Pfizer and BioNTech have completed their application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine: saying they stand ready to start shipping...
The WHO has updated its advice on COVID-19 booster doses: including recommendations on which groups should receive a second booster shot and how countries should plan around the upcoming availability of variant-specific vaccines.
The first Omicron bivalent COVID-19 vaccine has been authorized: with the UK’s regulatory agency giving the green light to Moderna’s Spikevax Bivalent Original/Omicron booster shot.
Pfizer is planning to deliver COVID-19 vaccines against two sets of omicron subvariants in the autumn in the belief its “robust manufacturing capabilities” are up to the task.
SK bioscience has extended its partnership with Novavax to include the manufacture and supply of Novavax’s Omicron COVID-19 vaccine candidate, which could become available later this year.
Arcturus Therapeutics Holdings Inc. has reported topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, its self-amplifying mRNA COVID-19 vaccine candidate.
Moderna’s bivalent COVID-19 booster vaccine candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to the original mRNA-1273 booster dose against all variants of concern, including Omicron, according to data released by the company...
Pfizer and BioNTech expect to produce four billion doses of their COVID-19 vaccine in 2022: regardless of whether the current vaccine or a new Omicron specific vaccine is needed.
While the last two years have seen the successful development of COVID-19 vaccines, the emergence of variants highlights the speed at which the pandemic - or indeed any other virus threat - can evolve. As a result, development of novel vaccine candidates...
A booster shot of Moderna’s COVID-19 vaccine increases neutralizing antibody levels against Omicron approximately 37-fold compared to pre-boost levels, according to data released by the company today.
A single booster dose of Sanofi and GSK’s recombinant adjuvanted COVID-19 vaccine candidate delivered ‘consistently strong immune responses’, according to data released by the companies.
Two doses of the Pfizer/BioNTech vaccine ‘may not be sufficient’ to protect against infection with the Omicron variant; but three doses of the vaccine neutralize the variant, according to a preliminary laboratory study released by the companies.
Medicago and GSK’s plant-based COVID-19 vaccine candidate has reported an overall efficacy rate of 71% in Phase 3 trials: with the final regulatory submission for the vaccine to be filed with Health Canada shortly.
CureVac is withdrawing its first-generation COVID-19 vaccine candidate, CVnCoV, from regulatory review: instead it is re-allocating its efforts to its second-generation vaccine program with GSK. ‘The goal has not changed, but the requirements to effectively...
Arcturus Therapeutics and its Vietnam partner Vinbiocare will take ARCT-154, a next-generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, into a Phase 1/2/3 trial. The companies will also establish a vaccine manufacturing centre in Vietnam....
With Scancell taking its DNA-based COVID-19 vaccine tech into clinical trials this year, it is already focusing its attention on the tech’s potential to be used as a needle-free booster shot to address Variants of Concern.
German company, CureVac, says it is in ongoing dialogue with the European Medicines Agency (EMA) and is continuing regulatory submissions on its first-generation mRNA COVID-19 vaccine candidate, CVnCoV.
