Why Has AstraZeneca Not Been Given Approval in the US & EU?

India approved the Oxford-AstraZeneca vaccine, but why are the US and EU lagging behind?

Why Has AstraZeneca Not Been Given Approval in the US & EU?

On Sunday, January 3, the COVID-19 vaccine developed by Oxford University and pharma major AstraZeneca received emergency use approval in India (as did Bharat Biotech’s vaccine covaxin.)

The UK became the first country in the world to approve the Oxford-Astra-Zeneca vaccine on 30 December, but where do other countries stand?

As we enter 2021, vaccine approvals seem closer than ever, but then why has the Oxford-Astra-Zeneca vaccine not yet been approved in the US and Europe?

FIT breaks it down.


Where Does USA Stand?

The US may not get the Astra-Zeneca vaccine until April 2021 because of lingering questions of its safety and efficacy, reported Politico.

Let’s wind it back. So earlier, the US ordered 300 million doses of the vaccine, but it wasn't a smooth ride since. A late-stage trial was immediately stopped when there was an adverse event. Trials were resumed after the US’s Food and Drug Administration (FDA) authorised them.

Another one of the big questions was the effect of the vaccine on elderly people since very few were enrolled in the trials. The elderly are one of the at-risk groups across the world as they are often immuno-compromised and more susceptible to the virus.

Besides, US regulators reportedly need more evidence effectiveness, and Moncef Slaoui, head of Operation Warp Speed - which is the US’ public-private partnership on vaccine - told Politico,

“We need a clear and concrete number more than a number that is accumulated by adding together different trials with different schedules and different materials.”
Moncef Slaoui, head of Operation Warp Speed

Slaoui was referring to the confusion with the vaccines efficacy rate, as it showed 62 per cent efficacy with two full doses in a span of 28 days, but also a trial with 90 per cent effectiveness when one group received a half-dose first.

Meanwhile, Mexico has approved the Oxford-Astra Zeneca vaccine for emergency use on Monday, 4 January, reported The New York Times.

What’s Happening in the EU?

The European Medicines Authority (EMA) is currently processing the data on the Oxford-AstraZeneca vaccine as part of a vaccine review. Reportedly, Astra Zeneca has not yet submitted an application to review their vaccine.

EMA deputy executive director Noel Wathion said that “They have not even filed an application with us yet. Not even enough to warrant a conditional marketing licence,” reported Pharmaceutical Technology.

The EU has requested more data on the quality, safety and efficacy of the vaccine, and more data from their ongoing clinical trials. The company will offer data from the interim trials in the US in the first half of 2021.

It is important to know that the EMA is working towards granting “conditional marketing authorisation of COVID-19 vaccines, with all the safeguards, controls and obligations that this imposes,” reported the European Medicines Agency.

As far as other vaccines go, Pfizer and BioNTech announced they will deliver an additional 100 million doses of their COVID-19 vaccine, COMIRNATY, to the 27 European Union (EU) member states in 2021.

Meanwhile, the United Kingdom became the first country in the world to approve the Oxford-Astra-Zeneca vaccine and approved it for emergency supply on 30 December said an Astra-Zeneca press release.

UK Medicines and Healthcare products Regulatory Agency (MHRA) provided authorisation for emergency supply of the vaccine for people aged 18 and up. On Monday, an 82-year old dialysis patient in Oxford became the first person in the world to get a shot.

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