FDA Authorizes Moderna and Pfizer Updated Booster Shots Against Omicron for Kids as Young as 5 to 11
Last month, the booster shots against Omicron got emergency authorization this week, and a CDC panel voted to recommend the shots for people over the age of 12.
The latest Covid booster was supposedly reformulated to ‘protect’ against Omicron subvariants.
The new COVID boosters were not tested on humans – only mice. . The Food and Drug Administration is only relying on the mice trial data.
On Wednesday, the FDA authorized Moderna and Pfizer the updated booster shots for children as young as 5 to 11.
From the news release:
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.
These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.
“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”
With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine continue to be authorized for primary series administration in individuals six months of age and older.
Dr. Paul Offit, MD, a top vaccine expert and FDA adviser has warned last month that there is insufficient evidence to recommend the new booster shot for healthy young adults and said it could carry risks.
During an interview with CNN, Dr. Offit said this new Covid booster shot is unlikely to benefit healthy young people and said it’s ‘unfair to make them take a risk.’
Dr. Offit: “When you’re asking people to get a vaccine, I think there has to be clear evidence of benefit. And we’re not going to have clinical studies, obviously, before this launches, but you’d like to have at least human data on people getting this vaccine. You see a clear and dramatic increase in neutralizing antibiotics, and then at least you have a correlate of protection against BA4, BA5. Because if you don’t have that, if there’s not clear evidence of benefit, then it’s not fair [to ask people to take a risk]. The benefits should be clear.”
Watch the video below:
FDA advisor and vaccine maker Paul Offit: “A healthy young person is unlikely to benefit from a booster dose… If there’s not clear evidence of benefit, then it’s not fair to ask people to take a risk.” pic.twitter.com/SgBp5WZbMS
— Max Blumenthal (@MaxBlumenthal) September 24, 2022