Pfizer, BioNTech say trials find Covid-19 vaccine safe for children of 5-11 yrs

Global pharma major Pfizer and BioNTech SE on Monday said trial results of Covid19 vaccine showed that it is safe and produced robust neutralizing antibody response in children aged five to 11 years and they plan to seek regulatory approvals as soon as possibleChildren aged five to 11 years were given a twodose regimen of 10 microgrammes microg administered 21 days apart a smaller dose than the 30 microg dose used for people 12 years and older the companies said in a joint statementIn participants 5 to 11 years of age the vaccine was safe well tolerated and showed robust neutralizing antibody responses the statement saidThe companies plan to submit these data to the US Food and Drug Administration FDA European Medicines Agency EMA and other regulators as soon as possible the statement saidAlso Read Covid19 vaccine protection wane over time boosters important Pfizer ModernaSince July paediatric cases of Covid19 have risen by about 240 percent in the US underscoring the public health need for vaccination These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old and we plan to submit them to the FDA and other regulators with urgency Pfizer Chairman and Chief Executive Officer Albert Bourla saidFor the United States the companies expect to include the data in a nearterm submission for Emergency Use Authorization EUA as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group the companies saidA request to the EMA to update the EU Conditional Marketing Authorization is also planned they addedWe are pleased to be able to submit data to regulatory authorities for this group of schoolaged children before the start of the winter season The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose BioNTech CEO and cofounder Ugur Sahin saidTopline readouts for the other two age cohorts from the trial children 25 years of age and children 6 months to 2 years of age are expected as soon as the fourth quarter of this year the statement saidThe Phase 123 trial initially enrolled up to 4500 children ages 6 months to 11 years of age in the United States Finland Poland and Spain from more than 90 clinical trial sites it addedIt was designed to evaluate the safety tolerability and immunogenicity of the PfizerBioNTech vaccine on a twodose schedule approximately 21 days apart in three age groups ages 5 to 11 years ages 2 to 5 years and ages 6 months to 2 years the statement saidBased on the Phase 1 doseescalation portion of the trial children aged 5 to 11 years received twodose schedule of 10 microg each while children under age 5 received a lower 3 microg dose for each injection in the Phase 23 study The trial enrolled children with or without prior evidence of SARSCoV2 infection it addedThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever