FILE - Pedestrians walk past a signs hanging outside Pfizer headquarters in New York and one hanging at a bus stop encouraging the COVID-19 booster, May 23, 2022. Beginning Oct. 24, the bivalent Pfizer COVID-19 vaccine booster, which includes the Omicron BA.4 and BA.5 subvariants, will be available for Albertans aged 12 years and older. New York: Pfizer Inc. and BioNTech SE have announced that the U.S. Food and Drug Administration (USFDA) has granted Emergency Use Authorization (EUA) for a 10-g booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. But the results come as the BA.4 and BA.5 variants diminish. 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. On Wednesday, U.S. regulators expanded access to the new bivalent booster shots to include children ages 5 and up. Moderna bivalent booster clinical trial with BA.1 mRNA-1273.214: 50 g bivalent: 25 g ancestral + 25 g BA.1 Pfizer-BioNTech bivalent booster clinical trial with BA.1 BNT162b2+BNT162b2 Omi: 30 g bivalent: 15 g ancestral + 15 g BA.1 No international data yet available for bivalent boosters After 28 days, the new shot triggered a stronger antibody response against the omicron variant than the booster that came before it. This Pfizers updated COVID-19 booster significantly revved up adults virus-fighting antibodies, the company said Friday, Nov. 4, 2022 early findings from a rigorous study of the new shots. NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) and BioNTech SE (BNTX) Thursday announced positive early data from the Phase 2/3 study of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster The bivalent booster targets both the original Wuhan strain no longer in circulation and the Omicron BA.4/BA.5 subvariants. Pfizer and BioNtech asked the U.S. Food and Drug Administration on Monday to approve their new Omicron-specific COVID-19 vaccine for children ages 5 to 11. Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-g booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. The CDC said it expects Pfizer-BioNTechs bivalent booster to be available for children ages 5 to 11 and Modernas bivalent booster to be available for children ages 6 to 17, pending authorization by the FDA. In May of 2022, Pfizer booster doses were expanded for use in California for children aged 5-11 years. Pfizer and BioNTech announced in a press release that bivalent booster shots result in far more antibodies to fight SARS-CoV-2, according to study results. Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 g and 60 g dose levels; bivalent vaccine candidate exhibited a 9.1 and 10.9-fold increase against Omicron Geometric mean ratios for Omicron neutralizing antibody response consistent with regulatory ACIP does not anticipate recommendations for frequent (e.g., every few months) booster doses of bivalent vaccine. Pfizer-BioNTech announced that they now have the first human data hinting at how effective the new Omicron booster might be. Pfizer Bivalent COVID-19 vaccine for those aged 5-11 is available. Pending recommendation from the Centers for Disease Control and Prevention A booster dose of the BA.4/BA.5-adapted bivalent vaccine has been authorized for emergency use by the FDA for ages 5 years and older and has also been granted marketing authorization in the EU. The Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-g booster dose of the companies Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. Neutralizing antibodies that target the BA.4 and BA.5 subvariants were four-fold higher in people aged 55 and older who received the bivalent booster than in those who received a monovalent booster. Pfizers booster was authorized for people 12 and older and Modernas for people 18 and up. The bivalent booster recommendation replaces previous booster recommendations for people age 5 years and older. New 30-day data shows the bivalent COVID booster from Pfizer-BioNTech is safe. And the new boosters from both Moderna and Pfizer appear to have NEW YORK and MAINZ, Germany, July 27, 2022 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 g dose level. using 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. In August of 2022, Moderna and Pfizer bivalent booster doses were authorized for use in California for everyone aged 12 years+ and 18 years+, respectively. The Pfizer booster requires a minimum of two months since the last dose or booster since either Pfizer or Moderna was received. A 30-g booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken 7 days after administration, with similar responses seen across individuals aged 18 to 55 years of age and those older than 55 years of age (40 Pfizer and BioNTech said that updated data from a Phase 2-3 clinical trial shows the bivalent booster performed better against the BA.4 and BA.5 omicron subvariants. . Pfizers updated COVID-19 booster significantly revved up adults virus-fighting antibodies, the company said Friday, Nov. 4, 2022 early findings from a rigorous study of the new shots. The Pfizer-BioNTech bivalent vaccine is authorized for administration at least 2 months following completion of primary or booster vaccination in children 5 years of age and older. 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