Egypt’s EDA approves AstraZeneca’s ‘Evusheld’ for emergency use for pre-exposure prevention of COVID-19

Doaa A.Moneim , Sunday 16 Jan 2022

AstraZeneca announced on Sunday that the Egyptian Drug Authority (EDA) has granted AstraZeneca’s ‘Evusheld’ an emergency use authorisation (EUA).

The Egyptian government
The Egyptian government on Thursday decided to postpone the first-term exams in all schools including universities until after the mid-year vacation over concerns of a second wave of the COVID-19 outbreak. AFP

The EUA follows a recent procurement agreement for Evusheld inked in December 2021 by AstraZeneca and the EDA for unified procurement, medical supply, and technology management for the Ministry of Health and Population. 

Evusheld is tixagevimab co-packaged with cilgavimab, a long-acting antibody combination for pre-exposure prevention of COVID-19.

AstraZeneca said that the first doses of the drug are expected to become available in Egypt in the coming weeks.

It added that Evusheld is meant to protect vulnerable populations who may be unable to mount an adequate immune response following a COVID-19 vaccination due to pre-existing medical conditions such as blood cancers, patients receiving chemotherapy, those on hemodialysis, and other conditions causing immunosuppression.

On 14 December, the EDA and AstraZeneca signed a procurement agreement for unified procurement, medical supply, and technology management (UPA) for the recently authorised long-acting antibody (LAAB) combination, Evusheld.

“Egypt is one of the first countries to sign a procurement agreement for doses of our new long-acting antibody medicine. Evusheld will play a critical role in fighting the COVID-19 pandemic to prevent virus symptoms and provide long-lasting protection,” said Hatem Werdany, AstraZeneca’s country president for Egypt.

The company noted that the primary data supporting the Evusheld EUA is from the ongoing PROVENT trial, which demonstrated an 83 percent reduction in the risk of developing symptomatic COVID-19, with protection from the virus continuing for at least six months.

Additionally, in the TACKLE outpatient treatment trial, Evusheld reduced the risk of developing severe COVID-19 or death by 88 percent when administered to non-hospitalised patients with mild to moderate COVID-19 within three days, according to the company.

Two independent studies from University College Oxford and Washington University School of Medicine have also shown that Evusheld retains neutralising activity against the Omicron variant.

These tests are in line with previous results from tests conducted by the US Food and Drug Administration and add to the growing body of evidence demonstrating that Evusheld retains activity against all tested SARS-CoV-2 variants of concern to date.

As part of its global fight against the COVID-19 pandemic, AstraZeneca has also supplied to date over 16.7 million doses of its COVID-19 vaccine to Egypt.

Also in December, Egypt received 347,460 doses of the AstraZeneca coronavirus vaccine under the umbrella of the COVID-19 Vaccines Global Access Initiative (COVAX).

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