AstraZeneca seeks extra virus vaccine trial over manufacturing error, efficacy rates

*Questions are mounting over one of the fastest-moving shots after the company acknowledged that a lower dosage level that appeared more effective resulted from a manufacturing discrepancy

Isola Moses | ConsumerConnect

In view of the stated dissimilar efficacy readouts for AstraZeneca-Oxford vaccine shots, AstraZeneca Plc’s COVID-19 vaccine seems headed for an additional global trial as the drug maker tries to clarify uncertainty and confusion surrounding favourable results in its current study.

Pascal Soriot, Chief Executive Officer (CEO), AstraZeneca Plc, said that the company desired the new test to confirm the 90% efficacy rate that the shot showed in a portion of an existing trial.

The drug maker is favouring that option rather than adding an arm to a separate study that’s already underway in the United States (US), agency report said.

It was learnt questions are mounting over one of the fastest-moving shots after the company acknowledged that a lower dosage level that appeared more effective resulted from a manufacturing discrepancy.

The company and its partner, the University of Oxford, didn’t initially disclose the error and other key details, leading to concern over their transparency.

However, Soriot in his first interview since the data were released, 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.”

According to AstraZeneca CEO, it will probably be another “international study, but this one could be faster because we know the efficacy is high; so we need a smaller number of patients.”

But he noted that he didn’t expect the additional trial to hold up regulatory approvals in the United Kingdom (UK) and European Union (EU).

The UK Government Friday said it had asked the medicines regulator to assess whether the Astra-Oxford vaccine was suitable for temporary authorisation.

The unusual step comes after the government amended legislation in light of the pandemic to allow the UK to approve a vaccine ahead of the European regulator, which Britain is still subject to until January 2021.

Soriot confirmed that clearance from the US Food and Drug Administration (FDA) may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results.

Authorisation in some countries is still expected before the end of the year, he said.

The CEO further noted: “The question for us was, will we need the US data to get approval in the US or can we get approval in the US with international data, and it was never clear.”

“Now with those results, it’s more likely that we will need the US data.”

It was gathered that Astra and its CEO are facing scrutiny as the drug maker responds to growing confusion over the vaccine.

The company’s late-stage data initially increased confidence that the world would soon have multiple shots to combat the pathogen, following positive reports from front-runners Pfizer Inc. and Moderna Inc.

Nevertheless, scant disclosures and the manufacturing discrepancy have sparked doubts among scientists and investors.

ConsumerConnect recalls the dissimilar vaccine trial result rates when Astra and Oxford reported Monday, November 23, 2020, that a lower initial dose of the vaccine, followed by a full dose, produced a 90% efficacy rate in a smaller set of participants, compared with 62% for two full doses.

A day after the data were unveiled the head of Operation Warp Speed, the US vaccine programme, said that the regimen showing the higher level of effectiveness was tested in a younger population.

The official also disclosed that the half-dose was given to some people because of an error in the quantity of vaccine put into some vials.

None of those details were disclosed in Astra or Oxford’s original statements, said the Head of US Operation Warp Speed.

On the possibility of Astra’s needing new COVID-19 vaccine trial beyond the US, Soriot however, disputed the idea that the half-dose regimen was an error.

He clarified that after researchers realised the dosing discrepancy, they formally changed the trial protocol with the blessing of regulators.

He said: “I won’t tell you we expected the efficacy to be higher,” adding, but “people call it a mistake ─it’s not a mistake.”

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