FDA Licenses Moderna’s mNEXSPIKE COVID Shot for Individuals at High Risk for Severe COVID Disease
On May 30, 2025, the U.S. Food and Drug Administration (FDA) licensed mNEXSPIKE (mRNA-1283), a newly developed mRNA COVID-19 biologic for individuals who have previously received any COVID shots and are either 65 years of age or older, or between 12 and 64 years old with at least one underlying medical condition that increases their […]
Moderna Withdraws Application for Combination COVID and Flu Vaccine
Moderna, Inc. withdrew its application for United States licensure for its combination COVID-19/Influenza vaccine known as mRNA-1083. The company stated the decision came “in consultation with” the U.S. Food and Drug Administration (FDA).1 The decision came just one day after the FDA announced the agency would require new clinical trials for approval of annual COVID […]
‘All New Vaccines’ in the U.S. to Undergo Placebo-Controlled Safety Testing
On Apr. 30, 2025, the U.S. Department of Health and Human Services (DHHS) announced that all newly developed vaccines will now be required to undergo placebo-controlled clinical trials before being licensed by the U.S. Food and Drug Administration (FDA). This landmark policy shift comes after years of advocacy from consumer organizations critical of vaccine safety […]
Study Shows Pfizer COVID Shot Has 37 Percent Higher Risk of Mortality Than Moderna Shot
According to a new study, adults who received the Pfizer Comirnaty COVID-19 shot were more likely to die than adults who had the Moderna Spikevax COVID-19 shot. The study looked at 9.2 million adults living in Florida who received either Comirnaty or Spikevax within six weeks, from December 2020 through January 2021. Half of the […]
Study Confirms Menstrual Irregularities Following COVID Shots
Throughout the debate over the safety of COVID-19 shots, many women have expressed concerns about the relationship between the shots and menstrual cycle irregularities and fertility. In a study published in the journal Frontiers in Immunology, researchers validated the view by these women that there are unsettling menstrual irregularities following receipt of the COVID shots […]
BARDA’s Big Bird Flu Vax Contract With Moderna
Last month, Moderna, Inc. slashed its revenue forecast for this year by $1 billion, prompting its stock price to plunge by more than 20 percent to $33.44. In September 2024, Moderna estimated its revenue for 2025 would be $2.5 billion to $3.5 billion, but the company revised its forecast on Jan. 13, 2025 to $1.5 […]