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GSK speeds up the race to bring first RSV vaccine for older adults to market

Pharmaceutical Technology

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic.

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FDA revokes EUAs of Pfizer/BioNTech’s and Moderna’s original Covid-19 vaccines

Pharmaceutical Technology

4/5 Covid-19 messenger RNA (mRNA) vaccines. The expanded EUAs state that these current bivalent vaccines are now to be used for all primary and booster doses administered to individuals ages six months of age and older. 1 vaccines by both companies were revoked by the FDA in August 2022, after the BA.5

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EC grants marketing authorisation for GSK’s RSV vaccine Arexvy

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults.

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Clover collaborates with Kyuan Trade to launch AdimFlu-S (QIS) in China

Pharmaceutical Technology

Clover Biopharmaceuticals has established a commercial collaboration with Keyuan Xinhai (Beijing) Medical Products Trading (Kyuan Trade) for the launch of its quadrivalent seasonal influenza vaccine, AdimFlu-S (QIS), in China. The vaccine contains haemagglutinin from four influenza virus strains, two A and two B.

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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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Meningitis vaccine comes to the forefront with impressive study results

Pharmaceutical Technology

A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. percentage points (96% CI, −0.3

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US FDA grants breakthrough therapy designation for Moderna’s RSV vaccine

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna ’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients. It contains a single mRNA sequence encoding for a stabilised prefusion F glycoprotein. The findings showed 83.7%

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