'FDA approves new Covid boosters as cases rise around US; Moderna and Pfizer shots approved with vaccinations potentially beginning as soon as this week'; problems with this booster given i)not tested

on humans, a mice model ii)it is based on the XBB.1.5 spike while other variants dominate & thus immune escape, antigenic sin is inevitable iii)BA.2.86 not lethal iv)antibodies NOT a key outcome

https://www.theguardian.com/us-news/2023/sep/11/new-covid-vaccine-booster-shot-fda-variants

‘The US has approved a series of Covid-19 booster vaccines amid rising cases of coronavirus around the country, the Food and Drug Administration (FDA) said on Monday.

The FDA said it had approved Moderna and Pfizer-BioNTech vaccines, which can be administered even to people who never previously received a Covid-19 vaccination.

Vaccinations with the new shots could begin as soon as this week, the Associated Press reported. The US Centers for Disease Control and Prevention (CDC), which must also sign off on the vaccines, is due to meet on Tuesday.

“Vaccination remains critical to public health and continued protection against serious consequences of Covid-19, including hospitalization and death,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.'

“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.”

As with earlier vaccinations, the new round of shots are cleared for adults and children as young as age six months.

Starting at age five, most people can get a single dose even if they have never had a prior Covid-19 shot, according to the FDA. Younger children might need additional doses depending on their history of Covid-19 infections and vaccinations.’

My take:

no one should take any drug, medical device, vaccine etc. unless they know both the benefits versus the harms and are fully informed. They should consult their medical professionals for decision-making. This while recognizing that the advice and consel since the start of COVID February 2020 has been sub-optimal, contradicting, did not match the science, and the result has been many have been harmed by lockdowns and the mRNA vaccine. Many people have died as a result of the COVID policies and vaccine. No one has made the case for why this XBB.1.5 booster is needed, no one. While the dominant variants show non-lethality and the population is largely immune. FDA making EUA decisions based on an antibody response or comparison is reckless given antibodies are not a proxy for immune response.

‘Moderna, Pfizer/BioNTech and relative newcomer to the COVID vaccine market Novavax (NVAX.O) have created versions of their shots aimed at the XBB.1.5 subvariant, the dominant variant through most of 2023. Those are expected to be rolled out this autumn.’

https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-says-updated-covid-vaccine-is-effective-against-newer-variant-2023-09-06/