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EU Launches Faster Process For Approving Variant Vaccines

EMA Outlines Basic Regulatory Requirements

 
• By Ian Schofield

Amid the growing threat posed by variants of the coronavirus, the European Commission has published new rules allowing modified vaccines to be approved more quickly. The UK has identified one version of the B.1.167 virus variant as the most transmissible, although the jury is still out on its ability to evade vaccine protection.

New Coronavirus variant outbreak and covid-19 virus cell mutation spread
Preparations are being made for the approval of vaccines against coronavirus variants • Source: Alamy

On 13 May, a new EU regulation comes into force that will allow regulators to speed up the authorization of COVID-19 vaccines whose composition has been modified to address the growing threat posed by variants of the SARS-CoV-2 virus.

The new regulation, which was published in draft form in March, amends the EU Variations Regulation (No 1234/2008) so that changes to coronavirus vaccines will only need to meet...

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More from Geography

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

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