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.

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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.”

https://www.thegatewaypundit.com/2022/10/fda-authorizes-moderna-pfizer-updated-booster-shots-omicron-kids-young-5-11/

CORONAVIRUSNew Study: Babies Born In Lockdown Less Likely To Speak Before First Birthday

A new study by researchers in Ireland has concluded that babies born during the COVID lockdown were less likely to be able to speak before their first birthday than children born previously.

The study, led by the Royal College of Surgeons in Ireland, found that children were less likely to be able to reach so called development milestones including waving ‘goodbye’ and pointing at objects.

The study, published in the Archives of Disease in Childhood, focused on 309 babies born in the first three months of lockdown in Ireland between March and May 2020, and tested for ten behavioural milestones at their first birthday, with results then compared against 2000 babies born between the years 2008 and 2011.

The study, titled Social communication skill attainment in babies born during the COVID-19 pandemic, found lockdown babies were 14 per cent less likely to have said their first word, nine per cent less likely to have started pointing, and six per cent less likely to wave goodbye.

Researchers believe that face masks limited the children’s ability to see people’s mouths and become accustomed to facial expressions, leading to enhanced difficulties learning to speak.

In addition, prohibiting relatives and friends of the parents from visiting the children is thought to have contributed to the stunting of social development.

“Lockdown measures may have reduced the repertoire of language heard and the sight of unmasked faces speaking to [infants],” a statement from researchers reads.

It continues, “It may also have curtailed opportunities to encounter new items of interest, which might prompt pointing, and the frequency of social contacts to enable them to learn to wave bye-bye.”

“They were still more likely to be crawling… which might be because they were more likely to have spent more time at home on the ground rather than out of the home in cars and strollers,” the statement also noted.

While the study was observational only, it adds to other evidence that lockdowns and masking in particular have had massively detrimental impacts upon children.

A study in Britain found that many children entering elementary school have severely underdeveloped verbal skills, with many are unable to even say their own name.

According to speech therapists, mask wearing has caused a 364% increase in patient referrals of babies and toddlers.

https://summit.news/2022/10/12/new-study-babies-born-in-lockdown-less-likely-to-speak-before-first-birthday/

'I should have never done this': Transgender patients reveal their regret over NHS sex change operations and why they 'detransitioned' after they were 'rushed' into life-changing procedures

EXCLUSIVE: Ritchie and Amber tell film they both regret their treatment and claim they were rushed into it

Brave testimony will revive fears young people are being pushed into invasive and unalterable procedures

Ritchie said: 'This is not reversible, the experiment is over for me, there really really isn't any turning back'

Two transgender patients today revealed their regret at going through NHS sex change operations and claimed they were 'rushed' into the life-changing procedures.

In powerful testimony that will raise fresh fears that vulnerable young people are being pushed into invasive and unalterable surgery by zealous transgender activists, they spoke of the terrible impacts on their mental and physical health.

After describing in graphic detail the nature of the surgery required to remove his male anatomy, 35-year-old Ritchie said: 'This is not reversible, the experiment is over for me, there really really isn't any turning back.'

Meanwhile, Amber - who had a mastectomy and took testosterone to transition from female to male - described the pain and health difficulties she had experienced since being 'rushed' into surgery, and said she wished she had been given therapy instead.

Their brave testimony in No Turning Back, a new film from Branded Film Studios that can be viewed in full on media platform Ickonic, is a rare example of 'detransitioners' coming forward to reveal their regrets.

'When Mermaids and Stonewall always talk about the people who don't get the chance to transition, they don't talk about the people who regret the process of transitioning,' filmmaker Charlotte Fantelli told MailOnline - referring to two charities who have faced scrutiny for their stance on transgender issues.

Ritchie, a civil servant from the north of England, detransitioned after spending nearly a decade as a trans woman.

After feeling 'different' as a young boy, he discovered gender dysphoria while browsing online forums in his early 20s. When he explained his feelings to other forum users he was told he was '100 per cent trans and should act on it'.

In March 2014, Ritchie drove to a private clinic in Scotland where after just three appointments in two days he obtained a diagnosis which would allow him to be prescribed cross sex hormones on the NHS. He then went to an NHS gender clinic in Brighton.

'The first question I was asked when I saw the psychiatrist was whether I wanted gender reassignment surgery,' he recalled on the film. 'I said to her, I'm not sure, I'd like some time and I heard you could have therapy.

'But I felt they communicated to me that they weren't a mental health service, they were there to help people medically transition. They wanted me to have surgery more than I wanted to have surgery - it was really bizarre.

'I refused it in 2015, I refused it in 2016, then in 2017 the psychiatrist said to me you're established on your hormones, if you don't want surgery we'll discharge you.

'But I was in the middle of that critical therapy, which was the anchor I needed in the world to keep me well. Then they told me I'd be discharged if I didn't go on this list.'

https://www.dailymail.co.uk/news/article-11302085/Patients-detransitioned-sex-change-operations-reveal-regret.html