AstraZeneca may have used outdated info in vaccine trial

Wednesday, 24 Mar, 2021

"The gap between the number of vaccines administered in rich countries and the number of vaccines administered through COVAX is growing every single day and becoming more grotesque every day".

"So far, AstraZeneca is the only company that has committed to not profiting from its COVID-19 vaccine during the pandemic".

The United States has said it is sharing 1.5 million doses of the AstraZeneca vaccine with Canada as early as this week.

First, the company's vaccine took longer than several others to be approved in multiple countries, in part because, in its first large-scale clinical trial, dose amounts given to subjects were inconsistent.

But the vaccine keeps running into trouble.

Now, the vaccine has suffered a new blow.

"We will immediately engage with the independent data safety monitoring board to share our primary analysis with the most up to date efficacy data".

The U.S. National Institute for Allergy and Infectious Diseases (NIAID) said on Monday that the board charged with ensuring the trial's safety and accuracy had expressed concern the company may have included outdated data that gave an incomplete view of the shot's effectiveness.

The fresh data may have arrived too late to make much difference in the USA, where the vaccine is not yet authorised and is unlikely to become available before May.

AstraZeneca responded with its statement on Tuesday afternoon saying it would reissue the key data. "If you look at it, the data really are quite good but when they put it into the press release it wasn't completely accurate".

The company has promised to publish more up-to-date data by Thursday. Photo via KFL&A Public Health. That is what the DSMB communicated to AZ in a rather harsh note.

The company said on Monday that it would continue to review the new data and prepare for emergency authorization from the Food and Drug Administration. There have been very rare cases of unusual blood clots accompanied by low levels of blood platelets (components that help blood to clot) after vaccination.

On 18 March, EMA said its experts could not rule out a connection to the vaccine and chose to add a warning to the product information. Most countries have done so, but five Nordic nations have not. A site in Leiden in the Netherlands is also producing some vaccine, although the pharmaceutical company said it was not significant, according to the BBC. A research group in Norway has come to a similar conclusion.

UPDATE: This alert has been updated with a response from AstraZeneca. And some of the cases do not fit the VIPIT description.

Use of the AstraZeneca vaccine was paused across Europe last week after reports of a relative handful of rare but worrying blood clots.

The Oxford-AstraZeneca vaccine is made in the United Kingdom at two sites: in Oxford and Keele. The European Union has ordered 400 million doses, which have arrived much more slowly than foreseen.

On Friday, Ottawa and the USA confirmed that the latter was finalizing a deal to "loan" 1.5 million AstraZeneca doses to Canada at the end of April. "The negative reports about this vaccine do not stop, although my assessment is that it is well tolerated and safe, but clearly less effective than the two mRNA vaccines", said Peter Kremsner, from the University Hospital in Tuebingen, Germany.