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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

A study involving 765 adults indicate that Bimervax, in addition to reducing antibodies against original SARS-CoV-2 strain, led to higher levels of antibodies against Beta and Omicron variants. The Sanofi vaccine contains an adjuvant, like Bimervax, to help strengthen the immune response to the vaccine.

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group. In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1)

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Experimental COVID-19 vaccine offers long-term protection against severe disease

Medical Xpress

In 2021, a group of scientists led by researchers at the University of North Carolina at Chapel Hill, Weill Cornell Medicine and NewYork-Presbyterian reported that the Moderna mRNA vaccine and a protein-based vaccine candidate containing an adjuvant, a substance that enhances immune responses, elicited durable neutralizing antibody responses to SARS-CoV-2 (..)

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Pfizer takes COVID jab with ‘enhanced’ spike protein into phase 2

pharmaphorum

The vaccine, codenamed BNT162b5, codes for “enhanced” prefusion spike proteins from the original wild-type strain of the virus and the Omicron variant that are designed to increase “the magnitude and breadth of the immune response.” Clinical data show strong neutralising antibody responses against Omicron BA.1,

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Leading innovators in coronavirus vaccine components

Pharmaceutical Technology

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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Vaxzevria induced immunity for at least one year following a single dose and strong immune responses following either a late second dose or a third dose

The Pharma Data

A sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose. There is an excellent response to a second dose, even after a 10 month delay from the first.”.