AstraZeneca to reissue vaccine data "within 48 hours" after questions raised

AstraZeneca manufacturing employee

Results from a US trial of AstraZeneca's COVID-19 vaccine may have used "outdated information", USA federal health officials said early Tuesday.

A company spokesman said on Tuesday it was "looking into it".

Last summer, at least some top FDA officials learned only from news reports that AstraZeneca had paused its Phase 2/3 vaccine trial in Britain after a participant developed neurological symptoms.

Many countries are relying heavily on the shot to end the pandemic, and several state leaders have taken it publicly to boost confidence.

The data will give credence to the British shot after results from earlier, separate late-stage studies raised questions about the robustness of the data. The earlier results were based on data gathered through February 17. The EMA announced last week that it could find no causal link, but since then not all countries have restarted using the vaccine.

The efficacy rate in the US trial was stronger than the 70 per cent figure AstraZeneca reported from an earlier study.

The statement came only hours after AstraZeneca released the results of its US -based phase three clinical trials, which began last August and wrapped up earlier this month.

He expressed hope it "puts to bed any doubts".

The Data and Safety Monitoring Board released a statement early Tuesday morning saying it was concerned that the information included in the trial could paint in inaccurate picture of how effective the shot truly is.

"We are urging the company to work with the Data and Safety Control Board to evaluate the effectiveness of the data, and to ensure that the most accurate, up-to-date and effective data will be published as quickly as possible", he added. He said AstraZeneca's issues may be even tougher to overcome "because every week it seems like there's some new concern".

A physician prepares a dose of AstraZeneca's COVID-19 vaccine in Bologna, Italy, on 19 March. "The bottom line is: that doesn't change recommendations on the AstraZeneca vaccine at this time".

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Mr Fauci said: "It really is unfortunate that this happened".

It is not yet clear, experts say, what impact the setbacks might have on global use of AstraZeneca's vaccine, a cornerstone of the World Health Organization's plan to help low-income countries beat the pandemic.

He insisted, when the vaccine is used in the United States it will be cleared by the Food and Drug Administration (FDA) beforehand.

France is a prime example of the confusion. It's now being given to people 18 and older in Canada.

"The issues referred to in the US have to do with the efficacy data and how to interpret them", Berthiaume said in French.

This development came amid reports that the UK's anti-coronavirus inoculation programme has been hit due to a delay in the supply of the second batch of vaccines. The problems appear to be more common among vaccinees than would be expected by chance.

Who is funding the AstraZeneca vaccine?

The World Health Organisation, UK health authorities and the European Medicines Agency have all voiced support for it.

When you subscribe we will use the information you provide to send you these newsletters. "We intend to issue results of the primary analysis within 48 hours", the company stated.

The federal government has also bought two million doses of the vaccine from the Serum Institute of India, which is manufacturing billions of shots. "It's better to be vaccinated rather than not".

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