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RSS FeedPosted by Michael Wonder on 20 Jul 2021
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
20 July 2021 - EMA’s CHMP has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. ...
Posted by Michael Wonder on 18 Jul 2021
U.S. FDA grants priority review for the biologics license application for Pfizer-BioNTech COVID-19 vaccine
16 July 2021 - Pfizer and BioNTech today announced that the U.S. FDA granted priority review designation for the biologics license ...
Posted by Michael Wonder on 17 Jul 2021
Merck announces U.S. FDA approval of Vaxneuvance (Pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes
16 July 2021 - Clinical data supporting approval demonstrated non-inferior immune responses for the serotypes shared with PCV13 (1, 3, 4, ...
Posted by Michael Wonder on 16 Jul 2021
International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines
16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...
Posted by Michael Wonder on 16 Jul 2021
Ocugen announces initiation of rolling submission to Health Canada for Covaxin
15 July 2021 - Ocugen today announced that it had initiated a rolling submission to Health Canada for Covaxin, the ...
Posted by Michael Wonder on 15 Jul 2021
‘Pharmacies are ready to go’: Chemists in hotspots fast tracked to deliver jabs
16 July 2021 - About 70 pharmacies in Sydney’s COVID-19 hotspots have been fast-tracked to administer AstraZeneca jabs from next ...
Posted by Michael Wonder on 15 Jul 2021
ATAGI update following weekly COVID-19 meeting (14 July 2021)
15 July 2021 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 14 ...
Posted by Michael Wonder on 15 Jul 2021
COVID-19 vaccine weekly safety report (15 July 2021)
15 July 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 13 Jul 2021
European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps
13 July 2021 - The developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators ...
Posted by Michael Wonder on 12 Jul 2021
FDA to announce new warning on J&J COVID vaccine related to a rare auto-immune disorder, report says
12 July 2021 - About 100 preliminary reports of Guillain-Barre syndrome have been detected after 12.8 million doses of the J&J ...
Posted by Michael Wonder on 12 Jul 2021
Experts warn full FDA COVID-19 vaccine approval is no quick fix for hesitancy
12 July 2021 - The FDA issuing full approval for two COVID-19 vaccines might not be the game changer it’s ...
Posted by Michael Wonder on 11 Jul 2021
COVID vaccine rollout: chemists brought in to fast track jabs
11 July 2021 - With Australia’s biggest city in lockdown, chemists have been brought in to fast track the Covid-19 vaccine ...
Posted by Michael Wonder on 11 Jul 2021
EMA advises against use of COVID-19 vaccine Janssen in people with history of capillary leak syndrome
9 July 2021 - EMA’s safety committee has recommended that people who have previously had capillary leak syndrome must not be ...
Posted by Michael Wonder on 09 Jul 2021
Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
9 July 2021 - EMA’s safety committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases ...
Posted by Michael Wonder on 09 Jul 2021
Pfizer plans to request FDA approval for COVID booster shot in August
9 Jul 2021 - Pfizer plans to request US emergency authorisation in August for a third booster dose of its ...