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FDA Grants EUA for Novavax’s COVID Vaccine

FDA Grants EUA for Novavax’s COVID Vaccine

Opinion | On July 13, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Novavax to distribute its experimental two-dose NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine for use by adults. The decision was expected, given the favorable recommendation by the FDA’s Vaccines and Related Biological Products Advisory […]

Claims for Injury, Death from COVID Shots Surge

Claims for Injury, Death from COVID Shots Surge

Opinion | The Countermeasures Injury Compensation Program (CICP) is a program of the U.S. government that provide financial compensation for people who have suffered serious injuries or death from vaccines, biologics, antivirals or other drugs, as well medical devices used to “diagnose, prevent or treat a declared pandemic, epidemic or security threat.” The program was […]

FDA Panel Recommends EUA for Novavax COVID-19 Vaccine

FDA Panel Recommends EUA for Novavax COVID-19 Vaccine

Despite concerns about the risk of developing myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart) following vaccination with Novavax’s experimental NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on June 6, […]

Guillain-Barré Syndrome Linked to COVID-19 Shots

Guillain-Barré Syndrome Linked to COVID-19 Shots

A study by the University College London showed that serious Guillain-Barré syndrome (GBS), which can result in temporary or permanent paralysis, is a “small but significant” risk associated with AstraZeneca/Oxford University’s AZD1222 (or “Vaxzevria”) vaccine. Of the 996 cases of GBS that were recorded in the United Kingdoms’ National Immunisation Management System database between January […]

Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly

Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly

On June 1, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) to distribute their messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) COVID-19 biologic for children as young as six months to five years old. The application is for a three-dose regimen, […]

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