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

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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Evaxion and ExpreS²ion partner to develop new CMV vaccine

Pharmaceutical Technology

Evaxion Biotech and ExpreS 2 ion Biotechnologies have entered a vaccine discovery collaboration agreement to co-develop a new cytomegalovirus (CMV) vaccine candidate. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.

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Positive initial results for srRNA rabies vaccine

Drug Discovery World

Replicate Bioscience has shared positive results from the Phase I trial of RBI-4000, its srRNA-based rabies vaccine. In this clinical trial, evaluating safety and immunogenicity of RBI-4000 , participants received one or two doses of srRNA vaccine at low doses (0.1mcg, 1mcg or 10mcg).

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

Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

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Phase I trial of next-generation srRNA rabies vaccine

Drug Discovery World

Replicate Bioscience has dosed the first participant in a Phase I trial of its RBI-4000 vaccine for the prevention of rabies. Replicate’s srRNA technology offers the potential for more robust and durable immune responses, and improved tolerability at lower doses than existing mRNA approaches,” said Zelanna Goldberg, CMO of Replicate. “In