The Food and Drug Administration on Wednesday granted an emergency use authorization to Pfizer and BioNTech’s Covid-19 vaccine booster, though for now the FDA said use of the booster should be restricted to people over the age of 65, adults 18 and older at high risk of severe Covid, and […]
Dr. Chris Beyrer is the Desmond M. Tutu Professor in Public Health and Human Rights at the Johns Hopkins Bloomberg School of Public Health. An infectious diseases epidemiologist, he currently serves as Senior Scientific Liaison to the COVID-19 Vaccine Prevention Network, the Co-VPN, for Community Engagement. He is a Professor […]
Although the FDA granted full approval for the Pfizer COVID-19 vaccine for ages 16 and up on Monday, officials have added a note of caution to parents and doctors — the shot isn’t yet intended for use in kids. In particular, the first fully approved COVID-19 vaccine shouldn’t be given to ages […]
La Agencia Estadounidense del Medicamento (FDA) ha ampliado la Autorización de Uso de Emergencia de baricitinib, medicamento de la compañía farmacéutica Lilly, para permitir su uso en monoterapia, sin la restricción previa de utilización exclusiva en combinación con remdesivir, en pacientes hospitalizados con la Covid-19 que requieran oxigenoterapia. De acuerdo […]
Johnson & Johnson’s Covid-19 vaccine may trigger a rare neurological condition in a small number of people who receive the vaccine, the Food and Drug Administration said Monday. Reports to a database operated jointly by the agency and the Centers for Disease Prevention and Control suggest there may be a […]
The US Food and Drug Administration (FDA) is adding a warning to the fact sheets for the Pfizer/BioNTech and Moderna mRNA COVID-19 vaccines as medical experts continue to investigate cases of heart inflammation, which are rare but are more likely to occur in young men and teen boys. Doran Fink, MD, […]
The US Food and Drug Administration (FDA) has granted Eli Lilly’s request to revoke emergency use authorization for the COVID-19 monoclonal antibody therapy bamlanivimab when used as a monotherapy, saying the evidence indicates that it is likely not effective against currently circulating variants. The agency said in a letter to Lilly that […]
The FDA and CDC on Tuesday recommended that use of the Johnson & Johnson COVID-19 be paused after reports of blood clots in patients receiving the shot, the FDA and CDC announced Tuesday. In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the […]
Pfizer and BioNTech have asked the US Food and Drug Administration (FDA) to expand authorization of their COVID vaccine to include children as young as 12 years of age. The companies said they plan to ask for similar rulings by other regulatory bodies around the world in coming days. The request follows […]
