FDA, CDC Green Light Pfizer’s Experimental COVID Biologic for Children 5 to 11 Years Old

FDA, CDC Green Light Pfizer’s Experimental COVID Biologic for Children 5 to 11 Years Old

One Oct 29, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the experimental messenger RNA (mRNA) Pfizer/BioNTech COVID-19 biologic BNT162b2 for children five to 11 years old. The FDA’s decision, which is based on a clinical trial earlier this year involving 2,268 kindergartners and elementary school-aged kids and an […]

Booster Shot for COVID May Eventually Be Required to Qualify as “Fully Vaccinated”

Booster Shot for COVID May Eventually Be Required to Qualify as “Fully Vaccinated”

As the COVID-19 booster vaccines are being rolled out for certain groups, the U.S. Centers for Disease Control and Prevention (CDC) said that the agency is considering changing the definition of “fully vaccinated” in the near future.1 “We have not yet changed the definition of ‘fully vaccinated.’ We will continue to look at this. We […]

White House Reveals Plans to Give COVID Shots to All 5 to 11 Year Old Children

White House Reveals Plans to Give COVID Shots to All 5 to 11 Year Old Children

On Oct. 20, 2021, the Biden administration outlined plans to begin giving COVID-19 vaccinations to children between five and 11 years old. Pending the results of reviews of the plan by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) over the […]

Nordic Nations Suspend Use of Moderna COVID Shot Over Heart Inflammation Concerns

Nordic Nations Suspend Use of Moderna COVID Shot Over Heart Inflammation Concerns

Following reports of an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart) in young adults after receiving Moderna/NIAID’s experimental messenger RNA (mRNA) COVID-19 biologic known as “Spikevax,” the governments of Denmark, Norway and Sweden have suspended the shot or will not make it available for […]

FDA’s Expert Panel Recommends COVID-19 Booster Dose for Seniors and Others, Rejects Booster Dose for Children

FDA’s Expert Panel Recommends COVID-19 Booster Dose for Seniors and Others, Rejects Booster Dose for Children

Despite not convening the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) last month to vote on effectiveness and safety of the Pfizer-BioNTech COVID-19 vaccine (licensed under the name COMIRNATY), the U.S. Food and Drug Administration (FDA) convened the advisory committee on Friday, Sept. 17, 2021 to vote on booster doses of the vaccine.1 The […]

Many Americans Worry About the Safety of COVID Biologics

Many Americans Worry About the Safety of COVID Biologics

A new poll conducted Yahoo! News/YouGov during July 13-15, 2021 found that 37 percent of unvaccinated Americans are more fearful of the three experimental COVID-19 biologics currently available in the United States than they are of the SARS-CoV-2 virus that can cause the disease. The survey of 1,715 adults in the U.S. found that only […]

Pfizer, Moderna COVID Shots Likely Linked to Inflammatory Heart Conditions Says CDC Advisory Committee

Pfizer, Moderna COVID Shots Likely Linked to Inflammatory Heart Conditions Says CDC Advisory Committee

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 […]

Mandating a Novel Vaccine is a Novel Legal Issue

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

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

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 […]

1 2 3