Experts Defend UK Agency Over Rapid Authorization Of COVID-19 Vaccine
EMA Explains Its ‘Softly Softly’ Approach
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.
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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.
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.
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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.