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August 17, 2021

Coronavirus company news summary – GSK/CureVac’s next-gen Covid-19 mRNA vaccine shows strong efficacy – Pfizer/BioNTech submit initial data to FDA for Comirnaty booster dose

By Chris Lo

GlaxoSmithKline (GSK) and CureVac have reported that their second generation Covid-19 mRNA vaccine candidate, CV2CoV, showed increased immune responses and protective efficacy against SARS-CoV-2 when compared with CureVac’s first-generation candidate, CVnCoV, in a study in non-human primates. The new vaccine had improved antibody neutralising capacity across all variants tested, including the Beta, Delta and Lambda variants. With the original viral strain, CV2CoV demonstrated higher protection in vaccinated animals via effective clearance of SARS-CoV-2 in the lungs and nasal passages.

Pfizer and BioNTech have submitted Phase I clinical trial data to the US Food and Drug Administration to support the review of a booster dose of their Covid-19 vaccine, Comirnaty (BNT162b2), for licensure in the future. The Phase I trial is part of the companies’ clinical trial programme analysing the safety, tolerability and immunogenicity of a third, or booster, dose in adults. Data revealed substantially greater levels of neutralising antibodies with the booster shot following the two-dose regimen. The data will also be submitted to the European Medicines Agency (EMA) and other regulatory agencies soon.

EMA has begun its review of Roche’s RoActemra (tocilizumab) to expand its use for treating hospitalised adults with severe Covid-19. The potential expansion of use is for patients who are on corticosteroids and need supplemental oxygen or mechanical ventilation. The agency’s human medicines committee (CHMP) will perform an accelerated evaluation of the evidence submitted in the application, including data from four large, randomised trials. The CHMP’s opinion, along with any need for additional studies and safety monitoring, will be provided to the European Commission, which will make the final regulatory decision. RoActemra was first authorised for use in the European Union in 2009, and is currently used to treat rheumatoid arthritis.

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