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RSS FeedPosted by Michael Wonder on 07 Oct 2021
Pfizer seeks US authorisation of Covid-19 vaccine for ages 5-11
8 October 2021 - The Pfizer vaccine could soon be available for children as young as five in the United States. ...
Posted by Michael Wonder on 06 Oct 2021
Johnson & Johnson announces submission of emergency use authorisation amendment to the U.S. FDA to support booster of its single shot COVID-19 vaccine
5 October 2021 - Submission includes data showing a booster increased protection to 94% against moderate to severe/critical COVID-19 in the ...
Posted by Michael Wonder on 05 Oct 2021
AZD7442 request for emergency use authorisation for COVID-19 prophylaxis filed in US
5 October 2021 - Filing includes data from PROVENT Phase 3 trial showing 77% reduction in risk of developing symptomatic COVID-19 ...
Posted by Michael Wonder on 28 Sep 2021
Pfizer and BionNTech submit initial data to U.S. FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age
28 September 2021 - Formal submission to request Emergency Use Authorization to follow in the coming weeks. ...
Posted by Michael Wonder on 23 Sep 2021
FDA authorises booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations
22 September 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine to allow ...
Posted by Michael Wonder on 18 Sep 2021
FDA advisory committee votes unanimously in favour of Comirnaty booster for emergency use in people 65 and older and certain high risk population
17 September 2021 - Committee reviewed clinical data showing a booster dose of Comirnaty elicits high neutralisation titres against SARS-CoV-2 and ...
Posted by Michael Wonder on 16 Sep 2021
Emergency use authorisation for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
16 September 2021 - Expanded emergency use authorisation includes certain people who have been exposed to someone infected with SARS-CoV-2 ...
Posted by Michael Wonder on 02 Sep 2021
FDA to hold Advisory Committee meeting to discuss Pfizer-BioNTech’s application for COVID-19 booster
2 September 2021 - Today, the U.S. FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory ...
Posted by Michael Wonder on 02 Sep 2021
Moderna announces submission of initial data to U.S. FDA for its COVID-19 vaccine booster
1 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40x against the ...
Posted by Michael Wonder on 26 Aug 2021
Biden Administration likely to approve COVID-19 boosters at six months
26 August 2021 - Pfizer, BioNTech have requested clearance for COVID-19 vaccine boosters that an official said could be administered six ...
Posted by Michael Wonder on 26 Aug 2021
Moderna completes submission of biologics license application to the U.S. FDA for its COVID-19 caccine
25 August 2021 - Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; ...
Posted by Michael Wonder on 26 Aug 2021
Pfizer and BioNTech initiate rolling submission of supplemental biologics license application to U.S. FDA for booster dose of Comirnaty in individuals 16 and older
25 August 2021 - New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralising antibody titres and ...
Posted by Michael Wonder on 23 Aug 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full U.S. FDA approval for individuals 16 years and older
23 August 2021 - Comirnaty is the first COVID-19 vaccine to be granted FDA approval. ...
Posted by Michael Wonder on 23 Aug 2021
FDA approves first COVID-19 vaccine
23 August 2021 - Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. ...
Posted by Michael Wonder on 19 Aug 2021
Booster shots ‘make a mockery of vaccine equity,’ the WHO’s Africa director says
19 August 2021 - The Africa director at the World Health Organization, Dr. Matshidiso Moeti, criticized the decisions by some ...