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SEC recommends approval for Zydus Lifesciences’ trivalent influenza vaccine in children

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

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FDA approves AstraZeneca’s FASENRA for asthma in children

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FASENRA in children aged six to 11 years with severe asthma and an eosinophilic phenotype.

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EMA CHMP recommends Moderna’s Covid-19 booster for children

Pharmaceutical Technology

1 (mRNA-1273.214) booster for usage in children aged six to 11 years. The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination. The EMA positive opinion is based on clinical findings of mRNA.1273.214,

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FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Bio Pharma Dive

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.

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Health Canada grants approval for Moderna’s Covid-19 vaccine in children

Pharmaceutical Technology

Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. So far, children aged below five years were not eligible to receive the Covid-19 vaccine in Canada.

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US FDA grants EUA for Pfizer-BioNTech’s Omicron-adapted vaccine in children

Pharmaceutical Technology

5-adapted bivalent Covid-19 vaccine for usage in children aged six months to four years. The vaccine is indicated for use as a third 3µg dose in the three-dose initial regimen for children of this age group. Earlier this month, the companies sought FDA EUA for the Omicron-adapted vaccine for use in children aged below five years.

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Omicron boosters from Pfizer, Moderna cleared by FDA for younger children

Bio Pharma Dive

Pfizer's reformulated vaccine is now authorized for use in children at least 5 years of age, while Moderna's will be available for kids as young as 6.