Manufacturing error in AstraZeneca-Oxford Covid-19 vaccine: What went wrong

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Concerns about the trial results and efficacy of the Covid-19 vaccine being developed by British–Swedish pharmaceutical company AstraZeneca and Oxford University have surfaced from many scientists, following a mistake in the dosage levels administered to trial participants.

Following Britain’s health secretary Matt Hancock, secretary of state for housing, communities and local government Rober Jenrick has also assured that the UK independent regulator would thoroughly assess the Covid-19 vaccine.

What went wrong?

On Monday, AZD1222 Covid-19 vaccine jointly developed by AstraZeneca and the Oxford University was declared to be 70 per cent effective based on combined data analysis after two dosage regimens. The vaccine was 62 per cent effective when administered as two complete dosages and 90 per cent effective when given as a half dose followed by a full dose, both with a month’s gap.

The clinical trial results were based on 23,000 volunteers from the UK and Brazil and the results invited significant positive response globally, considering that the world is in the race for finding a cure to the pandemic.

However, on Wednesday, a statement from Oxford University confirmed that the problem of some volunteers receiving only half a dose was due to the fact that the right concentration of the vaccine was not there in some vials, as reported by the Associated Press.

This manufacturing error didn’t find any mention in the earlier report by AstraZeneca, in which the efficacy of the vaccine was declared. Researchers at Oxford University have been uncertain about the reason behind these results.

What happens next?

AstraZeneca’s chief executive officer Pascal Soriot comments that the company might perform more research on their Covid-19 vaccine is a possibility, given that the earlier efficacy was declared by pooling the results obtained from two countries – the UK and Brazil.

UK’s independent regulator Medicines and Healthcare Products Regulatory Agency (MHRA) will now assess the vaccine for its efficiency and data accuracy, before granting any approval for usage in the UK. “No vaccine would be authorized for supply in the U.K. unless the expected standards of safety, quality and efficacy are met,” June Raine, chief executive of MHRA, was quoted as saying by AP.

However, AstraZeneca’s partner for the vaccine program in India, Serum Institute of India, has allayed all fears regarding the efficacy and said that trials in India have taken place with “strict adherence to all the necessary processes and protocols.”

(With agency inputs)

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