The U.S. Food and Drug Administration (FDA) advised COVID-19 vaccine manufacturers on June 30 that any modifications to booster shots for fall will need to target Omicron subvariants BA.4 and BA.5, which account for more than half of new virus cases in the U.S. Original vaccines based on the Wuhan strain that is no longer circulating will be used for anyone […]
FDA
FDA Panel Sets Dangerous Precedent by Recommending New COVID Boosters Without Data
The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel on Tuesday voted 19 to 2 to recommend new COVID-19 booster shots that include the Omicron variant this fall. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not issue guidance on whether additional data, if any, would be needed to recommend an […]
Cases of Shingles Following COVID-19 Vaccination on the Rise, Studies Show
COVID-19 vaccines may be associated with yet another inconvenient side-effect that for most, is far worse than actually getting COVID. Doctors and scientists are reporting an increase in cases of shingles following COVID-19 vaccination, but U.S. health agencies continue to claim the shots don’t cause shingles and no safety signals have been detected. Shingles and […]
Nonprofit Sues FDA to Obtain Moderna’s COVID-19 Vaccine ‘Spikevax’ Approval Documents
A nonprofit group is suing the U.S. Food and Drug Administration (FDA) in an effort to obtain documents relating to the FDA’s approval of Moderna’s Spikevax COVID-19 vaccine after the agency told the group there was “no compelling need” to expedite the release of the documents. Dallas, Texas-based Defending the Republic on June 7 filed the lawsuit in the U.S. District […]
FDA Had No Basis to Authorize COVID Vaccines for Infants and Toddlers
In a historically embarrassing decision, the FDA recently became the only international regulatory body to authorize the use of mRNA vaccines from Moderna and Pfizer for children aged six months to five years. For the overwhelming majority of young children and toddlers, there is likely no justification or need for this concerning authorization. They are at a […]