Mandating a Novel Vaccine is a Novel Legal Issue
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 […]
With Little Safety Data, CDC Recommends Pfizer COVID Vaccine for 12-Year-Old Children
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 […]
Johnson & Johnson’s COVID-19 Vaccine Suspended After Blood Disorder Reports
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 […]
Pfizer/BioNTech’s COVID-19 Vaccine Approved for Pregnant Women in Israel
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 […]
Pregnant Health Care Workers Can Get COVID-19 Vaccines Despite Lack of Safety Data Says CDC
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 […]
Over 3,000 “Health Impact Events” After COVID-19 mRNA Vaccinations
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) […]