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Norway and Sweden are advising men younger than age 30 and all people under 18 years old to avoid taking the Moderna COVID-19 vaccine because of its rare association with myocarditis and endocarditis. Read More
Francis S. Collins, the scientist who led the Human Genome Project, has announced that he will retire from his 12-year post as leader of the National Institutes of Health (NIH) at the end of 2021. Appointed in 2009 by President Barack Obama, he is NIH’s longest-serving director. Read More
Although efficacy of the Pfizer vaccine against nonDelta COVID-19 infection dropped from 97 percent to 67 percent after five months, its protection against COVID-19 hospital admission — including admissions with Delta variant illness — remained high, according to a large database study published this week in The Lancet. Read More
AstraZeneca has filed for an FDA Emergency Use Authorization (EUA) for its long-acting antibody (LAAB) combination, AZD7442, as a preventive for symptomatic COVID-19. Read More
Johnson & Johnson (J&J) submitted its application yesterday to the FDA for emergency authorization of a booster dose of its COVID-19 vaccine in adults 18 years and older. Read More
The European Medicines Agency (EMA) has decided that a COVID-19 booster dose from Pfizer/BioNTech or Moderna can be given to people with severely weakened immune systems 28 days following a second shot. Read More
The European Medicines Agency (EMA)’s safety committee said Johnson & Johnson’s (J&J) COVID-19 vaccine might be associated with cases of deep vein blood clotting — such as the leg, arm or groin — and recommended adding the rare side effect to the shot’s product information. Read More
Merck and Ridgeback Biotherapeutics have pulled ahead in the race to get the first Emergency Use Authorization (EUA) for an oral antiviral for COVID-19. They’re expected to file for approval this month. Read More
An FDA vaccines advisory committee will meet Oct. 14-15 to consider whether to recommend booster doses of Moderna’s and Johnson & Johnson’s (J&J) COVID-19 vaccines for adults 18 years and older, including assessing whether to support a mix-and-match approach using different jabs. Read More
Pfizer declined to comment on the precise timing of its submission to the FDA and said it can’t “speculate on how long the FDA’s review will take.” Read More