It is unlikely that seasonal flu vaccines would protect against a pandemic influenza virus.
CDC data show that over the last 13 years, the annual influenza vaccine’s effectiveness ranged from as low as 19% and up to 60% at its highest (between 2009 and 2021). The low level of efficacy of the annual vaccine often means that most people are at risk of contracting the disease.
Conventional inactivated avian influenza vaccines have performed poorly in past vaccine trials, leading to the hypothesis that they are less immunogenic than seasonal influenza vaccines.
Another question is how big a dose of vaccine you would need. H5N1 isn't something human populations have really been exposed to before, and at least with tests involving traditional vaccines, it takes a lot of vaccine to get a decent immune response. mRNA vaccines are already pretty reactogenic; they are associated with a bunch of mild, but common side effects. So, we don't know how mRNA will fare if big doses are needed.
U.S. officials began trying to diversify away from egg-based vaccines in 2005, when avian flu first gripped the world, and with added vigor after the 2009 fiasco. But "with the resources we have available, we get the best bang for our buck and best value to U.S. taxpayers when we leverage the seasonal infrastructure, and that's still mostly egg-based," Boucher said.
Flu vaccine companies "have a system that works well right now to accomplish their objectives in manufacturing the seasonal vaccine," he said. And without a financial incentive, "we are going to be here with eggs for a while, I think."
CSL/Arcturus: mRNA vaccine development
The CSL preclinical data of the bicistronic sa-mRNA vaccine demonstrates an immune response to H5N1 and also H1N1 since NA is sufficient for targeting. CSL has concluded a license agreement with Arcturus Therapeutics. Arcturus Therapeutics has received FDA clearance for a phase 1 bird flu vaccine trial
sa-mRNA bicistronic A/H5N1 vaccines induced potent H5 and N1 neutralizing antibody titers in mice
Due to the additional NA antigen, bicistronic A(H5N1) vaccines not only raised a potent neutralizing response to pandemic A(H5N1), but also to A(H1N1) and produced cross-reactive humoral and cellular responses in mice and ferrets. NA demonstrated a notable immune response without compromise of the immune response to HA raised by our sa-mRNA bicistronic influenza vaccines. The meaningful and cross-reactive immune responses raised by the sa-mRNA influenza vaccine candidates resulted in protection from influenza infection.
As we look toward initiating our Phase 1 clinical trials in the near future, these data are an encouraging testament to the value of pursuing innovative vaccine technology platforms, like sa-mRNA.
Under the agreement, CSL will have the exclusive license to Arcturus' next generation mRNA technology in the fields of influenza, COVID-19 and other respiratory viral diseases, and a non-exclusive license in the multi-pathogen pandemic preparedness field with the right to turn exclusive.
The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.
GSK/CureVac: mRNA vaccine development
The first GSK/CureVac mRNA vaccine study for seasonal influenza started in May 2023 and has advanced to a phase 2 study. In April 2024 positive phase 2 study interim data was published. Also in April 2024 the start of a phase 1/2 study of an mRNA vaccine for H5N1 has been announced.
CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GSK. The tested multivalent vaccine candidates address all four WHO-recommended flu strains.
CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), and GSK today announced that they have entered into a contract with the German federal government to supply mRNA vaccines within a broader tender for pandemic preparedness in Germany. Following a setup period of a maximum of two years, the contract grants the German federal government access to CureVac’s manufacturing capacity until 2029, enabling rapid availability of 80 million mRNA-based vaccine doses during the remainder of the current pandemic or in future infectious disease outbreaks.
GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac today announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialisation of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform.
CureVac’s leadership in mRNA technology, along with its mRNA manufacturing capability, complements GSK's existing scientific leadership in vaccines, including GSK's own self-amplifying mRNA (SAM) vaccine technology platform, and further builds on GSK's growing capability in mAbs innovation, aligned to its R&D focus on the science of immunology. Advancing mRNA-based vaccine and treatment technologies is also expected to play a role in further improving response against future pandemics.(...)
Under the terms of the deal, GSK will make an equity investment in CureVac of £130m (€150m), representing close to a 10% stake, an upfront cash payment of £104m (€120m) and a one-time reimbursable payment of £26m (€30m) for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany.
CureVac will be eligible to receive development and regulatory milestone payments of up to £277m (€320m), commercial milestone payments of up to £329m (€380m) and tiered royalties on product sales.
CureVac’s leadership in mRNA technology, along with its mRNA manufacturing capability, complements GSK's existing scientific leadership in vaccines, including GSK's own self-amplifying mRNA (SAM) vaccine technology platform, and further builds on GSK's growing capability in mAbs innovation, aligned to its R&D focus on the science of immunology. Advancing mRNA-based vaccine and treatment technologies is also expected to play a role in further improving response against future pandemics.(...)
Under the terms of the deal, GSK will make an equity investment in CureVac of £130m (€150m), representing close to a 10% stake, an upfront cash payment of £104m (€120m) and a one-time reimbursable payment of £26m (€30m) for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany.
CureVac will be eligible to receive development and regulatory milestone payments of up to £277m (€320m), commercial milestone payments of up to £329m (€380m) and tiered royalties on product sales.
CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced selection of a promising vaccine candidate for continued clinical development based on positive data from an interim analysis of the ongoing Phase 1 part of a combined Phase 1/2 study, conducted in collaboration with GSK.
“The Phase 2 interim data show that CureVac’s highly effective and flexible mRNA technology platform puts us on the right track to advance our joint seasonal influenza vaccine program,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “Results regarding influenza A strains were strong. Immunogenicity for B strains was in line with our expectations also in view of other initial mRNA-based clinical flu development programs. We are confident that planned optimizations will improve performance against these historically challenging influenza strains.”
The Phase 2 dose-confirmation study assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to all four WHO-recommended flu strains.
CureVac (...) today announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine candidate developed in collaboration with GSK. The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans. The monovalent vaccine candidate is based on CureVac’s proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen.
Moderna: mRNA vaccine development
A phase 3 study of an mRNA seasonal influenza vaccine was successfully completed. The final results show a stronger immune response against influenza A and influenza B. A phase 1/2 study of pandemic influenza vaccines is currently ongoing.
Moderna had high hopes for its first seasonal flu vaccine to enter the clinic, but, so far, the mRNA shot hasn't quite lived up to the hype. While the vaccine checked off two influenza A strains in a phase 3 trial, it struggled against two B strains in the same test and had a higher level of adverse events than an approved flu shot.
Moderna (MRNA.O) on Wednesday said its flu vaccine had generated a stronger immune response against all four A and B strains of the influenza virus compared to traditional flu shots in a late-stage trial.
The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate.
Pfizer/BioNTech: mRNA vaccine development
A phase 1/2 study of an mRNA seasonal influenza vaccine has been completed in 2023. Pfizer announced a phase 3 study in September 2022. This is estimated to be completed in March 2024. A phase-one trial for a pandemic influenza vaccine started in December 2023.
Official Title: A PHASE 1, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF SELF-AMPLIFYING RNA VACCINE PREPARATIONS AGAINST INFLUENZA IN HEALTHY INDIVIDUALS
Study Completion (Actual): 2023-01-27
Study Completion (Actual): 2023-01-27
We are excited to start the first Phase 3 efficacy study of an mRNA-based influenza vaccine that could potentially deliver an improved flu vaccine to help address the significant burden of this disease.
The flexibility of mRNA technology and its rapid manufacturing could potentially allow better strain matches in future years, and in a pandemic influenza situation, mRNA technology could allow rapid, large-scale manufacturing of vaccines.
Beyond the modRNA vaccine candidate, Pfizer has ongoing studies exploring more novel mRNA technology like self-amplifying RNA (saRNA), which has the potential to provide added benefit in the future.
In 2018, Pfizer entered into a worldwide collaboration and license agreement with BioNTech under which Pfizer has the exclusive right to carry out the clinical development and commercialization of mRNA‐based influenza vaccines. Upon potential approval and commercialization, BioNTech would receive a royalty on Pfizer’s sales.
This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.
Study Completion (Estimated) 2024-03-07
Study Completion (Estimated) 2024-03-07
Pfizer said in a statement on Wednesday that it “would be prepared to deploy the company’s capabilities to develop a vaccine for strategic stockpiles”, confirming that it had launched a phase-one trial for a pandemic flu vaccine last December.
Sanofi: mRNA vaccine development
While Sanofi was the first company to test mRNA influenza vaccines, there are no positive results reported so far. Sanofi believes that the underlying technology requires improvement.
Targeting 2022 initiation of its clinical studies for an influenza vaccine with modified mRNA, Sanofi launched a Phase 1 clinical trial in June 2021 evaluating an mRNA-based investigational vaccine against seasonal influenza. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus across two formulations (MRT5400 and MRT5401) with different lipid nanoparticles.
Sanofi and Translate Bio have developed and will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in the Phase 1 influenza mRNA vaccine clinical trial. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.
Official Title: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adults Aged 18 Years and Older
Actual Study Start Date : October 3, 2022
Estimated Primary Completion Date : January 19, 2024
Estimated Study Completion Date : January 19, 2024
Actual Study Start Date : October 3, 2022
Estimated Primary Completion Date : January 19, 2024
Estimated Study Completion Date : January 19, 2024
Sanofi (SASY.PA) said that trials show the currently available mRNA technology behind the most successful COVID-19 shots will not be effective against influenza and it is already working on a next generation of shots.
The fact that Sanofi’s competitors are also struggling to tackle B strains “suggests to us that low flu B responses are probably a class effect across mRNA platforms,” Sridhar explained. “We need to find a more comprehensive solution to ensure a strong B strength performance year on year with mRNA,” he added.
University of Pennsylvania: mRNA vaccine development
The mRNA H5N1 vaccine has successfully protected ferrets. Significant differences in antibody levels were observed between first and second dose, but also different H5N1 variants. The peer-reviewed publication can be found here.
We generated an mRNA lipid
nanoparticle (LNP) vaccine encoding the hemagglutinin (HA) glycoprotein from a clade 2.3.4.4b H5
isolate. We show that the vaccine is immunogenic in mice and ferrets and prevents morbidity and
mortality of ferrets following 2.3.4.4b H5N1 challenge.
The A/Astrakhan-3212/2020-based H5 mRNA-LNP vaccine elicited antibodies
that bound and neutralized both A/red fox/England/AVP-M1-21-01/2020 and
A/pheasant/New York/22-009066-001/2022. Antibody titers against these variant viruses were ~3 fold
lower compared to A/Astrakhan/3212/2020 titers .
The second dose of H5 mRNA-LNP boosted H5-reactive antibody levels ~8-fold higher relative to prior to the boost.
The vaccinated ferrets were then challenged with A/Bald eagle/North
Carolina/ W22-140/2022, an H5N1 strain (...) shown to be lethal in ferrets. All four H5 mRNA-LNP-vaccinated ferrets survived the
H5N1 challenge(...)
CSL/Seqirus: Audenz
Audenz is a monovalent, cell-based A strain H5N1 pandemic influenza vaccine produced by CSL/Seqirus.
AUDENZ™ combines Seqirus’ proprietary MF59® adjuvant technology with its cell-based manufacturing platform. Cell-based manufacturing, an alternative to traditional egg-based manufacturing, avoids egg-adapted changes, one source of strain mismatch between the vaccine and circulating influenza virus.
Influenza vaccines using the MF59® adjuvant are designed to enhance and broaden the body’s immune response by creating broad, cross-reactive antibodies. This adjuvant is an important part of pandemic preparedness planning as it reduces the amount of antigen required to produce an immune response, increasing the number of doses of vaccine developed, so that a large number of people can be vaccinated as quickly as possible. Under the terms of the public-private partnership, established in 2009, Seqirus would position itself to deliver 150 million influenza vaccine doses to the U.S. government to support an influenza pandemic response within six months.
CSL/Seqirus: Celldemic/Incellipan
Celldemic/Incellipan are identical monovalent, cell-based A strain H5N1 pre-pandemic/pandemic influenza vaccines produced by CSL/Seqirus.
They contain antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) viruses produced in MDCK cell cultures and the adjuvant M59C.1. The difference is purely bureaucratic, with one being recommended for a conditional marketing authorisation and the other one for a marketing authorisation, which allows for using a pre-pandemic vaccine and adjusting the same safety-tested vaccine to an actual pandemic strain.
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Celldemic, intended for active immunisation against the H5N1 subtype of Influenza A virus in adults and infants from 6 months of age and above.
The applicant for this medicinal product is Seqirus Netherlands B.V..
Celldemic will be available as a 7.5 micrograms per 0.5 ml dose suspension for injection. Celldemic is an influenza vaccine (ATC code J07BB02). It contains haemagglutinin and neuraminidase surface antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG 23) viruses produced in MDCK cell cultures and the adjuvant M59C.1. The Celldemic vaccine triggers an immune response against the H5N1 subtype of the influenza A virus.
The benefit of Celldemic is a robust immune response in adults and children three weeks after two doses of the vaccine given three weeks appart, as measured by haemagglutination inhibition titres against H5N1.
The applicant for this medicinal product is Seqirus Netherlands B.V..
Celldemic will be available as a 7.5 micrograms per 0.5 ml dose suspension for injection. Celldemic is an influenza vaccine (ATC code J07BB02). It contains haemagglutinin and neuraminidase surface antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG 23) viruses produced in MDCK cell cultures and the adjuvant M59C.1. The Celldemic vaccine triggers an immune response against the H5N1 subtype of the influenza A virus.
The benefit of Celldemic is a robust immune response in adults and children three weeks after two doses of the vaccine given three weeks appart, as measured by haemagglutination inhibition titres against H5N1.
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Incellipan, intended for active immunisation against influenza in an officially declared pandemic.
The applicant for this medicinal product is Seqirus Netherlands B.V.
Incellipan will be available as a 7.5 micrograms per 0.5 ml dose suspension for injection. Incellipan is an influenza vaccine (ATC code J07BB02). It contains haemagglutinin and neuraminidase surface antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) viruses produced in MDCK cell cultures and the adjuvant M59C.1. The Incellipan vaccine triggers an immune response against the H5N1 subtype of the influenza A virus.
The benefits of Incellipan are a robust immune response in adults and children three weeks after two doses of the vaccine given three weeks apart, as measured by haemagglutinin inhibition titres against H5N1.
The applicant for this medicinal product is Seqirus Netherlands B.V.
Incellipan will be available as a 7.5 micrograms per 0.5 ml dose suspension for injection. Incellipan is an influenza vaccine (ATC code J07BB02). It contains haemagglutinin and neuraminidase surface antigens purified from inactivated A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) viruses produced in MDCK cell cultures and the adjuvant M59C.1. The Incellipan vaccine triggers an immune response against the H5N1 subtype of the influenza A virus.
The benefits of Incellipan are a robust immune response in adults and children three weeks after two doses of the vaccine given three weeks apart, as measured by haemagglutinin inhibition titres against H5N1.
CSL/Seqirus: Foclivia
Foclivia is an adjuvanted, egg-based A strain H5N1 pandemic influenza vaccine produced by CSL/Seqirus.
Seqirus, a world leader in influenza vaccines and pandemic response, announced today that following Health Canada’s approval of FOCLIVIA® (adjuvanted, egg-based A strain H5N1 pandemic influenza vaccine), the Company is ready to fulfil its role in Canada’s influenza pandemic preparedness plans.
Seqirus Canada is an influenza pandemic vaccine partner to the Canadian Government through the Public Health Agency of Canada (PHAC). The contract requires Seqirus to be on standby to rapidly manufacture and deliver a large number of vaccine doses to help protect Canadians against the influenza strain identified by the World Health Organization (WHO) when an influenza pandemic is declared.
This medicine is authorised for use in the European Union.
CSL/Seqirus: Aflunov
H5N1
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23)
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
This medicine is authorised for use in the European Union.
GSK: Adjupanrix
H5N1
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
This medicine is authorised for use in the European Union.
GSK plc (LSE/NYSE: GSK) today announced it had signed a framework contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the reservation of future production and supply of 85 million doses of its pandemic influenza vaccine Adjupanrix [pandemic influenza vaccine (split virion, inactivated, adjuvanted).
This is one of the first contracts signed by HERA since it was established in September 2021. Its core mission is to prevent, detect, and rapidly respond to health emergencies through working closely with other EC and national health agencies, industry and international partners to improve Europe’s readiness for health emergencies.
This is one of the first contracts signed by HERA since it was established in September 2021. Its core mission is to prevent, detect, and rapidly respond to health emergencies through working closely with other EC and national health agencies, industry and international partners to improve Europe’s readiness for health emergencies.
Baxter: Pandemic Influenza Vaccine H5N1 Baxter AG
H5N1
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1)
pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
This medicine is authorised for use in the European Union.
VEPACEL has the potential to generate a broader immune response than conventional egg-derived vaccines due to its use of Vero cell technology, which allows for use of the natural influenza virus (identical in protein composition to the virus circulating in nature) in vaccine production. Unlike traditional egg-grown influenza vaccines, eggs are not used in the VEPACEL manufacturing process.
Sanofi Pasteur: Influenza Virus Vaccine, H5N1
H5N1
Sanofi pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed its H5N1 vaccine, the first avian influenza vaccine for humans in the U.S. Sanofi pasteur, in collaboration with the National Institutes of Health, submitted a Biologics License Application to the FDA for this H5N1 vaccine. The licensure serves as a first key step in achieving the government’s goal of stockpiling vaccine intended to protect those who are at increased risk of exposure to the H5N1 influenza virus contained in the vaccine during the early stages of a pandemic.
AstraZeneca: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
H5N1
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain
pandemic influenza vaccine (H5N1) (live attenuated, nasal)
This medicine is authorised for use in the European Union.
Novartis: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
H5N1
Inactivated subunit A/Vietnam/1203/2004
Withdrawn
This medicine is now withdrawn from use in the European Union.
Clinically relevant levels of heterologous immunity were observed when the 2 doses of vaccine were administered either 2 or 3 weeks apart; however, the licensure criterion for seroprotection was not met in this case.
GSK: Pumarix
H5N1
Withdrawn
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
This medicine is now withdrawn from use in the European Union.
GSK: Daronrix
H5N1
Withdrawn
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs
This medicine is now withdrawn from use in the European Union.
National Resilience/Ology Bioservices Ireland: Vepacel
H5N1
Withdrawn
Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1)
This medicine is now withdrawn from use in the European Union.
Resilience (National Resilience, Inc.), a company building the world’s most advanced biopharmaceutical manufacturing ecosystem, announced it has acquired Ology Bioservices, Inc., (Ology Bio) a privately held company that also specializes in biologic drug substance manufacturing from early stage through commercial products.
CSL/Seqirus: H5N8 A/Astrakhan virus vaccine candidate
H5N8
Cell-based influenza technology, building on the platform technology used by FDA-approved AUDENZ™
Under the terms of the $30.1 million agreement, CSL Seqirus will deliver an H5N8 A/Astrakhan virus vaccine candidate and will then sponsor a subsequent Phase 2 clinical trial to evaluate the candidate along with CSL Seqirus’ proprietary adjuvant MF59®. MF59 has been successfully combined with other influenza strains in vaccines to boost immune response, as well as to accelerate manufacturing output. The Phase 2 trial will assess the safety and immunogenicity of this vaccine. Additionally, the study will examine homologous and heterologous boosting after six months, as well as the use of heterologous priming pairs (H5N8 A/Astrakhan and H5N6 A/Guangdong).
CSL/Seqirus: H2N3 virus vaccine candidate
H2Nx
Cell-based influenza technology, building on the platform technology used by FDA-approved AUDENZ™
In October 2021, BARDA selected CSL Seqirus to develop one cell-based influenza vaccine candidate and clinically evaluate two influenza A(H2N3) virus vaccine candidates.
GSK: Pandemrix
H1N1
Withdrawn
This medicine is now withdrawn from use in the European Union.
GSK initially became aware of possible cases of narcolepsy following vaccination with the adjuvanted H1N1 pandemic vaccine Pandemrix through adverse event reports received by the Swedish Medical Products Agency, and subsequently via media reports in Finland.(...)
To date, over 30 million doses of Pandemrix have been administered throughout Europe, with the most recent EMA Pharmacovigilance Report (19 August 2010) concluding that the benefit-risk profile of the three centrally-approved H1N1 vaccines, including Pandemrix, continues to be positive.
To date, over 30 million doses of Pandemrix have been administered throughout Europe, with the most recent EMA Pharmacovigilance Report (19 August 2010) concluding that the benefit-risk profile of the three centrally-approved H1N1 vaccines, including Pandemrix, continues to be positive.
The authors acknowledge that currently available data suggest an increased risk of narcolepsy following vaccination with Pandemrix™; however, from an epidemiologist's perspective, significant methodological limitations of the studies have not been fully addressed and raise questions about the reported risk estimates.
The FDA did not, for example, approve Pandemrix. U.S. experts felt that traditional, non-adjuvanted H1N1 vaccines made by Sanofi SA and others offered enough protection against the virus.
GSK: Arepanrix
H1N1
Withdrawn
This medicine is now withdrawn from use in the European Union.
GSK's adjuvanted H1N1 pandemic vaccine, Arepanrix, manufactured in Quebec, was used extensively in Canada, with approximately 16 million doses administered. There are no reports of narcolepsy in Arepanrix recipients to date. However, given the background incidence of narcolepsy we cannot rule out the possibility of a small number of cases being reported in the future.
Sanofi Pasteur: Humenza
H1N1
Withdrawn
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.
pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
This medicine is now withdrawn from use in the European Union.
Poultry vaccines
The HVT-H5 vaccines from Ceva Sante Animale and Boehringer Ingelheim Animal Health were 100% effective. A poultry vaccine developed by Merck has been approved for the European Union.
Both HVT-H5 vaccines have been found to be 100% effective in preventing disease and mortality after infection with the HPAI H5N1 virus. This is in contrast to the other two vaccines in which disease was observed.
USDA’s Agricultural Research Service (ARS) began
testing candidate vaccines for H5N1 in poultry in 2023.
ARS scientists evaluated one H5N1 vaccine developed
in-house by USDA and four commercial HPAI vaccines.
These studies showed that the five vaccines reduced
oral and cloacal virus shedding significantly and
provided near 100% clinical protection in chickens;
however, they continue to rely on a two-dose regimen,
which can be impractical for distribution to flocks.
MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that the European Commission has granted the marketing authorization for the INNOVAX®-ND-H5 vaccine for chickens. This vaccine is the first centrally registered vaccine in the European Union against the currently circulating avian influenza virus strains of clade 2.3.4.4b, which cause high mortality in poultry.
Bird flu vaccines for laying hens are effective in practice, the Dutch government said on Tuesday, while confirming plans to vaccinate poultry against the virus that ravaged flocks around the world and is raising fears about human transmission. (...) More transmission trials will be conducted over the next year and a half to assess the vaccines' effectiveness during the entire laying period, the Dutch ministry said.
Current poultry vaccines against influenza A viruses target the globular head region of the hemagglutinin (HA1), providing limited protection against antigenically divergent strains. Experimental subunit vaccines based on the conserved ectodomain of the matrix protein 2 (M2e) induce cross-reactive antibody responses, but fail to fully prevent virus shedding after low pathogenic avian influenza (LPAI) virus challenge, and are ineffective against highly pathogenic avian influenza (HPAI) viruses. This study assessed the benefits of combining nanoparticles bearing three tandem M2e repeats (NR-3M2e nanorings or NF-3M2e nanofilaments) with an HA1 subunit vaccine in protecting chickens against a heterologous HPAI H5N1 virus challenge. Chickens vaccinated with the combined formulations developed M2e and HA1-specific antibodies, were fully protected from clinical disease and mortality, and showed no histopathological lesions or virus shedding, unlike those given only HA1, NR-3M2e, or NF-3M2e. Thus, the combined vaccine formulations provided complete cross-protection against HPAI H5N1 virus, and prevented environmental virus shedding, crucial for controlling avian influenza outbreaks.
Universal Influenza Vaccine Technology Landscape
A great vaccine database with a different focus is the Universal Influenza Vaccine Technology Landscape by CIDRAP.