Australian Therapeutic Goods Administration Vaccines overview, What is a vaccine?

Getting your bub vaccinated is free and helps keep everyone safe from diseases.

My name is Belinda, I have four children.

No I was never late with my vaccinations, because I always check the health book you were given and at the back you know it tells you when you’re due for your vaccinations.

If there are children in your community that are not up to date, let their parents know to bring them to the clinic as soon as possible.

On each vaccination, you know the childhood nurse she explained to me what each injection was for and how often they were to have it.

I would say to other parents that it’s important to have your children immunised. Nothing scary about it.

Vaccinating on time makes sure your bub gets the best protection against serious diseases.

Get the facts at immunisationfacts.gov.au

Australian Therapeutic Goods Administration Vaccines overview

14 May 2019

The Therapeutic Goods Administration (TGA) is responsible for assessing vaccines and other medicines before they can be used in Australia. We only register a vaccine for use in Australia if its benefits are much greater than its risks.

What is a vaccine?

Vaccines are medicines that protect you against specific diseases, such as measles, influenza (flu) or whooping cough. Vaccination is the act of receiving a vaccine, which in most cases involves having the vaccine injected with a needle.

Vaccines can contain:

• dead viruses or bacteria
• severely weakened forms of viruses or bacteria
• small, purified components of viruses or bacteria.

After receiving a vaccine, your body's immune system can remember the virus or bacterium and fight off an infection much more effectively than if it was encountering the virus or bacterium for the first time.

Vaccines protect you and the people around you from serious and life-threatening diseases. There are some people in the community who cannot be vaccinated because they are too young or too sick. Widespread vaccination helps protect these people by making it more difficult for a disease to spread.

Some people experience minor side effects following vaccination, such as mild fever or pain, redness, or swelling at the injection site. Serious side effects, like allergic reactions, are very rare.

The TGA assesses vaccines before they can be used in Australia

The TGA rigorously assesses vaccines for safety, quality and efficacy before they can be used in Australia. Vaccines receive the same high level of scrutiny as other prescription medicines and related therapeutic goods.

We use the best available scientific evidence to assess the risks and benefits of each vaccine. Our evidence requirements are based on international guidelines developed by the European Medicines Agency.

Clinical trials are a key part of the scientific evidence that we review during the assessment of a new vaccine. A clinical trial is a scientific study where a promising new medicine is given to a group of people to assess its risks and benefits.

We carefully assess the results of clinical trials and the way in which the trials were conducted. We require well-designed trials of a sufficient length with a sufficient number of people who represent the people for whom the vaccine is intended. The results must demonstrate that the benefits of the vaccine greatly outweigh the risks.

We also require vaccine manufacturers to meet manufacturing quality standards. As a further check, our laboratories assess the quality of every batch of a vaccine before it can be supplied in Australia.

TGA decisions are informed by independent advice

The TGA's decision of whether to register a vaccine for use in Australia is informed by the advice of the Advisory Committee on Vaccines (ACV).

The ACV is an independent committee appointed by the Australian Government Minister for Health. It is composed of members with expertise in science, medicine and public health.

The ACV complements our expertise in the TGA, ensuring that our assessments of vaccines are as robust as possible.

The TGA monitors vaccines after they are supplied in Australia

The TGA monitors vaccines for safety after they are supplied in Australia. If you experience an adverse event (side effect) from a vaccine, you should seek assistance from a health professional and report the adverse event to the TGA.

We receive adverse event reports from consumers, health professionals, the companies who supply vaccines, and state and territory health departments. We publish these reports in the publically available Database of Adverse Event Notifications (DAEN).

Reporting serious adverse events is mandatory for the companies who supply vaccines in Australia. These companies must also develop and implement risk management plans for their vaccines.

Our laboratories also help monitor vaccine safety. Alongside assessing the quality of all vaccine batches before they are supplied in Australia, our laboratories may also test the quality of selected vaccine batches after they are supplied in Australia. Laboratory testing results are published on our website.

If we suspect there is a problem with a vaccine, we will launch an investigation. In some cases, this could mean suspending the use of a vaccine during the investigation. We notify the community of safety concerns through the publication of alerts on our website.

Where can I find more information?

• The Australian Government Department of Health immunisation page includes information on getting vaccinated, vaccine safety, the National Immunisation Schedule and other topics. You can also call the National Immunisation Hotline on 1800 671 811.
• The Australian Government Department of Health 'Get the facts' website includes additional information about vaccinating your children.
• The NPS Medicinewise website includes information about vaccines and other medicines in the consumer information section. You can also call their Medicines Line on 1300 MEDICINE (1300 633 424).
• The National Centre for Immunisation Research and Surveillance (NCIRS) website includes a range of vaccine information, including factsheets on vaccine preventable diseases and vaccine safety.
• The Australian Academy of Science website includes information on the science of immunisation.

Homeopathic and Naturopathic Based Nosodes Are No Substitutes For Vaccines.

It has come to view that some homeopathic and naturopathic practitioners are promoting nosodes for “homeoprophylaxis,” suggesting they can protect children from illness. Health Canada has not approved any of these remedies as vaccine replacements or alternatives. In addition there is no evidence that these remedies work in preventing childhood deceases, such as measles, mumps, rubella, polio and whooping cough. What we have proof is that vaccine's do work preventing these deadly deceases. Please vaccinate your children.

OTTAWA – Health Canada is concerned about false claims being made in some marketing of homeopathic remedies, known as nosodes, stating that the product can prevent infectious diseases. Nosodes are not, and never have been, approved by Health Canada to be vaccine alternatives. There is no evidence supporting their effectiveness in preventing or treating infectious diseases. No homeopathic products should be promoted as an alternative to vaccines because there are no substitutes for vaccines.

Health Canada is aware of reports that some homeopathic and naturopathic practitioners are promoting nosodes for “homeoprophylaxis,” suggesting they can protect children from illness. The Department has not approved any nosodes with homeoprophylaxis claims. We are following up on these reports, and if we identify any non-compliance with the Food and Drugs Act or its regulations, we will take action.

Health Canada requires that the labels on all homeopathic nosode products include the following statements to make it clear that they are neither vaccines nor vaccine alternatives:

• “This product is neither a vaccine nor an alternative to vaccination.”
• “This product has not been proven to prevent infection.”
• “Health Canada does not recommend its use in children and advises that your child receive all routine vaccinations.”

Canadians with information about the sale or advertising of any health products that may not comply with the Food and Drugs Act or its regulations are encouraged to report it to Health Canada using this online complaint form.

Children given nosodes instead of vaccinations are at risk of developing serious and potentially fatal childhood illnesses such as measles, mumps, rubella, polio and whooping cough. Vaccination continues to be the very best way to prevent serious infectious diseases and to protect yourself, your family and your community.

We realize that Canadian parents care deeply about the health of their children. If you are the parent or guardian of a child who is not vaccinated, act now and speak with your healthcare provider about any concerns you may have. We also encourage you to seek out credible sources of information when deciding whether to vaccinate your children. Some credible sources include: 

• The Government of Canada 
• Immunize Canada
• Caring for Kids, a website developed by the Canadian Paediatric Society

Speaking to vaccine-hesitant parents is an important responsibility for healthcare providers. If you are a healthcare provider, we encourage you to answer parents’ questions about vaccination using evidence and an open manner.

Does Vaccines Cause Autism?

Yes and no. I am not convinced of either but if I had a child, I think I will let him or her take the risk and give the vaccines. My parents gave me all the vaccines and I am functional, at least I hope.
But I enjoyed reading an article on Harvard Health by Ann MacDonald, Editor, Harvard Mental Health Letter. You can read it too and form your own opinion. The article focuses on what British journalist Brian Deer uncovered. The arguments continue on the subject.
Harvard Health

Rotarix, A New Vaccine to Prevent Gastroenteritis Caused by Rotavirus Approved By FDA.

FOR IMMEDIATE RELEASE April 3, 2008

Media Inquiries: Siobhan DeLancey, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus

The U.S. Food and Drug Administration today announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.

Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each year—about 55,000 to 70,000 of those require hospitalization; and between 20 and 60 deaths are attributed to it. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5.

There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains.

"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.

In 1999, a different rotavirus vaccine from another manufacturer was voluntarily withdrawn from the U.S. market because of an association with an increased risk of intussusception, or intestinal folding, which can lead to potentially life-threatening intestinal blockage. Intussusception can occur in children spontaneously in the absence of vaccination, but to help ensure that Rotarix does not increase the risk of intussusception, its manufacturer conducted a study of more than 63,000 infants.

In that study, there was no increase in the risk of intussusception in those who received Rotarix (31,673 infants) compared to those who received placebo (31,552 infants). Increased rates of convulsion and pneumonia-related deaths were observed in the Rotarix recipients in the intussusception study, however these events were not observed in other studies conducted by the manufacturer. Although the FDA has concluded that the available data do not establish that these events are related to the vaccine, the agency has requested the manufacturer to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.

Rotarix is manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium.

tag: FDA Approval, Vaccines, Rotavirus, Gastroenteritis, Rotarix, intussusception, intestinal folding, GlaxoSmithKline Biologicals,

Vaccinate Your Children or Go To Jail

Hundreds of grumbling parents facing a threat of jail lined up at a courthouse Saturday to either prove that their school-age kids already had their required vaccinations or see that the youngsters submitted to the needle.

The get-tough policy in the Washington suburbs of Prince George's County was one of the strongest efforts made by any U.S. school system to ensure its youngsters receive their required immunizations.

Two months into the school year, school officials realized that more than 2,000 students in the county still didn't have the vaccinations they were supposed to have before attending class.

So Circuit Court Judge C. Philip Nichols ordered parents in a letter to appear at the courthouse Saturday and either get their children vaccinated on the spot or risk up to 10 days in jail. They could also provide proof of vaccination or an explanation why their kids didn't have them.

By about 8:30 a.m., the line of parents stretched outside the courthouse in the county on the east side of Washington.

Read more at AP at Google.

Tags: Vaccines, Prince George's County

A Parent's Guide to Kids' Vaccines (FDA)

Vaccines have contributed to a significant reduction in many childhood diseases, such as diphtheria, polio, measles, and whooping cough. It is now rare for American children to experience the devastating effects of these illnesses. Infant deaths due to childhood diseases have nearly disappeared in the United States and other countries with high vaccination coverage. But the germs that cause vaccine-preventable diseases and death still exist, and can be passed on to people who are not protected by vaccines.

Ensuring the safety and effectiveness of vaccines is one of the Food and Drug Administration's top priorities. Vaccines are developed in accordance with the highest safety standards; they must be safe to give to as many people as possible.

Like any medicine, vaccination has benefits and risks, and no vaccine is 100% effective in preventing disease. Most side effects of vaccines are usually minor and short-lived. A child may feel soreness at the injection site or experience a low-grade fever. Serious vaccine reactions are extremely rare, but they can happen. For example, signs of severe allergic reaction can include swelling, itching, weakness, dizziness, and difficulty breathing.

"But parents should also know that the risk of being harmed by a vaccine is much smaller than the risk of serious illness that comes with infectious diseases," says Norman Baylor, Ph.D., Director of the Office of Vaccine Research and Review in FDA's Center for Biologics Evaluation and Research (CBER). "Vaccination is an important step to get children off to a healthy start."

Vaccines may contain live, attenuated (but weakened) or killed (inactivated) forms of disease-causing bacteria or viruses, or components of these microorganisms. They trigger a response by the body's immune system when injected or given by mouth. Vaccines stimulate the body to make antibodies—proteins that specifically recognize and target the disease-causing bacteria and viruses, and help eliminate them from the body.

CBER is the part of FDA that regulates vaccines in the United States. CBER works with other agencies to study and monitor vaccine safety and effectiveness.

Steps to Take When You Vaccinate

Review the vaccine information sheets. These sheets explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Health practitioners are required by law to provide them.

Talk to your doctor about the benefits and risks of vaccines. Learn the facts about the benefits and risks, along with the potential consequences of not vaccinating against certain diseases. Some parents are surprised to learn that children can die of measles, chicken pox, and other vaccine-preventable diseases.

Tell your doctor about bad reactions. Before your child receives a vaccine, tell your doctor if you, your child, or a sibling has ever had a bad reaction to a vaccine. If your child or a sibling has had an allergic reaction or other severe reaction to a dose of vaccine, talk with your health care provider about whether that vaccine should be taken again.

Ask about conditions under which your child should not be vaccinated. This might include being sick or having a history of certain allergic or other adverse reactions to previous vaccinations or their components. For example, eggs are used to grow influenza (flu) vaccines, so a child who is allergic to eggs should not get a flu vaccine.

Report adverse reactions. Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the Centers for Disease Control and Prevention. For a copy of the vaccine reporting form, call 1-800-822-7967, or report online to www.vaers.hhs.gov

Commonly Used Vaccines

Diphtheria, Tetanus, Pertussis (DTaP)

• What it's for: Protects against the bacterial infections diphtheria, tetanus (Lockjaw), and pertussis (whooping cough). Tripedia, Infanrix and DAPTACEL are licensed for children 6 weeks to 7 years old. Diphtheria can infect the throat, causing a thick covering that can lead to problems with breathing, paralysis, or heart failure. Tetanus can cause painful tightening of the muscles, seizures, and paralysis. Whooping cough causes severe coughing spells and can lead to pneumonia, seizures, brain damage, and death.
• Common side effects: Mild fever, redness, soreness or swelling at the injection site, fussiness or crying more than usual.
  
• Tell your health care provider beforehand if: Your child is moderately or severely ill, or has had a severe reaction to a previous shot or has a known sensitivity to ingredients of the vaccine, including latex, which is used for the stopper vial.

Tetanus, Diphtheria, Pertussis (Tdap) Vaccine

• What it's for: Boostrix is licensed for use for people ages 10 to 18 years. Adacel is licensed for people ages 11 years and older, up to age 64. Protects against the bacterial infections diphtheria, tetanus (Lockjaw), and pertussis (whooping cough).
• Common side effects: Mild fever, pain and redness at injection site, headache, tiredness.
• Tell your health care provider beforehand if: Your child has had any allergic reaction to any vaccine that protects against diphtheria, tetanus, or pertussis diseases, any ingredient contained in the vaccine, or to latex.

Haemophilus influenzae type b (Hib) vaccine

• What it's for: Protects against Hib disease, which can cause meningitis (an infection of the covering of the brain and spinal cord), pneumonia (lung infection), severe swelling of the throat, and infections of the blood, joints, bones, and covering of the heart. Approved for children who are at least 2 months old.
• Common side effects: Redness, warmth or swelling at site of injection, fever.
• Tell your health care provider beforehand if: Your child is moderately or severely ill, or has ever had a life-threatening allergic reaction to a previous dose of Hib vaccine.

Hepatitis A Vaccine

• What it's for: Protects against liver disease caused by the hepatitis A virus. Hepatitis A can cause mild "flu-like" illness, jaundice (yellow skin or eyes), severe stomach pains, and diarrhea. A person who has hepatitis A can easily pass the disease to others within the same household. Havrix and VAQTA are licensed for use in children ages 12 months and up.
• Common side effects: Soreness at the injection site, headache, loss of appetite, tiredness.
• Tell your health care provider beforehand if: Your child has ever had a severe allergic reaction to a previous dose of the vaccine.

Hepatitis B Vaccine

• What it's for: Protects against liver disease caused by the Hepatitis B virus. Hepatitis B can lead to liver damage, liver cancer and death. Recombivax HB and Engerix-B are licensed for use in babies at birth.
• Common side effects: Soreness at injection site and fever.
• Tell your health care provider beforehand if: Your child is moderately or severely ill or has ever had a life-threatening allergic reaction to baker's yeast used for making bread, or to a previous dose of the vaccine.

Human Papillomavirus (HPV) Vaccine

• What it's for: Gardasil is licensed for the prevention of cervical cancer, abnormal and precancerous cervical lesions, abnormal and precancerous vaginal and vulvar lesions, and genital warts in females ages 9 to 26.
• Common side effects: Pain, redness or swelling, itching at the site of injection, dizziness, fainting.
• Tell your health care provider beforehand if: Your child has had an allergic reaction to yeast or another component of HPV vaccine, or to a previous dose of the vaccine.

Influenza (Flu) Vaccine—Inactivated Shot

• What it's for: Protects children six months and older against the influenza virus strains contained in the vaccine. Influenza is a contagious respiratory illness caused by the influenza virus. It can cause mild to severe illness, and at times can lead to death. The influenza viruses that cause disease in people may change every year, so yearly vaccination is needed to reduce the chances of getting sick.
• Common side effects: Soreness at the injection site, low-grade fever, and aches. The influenza vaccine is made from killed or inactivated influenza viruses, so your child can't get the flu from the flu shot.
• Tell your health care provider beforehand if: Your child is moderately or severely ill, has ever had an allergic reaction to eggs or to a previous dose of the flu vaccine, or has ever had Gullian-Barre Syndrome (GBS), a serious neurological disorder that can occur either spontaneously or after certain infections. The disorder typically involves weakness in the legs and arms that can be severe.

Influenza (Flu) Vaccine—Live Intranasal

• What it's for: FluMist is sprayed into both nostrils and protects against flu in healthy children and adolescents ages 5 to 17.
• Common side effects: Runny nose, headache, vomiting, muscle aches, low-grade fever. This vaccine, which contains weakened viruses, usually doesn't cause illness, because the viruses have lost their disease-causing properties.
• Tell your health care provider beforehand if: Your child is pregnant, moderately or severely ill, has a weakened immune system, has ever had an allergic reaction to eggs or to a previous dose of the flu vaccine, has a history of asthma or any other history of coughing, wheezing, or shortness of breath, or has a history of Gullian-Barre Syndrome (GBS).

Measles, Mumps, Rubella (MMR) Vaccine

• What it's for: Protects against measles, mumps, and rubella in children ages 12 months and up. Measles is a respiratory infection that causes skin rash and flu-like symptoms. It can cause severe disease leading to ear infection, pneumonia, seizures, and brain damage. Mumps causes fever, headache and swollen glands, especially salivary glands. It can also lead to deafness, meningitis (infection of the brain and spinal cord covering), painful swelling of the testicles or ovaries. Rubella, also called German Measles, is an infection of the skin and lymph nodes and can cause arthritis. Rubella infection during pregnancy can lead to birth defects.
• Common side effects: Fever and mild rash. In rare cases, swelling of the glands in the cheeks or neck.
• Tell your health care provider beforehand if: Your child is ill or has ever had an allergic reaction to gelatin, the antibiotic neomycin, or a previous dose of the MMR vaccine.

Meningococcal Disease Vaccine

• What it's for: Menactra is licensed for use in people ages 11 years and older, up to age 55. Menomune is licensed for use in children 2 years and older. These vaccines protect against meningococcal disease, a serious illness caused by a bacteria. It is a leading cause of bacterial meningitis in children 2-18 years old in the United States. Meningitis is an infection of fluid surrounding the brain and the spinal cord.
• Common side effects: Sore arm, headache, fatigue.
• Tell your health care provider beforehand if: Your child has had a severe allergic reaction to a previous dose of meningococcal vaccine, has a known sensitivity to vaccine components or latex, which is used in the vial stopper, or has bleeding disorders or a history of Gullian-Barre Syndrome (GBS), a serious neurological disorder that can occur either spontaneously or after certain infections. The disorder typically involves weakness in the legs and arms that can be severe.

Pneumococcal Conjugate Vaccine

• What it's for: Prevnar (Pneumococcal 7-valent Conjugate Vaccine) protects infants and toddlers against serious pneumococcal disease, such as meningitis and blood infections, and some ear infections.
• Common side effects: Redness, tenderness, swelling at injection site, fever, fussiness, drowsiness, loss of appetite.
• Tell your health care provider beforehand if: Your child is moderately or severely ill, or has ever had an allergic reaction to a previous dose.

Pneumococcal Vaccine Polyvalent

• What it's for: Pneumovax 23 is licensed for use in children with certain health conditions who are 2 years or older for the prevention of the 23 most prevalent types of pneumococcal bacteria. Pneumococcal disease can lead to serious infections of the blood, the lungs, such as pneumonia, and the covering of the brain (meningitis).
• Common side effects: Soreness, warmth, redness, swelling at the site of injection.
• Tell your health care provider beforehand if: Your child is allergic to any component of the vaccine, has a respiratory illness or other active infection, or has severely compromised cardiovascular and/or pulmonary function.

Polio Vaccine

• What it's for: The inactivated poliovirus vaccine (IPV) protects against the virus that causes polio, an illness that can cause paralysis or death. For children at least 2 months old.
• Common side effects: Soreness at injection site, muscle aches, low-grade fever.
• Tell your health care provider beforehand if: Your child has ever had a severe allergic reaction to a previous shot or an allergic reaction to the antibiotics neomycin, streptomycin, or polymyxin B.

Rotavirus Vaccine

• What it's for: RotaTeq is a live vaccine given by mouth to prevent rotavirus gastroenteritis in infants. This viral infection of the stomach and intestines can cause severe diarrhea, vomiting, and fever, which may lead to serious dehydration. For children who are at least 6 weeks old, but younger than 32 weeks.
• Common side effects: Mild, temporary diarrhea or vomiting.
• Tell your health care provider beforehand if: Your child has a known or weakened immune system, is allergic to any of the ingredients of the vaccine, or has ever had an allergic reaction after getting a dose of the vaccine.

Varicella (Chicken Pox) Vaccine

• What it's for: Varivax (varicella virus vaccine live) protects against chicken pox in people 1 year and older. Chicken pox, which is caused by the varicella-zoster virus, causes itchy blisters and fever. Complications of chicken pox can include skin infection, scarring, brain swelling, and pneumonia.
• Common side effects: Soreness or swelling at the injection site, fever, mild rash.
• Tell your health care provider beforehand if: Your child is moderately or severely ill, or has ever had a life-threatening allergic reaction to gelatin, the antibiotic neomycin, or a previous dose of chicken pox vaccine.

For More Information

FDA's Web Page on Vaccines
www.fda.gov/cber/vaccines.htm

Tags: diphtheria, polio, measles, whooping cough, FDA, Vaccines