The United States Food and Drug Administration (FDA) has approved the updated Covid-19 jabs for people of 12 years of age and older. The FDA has also authorised them for emergency use in babies as young as six months old.
The tweaked mRNA vaccines are “formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death”, said the FDA in an announcement made on Monday (September 11).
The FDA said: “Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”
“The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. As part of today’s actions, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.”
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said: “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
The FDA said: “The mRNA COVID-19 vaccines approved and authorized today are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component.
“Based on an evaluation of the totality of the evidence, the benefit-risk profile is favorable for individuals 6 months of age and older to receive an updated COVID-19 mRNA vaccine. Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.”
It comes just days after Florida’s surgeon general claimed there are a ‘lot of red flags’ about the safety of the latest Covid booster jabs. Dr Joseph Ladapo, a Harvard-trained doctor who was appointed by Florida’s Republican Governor and Donald Trump rival Ron DeSantis, also claimed there were no clinical trials to show that the new shots are safe or of benefit. However, these claims has been disputed.
Dr Marc Siegel, a professor of medicine at NYU Langone Medical Center, said that as the new vaccine was only a slight variation of the previous version, “there is no reason for full clinical trials prior to use.” He said that vaccines “have been given to trillions around the world and in the vast majority of cases, they are safe.”
Tina Polsky – a Democrat state senator who had Ladapo removed from her office during the pandemic when he refused to wear a mask – accused the surgeon general of “lying about scientific data”.
Polsky said: “The overwhelming scientific evidence is that vaccines are helpful and safe. The surgeon general is lying to people and scaring people, and the effect is going to be that more people are going to die from Covid. This is our top scientist, and he’s lying about scientific data. It truly freaks me out that there are many people who are going to listen to that.”
