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RSS FeedPosted 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 US 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 US FDA for its COVID-19 vaccine
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 ...
Posted by Michael Wonder on 19 Aug 2021
Contradicting WHO, US advises adults to receive COVID-19 boosters
19 August 2021 - The Biden administration is advising all American adults to receive a COVID-19 booster shot after accumulating ...
Posted by Michael Wonder on 18 Aug 2021
WHO calls on Roche to ensure fair access to COVID-19 drug amid shortage
18 August 2021 - The World Health Organization called on Wednesday on Roche to ensure fair distribution of its arthritis ...
Posted by Michael Wonder on 18 Aug 2021
Joint statement from HHS public health and medical experts on COVID-19 booster shots
18 August 2021 - Today, public health and medical experts from the U.S. Department of Health and Human Services released the ...
Posted by Michael Wonder on 18 Aug 2021
Update on Actemra (tocilizumab) supply in the U.S.
16 August 2021 - The unprecedented surge in worldwide demand and supply constraints driven by Delta variant spikes in much ...
Posted by Michael Wonder on 16 Aug 2021
Pfizer and BioNTech announce submission of initial data to U.S. FDA to support booster dose of COVID-19 vaccine
16 August 2021 - Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine ...
Posted by Michael Wonder on 15 Aug 2021
Coronavirus (COVID-19) update: FDA authorises additional vaccine dose for certain immunocompromised individuals
12 August 2021 - Other fully vaccinated individuals do not need an additional vaccine dose right now. ...