• Email Us: [email protected]
  • Contact Us: +1 718 874 1545
  • Skip to main content
  • Skip to primary sidebar

Medical Market Report

  • Home
  • All Reports
  • About Us
  • Contact Us

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

September 23, 2021 by David Barret Leave a Comment

September 23, 2021

By Emilio Parodi and Francesco Guarascio

BRUSSELS (Reuters) – The European Medicines Agency (EMA) expects to decide in early October on the possible use of a booster dose of the Pfizer-BioNTech COVID-19 vaccine, a source with direct knowledge of the matter told Reuters.

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.

“EMA’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.

Pfizer declined to comment, while BioNTech was not immediately available for comment.

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.

Moderna is also expected to submit data to the EMA this month on its booster dose, an EU document said.

In an opinion issued in early September and republished by the EMA, the European Centre for Disease Prevention and Control (ECDC) said there was no urgent need to administer booster doses to fully vaccinated individuals in the general population.

But it also noted that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

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 EMA.

The EU has signed three deals with Pfizer and BioNTech for a total of 2.4 billion doses.

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.

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.

The ECDC 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.

(Reporting by Emilio Parodi and Francesco Guarascio @fraguarascio; Additional reporting by Ludwig Burger; Editing by Josephine Mason and Jan Harvey)

Source Link Exclusive – EU regulator to decide on Pfizer booster at the start of October – source

David Barret
David Barret

Related posts:

  1. IFRC urges urgent global humanitarian support for Afghanistan
  2. Global reinsurance rates to keep rising next year – Moody’s
  3. Pro-Putin party heads for Russian election win after Navalny clampdown
  4. Italy reports 26 coronavirus deaths on Sunday, 3,838 new cases

Filed Under: News

Reader Interactions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Primary Sidebar

  • Earth’s Passage Through The Galaxy Might Be Written In Its Rocks
  • What Is An Einstein Cross – And Why Is The Latest One Such A Unique Find?
  • If We Found Life On Mars, What Would That Mean For The Fermi Paradox And The Great Filter?
  • The Longest Living Mammals Are Giants That Live Up To 200 Years In The Icy Arctic
  • Entirely New Virus Detected In Bat Urine, And It’s Only The 4th Of Its Kind Ever Isolated
  • The First Ever Full Asteroid History: From Its Doomed Discovery To Collecting Its Meteorites
  • World’s Oldest Pachycephalosaur Fossil Pushes Back These Dinosaurs’ Emergence By 15 Million Years
  • The Hole In The Ozone Layer Is Healing And On Track For Full Recovery In The 21st Century, Thanks To Science
  • First Sweet Potato Genome Reveals They’re Hybrids With A Puzzling Past And 6 Sets Of Chromosomes
  • Why Is The Top Of Canada So Sparsely Populated? Meet The “Canadian Shield”
  • Humans Are In The Middle Of “A Great Evolutionary Transition”, New Paper Claims
  • Why Do Some Toilets Have Two Flush Buttons?
  • 130-Year-Old Butter Additive Discovered In Danish Basement Contains Bacteria From The 1890s
  • Prehistoric Humans Made Necklaces From Marine Mollusk Fossils 20,000 Years Ago
  • Zond 5: In 1968 Two Soviet Steppe Tortoises Beat Humans To Orbiting Around The Moon
  • Why Cats Adapted This Defense Mechanism From Snakes
  • Mother Orca Seen Carrying Dead Calf Once Again On Washington Coast
  • A Busy Spider Season Is Brewing: Why This Fall Could See A Boom Of Arachnid Activity
  • What Alternatives Are There To The Big Bang Model?
  • Magnetic Flip Seen Around First Photographed Black Hole Pushes “Models To The Limit”
  • Business
  • Health
  • News
  • Science
  • Technology
  • +1 718 874 1545
  • +91 78878 22626
  • [email protected]
Office Address
Prudour Pvt. Ltd. 420 Lexington Avenue Suite 300 New York City, NY 10170.

Powered by Prudour Network

Copyrights © 2025 · Medical Market Report. All Rights Reserved.

Go to mobile version