Bcg: A Range Of Global Policies
While most experts agree that BCG is efficacious against severe forms of childhoodTB, its efficacy against TB in adults is highly variable . As a result of the uncertainefficacy of the BCG vaccine, countries have developed very different BCG vaccinationpolicies. Some countries, such as the United Kingdom, have or have had universal BCGvaccination programs, while others eitheronly recommended BCG for high-risk groups or did not advocate BCG countrywide. TheCanadian situation was further complicated by differing policies across provinces,where some provinces underwent mass vaccination programs and others did not. Inaddition, BCG vaccination policies have varied by the number of doses used, the ageat which vaccination was given, and the methods used to deliver the vaccine . Vaccination practices also havechanged within and across countries over the years, reflecting changes in evidence,health policy, public perception, increasing or decreasing TB incidence, and HIVincidence. As a result of these changes to the BCG policies in various countries, itis necessary to not only know the current BCG vaccination policies but also pastpolicies and applicable changes when dealing with adults who received BCGvaccination in childhood.
Home page of the BCG World Atlas and example of BCG policies andpractices in Japan.
When You Have It
You usually have BCG into the bladder once a week for 6 weeks. This is called the induction course.
You may then have BCG into the bladder every few weeks or months for the next 1 to 3 years. This will depend on your risk of developing invasive bladder cancer. This is called maintenance BCG therapy.
You usually have treatment at the cancer day clinic.
Who Needs The Vaccination
Most Australian children do not require BCG vaccination as the rates of TB in Australia are very low.
In Queensland, BCG vaccination is recommended for the following groups:
- Aboriginal and Torres Strait Islander newborn babies
- Children aged less than 5 years who will live in Aboriginal or Torres Strait Islander communities for a period of 3 months or more.
- Children aged less than 5 years who will be travelling to TB high risk countries for a period of 3 months or more. If the intended length of stay is less than 3 months but the risk of exposure to TB may be high, the need for BCG vaccination should be discussed with a TB doctor.
BCG can also help prevent leprosy . BCG vaccination is recommended for newborn babies of parents with leprosy or with a family history of leprosy. Leprosy is very rare in Australia.
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Who Should Not Have The Bcg Vaccination
The BCG vaccine is not recommended for:
- people who have already had a BCG vaccination
- people with a past history of TB
- people with a positive tuberculin skin test
- people who have had a previous severe allergic reaction to any of the substances used in the vaccine
- children under 2 years of age who might have TB because someone they live with has it
- people who have a septic skin condition at the site where the injection would be given
- infants born to a mother who has medicines that suppress the immune system during pregnancy
- babies who have or might have severe combined immunodeficiency
- people with a weakened immune system, either as a result of a health condition such as HIV, treatments such as chemotherapy, or medicines that suppress the immune system, such as steroid tablets
- people who have cancer of the white blood cells, bone marrow or lymph nodes, such as leukaemia or lymphoma
- people who are seriously unwell
- pregnant women
BCG vaccination is not usually offered to people over the age of 16 because there is limited evidence of how well the vaccine works in adults.
Page last reviewed: 26 April 2019 Next review due: 26 April 2022
Who’s Eligible For The Vaccine
The BCG vaccine’s offered to those babies who are more likely than the general population to come into contact with someone with TB. This is because they either:
- lived in an area with high rates of TB
- their parents or grandparents came from a country with high rates of TB – including countries in South-East Asia, sub-Saharan Africa and some countries in Eastern Europe
An up-to-date list of countries with high rates of TB is available on the GOV.UK website.
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What Happens During Treatment
A urinary catheter is inserted through your urethra and into your bladder. Then the BCG solution is injected into the catheter. The catheter is clamped off so the solution stays in your bladder. Some doctors may remove the catheter at this time.
You have to hold the medicine in your bladder. Youll be instructed to lie on your back and to roll from side to side to make sure the solution reaches your entire bladder.
After about two hours, the catheter is unclamped so the fluid can be drained. If the catheter was already removed, youll be asked to empty your bladder at this time.
Tb Exposed Tuberculin Skin Test
BCG vaccination is recommended for infants and children with negative tuberculin skin tests who are at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary tuberculosis and who cannot be removed from the source of exposure and cannot be placed on long-term primary preventive therapy, or continuously exposed to persons with infectious pulmonary tuberculosis who have bacilli resistant to isoniazid and rifampin, and the child cannot be separated from the presence of the infectious patient.
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Side Effects Of The Bcg Vaccine
Like all vaccines, the BCG vaccine can cause side effects, but they’re uncommon and generally mild.
Some common side effects may include:
- soreness or discharge from where the injection was given
- a high temperature
- swollen glands under the armpit in the arm where the injection was given
More serious complications, such as abscesses, bone inflammation and widespread TB are rare.
Most children develop a sore at the injection site. Once healed, the sore may leave a small scar. This is normal and nothing to worry about.
Serious side effects from the BCG vaccine, such as a severe allergic reaction , are very rare.
The Yellow Card Scheme allows you to report suspected side effects from a vaccine. It’s run by the medicines safety watchdog, the Medicines and Healthcare products Regulatory Agency .
Schedule : Controlled Drug
Schedule 8 drugs and poisons, otherwise known as Controlled Drugs, are substances and preparations for therapeutic use which have high potential for and . The possession of these medications without authority is an offence.
Like schedule 4 substances, the price of many Schedule substances are subsidized through the , some of which may require an authority. In addition, in some states, all drugs on schedule 8 require a doctor to have an S8 permit before prescribing treatment. For example, in the prescribing of Schedule 8 CNS stimulant medication requires authorisation from the NSW Ministry of Health and is generally restricted to specialists, such as paediatricians and psychiatrists. A GP cannot initiate the treatment, although they can prescribe in very limited circumstances, e.g. co-prescribing on behalf of the specialist and in rural areas, if the patient has been diagnosed with , a GP may apply for the authority to prescribe. Patients who may require Schedule 8 CNS stimulant medication should be referred to a specialist for assessment.
Examples:
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Dose Route Of Administration And Schedule
Dose
- Infants : 0.05 mL
- Children and adults: 0.1 mL
Route of administration
Reconstituted BCG vaccine should be administered by intradermal injection into the most superficial layers of the skin, in accordance with the instructions in the manufacturer’s product leaflet. The area over the deltoid muscle is the preferred administration site. Refer to Vaccine Administration Practices in Part 1 for additional information.
Do NOT administer the product by the intravenous, intramuscular or subcutaneous routes. Intramuscular or subcutaneous administration may result in an abscess at the injection site.
Schedule
One dose of BCG vaccine should be administered.
Bcg Protects The Elderly From Infections
According to the researchers, patients over 65 years of age who were admitted to hospital were randomised to receive BCG or placebo vaccination at their discharge. All participants were followed for a year to see if BCG could protect them against a broad range of infections. The team revealed that the ACTIVATE study had already started before the corona pandemic. A total of 198 elderly people were given either a placebo or a BCG vaccine upon discharge from the hospital. During the research, there was a noticeable difference: in the placebo group, 42.3 per cent of the elderly developed an infection, while this was the case in only 25 per cent of the BCG group.
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Who Should Be Immunised
- Aboriginal and Torres Strait Islander children < 5 years of age living in communities in Queensland
- Children < 5 years travelling to endemic countries
When travelling to endemic countries BCG should be administered at least 4-6 weeks prior to departure, to ensure vaccine effectiveness prior to exposure.
Why Is This Medicine Prescribed
BCG vaccine provides immunity or protection against tuberculosis . The vaccine may be given to persons at high risk of developing TB. It is also used to treat bladder tumors or bladder cancer.
This medication is sometimes prescribed for other uses ask your doctor or pharmacist for more information.
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Your Child Has A Higher Risk Of Catching Tb And Is Eligible For Free Bcg Vaccine If He Or She:
- will be living in a house or family/whnau with a person with either current TB or a past history of TB
- has one or both parents or household members or carers who have lived for a period of six months or longer in a country with high rates of TB
- will be living for three months or longer in a country with high rates of TB and will be likely to be exposed to those with TB.
Your midwife or doctor will advise if your child is at higher risk of catching TB. As a general indication, the following areas have high rates of TB:
- most of Africa
- Russia and the former Soviet states
- the Indian subcontinent
- China, including Hong Kong Taiwan
- South East Asia
- some Pacific nations .
Drug Cost Containment Strategies In The Us
In the United States there are many resources available to patients to lower the costs of medication. These include copayments, coinsurance, and deductibles. The is another example.
Generic drug programs lower the amount of money patients have to pay when picking up their prescription at the pharmacy. As their name implies, they only cover generic drugs.
Co-pay assistance programs are programs that help patients lower the costs of specialty medications i.e., medications that are on restricted formularies, have limited distribution, and/or have no generic version available. These medications can include drugs for HIV, hepatitis C, and multiple sclerosis. Patient Assistance Program Center has a list of foundations that provide co-pay assistance programs. It is important to note that co-pay assistance programs are for under-insured patients. Patients without insurance are not eligible for this resource however, they may be eligible for patient assistance programs.
Patient assistance programs are funded by the manufacturer of the medication. Patients can often apply to these programs through the manufacturer’s website. This type of assistance program is one of the few options available to uninsured patients.
The out-of-pocket cost for patients enrolled in co-pay assistance or patient assistance programs is $0. It is a major resource to help lower costs of medications however, many providers and patients are not aware of these resources.
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Bcg Vaccine And Diabetes
On June 25, 2021, researchers from Massachusetts General Hospital located in Boston, MA, presented positive updates on their trials of the bacillus Calmette-Guérin vaccine to safely and significantly lower blood sugars. Key findings include a new understanding of how the response to BCG vaccination differs depending on a patient’s age of onset and additional support for the role of BCG vaccination to alter glucose transport and change Tregs. Currently, 143 type 1 diabetics have received at least two doses of BCG, including 25 patients enrolled in a recently launched trial of adults who had pediatric onset. Pending US FDA approval, MGH aims to launch a multi-center pediatric trial later in 2021.
On February 27, 2020, the Journal of Internal Medicine published a study that concluded ‘New findings of immune and metabolic defects in type 1 diabetes that can be corrected with repeat BCG vaccination suggest that this therapeutic strategy may be applicable in other diseases with inadequate aerobic glycolysis, including Parkinson’s disease, dementia, depression and other disorders affecting the nervous system.’
Adults Aged 16 To 35 Who Should Have The Bcg Vaccine
BCG vaccination is recommended for people aged 16 to 35 who are at occupational risk of TB exposure, including:
- healthcare workers or laboratory workers who have either direct contact with patients with TB or with potentially infectious clinical samples and materials
- veterinary staff and other animal workers, such as abattoir workers, who handle animals or animal materials that could be infected with TB
The BCG vaccine is also sometimes offered to:
- prison staff who work directly with prisoners
- staff of hostels for homeless people
- staff who work in facilities for refugees and asylum seekers
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What Research Is Being Done
A number of research teams are taking a closer look at whether receiving a dose of the BCG vaccine may prevent or help people fight off a COVID-19 infection and reduce the number of COVID-19-related deaths.
A study looking at the global linkage between the BCG and COVID-19 found that there was a significant inverse correlation between the BCG index or how well the BCG vaccine was deployed in a country and deaths from COVID-19. The researchers only looked at mortality because while there are many conflicting counts of cases and deaths for many countries, the death count is more likely to be accurate. They found that every 10% increase in the BCG index was associated with a 10.4% reduction in COVID-19 mortality. They saw high mortality rates in France and the UK than Germany or Scandinavia and suggest that where the BCG vaccination was given to older children , it may have missed a critical window early in life where BCG vaccination could have resulted in lifelong enhanced immunity.
A team of Nigerian researchers undertook a similar multi-country level comparison of BCG vaccination policy and COVID-19 cases and deaths. They found a striking link between countries that had very high mortality and no BCG vaccination policy most notably, Italy and the USA.
Researchers in Australia have also launched a very similar trial and are hoping to study more than 10,000 healthcare workers, tracking their progress with email surveys and text messages.
Individual Requests For Bcg Vaccination
If you want BCG vaccination for yourself or your child, you’ll be assessed to see if you’re at high risk of catching TB.
If you’re not at risk, you will not be eligible for BCG vaccination.
If you’re at risk, you’ll have a tuberculin skin test. If this is negative, you’ll be offered BCG vaccination according to local arrangements.
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Older Children And Adults
Depending on the risk of acquiring TB, there may be benefits to vaccinating older children. A doctor experienced in the use of BCG can help decide if the vaccination will be useful.
In general, BCG is NOT given to adults but can be considered for healthcare workers who are likely to deal with large numbers of multi-drug resistant TB cases.
More information about BCG vaccine can be found in the patient fact sheet.
How Do We Know The Vaccine’s Safe
All medicines are tested for safety and effectiveness by the Medicines and Healthcare Products Regulatory Agency . The vaccine meets the high safety standards required for it to be used in the UK and other European countries. The vaccine has been given to millions of people worldwide.
Once they’re in use, the safety of vaccines continues to be monitored by the MHRA.
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Schedule : Pharmacy Medicine
Schedule 2 drugs and poisons, otherwise known as Pharmacy Medicines, are substances and preparations for therapeutic use that
- are substantially safe in use but where advice or counselling is available if necessary
- are for minor ailments or symptoms that
- can be easily recognised by the consumer and
- don’t require medical diagnosis or management.
Examples:
- , a cough suppressant
- Simple analgesics such as , and in packs containing more than 24 tablets
- , used to treat motion sickness, postoperative nausea and vomiting.
- containing or
The SUSMP March 2018 defines a Schedule 2 substance as “Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.”
The location of these medications in the pharmacy varies from state to state.
Bcg Vaccine A Resource Guide
Last updated on By Lab Testing Guru
If you are from a different country and have a scar on your upper arm, it is likely that you are one of millions of people who have received the BCG vaccine. Despite its widespread use, many people feel confused about what the BCG vaccine is and why it is done. Read on to learn more about this important tuberculosis vaccine.
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