Green light from the European Medicines Agency Ema al 20-valent pneumococcal conjugate vaccine Pfizer’s Apexxnar *. This was announced by the American pharmaceutical company, explaining that the product has been approved as active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in people aged 18 and over. The authorization is valid in all 27 EU Member States, as well as Iceland, Lichtenstein and Norway. The vaccine is already available on the US market under the name Prevnar 20 *.
“Apexxnar’s EMA clearance for adults confirms Pfizer’s continued commitment to help prevent certain potentially serious infectious respiratory diseases, including invasive pneumococcal disease and pneumonia,” said Nanette Cocero, Pfizer Vaccines Global President. The vaccine helps protect against the 20 serotypes responsible for most cases of invasive disease and pneumococcal pneumonia, Pfizer notes, and “today’s approval offers adults, through the administration of a single dose, the broadest serotype protection among all pneumococcal conjugate vaccines available in Europe “, Cocero points out.
The ok Ema follows the positive opinion expressed by the Committee for Medicinal Products for Human Use Chmp. The decision – reports a note – is based on the evidence of a clinical program conducted on adults, including the phase 1 and 2 trials and three phase 3 trials (NCT03760146, NCT03828617 and NCT03835975), which described the safety and evaluated the immunogenicity of the vaccine. Over 6,000 over 18s were enrolled in the three Phase 3 trials, including adults aged 65 and over. The population included adults with stable chronic medical conditions, pneumococcal vaccine naïve adults, and adults with a history of previous pneumococcal vaccination. Data on the outcome of the pivotal phase 3 studies of the 20-valent pneumococcal conjugate vaccine candidate in children are expected for the second half of 2022 and, if positive – Pfizer anticipates – will form the basis of potential presentations to the US drug agency. Fda and EMA by the end of the year.