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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 09 Apr 2021
Pfizer requests FDA clearance for vaccine in kids ages 12 to 15
9 April 2021 - The FDA's review process will probably take several weeks, experts say. The move would make Pfizer's vaccine ...
Posted by Michael Wonder on 06 Apr 2021
FDA makes two revisions to Moderna COVID-19 vaccine emergency use authorization to help increase the number of vaccine doses available
1 April 2021 - Today, the U.S. FDA announced two revisions regarding the number of doses per vial available for the ...
Posted by Michael Wonder on 23 Mar 2021
AstraZeneca vaccine trial data questions raised by US drug agency
23 March 2021 - Promising results announced on Monday from AstraZeneca’s American vaccine trials may have relied on an incomplete ...
Posted by Michael Wonder on 17 Mar 2021
U.S. plans to use real world and trial data to determine when vaccines need to be updated
17 March 2021 - U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as ...
Posted by Michael Wonder on 15 Mar 2021
Facebook to label all posts about coronavirus vaccines
15 March 2021 - Facebook, which has been criticised by politicians and researchers for allowing vaccine misinformation to spread on ...
Posted by Michael Wonder on 09 Mar 2021
Seqirus announces U.S. FDA approval of expanded age indication of its cell based quadrivalent influenza vaccine for people two years of age and older
5 March 2021 - Seqirus today announced that the U.S. FDA has approved Flucelvax Quadrivalent (influenza vaccine), the company's cell-based quadrivalent ...