Glaxosmithkline Flu Vaccine Lot Numbers

Preventing And Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccinationrelated adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of FLUARIX QUADRIVALENT.

Gsk Begins Shipping Record Number Of Its Influenza Vaccine Doses For 2020

GSK produces largest supply ever as CDC urges adults and high-risk individuals to be immunized against influenza during COVID-19 pandemic

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GSK today announced it started shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2020-21 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administrations Center for Biologics Evaluation and Research.

The flu is a serious and unpredictable disease that causes tens of millions of illnesses, hundreds of thousands of hospitalizations and tens of thousands of deaths in the US each year, said Judy Stewart, Senior Vice President, US Vaccines. GSK is looking at every opportunity to produce and distribute additional flu vaccines this upcoming season to meet anticipated demand. We are working closely with public health partners to improve flu immunization rates to reduce the spread of disease and burden on the healthcare system during the ongoing public health challenge presented by the COVID-19 pandemic.

The US Centers for Disease Control and Prevention recommends that everyone 6 months of age and older get a flu vaccine every season. In recent weeks, the CDC has repeatedly emphasized the importance of influenza vaccination this flu season to help reduce the burden of disease and the impact of influenza on the healthcare system and other critical infrastructures during the COVID-19 pandemic.

Fluarix Quadrivalent Efficacy And Immunogenicity

In clinical trials, FLUARIX QUADRIVALENT exhibited efficacy and immunogenicity in children aged 6 to 35 months compared to a non-influenza active comparator . FLUARIX QUADRIVALENT exhibited noninferior immunogenicity in children aged 3 through 17 years and adults aged 18 years and older, when compared to trivalent flu vaccine comparators.1

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Vaccine Efficacy Against Influenzaa And/or B In Children Aged6 Through 35 Monthsa 1

ATP=According-to-Protocol CI=confidence interval RT-PCR=Reverse Transcriptase Polymerase Chain Reaction.

• aTrial 7: NCT01439360.
• bNumber of subjects in the ATP cohort for efficacytime to event, which included subjects who met all eligibility criteria, who were followed for efficacy and complied with the study protocol until the influenza-like episode.
• cNumber of subjects who reported at least one case in the reporting period.
• dVaccine efficacy for FLUARIX QUADRIVALENT met the pre-defined criterion for the lower limit of the 2-sided 97.5% CI .
• eChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine .
• f Children 12 months and older: HAVRIX for those with a history of influenza vaccination or HAVRIX and a varicella vaccine for those with no history of influenza vaccination.
• gVaccine efficacy for FLUARIX QUADRIVALENT met the pre-defined criterion of > 10% for the lower limit of the 2-sided 95% CI.
• hVaccine efficacy for FLUARIX QUADRIVALENT met the pre-defined criterion of > 15% for the lower limit of the 2-sided 95% CI.

The vaccine efficacy against RT-PCR-confirmed influenza associated with adverse outcomes was 64.6% . The vaccine efficacy against RT-PCR-confirmed influenza associated with adverse outcomes due to A/H1N1, A/H3N2, B/Victoria, and B/Yamagata was 71.4% , 51.3% , 86.7% , and 68.9% , respectively.1

Flulaval Quadrivalent Influenza Vaccine News

– Despite increased influenza testing, levels continue to remain low, reported the WHO.

– The US CDC reported in week 41, that 0.1% of long-term care facilities reported > 1 influenza-positive test among residents. And no jurisdictions reported high or very high ILI activity.

– During week 40, the UK reported 8 influenza-positive cases.

– Nationwide during week 36, 2.3% of patient visits reported through ILINet were due to ILI. The percentage of patient visits for ILI remains below the baseline of 2.6% nationally.

– According to the US CDC, the percentages of visits for ILI reported in ILINet have been stable or decreasing among adult age groups and may be starting to stabilize among the younger age groups .

– The U.S. FDA confirmed lots for FluLaval Quadrivalent from ID Biomedical Corporation of Quebec have been released and available for distribution in the USA.

– The global influenza vaccines market is projected to exceed the US$ 9.5 Billion mark by 2027 and is presenting ample opportunities to the industry’s players. In 2020, GlaxoSmithKline plc influenza vaccines sales were up 35% from the previous year.

– The U.S. FDA issued a Supplement Approval letter to GSK for active immunization to prevent disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

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Gsk Shipping Record Number Of Flu Vaccine Doses For Upcoming Season

GSK has started shipping its quadrivalent influenza vaccines to U.S. healthcare providers and pharmacies for the 2020-2021 flu season. This immediately follows a licensing and lot-release approval from the Food and Drug Administration’s Center for Biologics Evaluation and Research.

GSK is producing the largest supply ever as CDC urges adults and high-risk individuals to be immunized against influenza during the COVID-19 pandemic.

In fact, GSK expects to supply more than 50 million doses of its influenza vaccines for the U.S. market in the 2020-2021 season, an increase from the 46 million it distributed during the 2019-2020 influenza season. With shipments this season, GSK will cross the 1 billion doses manufactured globally milestone during the company’s history.

“The flu is a serious and unpredictable disease that causes tens of millions of illnesses, hundreds of thousands of hospitalizations and tens of thousands of deaths in the United State each year,” said Judy Stewart, senior vice president, U.S. vaccines. “GSK is looking at every opportunity to produce and distribute additional flu vaccines this upcoming season to meet anticipated demand. We are working closely with public health partners to improve flu immunization rates to reduce the spread of disease and burden on the healthcare system during the ongoing public health challenge presented by the COVID-19 pandemic.”

Incidence Of Adverse Outcomes Associatedwith Rt

ATP=According-to-Protocol RT-PCR=Reverse transcriptase polymerase chain reaction.

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Children Aged 3 Through 17 Years

In a clinical trial in subjects aged 3 through 17 years, FLULAVAL QUADRIVALENT exhibited immunogenicity noninferior to two comparator trivalent inactivated influenza vaccine formulations, each containing an influenza type B virus that corresponded to one of the two B viruses in FLULAVAL QUADRIVALENT, a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage .

• Noninferiority was based on adjusted GMTs and seroconversion rates1
• Seroconversion was defined as a 4-fold increase over baseline in post-vaccination hemagglutination inhibition antibody titers from pre-vaccination titer 1:10, or an increase in titer from < 1:10 to 1:401

Table 1 Influenza Vaccines United States 202021 Influenza Season*

Abbreviations: ACIP = Advisory Committee on Immunization Practices FDA = Food and Drug Administration HA = hemagglutinin IIV3 = inactivated influenza vaccine, trivalent IIV4 = inactivated influenza vaccine, quadrivalent IM = intramuscular LAIV4 = live attenuated influenza vaccine, quadrivalent MDV = multidose vial NAS = intranasal PFS = prefilled syringe RIV4 = recombinant influenza vaccine, quadrivalent SDV = single-dose vial.

* Vaccination providers should consult FDA-approved prescribing information for 202021 influenza vaccines for the most complete and updated information, including indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccinesexternal icon. Availability and characteristics of specific products and presentations might change and/or differ from what is described in this table and in the text of the full 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.

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Percentage Of Patients With Solicitedsystemic Adverse Events Within 7 Daysaafter First Vaccination In Childrenaged 6 Through 35 Monthsb1

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n=Number of subjects with diary card completed.

• aSeven days included day of vaccination and the subsequent 6 days.
• bTrial 7: NCT01439360.
• cChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine .
• dChildren 12 months and older: HAVRIX for those with a history of influenza vaccination or HAVRIX and a varicella vaccine for those with no history of influenza vaccination.
• eGrade 3 irritability: Defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite: Defined as not eating at all. Grade 3 drowsiness: Defined as prevented normal activity. Grade 3 fever: Defined as > 102.2 °F . Fever: Defined as 100.4 °F .
• fFever: Defined as 100.4

Percentage Of Patients With Solicitedlocal Adverse Reactions Within 7 Daysaafter First Vaccination In Childrenaged 6 Through 35 Monthsb1

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

• aSeven days included day of vaccination and the subsequent 6 days.
• bTrial 7: NCT01439360.
• cChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine .
• dChildren 12 months and older: HAVRIX for those with a history of influenza vaccination or HAVRIX and a varicella vaccine for those with no history of influenza vaccination.
• eGrade 3 pain: Defined as cried when limb was moved/spontaneously painful. Grade 3 swelling, redness: Defined as > 50 mm.

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Adults Aged 18 Years And Older

In a clinical trial in subjects aged 18 years and older, FLULAVAL QUADRIVALENT exhibited immunogenicity noninferior to two trivalent inactivated influenza vaccine fomulations, each containing an influenza type B strain that corresponded to one of the two type B viruses in FLULAVAL QUADRIVALENT or a type B virus of the Yamagata lineage )1

• Noninferiority based on adjusted GMTs

Flulaval Quadrivalent Influenza Vaccine Side Effects

Flulaval Quadrivalent is generally well-tolerated, however, if you or your loved one has an adverse reaction to the vaccine, that information should be reported to VAERS.

VAERS is a U.S. passive reporting system, meaning it relies on individuals to send in reports of their experiences to a vaccine. Anyone can submit a report to VAERS, including parents and patients. Furthermore, healthcare providers are required by law to report to VAERS.

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Fda Warns Gsk Over Problems At Quebec Flu Vaccine Manufacturing Plant

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TORONTO The company that makes about half of Canadas seasonal flu vaccine order and has the countrys pandemic flu vaccine contract has been issued a warning from the U.S. Food and Drug Administration over problems with bacterial contamination in its Quebec manufacturing facility.

Health Canada completed its own previously scheduled inspection of the ID Biomedical plant last Friday and is in the process of writing a report on the Ste. Foy, Que., facility, the department said Tuesday.

Health Canada is aware of the issues identified by the U.S. FDA and is working closely with both ID Biomedical and the U.S. FDA to address these concerns. The U.S. FDA findings, along with Health Canadas own inspection findings, will be assessed to determine if any compliance actions are required, Health Canada said in an emailed response to questions.

The plant was acquired in 2005 by GSK . Because it owns the only flu vaccine production facility in Canada, GSK has the countrys long-term pandemic flu vaccine contract.

GSK had little to say Tuesday about its regulatory problems.

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We are making progress to address the concerns raised by the FDA and we are committed to working with them to fully resolve all outstanding issues. We are currently preparing a response to the FDA letter, it said in an email from Michelle Smolenaars Hunter, communications manager for GSK Canada.

Flulaval Quadrivalent Influenza Vaccine And Covid

The US Centers for Disease Control and Prevention previously issued interim clinical considerations stating that ‘COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing. And the annual influenza vaccination is recommended for all persons aged 6 months and older who do not have contraindications. ‘Providers should be aware of the potential for increased reactogenicity with coadministration and should consult the CDC for updated guidance as more information becomes available. If coadministered, COVID-19 vaccines and vaccines that might be more likely to cause a local reaction should be administered in different limbs, if possible.’

‘No data are currently available concerning coadministration of currently Authorized COVID-19 vaccines and influenza vaccines,’ stated Lisa Grohskopf, M.D., MPH, CDC’s ACIP vaccine committee presentation on June 24, 2021.

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Acip Recommendation On Hold

The ACIP was scheduled to vote on a recommendation concerning use of the vaccine in workers who have a risk of occupational exposure to the highly pathogenic Eurasian H5N1 virus, which rarely infects humans but is often deadly when it does.

But the first post-licensure lot of the vaccine won’t be available for 2 more years, because of a change in the manufacturing schedule, Sonja Olsen, PhD, of the Centers for Disease Control and Prevention told the ACIP.

As a result, an ACIP subcommittee decided to postpone its proposed recommendation on use of the vaccine in occupational risk groups, ACIP member Douglas Campos-Outcalt, MD, MPA, said at the meeting.

“We didn’t want to make a recommendation and have no vaccine for that,” ACIP chair Jonathan Temte, MD, PhD, told the group. The postponement prompted little discussion by the committee.

At the meeting, Olsen didn’t describe the reason for the change in the manufacturing schedule. In response to questions, GSK officials issued a statement to CIDRAP News this week.

Incidence Of Solicited Local Adversereactions And Systemic Adverse Reactionswithin 7 Daysa Of Vaccination In Adultsb1

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n=number of subjects with diary card completed.

• aSeven days included day of vaccination and the subsequent 6 days.
• bTrial 1: NCT01204671.
• cContained the same composition as FLUARIX manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
• dContained the same composition as FLUARIX manufactured for the 2010-2011 season .
• eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
• fGrade 3 pain: Defined as significant pain at rest prevented normal everyday activities. Grade 3 redness, swelling: Defined as > 100 mm. Grade 3 muscle aches, headache, fatigue, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity. Grade 3 fever: Defined as > 102.2 °F .
• gGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
• hFever: Defined as 99.5 °F .

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FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccines. FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are approved for use in persons aged 6 months and older.

Indication for FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT

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Fluarix Quadrivalent: Immune Responses To Each Antigen 28 Days After Last Vaccination In Children Aged 6 Through 35 Months 1a

aNote: For comparison of the non-influenza controls in the bar graph, please use the appropriate Y-axis scale corresponding to either FLUARIX QUADRIVALENT GMTs or seroconversion rates .

ATP=According-to-Protocol CI=confidence interval.

ATP cohort for immunogenicity included subjects for whom assay results were available after vaccination for at least one trial vaccine antigen.

• Trial 7: NCT01439360.
• Children younger than 12 months received pneumococcal 13-valent conjugate vaccine .
• Children 12 months and older received HAVRIX for those with a history of influenza vaccination or HAVRIX and a varicella vaccine for those with no history of influenza vaccination.

Percentage Of Patients With Solicitedsystemic Adverse Reactions Within7 Daysa After First Vaccination Inchildren Aged 3 Through 17 Yearsb1

Total vaccinated cohort for safety included all subjects for whom safety data were available. n=number of subjects with diary card completed.

• aSeven days included day of vaccination and the subsequent 6 days.
• bTrial 2: NCT01196988.
• cContained the same composition as FLUARIX manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
• dContained the same composition as FLUARIX manufactured for the 2010-2011 season .
• eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
• fGrade 3 drowsiness: Defined as prevented normal activity. Grade 3 irritability: Defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite: Defined as not eating at all. Grade 3 fever: Defined as > 102.2 °F . Grade 3 fatigue, muscle aches, headache, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
• gFever: Defined as 99.5 °F .
• hGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

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