Cell Based Flu Vaccine Brands

Children Aged 2 Years To Less Than 18 Years

These children should be offered the live attenuated influenza vaccine . JCVI recommended that at risk children for whom LAIV is not suitable should be offered QIVc , or QIVe, in that order of preference. However, please note that Public Health England has only procured LAIV and QIVc for this age group.

High Dose Of Hemagglutinin

Given the poor performance of TIVs in the elderly, Fluzone High-Dose, a new formulation of TIV that contains four times the standard dose of HA, was approved for use in the elderly in the United States in 2010. This vaccine is administered in a single dose and can induce antibody titers equal to or better than those induced by the standard TIV . High-dose HA was also shown to improve immunogenicity in HIV-immunocompromised patients, despite their low overall CD4 counts , indicating that increasing the antigenic dose can result in a correspondingly increased immune response . The high dose, however, may present a manufacturing burden, especially during a pandemic, when demand is anticipated to be high, and, although effective, may prove impractical outside high-risk groups.

What Is The Significance Of Fda Approving Cell

Growing flu viruses in eggs can introduce changes that can cause differences between the viruses in the vaccine and the ones that are circulating. These changes may have important implications for the bodys immune response to vaccination. For example, egg-adapted changes could cause the bodys immune system to produce antibodies that are less effective at preventing disease caused by the specific flu viruses in circulation. FDAs approval of cell-based CVVs for use in cell-based flu vaccines could possibly improve the effectiveness of cell-based flu vaccines.

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Surveillance And Generation Of Viral Seed Stocks

Seasonal influenza vaccine content is based on a surveillance system for monitoring influenza virus circulation . WHO officials collaborate with national health agencies to identify circulating strains that had a dominant presence during the previous vaccination season and that are likely to cause the flu during the following winter in the Northern and Southern Hemispheres.

The National Influenza Centre performs virus isolation on certain samples obtained from patients to determine if the virus grows in culture. The virus isolation is done using mammalian cells, such as Madin Darby canine kidney cells instead of using embryonated eggs as it was carried out in the past . Higher isolation rates have been obtained using MDCK cells rather than eggs, especially for H3N2 strain . The virus is identified using reagents provided by WHO Collaborating Centers. Representative samples are sent for a more detailed study to one of the Collaborating Centers for influenza reference and research based in London , Atlanta , Melbourne , Tokyo , Memphis , and Beijing .

The Jet Injector Method

Some sites that offer flu vaccination will offer a jet injection option sold under the brand name AFLURIA Quadrivalent. A jet injector uses a high-pressure, narrow stream of fluid to penetrate the skin instead of a hypodermic needle.

The injector method has typically been used to administer vaccines quickly to a large number of people, such as military recruits.

I havent seen it in use recently, says Conley, but apparently its coming back and its available in some places.

Philbrick stresses that the standard flu shot is going to be the easiest one to find and the availability of the other types may vary from location to location.

I think the important thing to note is that, currently, the CDC does not give preference to any one vaccine over the other, she says. If you look for an option, you should be able to find it eventually, but the most important thing is to settle on an option and get the vaccine.

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Table Influenza Vaccines United States 202122 Influenza Season*

Influenza vaccines United States, 202122 influenza season*

Abbreviations: ACIP = Advisory Committee on Immunization Practices FDA = Food and Drug Administration HA = hemagglutinin IIV4 = inactivated influenza vaccine, quadrivalent IM = intramuscular LAIV4 = live attenuated influenza vaccine, quadrivalent MDV = multidose vial mos = months NAS = intranasal PFS = prefilled syringe RIV4 = recombinant influenza vaccine, quadrivalent SDV = single-dose vial

* Vaccination providers should consult FDA-approved prescribing information for 202122 influenza vaccines for the most complete and updated information, including indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at . Availability and characteristics of specific products and presentations might change or differ from what is described in this table and in the text of this report.

§The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged 3 years.

Iv5 Additional Vaccine Safety Considerations

Influenza vaccine is safe and well tolerated. Contraindications, precautions, and common AEs are described in Section II. Additional information regarding egg-allergic individuals and GBS is provided below.

Egg-allergic individuals

After careful review of clinical and post-licensure safety data, NACI has concluded that egg-allergic individuals may be vaccinated against influenza using any appropriate product, including LAIV, without prior influenza vaccine skin test and with the full dose, irrespective of a past severe reaction to egg and without any particular consideration, including vaccination setting. The amount of trace ovalbumin allowed in influenza vaccines that are authorized for use in Canada is associated with a low risk of AE. The observation period post-vaccination is as recommended in Vaccine Safety in Part 2 of the CIG. As with all vaccine administration, vaccine providers should be prepared with the necessary equipment, knowledge, and skills to respond to a vaccine emergency at all times.

Refer to the Statement on Seasonal Influenza Vaccine for 2018-2019 for safety data supporting this recommendation for IIV and LAIV.

Guillain-Barré syndrome

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What Makes Flucelvax Different

The influenza virus is constantly changing and evolving, making vaccine creation difficult. FLUCELVAX®, the first FDA approved cell culture flu vaccine,1 hopes to change that. Through innovative technology, this vaccine protects against influenza and has been approved for individuals four years of age and older. The vaccine contains no preservatives, no antibiotics, and it uses cell culture technology to create a vaccine that doesnt require the use of fertilized chicken eggs in the production process.

I1 New Or Updated Information For 2020

NACI recently reassessed the wording for the recommendation on the vaccination of health care workers and other care providers as a group for whom influenza vaccination is particularly recommended. The existing evidence on HCW influenza vaccination and the reduction of morbidity associated with influenza in patients being cared for by a HCW in health care settings was considered in the context of ethics and acceptability. NACI continues to recommend that, in the absence of contraindications, HCWs and other care providers in facilities and community settings should be vaccinated annually against influenza, and recommends the inclusion of this group among the particularly recommended recipients of influenza vaccine. NACI considers the receipt of influenza vaccination to be an essential component of the standard of care for all HCWs and other care providers for their own protection and that of their patients. This group should consider annual influenza vaccination as part of their responsibilities to provide the highest standard of care.

Recommendation on the use of LAIV in HIV-infected individuals

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Flucelvax Quadrivalent Vaccine Description For 2022

Flucelvax Quadrivalent is a cell culture-based flu vaccine to protect against four flu virus strains recommended by the World Health Organization for the current influenza season. In addition, Seqirus announced on October 15, 2021, that the U.S. FDA had Approved FLUCELVAX® QUADRIVALENT for an expanded age indication for children as young as six months old.

With this FDA Approval, FLUCELVAX QUADRIVALENT, the first and only cell-based influenza vaccine in the U.S. and is now indicated for everyone eligible to receive an influenza vaccine in the U.S., says the Company.

Seqirus Flucelvax is the first FDA-Approved flu vaccine to use cells instead of chicken eggs and represented the first significant advance in flu vaccine manufacturing technology since flu vaccine production began in the 1930s. This modern manufacturing process allows the flu shot to be antibiotic-free, helps protect against the identified four flu strains for 2020-2021, and is well-tolerated.

The U.S. CDC says Cell-based influenza vaccine technology may offer advantages over the standard influenza manufacturing process, including being more scalable and offering faster production in the event of an influenza pandemic. October 20, 2021, Lisa Grohskopf, M.D., MPH, Influenza Division, NCIRD, CDC Advisory Committee on Immunization Practices, presented: Change in Age Indication for Flucelvax Quadrivalent.

Flucelvax Quadrivalent Vaccine News For 2021

– The CDC that there have been 5 pediatric deaths this flu season.

– Reporting on data up to December 5, 2021, the WHO encouraged that with the increasing detections of influenza during the COVID-19 pandemic, countries are encouraged to enhance integrated surveillance to monitor influenza and SARS-CoV-2 at the same time, and step-up their influenza vaccination campaign to prevent severe disease and hospitalizations in high-risk groups of influenza.

– The Lancet published results of a UK phase 4 study in which adults received concomitant administration of either an age-appropriate influenza vaccine or placebo alongside their second dose of CO ID-19 vaccine. 3 weeks later the group who received a placebo received the influenza vaccine nd vice versa. Concomitant vaccination with ChAdOx1 or BNT162b2 plus an age-appropriate influenza vaccine raised no safety concerns and preserved antibody responses to both vaccines.

– The WHO reported globally influenza activity continues to remain at lower levels than expected.

– For week 41, the CDC reported nationwide, 1.8% of patient visits reported through ILINet w re due to ILI. This percentage is below the national baseline of 2.5%.

– New Jersey-based Seqirus announced that the U.S. FDA had Approved FLUCELVAX® QUADRIVALENT for an expanded age indication for children as young as six months old.

– 8 influenza-positive cases were reported in week 40 by the UK respiratory Datamart.

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V Choice Of Seasonal Influenza Vaccine: Additional Information

With the recent availability of a number of new influenza vaccines, some of which are designed to enhance immunogenicity in specific age groups, the choice of product is now more complex. Section II.5 summarizes NACI’s recommendations on the choice of currently authorized influenza vaccines. This section provides more details for these recommendations.

Comparative Effectiveness Of Egg

Cell-based inactivated influenza vaccines have been shown to be modestly moreeffective than egg-based inactivated influenza vaccines. A 20172018 real-worldobservational study evaluated the relative effectiveness of inactivated influenzavaccines prepared in embryonated chicken eggs compared with those prepared inmammalian cells. The study included more than 13 million Medicare beneficiaries age 65yearsor oldernearly all the vaccine recipients in the United States in this agegroupwho had received inactivated influenza vaccines in a cell-based quadrivalentform or four types of egg-based vaccines quadrivalent , high-dose trivalent, adjuvanted trivalent, or standard dose trivalent. The primary data source was Medicareadministrative files with patient details on enrollment, inpatient and outpatientcare, physician office visits, and prescription drugs from 6 August 2017 to 4 August2018. The primary outcome was influenza-related hospital encounters . Other outcomes included only inpatient stays, influenza-related officevisits, and hospital outpatient visits. The results were adjusted for imbalancesbetween covariates using inverse probability of treatment weighting . APoisson regression was used to evaluate the prevention of influenza-related hospitalencounters.

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Appendix C: Recommended Influenza Vaccines

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: .

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/national-flu-immunisation-programme-plan/appendix-c-recommended-influenza-vaccines

The Joint Committee on Vaccination and Immunisation has reviewed the latest evidence on influenza vaccines and recommended the following for the 2021 to 2022 season . Providers should ensure that they have ordered adequate supplies of the recommended vaccines for their different adult patient groups, as set out in 2 letters from NHS England and Improvement on 4 February and on 1 April 2021.

Timetable In Conventional Vaccine Manufacturing

Seasonal influenza vaccine production is an enormous challenge for manufacturers because from the moment the WHO announces the seasonal strains in February for the Northern Hemisphere and in September for the Southern Hemisphere only a 6-month window is available for manufacturers to develop and supply the vaccines in July-August for the beginning of the vaccination campaign in September in the Northern Hemisphere and in March to start in April in the Southern Hemisphere .

Timeline for seasonal influenza vaccine production in the Northern Hemisphere.

Several factors may change the deadlines. One factor is the virus growth and a second factor is the fulfillment of all of the regulatory aspects . These regulatory aspects include the control for viable influenza virus, the determination of HA content, and the presence of NA, testing the effective virus disruption, endotoxin, and the total protein content and performing sterility and stability tests on the final bulk vaccine .

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Vaccine Production Using Cultured Cells: Tis Time To Roust

In the last 2 decades, cell-culture based systems have been advocated because of the drawbacks with ECE-derived vaccine technology. Vaccine production in cultured cells has several advantages. First, cell lines can be extensively characterized and stored for future use without the need for repeated full range testing, and cell culture avoids dependency on supply and quality control of a raw material such as ECE. Second, certain viruses grow better in cells, avoiding the down-time required for the generation of high growth reassortants. Alternatively, high growth reassortants can be directly generated in cells. Third, a much more standardized and controlled process can be set up to track vaccine manufacturing. Fourth, scalability is better with cell culture than with egg-based production platforms. Fifth, allergies to egg proteins can be avoided. Sixth, virus propagated in mammalian cell systems has been shown to be structurally or antigenically more similar or identical to the field virus as compared to that grown in ECE. Furthermore, immune responses elicited by mammalian cell-derived vaccines have been shown to be more cross-reactive than responses produced by ECE-derived vaccines, although protective efficacy may not be affected. Finally, the same facilities can be used for the production of other vaccines when not being used for the production of influenza vaccine for extended periods.

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• Tracking Australia’s COVID vaccine rollout

In Australia, vaccination for certain groups of people is funded under the National Immunisation Program .

To get the cell-based jab in Australia, patients need to specifically request it from their GP, and as it’s not funded under the NIP, it’s likely to set someone back about $40.

Vaccines using traditional egg-based technology have between 70 per cent and 90 per cent strain-specific effectiveness in healthy adults, and are free for those eligible under the NIP.

Professor Booy said the US started using cell-based flu vaccines about 10 years ago, and it was “about time” Australia caught up.

“A hundred million people in the US have had the vaccine, so we know it works and we know its safe,” he said.

Dr Pearce said in the next five years, he would expect cell-based technology to be “standard” for the flu jab in Australia.

“We would expect that we will move away from making them in eggs to making them more cellular based,” he said.

Jonathan Anderson, the medical director from Seqirus, the company behind the cell-based jab, said they had been upscaling the manufacturing process to meet the potential demand.

“It’s taken a while for us to improve the manufacturing so that we could produce the quantities that might be required in a country like Australia,” he said.

“Now we’re able to have a consistent supply.”

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Which Flu Vaccine Is The Most Effective

When flu vaccines are being produced, the strains included are standardized by the FDA. Each 2021-2022 vaccine includes:

• Two type B viruses

This means that no matter what vaccine you choose, youre being protected against the same strains. Flu vaccines are typically between 40% and 60% effective from year to year. But when it comes to picking the right flu vaccine for you, you have to take other factors into account.

Ii4 Efficacy Effectiveness And Immunogenicity

Efficacy and effectiveness

Influenza vaccine has been shown in randomized controlled clinical trials to be efficacious in providing protection against influenza infection and illness. However, the effectiveness of the vaccine-that is, how it performs in settings that are more reflective of usual health care practice-can vary from season to season and by influenza vaccine strain type and subtype. Influenza vaccine effectiveness depends on how well the vaccine strains match with circulating influenza viruses, the type and subtype, as well as the health and age of the individual receiving the vaccine. Even when there is a less-than-ideal match or lower effectiveness against one strain, the possibility of lower VE should not preclude vaccination, particularly for people at high risk of influenza-related complications and hospitalization, since vaccinated individuals are still more likely to be protected compared to those who are unvaccinated.

Immunogenicity

Antibody response after vaccination depends on several factors, including the age of the recipient, prior and subsequent exposure to antigens, and the presence of immune compromising conditions. Protective levels of humoral antibodies, which correlate with protection against influenza infection, are generally achieved by 2 weeks after vaccination however, there may be some protection afforded before that time.

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