NIAID urges AstraZeneca to release up-to-date data


"We look forward to filing our regulatory submission for Emergency Use Authorization in the USA and preparing for the rollout of millions of doses across America", said Mene Pangalos executive vice president of biopharmaceuticals research and development.

The vaccine was 85 per cent effective in preventing symptoms in volunteers 65 and older, the company said.

Canada's federal health agency announced Wednesday that it is updating the label on vials of the Oxford-AstraZeneca vaccine with information about "very rare reports of blood clots", but continued to stand by the vaccine's safety and effectiveness against COVID-19. Those claims were thrown into doubt just hours later when a key USA government oversight agency, the Data and Safety Monitoring Board, said AstraZeneca "may have included outdated information" from the late-stage clinical trial, "which may have provided an incomplete view of the efficacy data".

"We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible".

An interim analysis of the trial, which took place in the United States, Peru and Chile, showed Monday that the vaccine efficacy was 79 percent.

"The EU has an excellent portfolio of different vaccines and we have secured more than enough doses for the entire population".

The move came after an independent panel of experts appointed to supervise the trial expressed concern that AstraZeneca had failed to include updated data in its initially released figure.

"There were 190 cases in the primary analysis".

The company added there are 14 additional or probable Covid cases left to be adjudicated.

Earlier Wednesday, Dr. Anthony Fauci, the top U.S. infectious disease expert, told reporters he hoped that when all the data was publicly vetted by federal regulators, it would dispel any hesitancy caused by the spat.

"Health Canada reassures Canadians that the AstraZeneca COVID-19 vaccine continues to be safe and effective at protecting them against COVID-19 and encourages people to get immunized with any of the COVID-19 vaccines that are authorized in Canada", the agency said in a statement Wednesday evening.

At the time the EMA couldn't say if the clots were related to the vaccine.

He told ABC's Good Morning America on Tuesday that the AstraZeneca vaccine "is very likely a very good vaccine", and this situation does nothing but cast doubt about the vaccines and maybe contribute to vaccine hesitancy.

The AstraZeneca vaccine is still seen as vital to vaccinating the world because of its low price and the fact it can be stored long term at fridge temperatures.

It was the first immunization out of the gate in the western world, going into the arms of volunteers on January 4.

However, the health department said it had assessed the available data and has determined that the vaccine has not been associated with an increase in the overall risk of thrombosis.



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