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Given concerns about the rapidly spreading Delta variant, an eight-week window was deemed preferable by the researchers from Oxford and Newcastle universities. Read More
The real-world analysis comprised nearly 70,000 individuals who contracted the SARS-CoV-2 virus from December 2020 to May 2021 in the province of Ontario. Read More
The FDA has resumed routine domestic inspections this month after hitting the pause button for all but mission-critical inspections in March 2020, said Acting Commissioner Janet Woodcock yesterday on day-one of the FDA’s five-day Regulatory Education for Industry Annual Conference. Read More
The EMA’s human medicines committee is assessing data from two clinical trials and is expected to reach a decision by October, unless more information is required. Read More
AstraZeneca and Johnson & Johnson are looking at modifying their COVID-19 vaccines to reduce the risk of blood clots, while the European Medicines Agency (EMA), following the lead of the FDA, is analyzing data on rare cases of the nerve disorder Guillain-Barré syndrome (GBS) reported among people who had the J&J vaccine. Read More
Pfizer and BioNTech executives are meeting with federal health officials this week to emphasize that vaccinated people need COVID-19 booster shots — but the FDA and the Centers for Disease Control and Prevention (CDC) say that’s not what the science shows, at least not yet. Read More
The first doses are expected to arrive by the end of September or possibly later, depending on BioNTech’s production schedules and the progress of vaccinations in Taiwan. Read More