Covid19 Update: FDA authorises “emergency” boosters for children

Moderna Covid vaccine recommended by FDA for youngest children in the US

Image: Wikimedia

FDA grants “emergency use” authorisation for updated mRNA “booster” injections in children as young as 5.

Today, the U.S. Food and Drug Administration (FDA) amended the emergency use authorisations of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorise their use as a single booster dose in younger age groups.

The FDA announcement said: “The Moderna COVID-19 Vaccine, Bivalent is authorised 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 authorised 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.”

It added: “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 behaviours 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., PhD.

“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 hospitalised.

“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 authorisation, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorised 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 authorised for primary series administration in individuals six months of age and older.

For each of the bivalent COVID-19 vaccines authorised today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1.

The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups.

These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups, the FDA said.

Find out more information here.

Also on October 12, the EU parliament MEPs have called EU vaccine purchases “the biggest corruption scandal in history.”

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Written by

Brian O'Malley


    • Dr Trth

      12 October 2022 • 19:50


    • Naimah Yianni

      13 October 2022 • 11:56

      Ridiculous. Children aren´t even at risk from covid. More money grabbing by big pharma

    • John

      13 October 2022 • 19:38

      Children DO NOT need the vaccines. As it has also now emerged that Pfizer did not test for transmission ( so all that stuff about ‘save your granny by vaccinating your child’ was based on no science whatsoever), and subsequent evidence emerged showing that vaccinated people do still have the potential to transmit the virus, then for anyone who is not vulnerable, there is NO point in having a vaccine. I am triple-jabbed but that’s it, no more!

    • CCW60

      14 October 2022 • 00:43

      People are incredibly STUPID if they make their children get this jab. Unwarranted and extremely dangerous. We’ve already seen children dropping dead from cardiomyopathy, cardiac arrest, etc. Please just don’t give them to children.

    • M

      14 October 2022 • 02:21

      It’s time for people to look after their own health and reject these cocktails masquerading as vaccines (unlicensed), they are an insult to the traditional vaccines that involved years of research and clinical safety trials data before being awarded a license, and of which worked without the deadly health issues that are coming to light with these covid injections ( because no long term trial safety data is available). The EU has still not released any of the particulars of the contracts signed with big pharma, so this in itself speaks volumes of a cover up at all cost, just keep pushing the same narrative and hope the public will be duped again!

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