Exclusive - EU regulator to decide on Pfizer booster at the start of October - source

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By Reuters
Exclusive - EU regulator to decide on Pfizer booster at the start of October - source
Exclusive - EU regulator to decide on Pfizer booster at the start of October - source   -   Copyright  Thomson Reuters 2021   -  

<div> <p>By Emilio Parodi and Francesco Guarascio</p> <p><span class="caps">BRUSSELS</span> – The European Medicines Agency (<span class="caps">EMA</span>) expects to decide in early October on the possible use of a booster dose of the Pfizer-BioNTech <span class="caps">COVID</span>-19 vaccine, a source with direct knowledge of the matter told Reuters.</p> <p>It will be the EU drugs regulator’s first decision on boosters, the source said, after the U.S. Food and Drug Administration on Wednesday authorized a third dose of Pfizer for those 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus.</p> <p>“<span class="caps">EMA</span>’s decision on the third dose of Pfizer is expected for the beginning of October,” the source said, declining to be named because of the sensitivity of the matter.</p> <p>Pfizer declined to comment, while BioNTech was not immediately available for comment.</p> <p>The EU regulator said on Sept. 6 it had begun its evaluation of data submitted by Pfizer and BioNTech for a booster dose to be given six months after the second dose in people 16 years of age and older.</p> <p>Moderna is also expected to submit data to the <span class="caps">EMA</span> this month on its booster dose, an EU document said.</p> <p>In an opinion issued in early September and republished by the <span class="caps">EMA</span>, the European Centre for Disease Prevention and Control (<span class="caps">ECDC</span>) said there was no urgent need to administer booster doses to fully vaccinated individuals in the general population.</p> <p>But it also noted that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.</p> <p>Many EU states have already decided to administer a booster dose despite facing higher legal risks without a formal decision to do so by the <span class="caps">EMA</span>.</p> <p>The EU has signed three deals with Pfizer and BioNTech for a total of 2.4 billion doses. </p> <p>The latest contract covers the supply of at least 900 million shots, a large part of which is likely to be needed only if boosters are considered necessary, or if new virus variants emerge against which existing vaccination is not effective.</p> <p>Over 70% of the EU’s adult population has already been fully vaccinated, and the bloc has secured an ample supply of vaccines from several manufacturers.</p> <p>The <span class="caps">ECDC</span> has said crucial data on the need and safety of boosters are still missing, in part because it is not yet fully clear how long vaccines protect against the virus.</p> <p/> </div>