US Agency Questions AstraZeneca COVID Vaccine Trial Data, Claims 'Outdated Information' Released

Clay Curtis
March 24, 2021

"The trial protocol says the DSMB "will facilitate the interim analysis", so if everything was done as it should have been, the DSMB wouldn't be blindsided by a company press release", she said.

"The last thing this vaccine needs is more concern when we kind of thought we were at that point now where we'd put to bed all the other concerns", said Paul Griffin, an associate professor of medicine at the University of Queensland in Brisbane, who is conducting clinical studies in Australia on four COVID-19 vaccine candidates.

In the study of 30,000 people, the vaccine was 79% effective at preventing symptomatic cases of COVID-19 - including in older adults.

The U.S. has provided more than $1 billion to support the development of AstraZeneca's vaccine and ordered 300 million doses.

"The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine".

Where is the AstraZeneca vaccine made?

"We are sure, considering the gravity of the situation and prestige of our company as well as our country is at stake, you will definitely intervene and give permission to us to supply at least 50 lakh doses of Covishield to the United Kingdom this week". But Tuesday's statement from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) cast doubt on whether the U.S. would imminently green light the jab.

U.S. federal health officials said early Tuesday that results from a USA trial of AstraZeneca's Covid-19 vaccine may have relied on "outdated information" that "may have provided an incomplete view of the efficacy data", casting doubt on an announcement Monday that had been seen as good news for the British-Swedish company, as well as the global vaccination drive.

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Around 38,000 people have received their first shots. "We intend to issue results of the primary analysis within 48 hours", the statement concluded.

The institute urged AstraZeneca to work with the monitoring board to review the efficacy data and ensure that the most accurate and up to date data is made public "as quickly as possible".

As expected, the European Union's health regulators are standing behind the covid-19 vaccine developed by AstraZeneca and Oxford University.

"These data are further evidence that the Oxford-AstraZeneca vaccine is safe and effective", Tedros said.

In Norway, a top official warned on Monday it might not be able to resume its use of the AstraZeneca vaccine because so many people were rejecting it. There have been concerns about its efficacy, its safety and its availability, which appear to have lowered trust.

This is just the latest public communications issue the company has faced over the last three months.

Health Canada based its approval of AstraZeneca's vaccine in late February on earlier clinical trial data.

The efficacy rate in the US trial was stronger than the 70 per cent figure AstraZeneca reported from an earlier study. That will give it more opportunities to mutate, and so increase the risk of a new variant emerging that could make the vaccine less effective. After the earlier, mixed results, the clear-cut finding excited public health experts and raised hopes that the vaccine might soon be used in the United States, where AstraZeneca has not yet filed a request for emergency use authorization. That's in sharp contrast to much of Europe, which is facing a third wave of the pandemic and has been hampered by a limited vaccination campaign.

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