Pneumococcal conjugate vaccine, 13-valent manufacturers

About pneumococcal conjugate vaccine, 13-valent

Pneumococcal conjugate vaccine, 13-valent (PCV13) manufacturers include the originator Pfizer (Prevnar 13 / Prevenar 13), and Walvax and Beijing Minhai in China, with further producers in Argentina and Russia. PCV13 protects against 13 types of Streptococcus pneumoniae, a leading cause of pneumonia, meningitis and bloodstream infections. It is widely used in childhood immunisation programmes. Higher-valent vaccines are replacing PCV13 in some countries. Pharmaceutical companies can source PCV13 through supply, regional licensing or technology transfer.

Pneumococcal conjugate vaccine, 13-valent key facts

Pneumococcal conjugate vaccine, 13-valent manufacturers and licensing history

Wyeth developed PCV13 as a successor to its 7-valent vaccine, and Pfizer acquired Wyeth in 2009. The EU approved Prevenar 13 in December 2009, and the FDA approved Prevnar 13 in February 2010. The WHO prequalified it in August 2010, allowing UNICEF and Gavi to buy it for low-income countries.

For many years, Pfizer and GSK were the only global suppliers of pneumococcal conjugate vaccines. New producers entered from 2019: Walvax launched a Chinese PCV13 in 2019 and Beijing Minhai in 2020, both licensed in China. Sinergium in Argentina and Nanolek in Russia also supply PCV13 for local markets. Serum Institute of India supplies a WHO-prequalified PCV10.

In high-income countries, PCV13 is being replaced by higher-valent vaccines such as PCV15 and PCV20. Buyers should confirm WHO prequalification or national licensing, GMP status, cold-chain capability and supply capacity before choosing a supplier.

Pneumococcal conjugate vaccine, 13-valent dosage forms and dossier types

PCV13 is supplied as a suspension for intramuscular injection, in prefilled syringes or multi-dose vials.

Pneumococcal conjugate vaccine, 13-valent regulatory and patent status

PCV13 was approved in the EU in December 2009, in the US in February 2010, and prequalified by the WHO in August 2010. Each manufacturer's vaccine is licensed separately, as there are no generic vaccines. In the US and some other high-income countries, recommendations now favour higher-valent vaccines, but PCV13 remains widely used in national immunisation programmes.

Pneumococcal conjugate vaccine, 13-valent mechanism of action and therapeutic use

PCV13 contains capsular sugars from 13 pneumococcal types, each linked to the CRM197 carrier protein. This linkage allows even young infants to produce strong, long-lasting antibody responses and immune memory. PCV13 is used to prevent invasive pneumococcal disease, pneumonia and ear infections in infants and children, and pneumococcal disease in adults.

Pneumococcal conjugate vaccine, 13-valent licensing and sourcing

PCV13 suppliers and licensing partners typically offer finished vaccine supply, regional licensing or technology transfer. Buyers usually compare WHO prequalification, GMP status, supply capacity, price and territory availability. Current offers and supplier contacts are listed among the pneumococcal conjugate vaccine, 13-valent manufacturers on Pipelinepharma.

Frequently asked questions about pneumococcal conjugate vaccine, 13-valent

Who are the main PCV13 manufacturers? Pfizer is the originator and sells Prevnar 13 / Prevenar 13. Walvax and Beijing Minhai produce PCV13 in China, and other producers supply Argentina and Russia.

Is PCV13 WHO prequalified? Yes. Pfizer's Prevenar 13 has been WHO prequalified since August 2010. Chinese PCV13 vaccines are licensed in China.

Which serotypes does PCV13 cover? PCV13 covers serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Is PCV13 being replaced? In the US and some other high-income countries, higher-valent vaccines such as PCV15 and PCV20 are now preferred. PCV13 is still widely used elsewhere.

What forms of PCV13 are available? PCV13 is available as a 0.5 ml single-dose prefilled syringe and as a 4-dose multi-dose vial for immunisation programmes.