Brady Collins
The US Food and Drug Administration (FDA) has approved the use of cell-based vaccines for flu, rotavirus, measles, smallpox, and rabies. Cell-based vaccines are developed from mammalian, avian, or insect cell lines rather than the traditional method of using embryonic chicken eggs. The FDA's approval of cell-based vaccines for flu, for example, could improve the effectiveness of the vaccine as it does not rely on an adequate supply of chicken eggs, and there is no risk of the virus mutating during its long growth phase in the chicken egg. The FDA provides guidance for vaccine manufacturers on the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use.
| Characteristics | Values |
|---|---|
| Types of vaccines approved by FDA | Egg-based flu vaccine, cell-culture based flu vaccine, recombinant flu vaccine, Rotarix, RotaTeq, Attenuvax, ACAM2000, IPOL, Verorab |
| Cell-based vaccine manufacturing process | Uses mammalian cells (Madin-Darby Canine Kidney, or MDCK cells) to grow flu viruses instead of fertilized hen's eggs |
| Advantages of cell-based vaccines | Faster and more stable production of vaccines, ability to rapidly produce vaccine supplies during a pandemic, no risk of virus mutation |
| Disadvantages of cell-based vaccines | Requires purification, virus inactivation, and testing |
| FDA approval process | Rigorous review of laboratory and clinical data to ensure safety, efficacy, purity, and potency |
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What You'll Learn
The FDA approves cell-based flu vaccines
The US Food and Drug Administration (FDA) has approved cell-based flu vaccines for use in the United States. This approval was given to Seqirus, the sole FDA-approved cell-based flu vaccine manufacturer in the country. The FDA's decision was made in 2012, and it marked a significant shift from the traditional egg-based vaccine production method.
Cell-based flu vaccines are developed from mammalian cell lines, most commonly Madin-Darby Canine Kidney (MDCK) cells, rather than the conventional method of using embryonic chicken eggs. This alternative approach offers several advantages, including increased scalability, faster production times, and reduced reliance on egg supplies. The use of mammalian cells also eliminates the risk of egg-adapted changes in the virus, which can lead to reduced vaccine effectiveness.
The FDA's approval of cell-based flu vaccines followed rigorous testing and evaluation processes. All vaccines undergo a thorough review of laboratory and clinical data by the FDA to ensure their safety, efficacy, purity, and potency. The FDA's Center for Biologics Evaluation and Research (CBER) plays a crucial role in regulating vaccine products, and their approval has significantly contributed to the reduction of vaccine-preventable diseases.
One example of an FDA-approved cell-based flu vaccine is Flucelvax, which was licensed by Novartis in 2012. Flucelvax is the only cell-based influenza vaccine currently in use in the United States and is recommended for individuals aged six months and older. Clinical trials have demonstrated its effectiveness and safety across different age groups, including adults aged 50 and older and children aged 6 months to 17 years.
In summary, the FDA's approval of cell-based flu vaccines offers a promising alternative to traditional egg-based vaccines. This approach provides benefits such as improved scalability, faster production, and potentially better protection against circulating "wild" flu viruses. The FDA's rigorous evaluation processes ensure that these vaccines meet the highest standards for safety and effectiveness, contributing to the ongoing prevention and control of influenza and other vaccine-preventable diseases.
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Cell-based vaccines are grown in mammalian cells
Cell culture-based flu vaccine production does not require chicken eggs because the vaccine viruses are grown in mammalian cell cultures. This process offers several advantages. It does not harm any animals, and it provides shorter production times in more controlled processes. It also allows for the cultivation of viral stocks without significant egg passage-dependent antigenic changes. Additionally, cell-based vaccines might be easier to scale up in case of limited egg supply.
The use of cell-based CVVs in vaccine production may offer better protection compared to traditional, egg-based flu vaccines. The viruses used to make cell-based vaccines are more similar to circulating "wild" flu viruses than those grown in eggs. Growing flu viruses in eggs can introduce changes, called egg-adapted changes, that can cause differences between the viruses in the vaccine and the circulating viruses. These changes may have important implications for the body's immune response to vaccination, potentially resulting in the production of less effective antibodies.
The FDA has approved cell-based CVVs for use in cell-based flu vaccines, and this approval could potentially improve the effectiveness of these vaccines. Clinical trials and studies have demonstrated the effectiveness and safety of cell-based vaccines, such as Flucelvax, in different age groups, including adults and children. Flucelvax is the only cell-based influenza vaccine currently in use in the United States.
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Cell-based vaccines don't rely on chicken eggs
The US Food and Drug Administration (FDA) has approved three different flu vaccine production technologies for use in the United States: egg-based flu vaccines, cell-culture-based flu vaccines, and recombinant flu vaccines. All commercially available flu vaccines in the US are made by private sector manufacturers and meet FDA safety and effectiveness requirements.
Cell-based vaccines, also known as cell-culture-based vaccines, are grown in mammalian cells instead of chicken eggs. The manufacturing process involves using cultured mammalian cells to make CVVs (candidate vaccine viruses), which are then provided to a vaccine manufacturer. The manufacturer then inoculates the CVVs into cultured mammalian cells, allowing them to replicate for several days. The virus-containing fluid is then collected, and the virus antigen is purified. This process is used to create inactivated flu vaccines, or flu shots.
Cell-based flu vaccine production does not rely on chicken eggs because the vaccine viruses are grown in animal cells, specifically mammalian cell cultures. This method has several advantages over egg-based production. Firstly, it is not dependent on an egg supply, which means it may be easier to scale up production if egg supply is limited. Secondly, it has the potential for a faster start-up of the manufacturing process. Additionally, growing flu viruses in eggs can introduce changes, called egg-adapted changes, that can cause differences between the viruses in the vaccine and the circulating "wild" flu viruses. These changes may reduce the effectiveness of the vaccine by impacting the body's immune response.
Flucelvax is the only cell-based influenza vaccine currently in use in the United States and is licensed for people 6 months and older. It is important to note that individuals outside of the FDA-approved age range, those with severe allergic reactions to any ingredient in the vaccine, or those with a history of allergic reactions to cell-culture-based flu vaccines should not receive Flucelvax.
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Cell-based vaccines may be more effective
The US Food and Drug Administration (FDA) has approved the use of three different flu vaccine production technologies in the United States: egg-based flu vaccine, cell-culture-based flu vaccine, and recombinant flu vaccine. All commercially available flu vaccines in the US meet the FDA's safety and effectiveness requirements.
Cell-based vaccines are grown in mammalian cells, such as Madin-Darby Canine Kidney (MDCK) cells, instead of chicken eggs. This method offers a faster and more stable production of vaccines compared to embryonic chicken eggs, which produce 1-2 vaccine doses per egg. Cell-based vaccines also avoid the use of egg-allergens, which can cause adverse reactions in some people.
Observational studies have shown greater protection against flu or flu-like illness among people who received cell-based inactivated influenza vaccines compared to those who received standard-dose egg-based vaccines. Specifically, during the 2017-2018 influenza season, a study published in the Journal of Infectious Diseases found that the cell-based vaccine provided greater protection against flu-related hospitalizations in adults aged 65 and older. However, this difference was not observed in similar studies during the 2018-2019 and 2019-2020 flu seasons.
Additionally, cell-based vaccines may be easier to scale up in the event of a pandemic, as they are not dependent on an adequate supply of eggs. This can be crucial in ensuring a rapid response to a public health emergency.
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The FDA has approved cell-based vaccines for rotavirus, measles, smallpox, and rabies
The US Food and Drug Administration (FDA) has approved cell-based vaccines for rotavirus, measles, smallpox, and rabies. The FDA plays a critical role in regulating vaccines, ensuring their safety and effectiveness.
In the case of rotavirus, the FDA approved Rotarix, a liquid given in a two-dose series to infants aged 6-24 weeks, in 2008. This vaccine was designed to protect against rotavirus infection, which can cause severe gastrointestinal symptoms.
For measles, the FDA has approved the Priorix (GSK) vaccine, which combines protection against measles, mumps, and rubella. This vaccine is suitable for individuals aged 12 months and older. The FDA has also approved a combined measles and rubella vaccine, the M-R-Vax by Merck, which was licensed in 1972.
Regarding smallpox, the FDA has approved the ACAM2000 vaccine for distribution to civilian laboratory personnel, the military, and state public health preparedness programs. This vaccine was introduced in 2008, and it is also recommended for pre-exposure vaccination for individuals at risk of occupational exposure to orthopoxviruses.
While rabies vaccines are not explicitly mentioned, the FDA has provided updated recommendations for their use, suggesting regulatory involvement in their approval or authorization.
Cell-based vaccines offer an alternative to the traditional method of using embryonic chicken eggs to develop antigens. These vaccines are developed from mammalian cell lines, such as Madin-Darby Canine Kidney (MDCK) cells, and have the potential to offer improved protection. The FDA's approval of cell-based vaccines for influenza (flu) is a testament to their safety and efficacy.
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Frequently asked questions
Yes, the FDA allows cell-based vaccine production. The FDA tests and approves all flu vaccines prior to release and shipment.
Cell-based vaccines are a type of vaccine that is grown in mammalian cells instead of chicken eggs. The vaccine viruses used to make the vaccine are grown in animal cells.
Cell-based vaccines do not require chicken eggs, so the production process is not dependent on an adequate supply of eggs. Cell-based vaccines may also be more effective as there is a risk that the virus may mutate during its long growth phase in chicken eggs.
