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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 […]

‘COVID-19 Rebound’ May Be Worse Than Initial COVID Illness

‘COVID-19 Rebound’ May Be Worse Than Initial COVID Illness

On May 24, 2022, the U.S. Centers for Disease Control and Prevention (CDC) issued a health advisory to health care providers, public health departments and the general public regarding Pfizer’s antiviral drug Paxlovid, designed to treat symptoms of COVID-19. The advisory warns that some people who take Paxlovid may experience a recurrence of COVID symptoms […]

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 […]

U.S. Becomes First Country to Give mRNA COVID Vaccine to Babies

U.S. Becomes First Country to Give mRNA COVID Vaccine to Babies

On June 15, 2022 the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) unanimously advised the FDA staff to grant Moderna and Pfizer/BioNTech an Emergency Use Authorization (EUA) amendment to allow their mRNA COVID vaccines to be given to children under age five and as young as […]

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 […]

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