Why Has Oxford-Astra Vaccine Not Been Given Approval in US & EU?

UK, India and Mexico remain the only countries that have given a go-ahead for the use of Oxford-AstraZeneca vaccine.

With coronavirus vaccination underway in many countries, what’s the reason behind US and EU holding their approvals to Oxford-AstraZeneca?

(Photo: iStock)

The United Kingdom became the first country to approve the Oxford-AstraZeneca vaccine against coronavirus on 31 December. Three days later, the Indian government gave emergency use approval for the vaccine to curb the pandemic.

However, the vaccine has not received a green signal from any other countries, with the approvals pending in both United States and European Union.

With coronavirus vaccination underway in many countries, what’s the reason behind US and EU holding their approvals to Oxford-AstraZeneca? Here’s what we know.

How does the Oxford-AstraZeneca vaccine work?

The Oxford-AstraZeneca vaccine is based on a common cold virus found in chimpanzees. Scientists have tweaked this virus to carry genetic material that contains instructions for the spike protein of the novel coronavirus.

Once in, they start producing the coronavirus' spike proteins, forcing our body to mount an immune response via both neutralising antibodies and killer T cells, that squash the infected cells.

Where does USA stand on the approval?

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

Earlier in 2020, the US ordered 300 million doses of the vaccine. However, at a late-stage, trial was immediately stopped due to an adverse reaction and resumed in December 2020 only after the US’ Food and Drug Administration (FDA) authorised them.

What’s the big question that US has regarding the vaccine?

The big question was about the effect of the vaccine on elderly people as 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.

Moncef Slaoui, Head of Operation Warp Speed – which is the US’ public-private partnership on vaccine – told Politico that there was confusion regarding the effectiveness of the vaccine.

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

What’s the situation in European Union?

The European Medicines Authority (EMA) is currently processing the data on the Oxford-AstraZeneca vaccine as part of a vaccine review.

EMA deputy executive director Noel Wathion said, “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.

Which vaccines has the EU approved?

The EMA on 6 January has approved the Moderna vaccine, making it the second coronavirus shot to be cleared for general use across the EU, after Pfizer approved earlier in December 2020.

Has any other country, apart from India, recently approve the vaccine?

Yes. Mexico has approved the Oxford-Astra Zeneca vaccine for emergency use on Monday, 4 January.

(This was first published on FIT and has been republished with permission.)