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Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data

BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n2086 (Published 20 August 2021) Cite this as: BMJ 2021;374:n2086

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Linked Opinion

Does the FDA think these data justify the first full approval of a covid-19 vaccine?

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Re: Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data

Dear Editor,

I am delighted to see such a proactive response, by medical practitioners who care, to the hasty FDA approval of the Pfizer vaccines.

It is becoming clearer to me that we are in a period of social development when we are being invited to ensure that all our solutions address root cause and avoid symptomatic relief.

I am now curious to know what the approval process for this vaccine is in the UK. I am concerned that secretive and rapid approvals are for political and commercial expediency with significant social risk.

Many thanks.

Christopher Cooke

Competing interests: No competing interests

24 August 2021
Christopher Cooke
Company Managing Director
Change Management
Otley

Re: Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data

Dear Editor, Emergency use authorisation was perhaps a 'necessary and urgent' business against the challenge of Covid-19 with its numerical dimensions of morbidity and mortality and the rapidity of the course of events. There stands a difference between 'no inputs ' and 'no inputs received on a specific communication sent. ' Statutory bodies have their powers which are best exercised with 'discretion', and Covid pandemic exemplifies one situation where authoritative stamp matters ; short cuts can be viewed differently. Where vaccine hesitancy is still a raging feature of the pandemic, related products for large scale usage best pass 'certified through all formal stages ' that would appear in the interest of manufacturer as well, being for global usage. . Prof Murar E Yeolekar, Mumbai.

Competing interests: No competing interests

21 August 2021
Murar E Yeolekar
Consultant Physician
Fmr Prof & Head of Internal Medicine, KJSMC &LTMMC
Sion, Mumbai 400 022
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