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, […]
The Rise of Hepatitis
The number of previously healthy children younger than 16 years of age with mysterious hepatitis cases have doubled in two weeks to 450 cases worldwide, including 11 deaths. Most cases have been reported in the U.K. (160) and the U.S. (currently, 180). In Europe most cases are found in Italy (35) and Spain (22). Over 8-14 percent […]
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, […]
Paxlovid Users May Face Rebound SARS-CoV-2
The U.S. Centers for Disease Control and Prevention (CDC) has admitted that COVID-19 patients may experience a rebound SARS-CoV-2 infection after taking Pfizer’s antiviral drug, Paxlovid. Evidence has shown that patients, including those who have gotten COVID shots and been boosted, may suffer a reoccurrence of COVID two to eight days after completing a five-day […]
Smallpox Vaccine Manufacturers See Big Stock Price Increases After Monkeypox Outbreaks Reported
On May 26, 2022, U.S. Centers for Disease Control (CDC) officials held a press briefing and announced there had been nine cases of monkeypox identified in seven U.S. states and that two licensed smallpox vaccines were in the national stockpile and ready to be distributed.1 The CDC’s director said, “The U.S. has the resources we […]
Why are Standards So Lax on COVID Drug Approvals?
Many scientists made a career fighting for better regulatory standards. Strangely, when it comes to the regulatory policy around COVID-19, they are dead quiet. First, consider that EUA ( emergency use authorization) is like accelerated approval. Both require lower levels of evidence, and are predicated on the fact that we’re dealing with a situation that […]