Safety of trivalent inactivated influenza vaccines in adults: Background for pandemic influenza vaccine safety monitoring

The creation of new vaccines is one of the key challenges in the battle against global infectious diseases. Therefore, creating the optimal conditions for innovation in vaccines is one of the most important roles law may undertake in this battle. In relation to pharmaceuticals, the economic theory of patent protection is commonly cited by industry and in the academic literature to justify the patenting of life-saving medicines and vaccines. The economic theory of patent protection holds that innovation occurs due to patents protecting the research and development investment made by the innovator. Proponents of this theory claim that without patents such innovation in medicines and vaccines would occur at a significantly reduced rate. This Article considers the applicability of the economic theory of patent protection to pandemic influenza vaccines. This Article examines a number of factors relevant to patent law, theory, and innovation including: the patent landscape for pandemic influenza vaccines; the market dominance enjoyed by manufacturers; the actual risk posed by imitators making generic vaccines if patent protection were not in place; and, the licensing and regulatory provisions for creating generic vaccines.According to the economic theory of patent protection, a patent incentivizes innovation by providing an innovator with a temporary monopoly regarding their innovation, and by protecting them from the threat posed by imitators who wish to make a cheap replica of the product. However, even without a patent, pandemic influenza vaccine manufacturers are in this position. Due to economies of scale and the complicated regulatory and licensing frameworks relevant to bringing a pandemic influenza vaccine to market, manufacturers are at little to no risk from generic imitators. Moreover, there is a very strong incentive to innovate because pandemic influenza vaccine manufacturers are selling a product for which demand exceeds supply to a captive market of nations and organizations, each of which is hoping to secure as much vaccine as possible. The unique conditions associated with pandemic influenza vaccines appear to provide more of an incentive to innovate and research in this field than the fact that the innovations can be patented.

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Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy

American Journal of Preventive Medicine ◽

10.1016/j.amepre.2017.03.014 ◽

2017 ◽

Vol 53 (3) ◽

pp. 282-289 ◽

Cited By ~ 8

Author(s):

Melissa S. Stockwell ◽

Maria Cano ◽

Kathleen Jakob ◽

Karen R. Broder ◽

Cynthia Gyamfi-Bannerman ◽

...

Keyword(s):

Influenza Vaccine ◽

Text Message ◽

Safety Monitoring ◽

Vaccine Safety

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Allergic adverse events following 2015 seasonal influenza vaccine, Victoria, Australia

Eurosurveillance ◽

10.2807/1560-7917.es.2017.22.20.30535 ◽

2017 ◽

Vol 22 (20) ◽

Cited By ~ 6

Author(s):

Hazel J Clothier ◽

Nigel Crawford ◽

Melissa A Russell ◽

Jim P Buttery

Keyword(s):

Adverse Events ◽

Confidence Interval ◽

Influenza Vaccine ◽

Allergic Reaction ◽

Seasonal Influenza ◽

Vaccine Safety ◽

Clinical Severity ◽

Influenza Vaccines ◽

Seasonal Influenza Vaccine ◽

Initial Investigation

Australia was alerted to a possible increase in allergy-related adverse events following immunisation (AEFI) with 2015 seasonal trivalent influenza vaccines (TIV) by the Victorian state vaccine safety service, SAEFVIC. We describe SAEFVIC’s initial investigation and upon conclusion of the 2015 influenza vaccination programme, to define the signal event and implications for vaccine programmes. Allergy-related AEFI were defined as anaphylaxis, angioedema, urticaria or generalised allergic reaction. Investigations compared 2015 TIV AEFI reports to previous years as proportions and reporting risk (RR) per 100,000, stratified by influenza vaccine brand. The initial investigation showed an increased proportion of allergy-related AEFI compared with 2014 (25% vs 12%), predominantly in adults, with insufficient clinical severity to alter the programme risk-benefit. While overall TIV AEFI RR in 2015 was similar to previous years (RR: 1.07, 95% confidence interval (CI): 0.88–1.29), we identified a near-doubling RR for allergy-related AEFI in 2015 (RR: 1.78, 95% CI: 1.14– 2.80) from 2011 to 2014 with no difference by vaccine brand or severity increase identified. This increase in generalised allergy-related AEFI, across all used vaccine brands, supports evidence of variable reactogenicity arising from influenza vaccine strain variations. This investigation underlines the importance of effective seasonal influenza vaccine pharmacovigilance.

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Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015

Eurosurveillance ◽

10.2807/1560-7917.es.2015.20.43.30050 ◽

2015 ◽

Vol 20 (43) ◽

Cited By ~ 18

Author(s):

Alexis Pillsbury ◽

Patrick Cashman ◽

Alan Leeb ◽

Annette Regan ◽

Darren Westphal ◽

...

Keyword(s):

Young Children ◽

Adverse Events ◽

Influenza Vaccine ◽

Real Time ◽

Surveillance System ◽

Seasonal Influenza ◽

Vaccine Safety ◽

Influenza Vaccines ◽

Safety Surveillance ◽

Medical Attendance

Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination.

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The Pandemic Influenza Preparedness Framework: A viable procurement option for developing states?

Medical Law International ◽

10.1177/0968533217723683 ◽

2017 ◽

Vol 17 (4) ◽

pp. 227-248 ◽

Cited By ~ 5

Author(s):

Mark Eccleston-Turner

Keyword(s):

Influenza Vaccine ◽

World Health Organization ◽

Pandemic Influenza ◽

Influenza Vaccines ◽

World Health ◽

The World ◽

Health Organization

In this article, I argue that the Pandemic Influenza Preparedness (PIP) Framework is unlikely to have a significant impact on procurement of pandemic influenza vaccines by developing states during the next pandemic. I argue this on the basis that the vaccine stockpile that the Framework has created is not sufficiently large to meet the demand from developing states. I also argue that the fact that so few pandemic influenza vaccine manufacturers have committed to supply the PIP stockpile, and those that have, have given commitments lower than those initially proposed by the World Health Organization in the Framework, implies that the overall impact the PIP stockpile will have on procurement of pandemic influenza vaccines is even lower than initially anticipated within the literature.

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Neuraminidase, the Forgotten Surface Antigen, Emerges as an Influenza Vaccine Target for Broadened Protection

The Journal of Infectious Diseases ◽

10.1093/infdis/jiz017 ◽

2019 ◽

Vol 219 (Supplement_1) ◽

pp. S75-S80 ◽

Cited By ~ 23

Author(s):

Maryna C Eichelberger ◽

Arnold S Monto

Keyword(s):

Influenza Vaccine ◽

Surface Antigen ◽

Pandemic Influenza ◽

Influenza Vaccines ◽

Independent Contribution ◽

Vaccine Target ◽

Number Of Factors ◽

Influenza Outbreaks

Abstract For 50 years it has been known that antibodies to neuraminidase (NA) protect against infection during seasonal and pandemic influenza outbreaks. However, NA is largely ignored in the formulation and standardization of our current influenza vaccines. There are a number of factors that contributed to this antigen being forgotten, including the lack of an easily performed test to measure NA antibody. With the availability of that test, it has been possible to show its independent contribution to protection in various situations. The challenge now is to make it possible to include known amounts of NA in investigational vaccines or to routinely measure NA content in licensed vaccines. Vaccines containing optimal amounts of NA may be particularly useful when there are antigenic changes, either drift or shift, in the hemagglutinin because NA immunity offers broad protection. It is now time to remember the NA as we work toward improved influenza vaccines.

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Rapid assessment of influenza vaccine effectiveness: analysis of an internet-based cohort

Epidemiology and Infection ◽

10.1017/s0950268811001804 ◽

2011 ◽

Vol 140 (7) ◽

pp. 1309-1315 ◽

Cited By ~ 20

Author(s):

K. T. D. EAMES ◽

E. BROOKS-POLLOCK ◽

D. PAOLOTTI ◽

M. PEROSA ◽

C. GIOANNINI ◽

...

Keyword(s):

Influenza Vaccine ◽

Pandemic Influenza ◽

Seasonal Influenza ◽

Influenza Season ◽

Rapid Assessment ◽

Vaccine Effectiveness ◽

Influenza Vaccines ◽

Seasonal Influenza Vaccine ◽

Effectiveness Analysis ◽

Self Reports

SUMMARYThe effectiveness of influenza vaccination programmes is seldom known during an epidemic. We developed an internet-based system to record influenza-like symptoms and response to infection in a participating cohort. Using self-reports of influenza-like symptoms and of influenza vaccine history and uptake, we estimated vaccine effectiveness (VE) without the need for individuals to seek healthcare. We found that vaccination with the 2010 seasonal influenza vaccine was significantly protective against influenza-like illness (ILI) during the 2010–2011 influenza season (VE 52%, 95% CI 27–68). VE for individuals who received both the 2010 seasonal and 2009 pandemic influenza vaccines was 59% (95% CI 27–77), slightly higher than VE for those vaccinated in 2010 alone (VE 46%, 95% CI 9–68). Vaccinated individuals with ILI reported taking less time off work than unvaccinated individuals with ILI (3·4 days vs. 5·3 days, P<0·001).

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Regulatory issues in pandemic influenza vaccine development

Microbiology Australia ◽

10.1071/ma06172 ◽

2006 ◽

Vol 27 (4) ◽

pp. 172

Author(s):

Gary Grohmann

Keyword(s):

Pandemic Influenza ◽

Adverse Reactions ◽

Vaccine Development ◽

Vaccine Safety ◽

Influenza Vaccines ◽

Efficacy And Safety ◽

Batch Release ◽

Post Market ◽

Release Testing ◽

Selection Of

The Therapeutic Goods Administration (TGA) is responsible for the licensing of vaccines used in Australia. This includes pre-market evaluation aspects (such as assessing the quality, efficacy and safety of vaccines) and post-market aspects (such as batch release testing and the monitoring of adverse reactions). For inter-pandemic and pandemic influenza vaccines, TGA is also involved in the selection of appropriate vaccine viruses and the calibration and supply of reagents for the production of influenza vaccines. Together with industry, TGA has a responsibility to ensure that all regulatory and good manufacturing requirements (GMP) are met to ensure vaccine safety and efficacy.

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2017/18 and 2018/19 seasonal influenza vaccine safety surveillance, Canadian National Vaccine Safety (CANVAS) Network

Eurosurveillance ◽

10.2807/1560-7917.es.2020.25.22.1900470 ◽

2020 ◽

Vol 25 (22) ◽

Author(s):

Julie A Bettinger ◽

Gaston De Serres ◽

Louis Valiquette ◽

Otto G Vanderkooi ◽

James D Kellner ◽

...

Keyword(s):

Influenza Vaccine ◽

Online Survey ◽

Seasonal Influenza ◽

Vaccine Safety ◽

Influenza Vaccines ◽

Background Rate ◽

Current Season ◽

Seasonal Influenza Vaccine ◽

Sufficient Intensity ◽

Systemic Symptoms

Background The Canadian National Vaccine Safety (CANVAS) network monitors the safety of seasonal influenza vaccines in Canada. Aim To provide enhanced surveillance for seasonal influenza and pandemic influenza vaccines. Methods In 2017/18 and 2018/19 influenza seasons, adults (≥ 15 years of age) and parents of children vaccinated with the seasonal influenza vaccine participated in an observational study using web-based active surveillance. Participants completed an online survey for health events occurring in the first 7 days after vaccination. Participants who received the influenza vaccine in the previous season, but had not yet been vaccinated for the current season, were unvaccinated controls. Results In 2017/18, 43,751 participants and in 2018/19, 47,798 completed the online safety survey. In total, 957 of 30,173 participants vaccinated in 2017/18 (3.2%; 95% confidence interval (CI): 3.0–3.4) and 857 of 25,799 participants vaccinated in 2018/19 (3.3%; 95% CI: 3.1–3.5) reported a health problem of sufficient intensity to prevent their normal daily activities and/or cause them to seek medical care (including hospitalisation). This compared to 323 of 13,578 (2.4%; 95% CI: 2.1–2.6) and 544 of 21,999 (2.5%; 95% CI: 2.3–2.7) controls in each respective season. The event rate in vaccinated adults and children was higher than the background rate and was associated with specific influenza vaccines. The higher rate of events was associated with systemic symptoms and migraines/headaches. Conclusion In 2017/18 and 2018/19, higher rates of events were reported following seasonal influenza vaccination than in the pre-vaccination period. This signal was associated with several seasonal influenza vaccine products.

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