HEPATITIS B VACCINE

Hepatitis is the main manifestation of viral infection in humans is caused by only five virus species: hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV), and hepatitis E virus (HEV). All of the hepatitis viruses cause acute hepatitis; HBV frequently causes chronic hepatitis. Chronic hepatitis can lead to cirrhosis which may progress to hepatocellular carcinoma (HCC), the most common type of primary liver cancer.Infection with HBV may occur perinatally (vertical transmission-mother to child), during early childhood (the so-called horizontal spread-. child to child), through sexual contact, or nosocomially.

The World Health Organization (WHO) has recommended universal hepatitis B vaccination.

The currently available vaccine containing the surface antigen of hepatitis B is produced by recombinant technology in yeast and adjuvanted with aluminum salts and preserved with thimerosal (thimerosal-free vaccines are also available) since 1986. Hepatitis B vaccine is available as single- and multidose vials and should be stored at 2–8°C. The vaccine should not be frozen; frozen vaccine should be discarded.Hepatitis B vaccines are available as monovalent formulations for birth doses or for vaccination of older persons at risk, and in combination with other vaccines for infant vaccination, including diphtheria- tetanus-pertussis (DTP), Haemophilus influenzae type b (Hib), and inactivated polio vaccine (IPV).Interchange of brands is permitted but not routinely recommended

Immunogenicity, Efficacy and Effectiveness

The protective efficacy of hepatitis B vaccination is related to the induction of antibody to hepatitis B surface antigen (anti-HBs) antibodies, but also involves the induction of memory T-cells. An anti-HBs concentration of 10 mIU/mL measured 1–3 months after administration of the last dose of the primary vaccination series is considered a reliable correlate of protection against infection.The primary three-dose vaccine series induces protective antibody concentrations in >95% of healthy infants, children, and young adults.

Dosage and Administration

The dose in children and adolescents (aged less than 18 years) is 0.5 mL/10 μg and in those 18 years and older is 1 mL/20 μg. It should be injected intramuscularly in the deltoid/anterolateral thigh.Injections should be avoided due to low gluteal immunogenicity. The vaccine is extremely safe and well tolerated.

Immunization Schedules

Infants

The primary three-dose hepatitis B vaccination series for monovalent vaccines, consists of one monovalent birth dose followed by either two doses of monovalent or hepatitis B-containing combination vaccine administered during the same visits as the first and third doses of DTP-containing vaccines. Alternatively, four doses of hepatitis B vaccine may be given for programmatic reasons (e.g. one monovalent birth dose followed by three monovalent or hepatitis B-containing combination vaccine doses) administered during the same visits as the three doses of DTP-containing vaccines.The additional dose is not harmful. Delay in administration of the birth dose to infants of chronically infected mothers increases the risk of perinatal HBV transmission.The classical schedule is 0, 1, and 6 months. The vaccine is highly immunogenic and seroconversion rates are greater than 90% after a three-dose schedule.

Special cases

Seroconversion rates are lower in the elderly, the immunocompromised, and those with chronic renal failure (might require a booster after checking antibody titres) . Four doses at 0,1, 2, and 12 months of double dose may be given in these patients.Routine testing for anti-HBsAg levels 1 month after completion of the immunization schedule is recommended in children born to HBsAg positive mothers, health care workers, and those with comorbidities. Antibody titers greater than 10 mIU/mL signify a response and are considered protective.Nonresponders should be tested for hepatitis B carrier status. If found to be negative, the same three-dose schedule should be repeated. Almost all respond to a three-dose revaccination schedule.

Although the 0-1-6 schedule is the preferred schedule, hepatitis B vaccine schedules are very flexible and there are multiple options for adding the vaccine to existing national immunization schedules without requiring additional visits for immunization. These include:

  • Birth, 6, and 14 weeks
  • 6, 10, and 14 weeks
  • Birth, 6 weeks, 6 months
  • Birth, 6 weeks, 10 weeks, 14 weeks.

The birth dose can reduce perinatal transmission by 18–40%.Delay in the administration of the first dose beyond the 7th day of life has been shown to be associated with higher rates of HBsAg acquisition in later childhood. 

None of the above schedules needs a booster. 

Boosters:

Routine boosters are not needed in healthy children and adults. Studies have shown that individuals who had responded to the vaccination series and had levels of 10 mIU/mL after vaccination are protected against hepatitis B disease for life even if the levels drop to below protective levels or are undetectable later. This is due to immune memory. In the immunocompromised and those with comorbidities such as chronic renal disease, levels should be checked periodically and booster vaccination given whenever levels drop to below protective levels.

Coadministration

Hepatitis B vaccines do not interfere with the immune response to any other vaccine and vice versa. The immune responses and safety of hepatitis B-containing combination vaccines are comparable to those observed when the vaccines are administered separately.

HEPATITIS B IMMUNOGLOBULIN

Hepatitis B immunoglobulin (HBIg) provides passive immunity and is indicated along with hepatitis B vaccine in management of perinatal/occupational/sexual exposures to hepatitis B in susceptible individuals.5 The dose of HBIg in adults is 0.06 mL/kg and in neonates/infants 0.5 mL. HBIg should be stored at 2–8°C and should not be frozen. HBIg provides temporary protection lasting 3–6 months. HBIg should never be given intravenously. HBIg is also used alone following exposure to hepatitis B in patients who are nonresponders to hepatitis B vaccination (genetic reasons/ immunocompromised status). In this situation, two doses of HBIg 1 month apart are indicated. 

Management of an Infant Born to Hepatitis B Positive Mother

If the mother is known to be HBsAg negative, hepatitis B vaccine can be given in the 0–6 weeks–6 months schedule.

If the mother is HBsAg positive (and especially HBeAg positive), the baby should be given HBIg along with hepatitis B vaccine within 12 hours of birth, using two separate syringes and separate sites for injection. The dose of HBIg is 0.5 mL intramuscular. HBIg may be given up to 7 days of birth but the efficacy of HBIg after 48 hours is not known. 

IMMUNIZATION OF PRETERM INFANTS

Preterm infants and low-birth weight infants with birth weight less than 2,000 grams have a decreased response to hepatitis B vaccines administered before the age of 1 month. However, by the chronological age of 1 month, preterm babies irrespective of their initial birth weight and gestational age are likely to respond as adequately as full-term infants.

Recommendations for Preterm Infants

Greater than 2,000 g: As for full-term infants.

• Less than 2,000 g:

  • –  Mother HBsAg negative: Dose 1 at 30 days of age, dose 2 and 3
    as per schedule adopted for full-term infants.
  • –  Mother HBsAg positive: Hepatitis B vaccine + HBIg (within 12 hours of birth), continue vaccine series with three more doses beginning at 4–6 weeks of age as per schedule for full-term infants. Immunize with four doses, do not count birth dose as part of vaccine series.8 Check anti-HBs and HBsAg 1 month after completion of vaccine series.

POLIO VACCINES

UNDERSTANDING POLIO

February 2012 is a most remarkable and significant in the history of polio for India which celebrated a full year without a child paralyzed by indigenous wild poliovirus (WPV). The success was possible due to the (a) ability of the program to reach all children repeatedly, (b) the use of a new bivalent-oral polio vaccine (bOPV), (c) sustained political commitment and accountability, (d) societal support, and (e) the availability and mobilization of resources needed to complete the job. The country remains polio-free today.

Poliomyelitis is an acute infection by three poliovirus serotypes types 1, 2, or 3, and was the leading cause of permanent disability in children in the past. Almost all the children used to be infected by feco-orally or oro-orally, 0.5% of the infected developing disability. Most epidemic and endemic cases of poliomyelitis are caused by poliovirus type 1, followed by type 3.

DIAGNOSIS

World Health Organization (WHO) guidelines relay on acute flaccid paralysis (AFP) cases below 15 years to identify the cases of polio.

All cases of AFP are investigated and clinically examined, and stools samples are collected and subjected to virological investigations including molecular polymerase chain reaction (PCR) done to differentiate WPV, circulating vaccine-derived poliovirus (cVDPV),

NATURAL IMMUNITY

Normal children infected by polioviruses develop immunity through humoral (circulating antibody) and mucosal [secretory immunoglobulin A (IgA)] immune responses. The presence in blood of neutralizing antibody against polioviruses indicates protective immunity; detectable antibody is an excellent correlate of protection against paralytic disease.2

Mucosal immunity decreases the replication and viral shedding and acts as a potential barrier to its transmission.

VACCINES

Inactivated polio vaccine (IPV), first developed and licensed in 1955, is given by injection and is available only in trivalent form containing the three virus serotypes PV1, PV2, and PV3. OPV as a monovalent (mOPV) vaccine was initially licensed in 1961 followed by a trivalent version (tOPV) in 1963. Bivalent OPV (bOPV containing types 1 and 3 Sabin viruses) has been licensed and used in some settings since December 2009. Following the planned global switch from tOPV to bOPV in April 2016, tOPV will no longer be available and will be replaced by bOPV.

Oral polio vaccine is administered as two drops (~0.1 mL), directly into the mouth. It is highly heat-sensitive and must be kept frozen for long-term storage or, after thawing, at temperatures between +2°C and +8°C for a maximum of 6 months. Vaccine vial monitors VVM give a visual indication of whether the vaccine has been kept at the correct temperature conditions.

Intradermal Inactivated Polio Vaccine ( Government / CGHS )

Fractional doses of IPV 1/5 of a full dose reduces the cost and allows immunization of a larger number of persons with a given vaccine supply. Studies have generally demonstrated that a single fractional dose of IPV (one-fifth of the full dose) gives lower seroconversion rates than a full dose but after two doses, the rates are similar to those after two full doses.The median antibody titers induced by the two fractional doses, although high, were lower than with the two full doses. 

Schedule bOPV-bOPV, -bOPV + IPV or Birth 6–10–14 weeks

Due to shortage of IPV instead of using single dose of IPV which seroconverts lower level than two fractional doses can be used along with bOPV with a schedule birth.

bOPV-bOPV+fIPV, -bOPV, -bOPV+fIPV Birth 6–10–14 weeks

This is dose-sparing and results in better immunogenicity than a single full dose of IPV. To ensure early protection, a schedule of fractional intradermal doses administered at 6 and 14 weeks may be considered.

Concurrent IPV and OPV

The concurrent administration of tOPV and IPV has induced uniformly high antibody responses to all three poliovirus types.

National Immunization Days / Pulse Polio Days 

Objective is to reduce the widespread transmission of wild polio in the endemic countries. The NIDs are conducted twice annually for a period of 1–3 days when one dose of OPV is administered to all children <5 years of age, regardless of prior vaccination history. A second dose is repeated similarly after 4–6 weeks. Children residing in polio-endemic countries using NIDs may receive 13–14 doses of OPV by the time they reach their fifth birthday.

WHO PLAN

Immunization Systems Strengthening and OPV Withdrawal:Target is eventual withdrawal of all OPV, beginning with the withdrawal of the type 2 component of trivalent OPV (tOPV). Introducing at least one dose of affordable IPV into the routine immunization schedule globally and then replacing the trivalent OPV with bivalent OPV in all OPV-using countries—setting the stage for eventually ending bOPV use in 2019–2020.

BCG Vaccine (Bacillus Calmette Guerin)

Mycobacterium tuberculosis is the causative agent of human tuberculosis (TB). 

Tuberculosis occurs most commonly in children less than 5 years. While pulmonary TB (PTB) is the predominant form of TB in children, extrapulmonary TB is also common (around 30–40% of cases).

Children, who develop TB disease, usually do so within 1 year following infection, and childhood TB is therefore, an indicator of ongoing transmission of M. tuberculosis in the community.

Infants and young children (especially <2 years) are at risk of developing severe disseminated disease associated with a high rate of mortality. In infants, the time between infection and disease can be shorter than in older children and the presentation may be more acute, resembling severe recurrent or persistent pneumonia where in PTB is suspected, if there is no response to usual antibiotics.

Adolescents are at increased risk of TB, in whom sputum positive adult type of pulmonary disease is known. They may be the source of transmission to others.Bacillus Calmette–Guérin vaccine is one of the oldest vaccines first used in humans in 1921. BCG vaccine is derived from the bovine tuberculosis strain.6 It was the result of painstaking efforts by the French microbiologist, Albert Calmette, and the veterinary surgeon, Camille Guerin, who performed 231 repeated subcultures over 13 years. It continues to be the only effective vaccine against tuberculosis. Thetwo common strains in use are Copenhagen (Danish 1331) and Pasteur, of which the former was produced in India at the BCG Vaccine Laboratory, Guindy, Tamil Nadu till recently.

The vaccine contains 0.1–0.4 million live viable bacilli per dose. It is supplied as a lyophilized (freeze-dried) preparation in vacuum-sealed, multi-dose, amber-colored ampoules or 2 mL vials with normal saline as diluent. The vaccine is light sensitive and deteriorates on exposure to ultraviolet rays. In lyophilized form, it can be stored at 2–80°C for up to 12 months without losing its potency. Diluent should be used for reconstitution. Sterile normal saline may be used, if diluent is not available. As the vaccine contains no preservative, bacterial contamination and consequent toxic shock syndrome may occur, if kept for long after reconstitution. The reconstituted vaccine should be stored at 2–8°C, protected from light, and discarded within 4–6 hours of reconstitution. WHO recommends that all BCG vaccines used in immunization programs adhere to WHO standards. BCG is currently the only available TB vaccine. Even though BCG has demonstrated significant effectiveness, protection has not been consistent against all forms of TB and in all age groups. BCG is not effective when used as post-exposure prophylaxis.1,7 Several new TB candidate vaccines are in development, some of which are in advanced clinical trials. Some are designed to be used for booster vaccination following neonatal BCG vaccination.

Vaccine Characteristics

Bacillus Calmette–Guérin vaccine is usually administered by intradermal injection. Correct vaccine administration technique by a trained health worker is important to ensure correct dosage and optimal BCG vaccine efficacy and safety. Correct intradermal administration can be verified by a wheal of 5 mm formation. BCG vaccine should be injected in a clean, healthy area of skin. The vaccine should be given preferably in the lateral aspect of the upper arm. The injected site usually shows no visible change for several days. Subsequently, a papule develops after 2–3 weeks, which increases to a size of 4–8 mm by the end of 5–6 weeks. This papule often heals with ulceration and results in a scar after 6–12 weeks. The ulcer at vaccination site may persist for a few weeks before formation of the final scar. No treatment is required for this condition.

There are no details related to efficacy/effectiveness and safety for other anatomic sites of administration. BCG vaccination usually causes a scar at the site of injection due to local inflammatory processes. Approximately, 10% of vaccine recipients do not develop a scar and that does not mean that protection has not been achieved.

The standard dose of reconstituted vaccine is 0.05 mL for infants aged 1 year. BCG vaccine is not available in combination with other vaccines.

Duration of Protection and Revaccination

A systematic review concluded that protection after primary infant BCG vaccination could last for up to 15 years in some populations.8,9 Longer duration of protection was found in persons who had a negative TST result prior to vaccination, and in those who had received neonatal BCG vaccination.

Safety

About 95% of BCG vaccine recipients experience a reaction at the injection site characterized by a papule which may progress to become ulcerated, with healing after 2–5 months leaving a superficial scar.  This is considered normal.

Adverse events following immunization (AEFI):

They are dependent on a number of factors including the strain used in the vaccine, number of viable bacilli in the batch, and variation in injection technique. Severe AEFI include local reactions such as injection site abscess, severe ulceration or suppurative lymphadenitis usually caused by inadvertent injection of the vaccine subdermally.9 Disseminated BCG diseases that may occur between 1.56 and 4.29 cases per million doses and has a high-case fatality rate. BCG disease also varies with the strain and can have an incidence of up to 1% of infants and HIV- infected children. BCG vaccine-related complications may occur distal to the site of inoculation in the skin, intestines, bones (osteitis) or bone marrow (osteomyelitis) >12 months after vaccination. BCG immune reconstitution inflammatory syndrome (IRIS) also occurs in association with HIV infection. Other noted BCG syndromes have included uveitis and skin lesions such as lupus vulgaris.

A recent RCT in Denmark noted a regional lymphadenitis rate of 6.1 (95% CI: 3.3–10) per 1,000 vaccinated. All children, even those with suppuration, recovered without sequelae within 4–6 months with conservative treatment. However, in some circumstances aspiration or surgery may be required for treatment of such conditions.10-12

Disseminated BCG disease is seen mainly in persons with primary immunodeficiencies (and family outbreaks may occur, if this complication is not recognized before all are given BCG) or HIV infection.

It has been observed that children who were HIV-infected at birth and vaccinated with BCG at birth, and who later developed AIDS, were at increased risk of developing disseminated BCG disease.2 Although BCG is a safe vaccine in immune-competent infants, severe AEFI can occur in HIV-infected infants.

Preterm infants and low birth weight infants:

BCG vaccination at birth in healthy preterm infants born after 32–36 weeks of gestation was found to be safe and effective.

Co-administration of Vaccines

There is evidence that BCG vaccine can be safely coadministered with diphtheria-pertussis-tetanus (DTP), polio, hepatitis B, Haemophilus influenzae type b (Hib) and measles and rubella vaccines. There is no evidence to suggest reduced immunogenicity, and no safety concerns have been reported.

WHO Position

Universal Vaccination Strategy at Birth

In countries or settings with a high incidence of TB, a single dose of BCG vaccine should be given to all healthy neonates at birth, for prevention of TB and leprosy. If the BCG vaccine cannot be given at birth, it should be given at the earliest opportunity thereafter and should not be delayed, in order to protect the child before exposure to infection occurs. Coadministration of BCG with the hepatitis B birth dose is safe and strongly recommended. In order to avoid missed opportunities for neonatal vaccination, BCG multi-dose vials should be opened and used despite of any wastage of unused vaccine.

Vaccination of Older Age Groups

Bacillus Calmette–Guérin vaccination of unvaccinated, TST-negative school children may provide long-term protection (Up to 20 years or longer). BCG vaccination of older age groups is recommended for the following:

  • Unvaccinated TST- or interferon-gamma release assay (IGRA)- negative older children, adolescents, and adults from settings with high incidence of TB and/or high leprosy burden.
  • Unvaccinated TST- or IGRA-negative older children, adolescents, and adults moving from low to high TB incidence of leprosy burden settings.
  • Unvaccinated TST- or IGRA-negative persons at risk of occupational exposure in low- and high-TB incidence areas (e.g., healthcare workers, laboratory workers, medical students, prison workers, other individuals with occupational exposure).

Vaccination of Special Populations, Contraindications, and Precautions

Bacillus Calmette–Guérin vaccination is contraindicated for individuals known to be allergic to any component of the vaccine.

Pregnant and Lactating Women

As a precaution, in the absence of adequate evidence on safety, BCG vaccination is not recommended during pregnancy. BCG vaccines may be administered to lactating women.

Immunocompromised and HIV-infected Persons

Children who are HIV-infected when vaccinated with BCG at birth are at increased risk of developing disseminated BCG disease. However, if HIV-infected individuals, including children receiving antiretroviral therapy (ART), are clinically well and immunologically stable; (CD 4% > 25% for children aged 5 years) they should also be vaccinated with BCG.

Neonates born to women of unknown HIV status should be vaccinated as the benefits of BCG vaccination outweigh the risks.

Neonates of unknown-HIV status born to HIV-infected women should be vaccinated, if they have no clinical evidence suggestive of HIV infection, regardless of whether the mother is receiving ART.

Young unvaccinated children traveling to high-TB incidence countries, particularly those likely to have repeated travel during childhood, should be vaccinated.

Neonates born to mothers with pulmonary TB (PTB):

Asymptomatic neonates born to mothers with bacteriologically confirmed PTB should receive preventive treatment, if TB disease has been excluded, and should be regularly followed to verify absence of TB. If an infant remains asymptomatic and has no immunological evidence of TB at the end of preventive treatment, and is also HIV-negative, BCG vaccination should be provided using a normal infant dose.

Vaccination Schedules

Indian Government Immunisation schedule

*Give Td-2 or booster doses before 36 weeks of pregnancy. However, give these even if more than 36 weeks have passed. Give Td to a woman in labor, if she has not previously received Td.

†JE vaccine (SA 14-14-2) is given in select endemic districts, after the campaign is over in that district.

‡Rubella vaccine will be given as part of measles second dose

§The second to ninth doses of vitamin A can be administered to children 1–5 years old during biannual rounds, in collaboration with Integrated Child Development Services (ICDS). (DPT: diphtheria, pertussis, and tetanus; IPV: inactivated polio vaccine; JE: Japanese encephalitis; OPV: oral polio vaccine)

IAP Immunisation schedule

Missed your injections?Not to worry CATCH-UP IMMUNIZATION

Missed immunization does not require restarting of the entire series or addition of doses to the series for any vaccine in the recommended schedule. Two or more inactivated vaccines can be given simultaneously or at any interval between doses without affecting the immune response. An inactive vaccine can similarly be given simultaneously or at any interval with a live vaccine. However, two live (intranasal/injectable) vaccines should either be given simultaneously or at least 4 weeks apart. If a dose of DTP, IPV, Hib, pneumococcal conjugate, hepatitis A, hepatitis B, human papillomavirus (HPV), measles, mumps, rubella (MMR), or varicella vaccine is missed, subsequent immunization should be given at the next visit as if the usual interval had elapsed. For Rotavirus vaccine, the same principle can be followed, though the upper age limit of the last dose should be maintained. Minimal interval recommendation should be followed for administration of all doses.

HOW TO REPORT ADVERSE EVENTS FOLLOWING IMMUNIZATIONS (AEFI)

Most vaccinations in India are given through the government system through outreach sessions by auxiliary nurse midwives (ANMs) and sessions in health facilities. To make reporting simple and to get as many cases reported, health workers and medical personnel are asked to notify serious and severe AEFIs immediately to the nearest primary health center (PHC) medical officer (MO) or the District Immunization Officer (DIO). Private practitioners are also encouraged to notify AEFIs similarly to the DIO. The MO at the PHC then reports the case in the case reporting format (CRF) within 24 hours to the DIO who has another 24 hours to verify the case and send it to the State Immunization/EPI (Expanded Program of Immunization) Officer and the Immunization Division, Ministry of Health and Family Welfare (MOHFW) simultaneously. The CRF gives only the most basic details of the affected person, vaccines and session details, and status of the patient (brief clinical summary) at the time of filling the format.

What is Adverse Event Following Immunisation ( AEFI )

Vaccines are among the safest medicines to use and these are considered very effective tools for preventing infectious diseases. Like any other drug, no vaccine is 100% effective or 100% safe 100% of time. As with other drugs, adverse events can occur with vaccines too. In addition to the vaccines themselves, the process of administration of vaccines is a potential source of an adverse event following immunization.

An adverse event following immunization (AEFI) surveillance system is usually a passive system to enable spontaneous reporting of all adverse events. It is a part of the National Regulatory Authority (NRA) for vaccines. The primary purpose of spontaneous AEFI report- ing is to monitor the known adverse events associated with vaccine use, and to identify the new adverse events, i.e. safety signals after a product is marketed. India is a major vaccine producing and exporting nation supplying 70% of UN vaccine requirements. A functional NRA is a prerequisite for supplying vaccines to UN agencies. The Operational Guidelines for Surveillance and Response to AEFI (2015) provides guidance for the AEFI surveillance system in India.

An AEFI is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine, i.e. might have not been caused by vaccine ingredients or the process of vaccination or immunization but have a temporal relationship with administration of vaccine (Table 1). It can be any unfavorable or unintended sign, abnormal laboratory finding, symptom, or disease. Sometimes, mass use of vaccines can cause anxiety in the community and even such responses can be considered as AEFI.

CAUSE-SPECIFIC TYPES OF AEFI:

Vaccine product-related reaction: An AEFI that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product (or ingredients), e.g. extensive limb swelling following DTP vaccination. In this scenario, the vaccine might have been used correctly without compromising with manufacturing process, transport, or storage. Thus, absolutely correct use of the vaccine may also cause this type of AEFI. In most cases, such events are usually not serious in nature.

Vaccine quality defect-related reaction: An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccine product including its administration device as provided by the manufacturer, e.g. failure by the manufacturer to completely inactivate a lot of IPV leads to cases of paralytic polio. 

Immunization error-related reaction: An AEFI that is caused by inappropriate vaccine handling, prescribing, or administration and thus by its nature is preventable, e.g. transmission of infection by contaminated multidose vial.

Immunization anxiety-related reaction: An AEFI arising from anxiety about the immunization, e.g. vasovagal syncope in an adolescent following vaccination. The anxiety may spread to the community too, at times.

Coincidental event: An AEFI that is caused by something other than the vaccine product, immunization error, or immunization anxiety, e.g. fever after vaccination (temporal association) and malarial parasite isolated from blood (Table 1).

TYPES OF ADVERSE EVENTS FOLLOWING IMMUNIZATIONS BASED ON SEVERITY

Serious AEFI: An AEFI is considered serious if it (1) results in death, hospitalization, or persistent or significant disability/incapacity, (2) occurs in clusters, (3) causes parental/community concern, or (4) results in congenital anomaly/birth defect.

Severe AEFI: Severe AEFIs are minor AEFIs with increased intensity/severity, e.g. high grade fever following pentavalent vaccination or post-DPT swelling extending beyond the nearest joint. The patient may not be hospitalized and will not have sequelae.

Minor AEFI: Minor AEFIs can be local reactions (pain, swelling, and redness) or systemic reactions (fever > 38°C, irritability,malaise, etc.), which can be managed with antipyretics and anti- inflammatory and resolves within 2–3 days.

RECORD KEEPING at Vaccine Panda

We always maintain the records of  the type of vaccine, brand name, and date of administration of the vaccine in the patient’s file/ immunization record (digitally). In addition, recording of the batch number of the vaccine is also done. Record keeping is very important as guidelines issued for reporting of AEFI are also applicable to all private practitioners.

‘Medical Emergency Equipments’ Vaccine Panda Medical Team always Carries for patient safety:

The list of bare minimum equipment and drugs needed to take care of any immediate adverse events following immunization, particularly any hypersensitivity reaction to the vaccine

Our medical team explains in detail the characteristics and anticipated side effects of the vaccine in reasonable detail to the caregivers prior to immunization. We take an implied verbal consent. The patient is observed for any allergic effects for 15 minutes after vaccination and all resuscitative equipment are  kept standby for possible anaphylaxis. Our medical team has been counseled about possible side effects, their management, and danger signs. They have been extensively trained to handle such emergencies. 

CONTRAINDICATIONS AND PRECAUTIONS to vaccines

It Increases the chance of a serious adverse reaction. It is a condition in the recipient of the vaccine, not with the vaccine per se. If the vaccine were given in the presence of that condition, the resulting adverse reaction could seriously harm the recipient.

For instance, administering influenza vaccine to a person with a true anaphylactic allergy to egg could cause serious illness or death in the recipient. In general, vaccines should not be administered when a contraindication condition is present.

The most common animal protein allergen is egg protein found in vaccines prepared using embryonated chicken eggs (e.g. yellow fever and influenza vaccines). Ordinarily, a person who can eat eggs or egg products can receive vaccines that contain egg; persons with histories of anaphylactic or anaphylactic-like allergy to eggs or egg proteins should not. Asking persons whether they can eat eggs without adverse effects is a reasonable way to screen for those who might be at risk from receiving yellow fever and influenza vaccines.

True contraindications are very few. Only three permanent contraindications are:

  1. Severe allergic reaction to a vaccine component or following a
    prior dose of a vaccine
  2. Encephalopathy occurring within 7 days of pertussis vaccination
  3. Severe combined immunodeficiency (SCID) as a contraindication
    to rotavirus vaccine (Flowchart 1).

A precaution might increase the chance or severity of a serious adverse reaction, or that might compromise the ability of the vaccine to produce immunity (such as administering measles vaccine to a person with passive immunity to measles from a blood transfusion). Injury could result, but the chance of this happening is less. In general, vaccines are deferred when a precaution condition is present (Flowchart 2).