Sarah Bennett
GlaxoSmithKline did indeed develop a hepatitis A vaccine. The pharmaceutical company's Havrix hepatitis A vaccine was first approved in Europe in 1991, and in the US in 1995. Havrix is an inactivated hepatitis A vaccine, and is given in two doses for the best protection. GlaxoSmithKline also developed the TWINRIX vaccine, which contains the HAVRIX hepatitis A vaccine and the ENGERIX-B hepatitis B vaccine. This was approved for use in adults in 2001.
| Characteristics | Values |
|---|---|
| Company | GlaxoSmithKline |
| Vaccine Name | Havrix |
| Year of Approval | 1995 |
| Country of Approval | United States |
| Age Group | Adults and children two years of age and older |
| Type of Vaccine | Inactivated hepatitis A vaccine |
| Dosage | Two doses |
| Time Between Doses | Six to twelve months |
| Protection Duration | At least 15 years |
| Booster Shot | Recommended for long-term protection |
| Effectiveness | 94%-95% |
| Side Effects | Soreness, redness, fever, headache, tiredness, loss of appetite |
| Risk | Severe allergic reaction, serious injury, or death |
| Other Names | TWINRIX (combined hepatitis A and B vaccine) |
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What You'll Learn
GlaxoSmithKline's Havrix vaccine
GlaxoSmithKline's Havrix is a vaccine for hepatitis A, which is caused by the hepatitis A virus (HAV). The vaccine was first approved in Europe in 1991 and by the US Food and Drug Administration (FDA) in 1995 for use in adults and children two years of age and older. In 2005, Havrix received FDA approval for use in children beginning at one year of age. This approval was based on clinical trials involving 723 children younger than two years.
Havrix is an inactivated hepatitis A vaccine, produced in MRC-5 cells. Each adult dose contains 1440 ELISA units of viral antigen adsorbed on aluminium hydroxide (0.5 mg Al). The pediatric (child) doses contain half the amount of viral antigen and aluminium. Protection against hepatitis A begins approximately two to four weeks after the initial vaccination. Two doses are recommended, with the initial dose followed up by a booster six to twelve months later.
GlaxoSmithKline published research in 1994 reporting that Havrix was 94% effective in preventing hepatitis A infections. This research involved over 40,000 children between the ages of one and 16 living in Thailand. The World Health Organization (WHO) has included the hepatitis A vaccine on its List of Essential Medicines and recommends universal vaccination in areas where the disease is moderately common.
In 2001, GlaxoSmithKline's TWINRIX vaccine, a bivalent vaccine containing Havrix and the ENGERIX-B hepatitis B vaccine, received approval for use in adults aged 18 and older.
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Hepatitis A vaccine development history
Hepatitis A is an inflammation of the liver caused by the hepatitis A virus (HAV). It is transmitted primarily by the faecal-oral route through ingestion of contaminated food or water or direct contact with an infected person. The development of the hepatitis A vaccine has been a crucial step in preventing this disease.
The first hepatitis A vaccine was approved in the European Union in 1991 and in the United States in 1995. The vaccine was phased in around 1996 for children living in high-risk areas, and its use was expanded over time. The initial vaccine, Vaqta, was developed by Maurice Hilleman and his team at Merck & Co. It was licensed in 1995 and has been widely used since.
Following the success of Vaqta, GlaxoSmithKline (GSK) developed and obtained approval for the world's first licensed inactivated hepatitis A vaccine, Havrix, in early 1992. This vaccine is produced in MRC-5 cells and contains 1440 ELISA units of viral antigen adsorbed on aluminium hydroxide for adults. The paediatric doses contain half the amount of viral antigen and aluminium. Havrix has been shown to be highly effective, with a 94% success rate in preventing hepatitis A infections in clinical trials involving over 40,000 children in Thailand.
In 1999, the Advisory Committee on Immunization Practices (ACIP) updated its recommendations to include routine vaccination for all children aged two and older in areas with elevated hepatitis A infection rates. This decision contributed to the decreasing trend of hepatitis A infections, with reported cases dropping significantly from 1999 to 2005.
In addition to Havrix, GlaxoSmithKline has continued to innovate in the field. In 2001, their TWINRIX vaccine, a combination of HAVRIX and ENGERIX-B hepatitis B vaccine, was approved for adults. Furthermore, in collaboration with the U.S. Army, GlaxoSmithKline Biologicals is actively involved in developing a hepatitis E vaccine, showcasing their ongoing commitment to advancing vaccine research and public health.
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Effectiveness and side effects
GlaxoSmithKline's Havrix hepatitis A vaccine was approved by the FDA in 1995 for use in adults and children two years of age and older. The vaccine was first tested on over 40,000 children between the ages of one and 16 in Thailand, with a reported 94% effectiveness in preventing hepatitis A infections. In 2005, Havrix received FDA approval for use in children from one year of age.
The hepatitis A vaccine is considered safe and effective at preventing hepatitis A infections. It is the best way to prevent infection, and it is recommended for all children between 12 months and 18 years of age in the United States. It is also recommended for those who are at increased risk of infection, including international travellers, those in close contact with children adopted from countries with high hepatitis A rates, and people who have been exposed to hepatitis A in the last two weeks. Vaccination is also important for those who are immunocompromised or have chronic liver disease.
The vaccine is given in two doses, with the second dose administered at least six months after the first. Protection against hepatitis A begins approximately two to four weeks after the initial vaccination and lasts at least 15 years. It is estimated that protection lasts at least 25 years if a booster is administered.
Common side effects are usually mild and last 1-2 days. These may include soreness, redness, fever, headache, tiredness, or loss of appetite. As with any medicine, there is a very small chance of a severe allergic reaction or other serious injury. However, the body of scientific evidence overwhelmingly supports the safety of the hepatitis A vaccine.
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FDA approval
GlaxoSmithKline is one of the manufacturers of the hepatitis A vaccine, which is given in two doses, with the initial dose followed by a booster after six to twelve months. The vaccine is effective in around 95% of cases and offers protection for at least 15 years, with estimates that it could last up to 25 years if the booster is administered.
In 1994, GlaxoSmithKline published research on its HAVRIX hepatitis A vaccine, which was tested on over 40,000 children aged between one and 16 in Thailand. The research reported the vaccine to be 94% effective in preventing hepatitis A infections.
On February 22, 1995, the HAVRIX vaccine received FDA approval for use in adults and children aged two and older. This was four years after the vaccine was approved in Europe. In 2001, GlaxoSmithKline's TWINRIX vaccine, a bivalent vaccine containing HAVRIX and ENGERIX-B hepatitis B vaccine, received approval for use in adults aged 18 and older. This approval followed clinical studies involving less than 2,200 healthy adults.
In 2005, GlaxoSmithKline's HAVRIX vaccine received FDA approval for use in children beginning at one year of age. This approval followed clinical trials involving 723 children younger than two years.
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Comparison with other vaccines
Hepatitis A vaccines only protect against hepatitis A. There are separate vaccines for hepatitis B, as well as a combination hepatitis A and hepatitis B vaccine that protects against both viruses. There is currently no vaccine for hepatitis C.
The hepatitis B vaccine is also known as the first "anti-cancer" vaccine because it prevents hepatitis B, the leading cause of liver cancer worldwide. The hepatitis B vaccine is recommended for all infants at birth, for children up to age 18, and adults at high risk. The hepatitis B vaccine is also recommended for adults living with diabetes and those at high risk for infection due to their jobs, lifestyle, living situations, or country of birth.
The hepatitis A vaccine is given in the muscle of the upper arm, in two doses for the best protection. The initial dose of the vaccine should be followed up by a booster six to twelve months later. Protection against hepatitis A begins approximately two to four weeks after the initial vaccination and lasts at least 15 years, and is estimated to last at least 25 years if the booster is administered.
The hepatitis A vaccine is safe and highly effective, even for people with compromised immune systems. The most common side effect is soreness in the area around the shot site. Other possible side effects include redness where the shot is given, fever, headache, tiredness, or loss of appetite.
In comparison, the hepatitis B vaccine is also safe and effective, and common side effects may include soreness, swelling, and redness at the injection site. The hepatitis B vaccine may not be recommended for those with documented yeast allergies or a history of adverse reactions to the vaccine.
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Frequently asked questions
Yes, GlaxoSmithKline developed the first Hepatitis A vaccine, Havrix, which was approved in Europe in 1991 and in the US in 1995.
The Hepatitis A vaccine is a vaccine that prevents Hepatitis A, a disease that infects and damages the liver, causing a yellowing of the skin, abdominal cramps, nausea and fever.
The Hepatitis A vaccine is effective in around 95% of cases and lasts for at least 15-20 years, and possibly a person's entire life.
