Pneumococcal Polysaccharide Vaccine - Indications, Pharmacology, Warnings, and Precautions

Overview:

The Pneumococcal polysaccharide vaccine is being recognized as a great boon for individuals vulnerable to pneumococcal infections, which can potentially endanger their lives. The Pneumococcal polysaccharide vaccine received authorization from the drug regulatory body of the United States, the Food and Drug Administration, in 1983. The Pneumococcal polysaccharide vaccine can offer considerable protection from deadly pneumococcal infections. It is currently marketed and distributed under various brand names, protecting against pneumococcal infections. It offers an augmented range of protection for various pneumococcal bacterial strains.

Available Doses and Dosage Forms:

The vaccines are employed in liquid form and are intended to be injected into the body. It is made available in single-dose vials with 0.5 milliliters of solution. It is also marketed as prefilled syringes where the syringes come loaded with the vaccine solution so that a medical professional can give the shot immediately.

For Patients:

What Is Pneumococcal Infection?

Pneumococcal infections encompass a spectrum of bacterial infections triggered by a specific category of Streptococcus bacteria. Pneumococcus, otherwise known as Streptococcus pneumonia, is the prime culprit behind pneumococcal infections. These are catchy infections, which can be acquired from an infected person upon direct contact or interactions. All individuals who house pneumococcal bacteria may not reflect obvious manifestation. Some healthy individuals serve as carrier agents and pass on the bacteria to susceptible individuals. Upon gaining access to a human body with impaired immune response, Pneumococcal bacteria can bring in grave outcomes. However, not all forms of pneumococcal infections are alarming; some are mild and do not risk the patient's life.

Some of the frequently encountered pneumococcal infections include the following:

• Pneumonia: Lung infection, where the fluid assembles in the tiny units concerned with respiratory gas exchange (alveoli) within the lungs and compromises breathing.

• Meningitis: The brain and other structures within the skull are shielded with certain tissue layers called meninges. When the meningeal cells get inflamed and swell up in response to infection, it results in meningitis.

• Sepsis: It is an exaggerated body response to an existing infection, impeding the functions of multiple vital organs and organ systems.

• Sinus Infection: The facial bone encloses certain air-filled spaces. Any form of infection concerning the sinus is generally coined as a sinus infection.

• Ear Infections: Pneumococcal bacteria can also give rise to ear infections that are generally mild and less dangerous.

The pediatric population, whose immune system is premature, and the geriatric population, with a collapsed immune status, are the two groups vulnerable to pneumococcal infections. Pneumococcal vaccines offer promising defense and are advised for vulnerable populations.

How Does the Pneumococcal Polysaccharide Vaccine Work?

As the name suggests, the pneumococcal polysaccharide vaccine is structurally composed of polysaccharide (sugar) molecules. These polysaccharides are derived from bacterial cells. Pneumococcal polysaccharides hold immunity against 23 pneumococcal bacterial strains, as the polysaccharide molecules incorporated in the vaccine are obtained from these 23 strains. The immune cells recognize the bacterial polysaccharide molecules and elicit an immunological response, making the immune system aware of them. An immediate response can be elicited upon pneumococcal infection since the immune system is familiar with it.

What Is the Dosage of the Pneumococcal Polysaccharide Vaccine?

0.5 milliliters (ml) is the recommended dosage of the pneumococcal polysaccharide vaccine. The vaccine is available in a single-dose vial from which the specified dose, 0.5 ml, is withdrawn and loaded into a new and sterile syringe.

How Effective Is the Pneumococcal Polysaccharide Vaccine?

The pneumococcal polysaccharide vaccine is efficacious in extending protection and defense against 23 different pneumococcal bacterial serotypes (strains). The pneumococcal polysaccharide vaccine can impart pneumococcal immunity to individuals over 50 years of age and children over two years of age. Studies have revealed that pneumococcal polysaccharide vaccine protection is more extensive than that of other pneumococcal vaccine formulations. However, the vaccine's potency varies depending on certain patient factors, like health status, age, the presence of debilitating ailments, and the pneumococcal bacterial serotype involved in the infection. The vaccine’s effectiveness is estimated to be around 60 to 70 percent, which is much appreciated in the elderly population. The pneumococcal polysaccharide vaccine failed to elicit fruitful results for younger patients under two years, thus limiting its application in such patients.

What Are the Things to Inform the Doctor Before Taking the Vaccine?

Every treatment commences after a thorough discussion with the concerned doctors. Similarly, before getting any vaccine shot, it is necessary to have a proper discussion with the concerned healthcare providers. It aids in guiding doctors to make the most effective and safest vaccine choice.

• Medical History: The doctors should have a comprehensive history of the patient’s medical background. It should encompass previous surgeries, underlying ailments, and even those presently undergoing therapies. Certain disease conditions can interrupt the working mechanism of the pneumococcal polysaccharide vaccine and eventually lead to unpleasant outcomes. Therefore, it is better to inform the doctor about the patient's medical background beforehand to ensure the appropriateness of the vaccine for that particular individual.

• Drug History: A detailed drug history is another important thing that doctors should know before giving the vaccine shots. The drug history should encompass all the recent and current medications, whether nonprescription medicine, dietary supplements, herbal, or alternative medicines. In addition to the drug details, informing the patient’s vaccination history is imperative.

• Allergy: Previous allergic or exaggerated reactivity encounters with any vaccine ingredients must be reported. In cases of suspected hypersensitivity, instead of directly proceeding with the vaccine shot, it needs to be ruled out with the help of an appropriate allergic test.

• Pregnancy: The doctors should know the patient’s pregnancy and lactation status. Expecting and breastfeeding women need special attention, and doctors must reconsider their necessity for the pneumococcal polysaccharide vaccine.

How Is Pneumococcal Polysaccharide Vaccine Administered?

Pneumococcal polysaccharide vaccine shots should be given directly to the muscle or below the skin layer. However, injecting the solution directly into the vein or skin is not recommended. The shoulder and thigh regions are routinely preferred sites for the pneumococcal polysaccharide vaccine shot.

Specific vaccine doses must be loaded into a fresh syringe with a sterilized needle. In prefilled syringes, the vaccine can be jabbed into the individual’s body, preferably the thigh or shoulder, after attaching a sterile needle.

What Are the Side Effects of Pneumococcal Polysaccharide Vaccine?

Pneumococcal polysaccharide vaccines can also cause certain unpleasant events. These adverse reactions are typically reported within the first two weeks following the pneumococcal polysaccharide vaccination. Some of the routinely encountered side effects following pneumococcal polysaccharide vaccine shots include the following:

• Reactions at the point where the vaccine shot was given. It can be in the form of tenderness, redness (erythema), puffiness (swelling), or skin hardening (induration).

• Apart from these skin reactions, there are reports of headaches, general weakness, body pain, and muscle pain following the vaccine administration.

Compared to the initial vaccine dose, there is an exaggerated incidence of side effects following revaccination using the pneumococcal polysaccharide vaccine. Revaccinations are advised by healthcare professionals only for stipulated cases and are not routinely recommended.

Dietary Considerations:

There are no specific dietary regulations for getting the pneumococcal polysaccharide vaccine. However, if the doctor recommends any dietary changes, they must be followed. Ensuring good health is a way to elicit effective and appropriate immune responses toward the vaccine shots. Therefore, healthy eating, particularly vitamin C-loaded food, can enhance immune function and facilitate the vaccine’s effectiveness.

Overdose:

Administering more than the intended dose of the pneumococcal polysaccharide vaccine or accidental exposure to multiple vaccine shots of pneumococcal polysaccharide vaccine formulations are the two distinct ways that can eventually bring about overdose issues. However, there is only limited data available concerning the vaccine overdose. The overdose issues may range from neurological issues to psychiatric problems, injection point reactions, and infections.

Storage:

The recommended storage temperature for the pneumococcal polysaccharide vaccine is two to eight degrees Celsius (36 to 46 degrees Fahrenheit). It is marketed in single-dose vials and as prefilled syringes. Once the vaccine shots are delivered, the vials and syringes must be disposed of. Before delivering the vaccine shots, ensure the vial solution is within the usage period without discoloration. Vials found during the safe usage period are strictly not advised to be used. Instead, those vials need to be either disposed of or handed over to drug take-back authorities.

For Doctors:

Indication:

Pneumococcal polysaccharide vaccines are recommended for individuals over 50 and children over two years of age who are identified as being vulnerable to pneumococcal infections.

Dose:

The recommended vaccine dose is a single shot of 0.5 milliliters of the vaccine solution. Revaccination is considered for individuals with an enhanced susceptibility to developing pneumococcal infections. However, there should be a sufficient gap between the two vaccine shots. Patients are advised to adhere to the doctor’s guidelines concerning dose and revaccination.

Dosing Considerations:

Unless instructed by the concerned medical professional, no specific dosing considerations need to be followed for the Pneumococcal polysaccharide vaccine.

What Are the Pharmacological Aspects of the Pneumococcal Polysaccharide Vaccine?

Mechanism of Action:

As the name suggests, the pneumococcal polysaccharide vaccine has incorporated polysaccharide molecules derived from the bacteria’s outer polysaccharide layer. The polysaccharide coating of 23 pneumococcus bacterial serotypes is amalgamated to form the vaccine. Upon delivering the vaccine shots, the immune cells, particularly the antigen-presenting cells, immediately pick up those polysaccharide molecules as they function like an antigen.

Once the immune system recognizes those polysaccharide antigens, it precipitates an immune response by forming a counteragent, an antibody, to tackle the antigen. The thus-formed antibody wrecks the polysaccharide antigen. However, vaccine exposure primes the immune system and familiarizes them with pneumococcal antigens.

Upon subsequent exposure to pneumococcal antigen, the memory cells immediately recall the antibody appropriate for this polysaccharide antigen and signal the immune system. Vaccination pre-activates the immune system and facilitates the body’s response to subsequent encounters with pneumococcal bacteria.

• Pharmacodynamics: Upon recognizing the polysaccharide component in the vaccine by antigen-presenting cells, there will be a general immune activation. It also triggers memory B cell generation, which keeps memory of the antigen and enables a faster response during subsequent encounters.

• Pharmacokinetics: The pharmacokinetic profile flagged by the Pneumococcal polysaccharide vaccine (PPSV) differs greatly from other therapeutic drugs. Following the delivery of the vaccine shot, the antigenic components in the vaccine formulations are recognized and processed by the immune cells. It is through the lymphatic system that the antigenic component gets circulated. Unlike other drugs, PPSV will then get processed by the immune cells, and there is no metabolism associated with these vaccine molecules. The action of various immune cells eliminates the vaccine components.

Clinical Studies:

Numerous clinical studies have been presented to elucidate the protective shielding of the pneumococcal polysaccharide vaccine. The efficacy was reported to be in the range of 76 to 92 percent. Vaccinated individuals exhibited considerable defense against pneumococcal infections, which otherwise could have threatened their lives.

What Are the Contraindications of the Pneumococcal Polysaccharide Vaccine?

• Individuals with allergic encounters with the pneumococcal polysaccharide vaccine component are advised not to get the vaccine shots. Subsequent exposure to allergic components can evoke life-threatening reactions like anaphylaxis.

• Individuals diagnosed with severe acute ailments should refrain from getting vaccine shots unless the doctors insist. However, it is a relative contraindication, and once the patient recovers from it, they can go ahead with the PPSV vaccination.

Warnings and Precautions:

• Chronic Cerebrospinal Fluid Leakage: The PPSV vaccine does not offer shielding against pneumococcus-triggered meningitis in the presence of chronic cerebrospinal fluid leakage precipitated by surgical intervention, fractured skull bone, or other inborn conditions.

• Compromised Immune Status: The pneumococcal polysaccharide vaccine may fail to extend its full range of protection in individuals with remarkably depleted immune status. Since the effectiveness of the PPSV is gained through immune activation, a compromised immune response curbs the vaccine’s effectiveness.

• Severe or Moderate Acute Ailments: Pneumococcal polysaccharide vaccines are not supposed to be administered in the presence of an existing acute ailment of either moderate or severe form. It is better advised to keep the vaccination on hold until the acute ailment gets resolved.

• Deteriorated Lung and Heart Function: When the pneumococcal polysaccharide vaccine is employed for a patient with impaired heart and lung functioning, it necessitates close surveillance and warrants caution, as it is always associated with enhanced health risk.

• Checking Antibiotic Prophylactic Therapy: Certain patients consider the pneumococcal polysaccharide vaccine a substitute for their antibiotic prophylaxis. It is strictly advised not to check antibiotic coverage that doctors advise against pneumococcal infection, even after getting shots of the pneumococcal polysaccharide vaccine.

What Are the Drug Interactions of the Pneumococcal Polysaccharide Vaccine?

When simultaneously ingested with other vaccine formulations, the pneumococcal polysaccharide vaccine can alter the vaccine’s mechanism and effectiveness. Parallel administration of the Herpes zoster vaccine and the pneumococcal polysaccharide vaccine can significantly impair the pneumococcal polysaccharide vaccine’s immune response, directly depreciating the PPSV’s effectiveness. Various clinical studies have demonstrated the need for a minimum interval of four months between these two vaccine administrations. The interaction of the pneumococcal polysaccharide vaccine with other vaccine formulations apart from the Herpes zoster vaccine must be explored more to expose adverse complications.

Specific Considerations:

• Pneumococcal Polysaccharide Vaccine During Pregnancy: Generally, expectant women are advised to refrain from the Pneumococcal Polysaccharide vaccine. Like other drugs, PPSV also bears the risk of having undesirable impacts on expectant women and fetuses. There is no clear evidence to disprove its potential fetal toxicity profile. However, the doctor can advise on the vaccine, considering the vaccine's need for the maternal body.

• Pneumococcal Polysaccharide Vaccine During Lactation: Lack of clear information concerning the discharge of vaccine formulation through the breastmilk potentially limits the Pneumococcal polysaccharide vaccine’s usage in breastfeeding women. However, suppose the maternal body necessitates the employment of the pneumococcal polysaccharide vaccine. In that case, the doctor advises the patient accordingly and may, sometimes, ask the patient to refrain from breastfeeding for a specific period to ensure the baby’s safety.

• Geriatric Use: Advanced age can also pose challenges in medical management. However, the vaccine's potency remains more or less comparable in both groups of individuals below and over 65. Since the health status of the over-65 age group is more likely to be severely impaired, there is an exaggerated possibility for adverse outcomes following vaccination.

• Pediatric Use: Pneumococcal polysaccharide formulations are not recommended for babies below two years of age. Infants and young babies fail to elicit the required immune response from the polysaccharide formulations of the pneumococcal vaccine, making it ineffective.