On June 23, 2021, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) determined that there is a “likely association” between reported cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) following vaccination with experimental messenger RNA (mRNA) biologics for COVID-19 […]
The emergency use authorization (EUA) granted to vaccine manufacturers by the U.S. Food and Drug Administration (FDA) to allow experimental COVID-19 vaccines to be distributed to the U.S. population states that the product is “an investigational vaccine not licensed for any indication” and requires that all “promotional material relating to the COVID-19 Vaccine clearly and […]
Opinion | I monitor meetings of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) for the National Vaccine Information Center (NVIC). On May 10, 2021, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) granted Pfizer/BioNTech to distribute its experimental mRNA vaccine in […]
A manufacturing plant in Baltimore, Maryland where two experimental COVID-19 vaccines are manufactured has caused the U.S. Food and Drug Administration (FDA) to delay authorization of the plant’s production lines due to the contamination of 15 million doses of Johnson & Johnson’s (J&J) COVID-19 vaccine.1 Ingredients Used in Two COVID-19 Vaccines “Mixed Up” During Production […]
Story Highlights The World Health Organization issued a Jan. 26, 2021 statement recommending that pregnant women should not be vaccinated with Moderna’s COVID-19 vaccine, approved for use under emergency authorization, citing a lack of data in pregnancy. Previously, most countries were in agreement with that opinion, but Israel is now recommending that pregnant women should […]
The supply of emergency use authorization (EUA) COVID-19 vaccines in the United States is initially expected to be limited and the U.S. Centers for Disease Control and Prevention (CDC) has provided recommendations to federal, state and local governments about who should be vaccinated first.1 The Advisory Committee on Immunization Practices (ACIP) has recommended that healthcare […]
Between Dec. 11 and 18, 2020, the U.S. Food and Drug Administration (FDA) granted Pfizer/BioNTech and Moderna pharmaceutical companies an Emergency Use Authorization (EUA)1 to distribute COVID-19 vaccines using messenger RNA (mRNA) technology that to date has not been licensed for use in humans.2 3 4 5 Although the Advisory Committee on Immunization Practices (ACIP) […]
A U.S. advisory panel says the first doses of a COVID-19 vaccine should be given to health care workers and residents of long-term care facilities. The Advisory [Committee] on Immunization Practices advises the Centers for Disease Control and voted Tuesday that, with initial doses expected to be scarce, frontline health workers are a top priority. […]
The chief scientist for the U.S. government’s Operation Warp Speed (OWS) program aimed at facilitating development of COVID-19 vaccines confirmed on Dec. 1, 2020 that 10-15 percent of the volunteers, who participated in clinical trials to test the safety and effectiveness of experimental vaccines developed by Pfizer, Inc. (in partnership with BioNTech SE) and Moderna, […]
The Advisory Committee on Immunization Practices (ACIP) for the U.S. Centers for Disease Control and Prevention (CDC) has issued new updates for influenza vaccines for 2020–2021 “flu season,” primarily for Fluzone and Fluad vaccines. In November 2019, U.S. Food and Drug Administration (FDA) licensed inactivated injectable Fluzone High-Dose Quadrivalent (HD-IIV4) for use in persons aged […]
