Blog
RSS FeedPosted by Michael Wonder on 10 May 2021
America wants to waive patent protection for vaccines
8 May 2021 - But it will not have an immediate effect on supplies. ...
Posted by Michael Wonder on 09 May 2021
US wary of boosting China biotech with COVID vaccine patent waiver
9 May 2021 - The Biden administration is examining ways to ensure that a waiver of COVID-19 vaccine patents to ...
Posted by Michael Wonder on 08 May 2021
AstraZeneca weighs seeking full U.S. approval for COVID-19 shot, skipping emergency use application
7 May 2021 - British drugmaker faces challenges gathering data; may wait to apply for full approval by the FDA, which ...
Posted by Michael Wonder on 07 May 2021
Pfizer and BioNTech initiate rolling submission of biologics license application for U.S. FDA approval of their COVID-19 vaccine
7 May 2021 - - Pfizer and BioNTech today announced the initiation of a biologics license application with the U.S. FDA ...
Posted by Michael Wonder on 06 May 2021
Designing an independent public health agency
6 May 2021 - The COVID-19 pandemic has revealed the importance of having trustworthy and competent institutions to protect public ...
Posted by Michael Wonder on 05 May 2021
BioNTech nearing request for approval of longer lasting version of COVID vaccine
4 May 2021 - BioNTech is working on getting approval for a version of its COVID-19 vaccine which can be ...
Posted by Michael Wonder on 05 May 2021
Pfizer says it will seek clearance in September for its vaccine to be used in children aged 2 to 11
4 May 2021 - Pfizer expects to apply to the FDA in September for emergency authorisation to administer its coronavirus ...
Posted by Michael Wonder on 04 May 2021
Pfizer will file for full FDA approval by end of May
4 May 2021 - Pfizer and BioNTech, the manufacturers of one of the three authorised COVID-19 vaccines in the U.S., plan ...
Posted by Michael Wonder on 30 Apr 2021
AstraZeneca struggles with data needed for COVID-19 vaccine’s approval
29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...
Posted by Michael Wonder on 24 Apr 2021
FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 vaccine use following thorough safety review
23 April 2021 - Agencies underscore confidence in vaccine’s safety and effectiveness following data assessment; available data suggest potential blood clots ...
Posted by Michael Wonder on 21 Apr 2021
FDA continues important steps to ensure quality, safety and effectiveness of authorised COVID-19 vaccines
21 April 2021 - The U.S. FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. ...
Posted by Michael Wonder on 19 Apr 2021
Fauci says he expects a decision Friday on whether the U.S. can resume using Johnson & Johnson’s vaccine
18 April 2021 - A decision about whether to resume administering the Johnson & Johnson COVID-19 vaccine should come this ...
Posted by Michael Wonder on 16 Apr 2021
FDA revokes emergency use authorisation for monoclonal antibody bamlanivimab
16 April 2021 - Alternative monoclonal antibody therapies authorised to treat patients with COVID-19 remain available. ...
Posted by Michael Wonder on 13 Apr 2021
U.S. FDA to scrutinise vaccine design behind COVID-19 shots linked to blood clots
13 April 2021 - With two COVID-19 vaccines now under scrutiny for possible links to very rare cases of blood ...
Posted by Michael Wonder on 13 Apr 2021
Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine
13 April 2021 - The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation ...