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AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US

pharmaphorum

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.

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Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

The Burnaby, BC-based company developed the oral DNA-based vaccine using its proprietary bacTRL Gene Therapy Platform, which uses genetically modified bifidobacteria as carriers of genetic vaccine elements on a DNA plasmid. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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HIV Vaccine Trial of Vir Biotech’s New Candidate VIR-1388 Begins

XTalks

The trial’s primary objective is to assess the safety of VIR-1388 and its capacity to stimulate a specific immune response against HIV in study participants. This groundbreaking endeavor has received support from the National Institute of Allergy and Infectious Diseases (NIAID).

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Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer

(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 µg dose level. IMPORTANT SAFETY INFORMATION . has a fever.

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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. has a fever.

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Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

Pfizer

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. IMPORTANT SAFETY INFORMATION Tell your vaccination provider about all the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies.

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Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer

Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. are immunocompromised or are on a medicine that affects the immune system. IMPORTANT SAFETY INFORMATION . have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart).