Pneumococcal polysaccharide conjugate vaccine

Prevenar 20 addresses an additional seven serotypes of Streptococcus pneumoniae that give rise to invasive pneumococcal disease. Credits: create jobs 51/Shutterstock.com Following a US Food and Drug Administration (FDA) approval in April 2023, the European Commission (EC) has awarded marketing approval to Pfizer ’s Prevenar 20 (20-valent Pneumococcal Conjugate Vaccine) for the active immunisation and protection of infants and children against common pneumococcal diseases. The latest EU approval is based on data from four Phase III studies evaluating the safety and immunogenicity of Prevenar 20 in pediatric patients and is accompanied by a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The vaccine is marketed as Prevnar 20 in the US. Prevenar 20 is a 20-valent pneumococcal conjugate vaccine designed to stave off invasive pneumonia, and acute otitis media caused by 20 different serotypes of Streptococcus pneumoniae . While the vaccine is already approved for use in adults, the latest approval authorises its use in those between the ages of 6 weeks and 18 years. As per the 13 March press announcement, the latest version of the vaccine expands on Pfizer’s Prevenar 13 and includes protection against serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F, which are global causes of invasive pneumococcal disease. Marketing authorisation of Prevenar 20 addresses “the majority of currently circulating pneumococcal disease in the EU and globally,” Alexandre de Germay, executive VP of Pfizer said in the announcement. GlobalData’s consensus forecasts predict that Prevenar 20 will bring in $3.7bn in sales in 2028. GlobalData is the parent company of Pharmaceutical Technology . See Also: Biotheus and Hansoh Pharmaceutical expand ADC collaboration Bright Green invests $250m to expand facility in New Mexico Pfizer is not alone in the space to develop vaccines against streptococcal pneumonia. Hot on the pharma giant’s heels is MSD’s investigational 21-valent pneumococcal conjugate vaccine V116. The FDA is set to make a decision on the vaccine’s approval by the Prescription Drug User Fee Act (PDUFA) date of 17 June 2024. MSD’s biologics licence application (BLA) is partially supported by data from the Phase III STRIDE-3 study (NCT05425732), which compared the safety, tolerability, and immunogenicity of V116 and Pfizer’s pneumococcal vaccine in adults who have not received prior pneumococcal conjugate vaccination. As per the trial findings , V116 induced non-inferior immune responses in both cohorts of the study. Data from the Phase III STRIDE-4, STRIDE-5, and STRIDE-6 studies also supplement the BLA.

The funding will aid in expanding the existing unit at Grants. Credit: RGtimeline via Shutterstock. Bright Green has announced plans to expand its controlled substances drug production facility in Grants, New Mexico, US, with an investment of $250m. The company has entered an agreement with Dalsem Greenhouse Technologies BV for the construction project. The funding will aid in expanding the existing research, manufacturing and extraction processing unit, adding a further 7,000ft² of space. The agreement outlines a modular construction tailored to Bright Green’s specifications. The expansion is enabled by Bright Green’s regulatory approvals to produce Schedule I and II controlled substances. In March 2024 the company sought approval from the US Drug Enforcement Administration and the State of New Mexico Board of Pharmacy. See Also: Pfizer’s Prevenar 20 expands EU label for pediatric streptococcal pneumonia Novo expands Wegovy’s US label to reduce cardiovascular events Bright Green has also secured $60m senior debt financing under a credit agreement with an undisclosed lender. With a ten-year term with a fixed interest rate, the credit agreement includes a $5m tranched draw schedule, allowing for up to 12 draw requests over the period. Bright Green will secure the remaining funds to execute the project from its EB-5 investment visa opportunity, currently being promoted by Asia Capital Pioneers Group. The company’s ‘Drugs Made in America’ initiative is set to benefit from the expansion, as it aims to produce generic prescription drugs and process active pharmaceutical ingredients. Final negotiations are underway for essential services from the city, acquisition of land parcels from landowners and state permits for construction and occupancy. The facility in rural Grants will aid in lowering drug costs for the state of New Mexico.