AstraZeneca vaccine approval filing delayed in US
May 17, 2021
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by Snigdh Baunthiyal

AstraZeneca vaccine approval on hold
AstraZeneca has delayed filing for FDA approval in the United States and has said it plans on seeking approval from the country in the coming weeks. The company was expected to file for approval in mid-April.  

AstraZeneca’s file for approval from the US Food and Drug Administration will include data from US trials as well all other studies completed so far and real-world data collected from use of the vaccine in other countries.

The reason behind the delay in AstraZeneca vaccine approval is because of disparity in data from multiple trials and the real-world use of the shot.

An independent panel had raised concerns over the company’s trial data being outdated in March. AstraZeneca followed up with a more thorough analysis of the trial, which resulted in the efficacy rate falling from 79% to 76%. The shot is 85% effective in people aged over 65.
The company has so far delivered 68 million doses of the vaccine to the European Union, United Kingdom and other countries in the first three months of the year.

To date, AstraZeneca and partners such as the Serum Institute of India and Fiocruz in Brazil have supplied more than 300 million COVID-19 vaccine doses to over 165 countries, the Anglo-Swedish drug maker said

AstraZeneca’s vaccine accounts for 90% of India’s shots and 98% of supplies for Covax, the World Health Organization-backed program to help spreas immunisations all across the world.

AstraZeneca’s head of biopharmaceuticals research, Mene Pangalos has said that the company will pursue the usual non-emergency approvals path if necessary.

AstraZeneca first released data from its US vaccine trial on March 22 and company officials had claimed that they will apply for FDA authorisation in April.

The company’s VP has said that after they get the FDA approval, the company will deliver 30 million doses to the US immediately, followed by another 20 million within the first month.

The White House has said that the US will share its stock of AstraZeneca vaccine with the world when it clears the federal safety reviews. It is expected that the US will receive as many as 60 million doses in the coming months. US President Joe Biden had earlier committed to sharing 4 million doses of the vaccine with Canada and Mexico.

AstraZeneca has reported revenue of $275 million during its first quarter. The company has pledged that it will deliver the vaccine on a non-profit basis till the pandemic lasts.
The company said 30 million doses went to the EU; 26 million to the UK; 7 million to Gavi, the Vaccine Alliance, which secures vaccines for low-income countries; and 5 million to other nations.

The vaccine was developed by researchers at the University of Oxford. The vaccine was licensed to AstraZeneca which is known for its global manufacturing and distribution capacity. AstraZeneca in turn authorises other companies to produce the shots around the world.

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