Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Experts Defend UK Agency Over Rapid Authorization Of COVID-19 Vaccine

EMA Explains Its ‘Softly Softly’ Approach

Executive Summary

As arguments rage over whether the UK regulator has rushed its assessment of the Pfizer/BioNTech vaccine, the European Medicines Agency explains why its conditional marketing authorization approach is taking a little longer.

You may also be interested in...



EMA Chief: ‘Safety Is Our Priority’ In Review Of COVID-19 Vaccine

The EMA says its experts are working “around the clock” on a recommendation for conditional marketing authorization of a COVID-19 vaccine, but that it will only OK a vaccine if it is satisfied that the evidence convincingly shows the benefits are greater than the risks.

Fauci Apologizes For UK V US Vaccine Comments: Not Better, Not Worse, Just Different

The UK’s rapid authorization of the Pfizer/BioNTech COVID-19 vaccine has sparked a public debate over regulatory processes at some of the world’s key regulatory bodies.

CBER Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., Marks Says

Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.

Related Content

Topics

UsernamePublicRestriction

Register

LL043624

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel