Pharmaceutical giant Pfizer has announced today that it can market its pneumococcal 13-valent conjugate vaccine, Prevenar 13®, in China after getting it approved from the Chinese Food and Drug Administration (CFDA). Prevenar 13 will help restore active immunization for the prevention of invasive diseases such as bacteremic pneumonia, meningitis, septicemia, and bacteremia caused by Streptococcus pneumoniae in children aged 6 weeks to 15 months.
Prevenar 13 is a pneumococcal vaccine that contains extracts from thirteen of the most common types of Streptococcus pneumoniae bacteria (S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). These bacteria are responsible for spreading diseases such as pneumonia, blood poisoning and meningitis. The vaccine works by activating the body’s immune response to the bacteria, without initiating the diseases.
Prevenar 13 is given in the form of an injection into the muscle of the thigh for babies under one year and the upper arm for older children and adults. Pneumococcal disease is a leading cause of deaths globally in children under five which could have been prevented by vaccines. In China alone, approximately 30 thousand children in this age group die due to pneumococcal diseases annually.
President of Pfizer China Dr Xiaobin Wu was delighted by CFDA’s decision and had this to say, “We applaud the efforts of CFDA and other relevant Chinese government agencies to bring new medicines and vaccines to the Chinese healthcare system. Pfizer is committed to working closely with the CFDA in these efforts, and also looks forward to partnering with the Chinese government to help improve the lives of patients and people of all ages in China.”
Prevenar 13 is part of the childhood immunization schedule. This vaccine will usually be given in the form of three injectable doses, at two, four and 12 to 13 months of age. In China, however, Prevanar 13 will be given as a primary series administered at 2, 4 and 6 months of age with a fourth (booster) dose administered at approximately when the infant is 12 to 15 months of age.
Whereas children who are over five years and adults who require a pneumococcal vaccine will usually be given a single dose of a different pneumococcal vaccine called Pneumovax II, which contains extracts from 23 of the most common types of Streptococcus pneumoniae bacteria.
It is important to remember that Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other serotypes not contained in the vaccine or other microorganisms that cause invasive disease, pneumonia or infections.
It is the most popular neumococcal conjugate vaccine in the world, and is included in the pediatric national immunization programs of several countries in the Asia Pacific region including Australia, Hong Kong, Japan and Taiwan.
Pneumococcal disease is a leading cause of vaccine-preventable deaths in children under five globally and in China. Due to health impact of pneumococcal disease, the World Health Organization (WHO) has prioritized vaccination against this disease worldwide.
This drug is especially essential for Chinese population due to the extremely high air pollution levels in the country. The most commonly associated diseases with air pollution include respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis and lung cancer. In addition to this, cardiovascular disease, adverse pregnancy outcomes like preterm birth and in worst cases death are also attributed to air pollution.
About Streptococcus Pneumoniae
This bacterium affects the air passageways, particularly respiratory tract, sinuses and nasal cavity as these regions are the ones to get infected first. However, in susceptible individual such as elderly and immunocompromised people and children, the bacterium may become pathogenic, spread to other locations and may even prove fatal.
pneumoniae is the main cause of pneumonia caused by humans and meningitis, infection of meninges covering area around the brain and spinal cord, in children and the elderly, and of septicemia in HIV-infected persons. The methods of transmission include sneezing, coughing, and coming into direct contact with an infected person.
Symptoms of pneumococcal disease depend on the region of the body which gets infected. They can include fever, cough, shortness of breath, nausea, chest pain, stiff neck, confusion and disorientation, sensitivity to light, joint pain, chills, ear pain, sleeplessness and irritability. In severe cases, pneumococcal disease can cause hearing loss, brain damage and even result in fatalities.
Pneumococcal disease is a global phenomenon. Travelers may be at higher risk if they spend time in crowded settings or in close contact with children in countries where pneumococcal conjugate vaccine is not widely administered. Pneumococcal disease is more common in economically challenged countries.
Pneumococcal disease is also more common during months of winter and early spring but is common year-round in the tropical countries. Outbreaks of pneumococcal disease are uncommon in countries that have introduced the pneumococcal conjugate vaccine, but may occur under special circumstances and confined areas, such as in nursing homes, childcare centers or sanitized medical facilities such as hospitals or clinics.