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 […]
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 […]
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 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 […]
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, […]
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 […]
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 […]
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 […]
Following the granting by the U.S. Food and Drug Administration (FDA) of Emergency Use Authorization (EUA) status for Pfizer/BioNTech’s BNT162b2 and Moderna/NIAID’s mRNA-1273 messenger RNA (mRNA) COVID-19 biologics in December 2020, there have been increasing reports of alopecia areata following vaccination with these products.1 Alopecia areata is an autoimmune disorder characterized by hair loss due […]
Opinion | Last month, a United States Air Force Academy cadet was informed by a superior officer that upon returning from the Cadet Wing’s spring break, he would receive an ultimatum: Receive the Department of Defense (DoD) mandatory COVID vaccine or be expelled from the academy upon return. Shortly thereafter, the order became official, giving […]