Chloe Ramirez
There have been several instances of vaccines being voluntarily withdrawn in recent years. Vaccine recalls or withdrawals are typically initiated by the manufacturer in collaboration with relevant health authorities, such as the U.S. Food and Drug Administration (FDA), due to safety concerns or declining demand. Notable examples include the withdrawal of the rotavirus vaccine in the United States in 1999 due to potential adverse effects, and more recently, AstraZeneca's decision to voluntarily withdraw its COVID-19 vaccine, Vaxzevria, in 2024 due to declining demand and safety concerns. Additionally, in 2025, VBI Vaccines Inc. voluntarily withdrew its Hepatitis B vaccine, PreHevbrio, and Takeda withdrew its U.S. Biologics License Application for its dengue vaccine candidate, TAK-003. These withdrawals highlight the ongoing efforts to ensure vaccine safety and respond to market dynamics.
| Characteristics | Values |
|---|---|
| Reason for withdrawal | Safety concerns, possible contamination, surplus of newer vaccines |
| Who initiates the recall | Vaccine manufacturer |
| Recent examples | AstraZeneca's Covid-19 vaccine, RotaShield, PreHevbrio (Hepatitis B Vaccine) |
| Year of withdrawal | 2024, 1999, 2024 |
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What You'll Learn
Rotavirus vaccine withdrawn in the US
In 1999, the Advisory Committee on Immunization Practices (ACIP) withdrew its recommendation to vaccinate infants with the RotaShield® vaccine, and the manufacturer, Wyeth Pharmaceuticals, voluntarily withdrew it from the market. RotaShield was the first vaccine for rotavirus and had been licensed and recommended for routine childhood immunization in 1998. However, scientists associated the vaccine with intussusception, a rare intestinal problem that involves a potentially fatal telescoping of part of the bowel.
Rotavirus is a highly contagious disease that is the most common cause of severe diarrhea in children and infants worldwide. It is a double-stranded RNA virus of the reovirus family and is shaped like a wheel (rota being Latin for "wheel"). Before a vaccine was introduced in the United States, rotavirus caused a significant number of doctor visits, emergency room visits, and deaths each year, particularly in children under five. Worldwide, rotavirus caused about 450,000 deaths in children under five annually, with most deaths occurring in developing countries.
Following the withdrawal of RotaShield, other rotavirus vaccines were developed and introduced. In 2006, the Advisory Committee on Immunization Practices recommended routine infant immunization with three doses of the RotaTeq vaccine. The Food and Drug Administration licensed another rotavirus vaccine, Rotarix, for use in the United States in 2008. Rotarix is given to infants in two doses, and both RotaTeq and Rotarix are administered orally as drops.
The withdrawal of the RotaShield vaccine highlights the importance of post-marketing surveillance for vaccine safety. While prelicensure clinical trials suggested that the vaccine was safe, postlicensure surveillance revealed an increased risk of intussusception, particularly in the week following the first dose. This information led expert committees to withdraw their recommendations for the use of the vaccine. The events surrounding the RotaShield vaccine withdrawal demonstrate the value of active surveillance systems and the need for strong post-marketing surveillance for newly introduced vaccines.
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AstraZeneca withdraws COVID-19 vaccine
Vaccine recalls or withdrawals are usually initiated voluntarily by the manufacturer. While vaccines go through rigorous testing, they can be withdrawn due to safety concerns or effectiveness.
In May 2024, AstraZeneca announced the withdrawal of its COVID-19 vaccine, citing a decline in demand. The vaccine, Vaxzevria, was developed in partnership with the University of Oxford and has been one of the world's primary vaccines, with over 3 billion doses supplied since January 2021. However, the emergence of new vaccines targeting COVID-19 variants has led to a surplus of updated vaccines, making AstraZeneca's vaccine less relevant. The company stated that their vaccine was no longer being manufactured or supplied, and it had not generated revenue since April 2023.
AstraZeneca's vaccine faced setbacks in April 2021 when regulators in the EU and the UK updated information on the vaccine to include the rare risk of a dangerous blood clotting condition. Despite these challenges, AstraZeneca sold almost $4 billion worth of Vaxzevria worldwide in 2021. The vaccine was also associated with a rare but serious side effect called thrombosis with thrombocytopenia (TTS), occurring in about 2 to 3 people per 100,000 vaccinated.
The withdrawal of the AstraZeneca vaccine highlights the evolving nature of the pandemic and the ongoing development of new vaccines to address emerging variants. While AstraZeneca's vaccine played a pivotal role in the early stages of the pandemic, the availability of newer, more effective vaccines has reduced its demand.
This decision by AstraZeneca is a voluntary withdrawal, and the company expressed its recognition of the contributions its vaccine has made in the global pandemic response.
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Takeda withdraws dengue vaccine in the US
Vaccine recalls or withdrawals are usually initiated voluntarily by the vaccine manufacturer. While vaccines go through rigorous testing before being used, they can still be withdrawn or recalled due to concerns about their effectiveness or safety.
In July 2023, Takeda Pharmaceutical Co. voluntarily withdrew its application for a dengue vaccine in the United States. The vaccine, known as TAK-003 or QDENGA, had been approved for use in several other regions, including the European Union, the United Kingdom, Brazil, Argentina, Indonesia, and Thailand.
Takeda's decision to withdraw the application in the US was due to data collection issues raised by the FDA. The FDA requested additional data that was not incorporated into the original TIDES trial design, which the company stated was designed per World Health Organization (WHO) guidance for a second-generation dengue vaccine. The TIDES trial evaluated the safety and efficacy of TAK-003 in preventing laboratory-confirmed symptomatic dengue fever in children and adolescents. The trial included over 20,000 participants and showed that the vaccine induced immune responses against all four dengue serotypes, with overall vaccine efficacy (VE) against virologically confirmed dengue at 12 months.
The withdrawal of the dengue vaccine application by Takeda highlights the rigorous regulatory processes in place to ensure vaccine safety and effectiveness. While this may cause disappointment for those seeking an alternative dengue vaccine in the US, it underscores the priority given to public health and safety. The future plan for the vaccine candidate in the United States will be further evaluated, considering the need for protection in dengue-endemic areas.
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VBI Vaccines Inc withdraws Hepatitis B vaccine
Vaccine recalls or withdrawals are typically initiated voluntarily by the vaccine manufacturer. While the FDA rarely issues a recall, it plays a role in overseeing the manufacturer's strategy and ensuring the recall goes well. Recalls are usually due to concerns about the safety of the vaccine or its effectiveness.
In 2024, VBI Vaccines Inc. voluntarily withdrew its hepatitis B vaccine, PreHevbrio, from the market. The vaccine was indicated for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults aged 18 years and older. The company initiated the recall after filing for Chapter 15 bankruptcy earlier that year. VBI Vaccines also requested the "immediate destruction" of all remaining PreHevbrio vials.
PreHevbrio was VBI Vaccines' sole FDA-approved product, launching in the US market in 2021. Despite expectations of entering a "very hot market for the next several years," the product only brought in $3.1 million in sales throughout 2023. As a result, the company reduced its internal workforce by 30-35% to cut down on operating expenses.
The most common side effects of PreHevbrio in adults included pain and tenderness at the injection site, myalgia, fatigue, and headache. It is important to note that PreHevbrio may not prevent hepatitis B infection in individuals with an unrecognized hepatitis B infection at the time of vaccine administration. Consumers who received PreHevbrio are advised to reach out to their healthcare providers with any questions or concerns related to the use of the vaccine.
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Withdrawn measles vaccines in the US
In the United States, a version of the measles vaccine that used an inactivated form of the virus was available between 1963 and 1968. This vaccine was found to be ineffective and was withdrawn in 1967. Only about 600,000–900,000 people in the US received this vaccine, a very small percentage of the current population.
The inactivated measles vaccine was associated with a severe form of measles disease. Children who received this vaccine and were later exposed to the measles virus in the community developed high fever, an unusual type of rash, and severe pneumonia. Since the withdrawal of the inactivated measles vaccine, atypical measles syndrome has been rarely reported.
It is important to note that the currently available measles, mumps, and rubella (MMR) vaccine is very safe and effective. When more than 95% of people in a community are vaccinated, most individuals are protected through herd immunity. However, vaccination coverage among US kindergarteners has decreased in recent years, falling below the 95% target and leaving many children at risk.
Falling vaccination rates and the spread of misinformation have led to concerns about potential measles outbreaks in the US. Measles is a highly contagious disease that can cause severe health problems, including pneumonia, encephalitis, brain damage, and pregnancy complications.
While there have been no recent examples of measles vaccines being voluntarily withdrawn in the US, the voluntary withdrawal of the inactivated measles vaccine in the 1960s demonstrates the importance of vaccine safety and effectiveness.
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Frequently asked questions
Yes, there have been a few recent instances of vaccines being voluntarily withdrawn. In May 2024, AstraZeneca announced the worldwide withdrawal of its Covid-19 vaccine due to a surplus of newer vaccines that target new variants of the virus. In March 2023, VBI Vaccines Inc. voluntarily withdrew PreHevbrio (Hepatitis B Vaccine, Recombinant) from the market. In July 2023, Takeda Pharmaceutical Co. voluntarily withdrew its application for a dengue vaccine candidate in the US due to data collection issues.
AstraZeneca withdrew its Covid-19 vaccine because there was a surplus of newer vaccines available that had been adapted to target Covid-19 variants, leading to a decline in demand for their vaccine.
The European Medicines Agency issued a notice in May 2024 stating that the AstraZeneca vaccine is no longer authorised for use.
