trial to hold up regulatory approvals in the UK.
