Editor's Note Pfizer and BioNTech announced November 9 that their COVID-19 vaccine is more than 90% effective 7 days after the second dose in preventing COVID-19 infection in participants without evidence of prior infection. This means that protection is achieved 28 days after initiation of the vaccination, which consists of…

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Editor's Note The Food and Drug Administration (FDA) on November 3 issued a letter alerting clinical laboratory staff and healthcare providers that false positive results can occur with antigen tests, including when users do not follow instructions for use of antigen tests for the rapid detection of COVID-19. Among the…

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Editor's Note Johnson & Johnson (J&J) has announced plans to test their COVID-19 vaccine in young individuals between the ages of 12 and 18, the October 30 Reuters reports. J&J started testing its vaccine in 60,000 volunteer adults in late September. Depending on safety, J&J also plans to test the…

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Editor's Note The Food and Drug Administration’s (FDA’s) Office of Biostatistics and Epidemiology is currently developing master protocols to be used in monitoring the safety and effectiveness of a COVID-19 vaccine once it is authorized or approved, in addition to postmarket surveillance requirements, the October 22 Regulatory Focus reports. The…

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Editor's Note ECRI announced October 21 that its President and CEO, Marcus Schabacker, MD, PhD, will tell the Food & Drug Administration Vaccines and Related Biological Products Advisory Committee on October 22 that a thorough review of 6 months of completed clinical trial data for COVID-19 vaccines is needed to…

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Editor's Note The Food and Drug Administration (FDA) on October 15 announced that it reissued the Emergency Use Authorization (EUA) for certain N95 and other filtering face-piece respirators that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety…

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Editor's Note The Food and Drug Administration (FDA) on October 6 released guidance on the data and information needed to support the issuance of emergency use authorization (EUA) for COVID-19 vaccines. The recommended data and information include: chemistry, manufacturing, and controls information clinical and nonclinical data and information administration and…

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Editor's Note Secretary of Health and Human Services (HHS), Alex Azar, on October 2, renewed the national public health emergency (PHE) for COVID-19 for another 90 days. The renewal will take effect October 23. This is the third renewal of PHE, which has been in effect since late January. The…

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Editor's Note The Food & Drug Administration (FDA) on August 27 (updated September 2) issued a warning about alcohol-based hand sanitizers packaged in containers that may appear as food or drinks and could put consumers at risk of serious injury or death if ingested.( https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-warns-consumers-about-hand-sanitizer-packaged-food-and-drink-containers ) Some hand sanitizers are…

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Editor's Note The US Department of Health and Human Services (HHS) and Department of Defense (DOD) on September 16 released two documents outlining a detailed strategy for delivering safe and effective COVID-19 vaccine doses to the American people as quickly and reliably as possible. The documents, which were developed in…

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