Free Republic

Parents should be concerned that the U.S. Food and Drug Administration (FDA) earlier this month granted full approval to Moderna’s “Spikevax” COVID-19 vaccine for children 12 years old and older — because now that the vaccine for school-age kids is no longer an Emergency Use Authorization (EUA) product, states and schools may be more likely to mandate the shots, according to Dr. Meryl Nass.Nass, an internal medicine physician and member of the Children’s Health Defense (CHD) scientific advisory board, called the FDA’s decision “outrageous and illegitimate.”“The ACIP [Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices] actually voted...

The documents, previously submitted by Moderna to the U.S. Food and Drug Administration as part of the licensing process for Moderna’s Spikevax COVID-19 vaccine, included details on unexplained deaths and fetal abnormalities in animal studies. A 13,685-page tranche of documents related to Moderna’s COVID-19 vaccine clinical trials released Tuesday contain details about the deaths of 16 trial participants, the prevalence of severe adverse events (SAEs) and other abnormalities. The documents, previously submitted by Moderna to the U.S. Food and Drug Administration (FDA) as part of the licensing process for Moderna’s Spikevax COVID-19 vaccine, also exposed an “utter lack of thoroughness”...

Amid a torrent of biotech layoffs, Massachusetts mRNA star Moderna is staffing up big time, and the company’s new chief technical operations officer figures this is just the start. Eyeing potential launches beyond its COVID-19 vaccine Spikevax, Moderna will hire roughly 2,000 new employees in 2023, the company recently told Fierce Pharma. That should bring the biotech’s total headcount to around 6,000 before the year is out, Jerh Collins, Ph.D., Moderna’s chief technical operations and quality officer, said in an interview. Recent clinical wins for Moderna's mRNA candidates in melanoma and respiratory syncytial virus (RSV) show "that the pipeline is...

The tally for how much the federal government spent to combat COVID-19 is now estimated to be $5 trillion. It is more than the combined costs of World Wars I and II. The left is celebrating that politicians in Washington saved us. Really? From what exactly? Two years later, it is time for an honest assessment. Could things have worsened for the country if the government had spent nothing and done nothing? What would have happened if we had not shut down our businesses? Our churches, schools, and restaurants. Our parks, basketball courts, and playgrounds. Would the public have made...

Two FDA “approvals,” two shell games. On Monday, the FDA “approved” Moderna’s Spikevax COVID-19 vaccine for all US customers. Just like the Pfizer “approval” episode, this vaccine will not be able for anyone for an indefinite period of time. And according to the FDA, the shot was approved without being tested for Omicron, which accounts for 99.9% of current U.S. COVID cases. “Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18...

The Swedish Public Health Agency revealed on Wednesday that it is recommending use of the Moderna SpikeVax be discontinued in young people born after 1991, citing serious cardiac issues incuding myocarditis and pericarditis. Denmark implemented a ban for people aged 12-17 the same week. “The Swedish Public Health Agency has decided to suspend the use of Moderna’s vaccine Spikevax, for everyone born in 1991 and later, for precautionary reasons,” the Agency stated on Wednesday. “The cause is signals of an increased risk of side effects such as inflammation of the heart muscle or heart sac. However, the risk of being...