The Drug Regulator Reviewed The Phase I Ii And Iii Clinical Trial Data Submitted By Pune
The vaccine is administered in an intramuscular manner.
The country’s first fully indigenously developed vaccine against pneumonia has got approval from the Drug Controller General of India , the Union health ministry said on Wednesday.
With the help of Special Expert Committee for vaccines, the drug regulator reviewed the phase I, II and III clinical trial data submitted by Pune-based firm Serum Institute of India and then granted the market approval for Pneumococcal Polysaccharide Conjugate Vaccine.
The vaccine is administered in an intramuscular manner.
The ministry said the vaccine will be used for active immunisatiuon against invasive disease and pneumonia caused by ‘Streptococcus pneumonia’ among infants.
The Serum Institute of India first obtained the approval of the DCGI to conduct Phase I, II and III clinical trials of the vaccine in India. These trials have since been concluded within the country. The company also conducted the clinical trials in Gambia.
Thereafter, the company applied for approval and permission to manufacture the vaccine.
The Special Expert Committee recommended for grant of permission of market authorization to the said vaccine. On July 14, Serum Institute of India Pvt Ltd was granted permission to manufacture domestically developed first Pneumococcal Polysaccharide Conjugate Vaccine, the ministry said.
“This is the first indigenously developed vaccine in the field of pneumonia,” it said.
A Look At Each Vaccine: Pneumococcal Vaccine
Much like Haemophilus influenzae type b , pneumococcal bacteria affect the most defenseless of the population . The diseases caused by pneumococcus include meningitis , bloodstream infections and pneumonia . The pneumococcal vaccine was first introduced for use in all infants in the United States in 2000. Before the vaccine, every year pneumococcus caused about 700 cases of meningitis, 17,000 cases of bloodstream infections, 200 deaths and 5 million ear infections in children.
Infants and young children are at greatest risk of serious infection because they are unable to develop immunity to the sugar that coats the bacteria, something that older children can do when they are more than 2 years of age.
Symptoms And Causative Agent
Streptococcus pneumoniae bacteria, also called pneumococcal bacteria, pneumococci , and pneumococcus , are one of the leading causes of illness in young children. At least 90 types of pneumococcal bacteria are known to exist. As the name implies, they can cause pneumonia however, these bacteria also can cause bloodstream infections , meningitis, sinusitis, and middle ear infection, among other illnesses. Collectively, the different illnesses caused by Streptococcus pneumoniae are referred to as pneumococcal disease.
Symptoms of pneumococcal disease vary based on the specific illness the bacteria have caused. Pneumococcal pneumonia symptoms include fever, chest pain, cough, and shortness of breath. When pneumococci infect normally sterile locations, so-called invasive pneumococcal disease may result. The two major types of invasive pneumococcal disease are bacteremia and meningitis . Pneumococcal meningitis symptoms include fever, headache, stiffness in the neck, light sensitivity, and disorientation. Pneumococcal bacteremia may complicate localized infections such as pneumonia and is commonly associated with high fever and shaking chills.
Invasive pneumococcal disease can be fatal survivors of meningitis may have permanent injury, including brain damage, seizures, or hearing loss.
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Immunogenicity And Vaccine Efficacy
Pneumococcal Polysaccharide Vaccine
More than 80% of healthy adults who receive PPSV23 develop antibodies against the serotypes contained in the vaccine, usually within 2 to 3 weeks after vaccination. Older adults and persons with some chronic illnesses or immunodeficiency may not respond as well, if at all. Elevated antibody levels following vaccination persist for at least 5 years in healthy adults but decline more quickly in persons with certain underlying illnesses. In children younger than age 2 years, antibody response to PPSV23 is generally poor.
PPSV23 vaccine efficacy studies have resulted in various estimates of clinical effectiveness. Overall, the vaccine is 60% to 70% effective in preventing invasive disease caused by serotypes included in the vaccine. Despite the vaccineâs reduced effectiveness among immunocompromised persons, PPSV23 is still recommended for such persons because they are at increased risk of developing severe disease. There is no consensus regarding the ability of PPSV23 to prevent non-bacteremic pneumococcal pneumonia. For this reason, providers should avoid referring to PPSV23 as a âpneumonia vaccine.â
Studies comparing patterns of pneumococcal carriage before and after PPSV23 vaccination have not shown clinically significant decreases in carriage rates among vaccine recipients.
Pneumococcal Conjugate Vaccine
Pneumococcal Vaccine Contraindications and Precautions
Timeline Of Human Vaccines
This is a timeline of the development of prophylactic human vaccines. Early vaccines may be listed by the first year of development or testing, but later entries usually show the year the vaccine finished trials and became available on the market. Although vaccines exist for the diseases listed below, only smallpox has been eliminated worldwide. The other vaccine-preventable illnesses continue to cause millions of deaths each year. Currently, polio and measles are the targets of active worldwide eradication campaigns.
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Who: 3rd Pneumonia Vax At Parity With Other Vaccines
The World Health Organization , in a recent study, declared that a third pneumococcal vaccine developed by the Serum Institute of India is at parity with two other vaccines being offered to address child pneumonia, the number one killer disease among kids.
At present, two PCVs, both coming from global vaccine manufacturers, are being offered to address child pneumonia Pfizers Prevnar or PCV 13 and GlaxoSmithKline Synflorix or PCV 10.
The third PCV, Serum Institutes Pneumosil, has been declared by a 2021 WHO study as non-inferior to both Prevnar and Synflorix.
According to UNICEF, one child dies globally every 39 seconds because of pneumonia.
The situation has been exacerbated by the global attention on COVID-19, which has somehow taken attention away from pneumonia and other top diseases that could have otherwise been prevented by vaccination.
In the Philippines, the Pediatric Infectious Disease Society of the Philippines in its December 2021 journal cited pneumonia as the third leading cause of death among children 5 years old and below, accounting for 14 percent in child mortality.
In its 2021 study on prequalifying PCVs for childhood immunization programs, the WHO said the 10-valent has the same substantial impact against pneumonia, vaccine-type , invasive pneumococcal disease , and nasopharyngeal carriage in a variety of settings, when compared to the earlier prequalified 13-valent vaccine.
Invasive Disease And Its Risk Factors
For disease surveillance purposes, detection of S. pneumoniae in a normally sterile site, such as blood, cerebrospinal fluid or pleural fluid, by culture or polymerase chain reaction, is classified as invasive pneumococcal disease. The highest incidence of invasive pneumococcal disease is seen among young children, especially those under two years, and in the elderly.3,4 The major categories of invasive pneumococcal disease are:
Various medical, environmental and lifestyle factors are associated with an increased risk of developing invasive disease . 5,6 Aboriginal and Torres Strait Islander children and adults have a higher rate of invasive pneumococcal disease compared with other Australians.7,8
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Prevention And Control Measures For Pneumococcal Disease
Childhood immunisation against S. pneumoniae is the most effective public health measure for preventing IPD both among vaccine recipients , and among unimmunised populations .
There are two principal types of pneumococcal vaccines currently in use: pneumococcal polysaccharide vaccine and pneumococcal conjugate vaccines :
PPV-23 contains purified capsular polysaccharide from the 23 serotypes that most commonly cause IPD. It is poorly immunogenic in children younger than two years of age and does not reduce pneumococcal carriage. The vaccine induces a T-cell independent response and there is no booster effect from repeated immunisations.
PCV-7 contains capsule polysaccharide conjugated to a protein that stimulates the immune response. PCV 7 is effective for infants, induces immunologic memory and reduces pneumococcal carriage rates.
PCV 7 is the pneumococcal vaccine currently used in most European immunisation programmes.
New pneumococcal conjugate vaccines are being introduced. In 2009 for example, the European Medicines Agency approved 10-valent and 13-valent vaccines that protect against a wider range of the most pathogenic serotypes.
PCV 7 was first licensed in Europe in 2001 and more than half of the European countries reporting to the European surveillance network for vaccine-preventable diseases have since introduced PCV 7 to their routine childhood immunisation programs. Current national immunisation schedules can be accessed here.
Factors Increasing Pneumonia Risk In Pneumococcal Infections
Influenza virus, respiratory syncytial virus, parainfluenza virus, adenovirus, and coronavirus are commonly detected in patients with CAP, but it may be unclear to what extent any of these organisms are causing the disease or have predisposed the patient to secondary bacterial infection .
When influenza A virus is serially infected with bacteria, its lethality is increased . For example, pneumococcal coinfection was responsible for high mortality during the 2009 H1N1 pandemic . Moreover, it has been reported that influenza virus coinfection comprises 22% of CAP cases .
Although influenza virus and pneumococcus coinfection is responsible for higher mortality and morbidity, the current pneumococcal conjugate vaccine does not provide sufficient protection in the serial coinfection model . Therefore, the development of a new type of vaccine, which can protect against influenza virus and pneumococcus coinfection, is required.
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Children Age 2 Through 23 Months
Children should routinely receive a 3-dose primary series of PCV13 at age 2, 4, and 6 months, and dose 4 at age 12 through 15 months. Dose 1 can be administered as early as 6 weeks. For doses given before the 1st birthday, the minimum interval between doses is 4 weeks doses given at age 12 months or older should be separated by at least 8 weeks. PCV13 can be administered at the same time as other routine immunizations.
Unvaccinated children age 7 months or older do not require a full series of four doses. The number of doses depends on the childâs current age and the age at which the first dose of PCV13 was administered. If the childâs current age is 7 through 11 months, the recommended series is 2 doses at least 4 weeks apart, and a booster dose at age 12 through 15 months. If the vaccination series is initiated at age 7 through 11 months, and the next dose is administered after the 1st birthday, another dose should be administered 8 weeks later. If the childâs current age is 12 through 23 months, the recommended series is 2 doses at least 8 weeks apart.
How Do You Catch Pneumococcus
Pneumococcus is a bacterium that is commonly found lining the surface of the nose and the back of the throat in fact, about 25 of every 100 people are colonized with pneumococcus. Many children will come in contact with pneumococcus sometime in the first two years of life. Because most adults have immunity to pneumococcus, a mother will passively transfer antibodies from her own blood to the blood of her baby before the baby is born. The antibodies that the baby gets before birth usually last for a few months. However, as these maternal antibody levels diminish, the baby becomes vulnerable. Most children who first come in contact with pneumococcus don’t have a problem. But every year tens of thousands of children suffer severe, often debilitating, and occasionally fatal infections with pneumococcus most of these children were previously healthy and well nourished.
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Vaccine Storage And Handling
PCV13 and PPSV23 should be maintained at refrigerator temperature between 2Â°C and 8Â°C . Manufacturer package inserts contain additional information. For complete information on best practices and recommendations for vaccine storage and handling, please refer to CDCâs Vaccine Storage and Handling Toolkit pdf icon.
Clearing Up The Confusion Around Pneumococcal Vaccines
By Dr. Susan Hollenberg on March 17, 2021
Clinical Assistant Professor, Family Medicine, UBC Education Lead, UBC Health Clinic
What I did before
In my office, we are fielding increasing patient questions about pneumococcal vaccines as COVID pandemic concerns are focussing attention on vaccine-preventable respiratory illness. People are seeing glossy advertising for pneumococcal conjugate vaccine , and pharmacists are mentioning that adults should consider this product. I have routinely offered pneumococcal vaccine to my patients as they turned 65. Since 1997 in BC, polysaccharide pneumococcal vaccine became a public health-funded vaccine on a one-time basis for all healthy seniors. Pneumococcal vaccine became increasingly indicated for special populations, and I added other medical conditions to my immunization offer. When seniors came in for a flu shot it became a reminder to ask if they had received pneumonia vaccine. In the early 2000s we began using other types of pneumococcal vaccine in infants, and I struggled to understand the differences between products. I was left confused as to the evidence base for these vaccines and how to frame a discussion with patients.
What changed my practice
What I do now
Reference Table of Adult Pneumococcal Vaccine recommendations from Canadian Immunization Guide
|Table 4: Recommended Schedules for Adult Immunization with Pneumococcal Vaccine|
|Age, underlying condition|
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Vaccines For Adolescents: A New Generation Of Vaccines
Adolescents, like adults, were recommended to get tetanus boosters every 10 years most requiring their first booster dose around age 11. Other than this, however, most adolescents did not require additional vaccines unless they missed one in childhood. By 2005, vaccines specifically recommended for adolescents were only recommended for sub-groups based on where they lived or medical conditions that they had. However, a new group of vaccines became available in the latter part of the decade.
- New vaccines: Tdap, 2005, meningococcal conjugate , HPV , meningococcal serogroup B vaccine
- Additional recommendations for existing vaccines: HPV , intranasal influenza vaccine
- New versions of existing vaccines: HPV
- Discontinuation of vaccine: intranasal influenza vaccine
How The Pneumococcal Vaccine Works
Both types of pneumococcal vaccine encourage your body to produce antibodies against pneumococcal bacteria.
Antibodies are proteins produced by the body to neutralise or destroy disease-carrying organisms and toxins.
They protect you from becoming ill if you’re infected with the bacteria.
More than 90 different strains of the pneumococcal bacterium have been identified, although most of these strains do not cause serious infections.
The childhood vaccine protects against 13 strains of the pneumococcal bacterium, while the adult vaccine protects against 23 strains.
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Adults At High Risk Of Ipd
Adults with immunocompromising conditions resulting in high risk of IPD, except HSCT, should receive 1 dose of Pneu-C-13 vaccine followed at least 8 weeks later by 1 dose of Pneu-P-23 vaccine, if not previously received. The dose of Pneu-C-13 vaccine should be administered at least 1 year after any previous dose of Pneu-P-23 vaccine. Refer to Immunocompromised persons for information about immunization of HSCT recipients.
Immunocompetent adults with conditions or lifestyle factors resulting in high risk of IPD should receive 1 dose of Pneu-P-23 vaccine, if not previously received. One dose of Pneu-P-23 vaccine is also recommended for all adults who are residents of long-term care facilities and should be considered for individuals who use illicit drugs.
Some experts also suggest a dose of Pneu-C-13 vaccine, followed by Pneu-P-23 vaccine, for immunocompetent adults with conditions resulting in high risk of IPD as this may theoretically improve antibody response and immunologic memory. However, Pneu-P-23 vaccine is the vaccine of choice for these individuals, and if only one vaccine can be provided, it should be Pneu-P-23 vaccine, because of the greater number of serotypes included in the vaccine.
Adults at highest risk of IPD should also receive 1 booster dose of Pneu-P-23 vaccine refer to Booster doses and re-immunization.
Table 4 – provides recommended schedules for adult immunization with pneumococcal vaccines.
Medical Conditions Resulting In High Risk Of Ipd
Table 1: Medical Conditions Resulting in High risk of IPD
IPD is more common in the winter and spring in temperate climates.
Spectrum of clinical illness
Although asymptomatic upper respiratory tract colonization is common, infection with S. pneumoniae may result in severe disease. IPD is a severe form of infection that occurs when S. pneumoniae invades normally sterile sites, such as the bloodstream or central nervous system. Bacteremia and meningitis are the most common manifestations of IPD in children 2 years of age and younger. Bacteremic pneumococcal pneumonia is the most common presentation among adults and is a common complication following influenza. The case fatality rate of bacteremic pneumococcal pneumonia is 5% to 7% and is higher among elderly persons. Bacterial spread within the respiratory tract may result in AOM, sinusitis or recurrent bronchitis.
Worldwide, pneumococcal disease is a major cause of morbidity and mortality. The World Health Organization estimates that almost 500,000 deaths among children aged less than 5 years are attributable to pneumococcal disease each year. In Canada, IPD is most common among the very young and adults over 65 years of age.
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Historic Dates And Events Related To Vaccines And Immunization
|It was not too many years ago when we celebrated the 200th anniversary of Edward Jenner’s first smallpox vaccination in 1796. The development of vaccines continued at a fairly slow rate until the last several decades when new scientific discoveries and technologies led to rapid advances in virology, molecular biology, and vaccinology. The chart which follows displays many of the vaccine- and immunization-related events that have occurred since Jenner’s critical discovery. This list is by no means exhaustive. If you know of an event that you would like us to add, contact us at .|
Persons New To Canada
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals, as necessary. Review of pneumococcal vaccination status is particularly important for persons from areas of the world where sickle cell disease is present, as persons with sickle cell disease are at risk of serious pneumococcal infections. In many countries outside of Canada, pneumococcal conjugate vaccine is in limited use. Refer to Immunization of Persons New to Canada in Part 3 for additional information about vaccination of people who are new to Canada.
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