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EMA

EU to decide on Pfizer booster on Oct. 4: document
World

EU to decide on Pfizer booster on Oct. 4: document

  • EMA's opinion on Pfizer booster due on Monday: document
  • Unlikely that EMA will indicate age or risk groups: sources
  • Lack of clear guidance leaves states free to decide risk groups
  • EU states already administering boosters, have many spare doses
Updated 29 Sep, 2021 08:46pm
EU regulator backs Pfizer-BioNTech COVID-19 vaccine for adolescents
World

EU regulator backs Pfizer-BioNTech COVID-19 vaccine for adolescents

  • The European Medicines Agency's endorsement comes weeks after it began evaluating extending use of the vaccine, developed with Germany's BioNTech, to include 12- to 15-year-olds. It is already being used in the European Union for those aged 16 and older.
  • Inoculating children and young people is considered a critical step toward reaching "herd immunity" and taming the pandemic.
Published 28 May, 2021 08:23pm
Not enough data to back use of inhaled steroids for COVID-19: EU regulator
World

Not enough data to back use of inhaled steroids for COVID-19: EU regulator

  • Scientists have been studying the benefits of several inflammation-fighting medicines to treat COVID-19, including some arthritis treatments and corticosteroids such as dexamethasone and budesonide.
  • An infection of the novel coronavirus can cause swelling in organs, including the lungs, which can also lead to severe complications.
Published 27 May, 2021 06:49pm
J&J stands ready to roll out COVID-19 vaccine in Europe
World

J&J stands ready to roll out COVID-19 vaccine in Europe

  • "It's an extremely rare event. We hope by making people aware as well as putting clear diagnostic and therapeutic guidance in place that we can restore the confidence in our vaccine," said J&J's Chief Scientific Officer Paul Stoffels.
  • J&J, during a call to discuss its first-quarter results, said it would fulfill its commitments to ship 200 million doses in Europe and 100 million in the United States.
Published 20 Apr, 2021 07:50pm
EU regulator finds possible link between J&J COVID-19 vaccine and blood clots
World

EU regulator finds possible link between J&J COVID-19 vaccine and blood clots

  • The European Medicines Agency (EMA) said its safety committee concluded that a warning about unusual blood clots with low blood platelets should be added to the vaccine's labels.
  • The EMA found that all instances had occurred in adults under 60 years, mostly women, within three weeks of vaccination, adding that all available evidence, including eight reports of cases in the United States, were part of its assessment.
Updated 20 Apr, 2021 07:32pm
Austria will only use Sputnik V vaccine after EMA approval, Kurz says
World

Austria will only use Sputnik V vaccine after EMA approval, Kurz says

  • Austria has been in talks with Russia to buy a million doses of the vaccine, and Kurz said on March 31 the order would probably be placed the following week. However, that order has yet to be announced.
  • Kurz had recently avoided saying whether his country would await EMA approval of the vaccine, which has been used in the European Union only by Hungary so far. EMA has launched a rolling review of Sputnik V.
Published 19 Apr, 2021 04:58pm
EU expects impact on vaccination plans from new guidance on AstraZeneca shot
World

EU expects impact on vaccination plans from new guidance on AstraZeneca shot

  • "We expect this announcement will have a direct and immediate impact not only on our national vaccination plans, but also in our citizens' trust in vaccines against COVID-19," the letter said.
  • The EU is grappling with a slow vaccine rollout caused by supply problems and by repeated changes in the use of the AstraZeneca shot, which have increased vaccine hesitancy.
Published 07 Apr, 2021 08:05pm
Norway keeps AstraZeneca vaccine on hold for another 3 weeks
World

Norway keeps AstraZeneca vaccine on hold for another 3 weeks

  • "We have decided to continue the pause and make a new decision by April 15," FHI chief Camilla Stoltenberg told broadcaster NRK.
  • "We have started several processes to map out whether there is a causality and to have a better basis to establish the real risk and a cost-benefit analysis for different age groups. To get more knowledge, it is necessary to have more time."
Published 26 Mar, 2021 06:04pm
Sweden to resume AstraZeneca jabs for over 65s
World

Sweden to resume AstraZeneca jabs for over 65s

  • The vaccine is of great use for the elderly, among whom many fall seriously ill each day.
  • "At the same time, we haven't seen these rare and serious side effects among our elderly. That is the background to why we are lifting the suspension for people older than 65."
Published 25 Mar, 2021 08:53pm