Why is AstraZeneca not approved in the US?

This Morning: Nick Ferrari discusses AstraZeneca vaccine

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The AstraZeneca Covid vaccine has been rolled out across the UK and in several European countries. However, some nations, such as the US, are yet to approve the vaccine. The USA has so far authorised three Covid vaccines for use from Pfizer/BioNTech, Moderna and Janssen.

Why is AstraZeneca not approved in the US?

The AstraZeneca vaccine is currently being investigated by the US Food and Drug Administration (FDA) and approval is needed before the vaccine can be rolled out to the population.

The FDA’s pending decision comes as the AstraZeneca vaccine faces heavy scrutiny around the world.

Over the last few months, AstraZeneca has been embroiled in issues with the EU regarding supply of vaccines to the bloc.

The rollout of the AstraZeneca vaccine was also paused in several European nations in recent weeks, while a possible link between rare blood clots and the vaccine were investigated.

The European Medicines Agency (EMA) concluded on Wednesday that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the Oxford/AstraZeneca vaccine.

In the UK, Dr June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said the benefits of the AstraZeneca vaccine outweigh the risks for the “vast majority” of people after cases of blood clots were detected in an “extremely small” number of people.

The UK has, however, changed its advice to state it is “preferable” people under the age of 30 receive an alternative Covid vaccine to the AstraZeneca jab.

As well as facing problems with Europe, the AstraZeneca vaccine has also faced hurdles in its quest for approval in the US.

In March, questions were raised regarding the AstraZeneca vaccine’s efficacy data.

On March 22, AstraZeneca released an analysis of its Phase III trial carried out in the US, Chile and Peru.

The company said the data showed the vaccine was 79 percent effective at preventing symptomatic COVID-19.

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However, officials from the monitoring board overseeing the vaccine trial expressed concern the data released by AstraZeneca may have “provided an incomplete view of the efficacy data”, according to the National Institute for Allergy and Infectious Diseases.

The National Institute for Allergy and Infectious Diseases then urged AstraZeneca “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.”

On March 24, AstraZeneca announced its vaccine was 76 percent effective at preventing symptomatic disease.

The findings were based on a Phase III trial including more than 32,000 participants.

Last month Mene Pangalos, AstraZeneca’s executive vice-president, said the latest analysis “confirms that our Covid-19 vaccine is highly effective in adults, including those aged 65 years and over”.

Mr Pangalos added: “We look forward to filing our regulatory submission for emergency use authorisation in the US and preparing for the rollout of millions of doses across America.”

The FDA is now tasked with scrutinising the AstraZeneca vaccine’s data, to see whether it will receive approval in the US.

Will the US roll out the AstraZeneca vaccine?

Earlier this month Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, told Reuters the US may not need the AstraZeneca vaccine if it gets regulatory approval.

Asked whether the United States will use the AstraZeneca vaccine doses, he said: “That’s still up in the air.

“My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfil all of our needs without invoking AstraZeneca.”

He added: “If you look at the numbers (of doses) that we’re going to be getting, the amount that you can get from J&J, from Novavax from Moderna if we contract for more, it is likely that we can handle any boost that we need, but I can’t say definitely for sure.”

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