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European Medicines Agency

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

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

Updated 29 Sep, 2021 08:46pm
  • 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
Covid vaccine access needed 'thoughout world'

Covid vaccine access needed 'thoughout world'

Published 12 Jun, 2021 12:42am
  • "This is not within the competence of the EMA so I can only speak from a personal perspective, where I really believe we need to ensure access, availability and access throughout the world, not just in the countries that have the means to pay for them," EMA Executive Director Emer Cooke said in an interview.
Pfizer and BioNTech request EU to approve vaccine for 12 to 15 year olds

Pfizer and BioNTech request EU to approve vaccine for 12 to 15 year olds

Updated 30 Apr, 2021 05:19pm
  • Pfizer and BioNTech will be seeking approval from the European Medicines Agency (EMA) to approve their coronavirus vaccine for use on 12-15 year olds.
  • The companies articulated that the children will continue to be monitored for longer-term protection and safety for an additional two years.
EMA starts review of GSK's monoclonal antibody to treat COVID-19 patients

EMA starts review of GSK's monoclonal antibody to treat COVID-19 patients

Updated 15 Apr, 2021 06:03pm
  • In late March, the companies filed an application to US regulators for emergency use authorization of VIR-7831 to treat early-stage COVID-19 infections.
  • The United States has already recommended similar therapies from Eli Lilly and Co and Regeneron Pharmaceuticals Inc .
Madrid residents snub AstraZeneca shots amid shifting safety guidance

Madrid residents snub AstraZeneca shots amid shifting safety guidance

Published 09 Apr, 2021 06:51pm
  • Spain introduced the restriction on Wednesday after the European Medicines Agency reported a link between the shots and a rare form of brain blood clots affecting roughly one in every 100,000 people under 60 vaccinated.
  • As of Thursday night, only around 45% of people had confirmed their vaccine appointments for Friday, he added.
EU reviews J&J COVID-19 vaccine for blood clots, expands AstraZeneca probe

EU reviews J&J COVID-19 vaccine for blood clots, expands AstraZeneca probe

Published 09 Apr, 2021 05:54pm
  • Four serious cases of rare blood clots with low platelets, one of which was fatal, have been reported after inoculation with J&J's vaccine from its Janssen unit, the European Medicines Agency said, adding five cases of capillary leak syndrome linked to AstraZeneca's vaccine were reported.
German vaccine official: rare clots after AstraZeneca shots were 20 times higher

German vaccine official: rare clots after AstraZeneca shots were 20 times higher

Updated 07 Apr, 2021 08:01pm
  • His comments came as the European Medicines Agency and Britain's medical regulator acknowledged a possible link between the AstraZeneca vaccine to very rare cases of unusual blood clots with low blood platelets, with most cases reported in women under 60 years of age within two weeks of vaccination.
Austria in talks to buy a million doses of Russia's Sputnik V vaccine

Austria in talks to buy a million doses of Russia's Sputnik V vaccine

Published 30 Mar, 2021 07:10pm
  • Conservative leader Kurz is under fire from opposition parties because his government did not buy as many coronavirus vaccines as it could have under the European Union's collective purchasing scheme.
  • "There must be no geopolitical blinkers regarding vaccines," Kurz said in a statement issued by his office, adding that Austria is in talks with Russia and Moscow has offered to sell it a million doses as of April. "The only thing that must count is whether the vaccine is effective and safe."
Sweden to resume AstraZeneca jabs for over 65s

Sweden to resume AstraZeneca jabs for over 65s

Published 25 Mar, 2021 08:53pm
  • 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."
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