FDA Authorizes Covid Injections For Children As Young As 6 Months Old


Pfizer and BioNTech said Monday they are seeking Emergency Use Authorization for an updated COVID-19 bivalent booster vaccine for children ages 6 months to 4 years old. The Food and Drug Administration responded on Thursday by authorizing their updated Covid shots that target new omicron variants for children as young as 6 months old.

Pfizer on Monday said if the bivalent booster receives EUA, children in this age group will receive two doses of the original COVID-19 vaccine, followed by a dose of the “updated” vaccine targeting new Omicron subvariants. Previously, children under age 5 could receive a three-dose series of the original COVID-19 vaccine. However, since the shots received EUA in June, only 2% of children under 2 and about 4% of 2- to 4-year-olds have received their primary doses, according to the Centers for Disease Control and Prevention (CDC).

Dr. Peter Marks, head of the FDA’s vaccine division, told parents in a statement that the agency carefully reviewed the shots before authorizing them. Dr. Robert Califf, head of the FDA, said it’s important for people to stay up to date on their shots this winter because immunity against the virus wanes. “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

Dr. Meryl Nass and Michelle Perro were critical of Pfizer and BioNTech’s bid to receive EUA for the bivalent booster for young children. Nass told The Defender, “There was never anything to recommend the bivalent boosters before they were given an EUA for adults on August 31. It is unconscionable, given what we know about the poor performance of the existing vaccines and their very concerning side effects, that FDA and CDC went along with the new ‘boosters’ without a single human trial — and now the manufacturers want to give these untested vaccines to children as young as 6 months of age. It is only by continuing to declare a pandemic emergency that these exceedingly dangerous, unlicensed EUA vaccines could be used,” she said. “If the government was honest and admitted the emergency was over, by law no EUA vaccines could be given to anyone.”

Similarly, McCullough, a cardiologist, questioned the bivalent booster for the youngest age group, telling The Defender that they are obsolete and dead on arrival. “The bivalent booster failed to stop Omicron BA.4/BA.5 in animals, but because it was pre-purchased, HHS [U.S. Department of Health and Human Services] decided to use the vaccine and its surrogate antibody rise, irrespective of its failed efficacy or lack of demonstrated safety since there were no human trials. In the last several months BA.4/BA.5 has moved out, giving way to BQ.1 and BQ1.1, so the bivalent boosters are now obsolete even on theoretical grounds. With no theoretical or actual benefit and with no assurances on short or longer term safety, the bivalent boosters are dead on arrival.”

Meanwhile the CDC and FDA are holding their stance. “More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so – especially as we head into the holidays and winter months where more time will be spent indoors,” said FDA Commissioner Robert M. Califf, M.D.

Sources:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months
https://childrenshealthdefense.org/defender/pfizer-bivalent-covid-vaccine-booster-babies-kids/
https://www.cnbc.com/2022/12/08/fda-authorizes-covid-omicron-vaccines-for-children-as-young-as-6-months-old.html
https://www.dailymail.co.uk/health/article-11517749/FDA-approves-unpopular-bivalent-Covid-booster-vaccines-BABIES.html