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Corrections

PVax is committed to clarifying its content when appropriate. We promptly edit minor errors like spelling, grammar, or stylistic changes. Because style changes do not change the content's meaning, they will be updated on our site without notice. 

Editorial

We are committed to publishing information on various immunization topics. However, we rely on you, our reader, to choose the most appropriate information for your needs. Therefore, information on PVax should not be used as a substitute for professional healthcare advice.

2 min read
Last Reviewed: 
Friday, May 2, 2025 - 13:40

R21 / Matrix-M Malaria Vaccine

R21/Matrix-M™ Malaria Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage

The R21/Matrix-M™ vaccine includes Novavax AB's proprietary saponin-based Matrix-M adjuvant and is licensed to and manufactured by the Serum Institute of India Private Ltd (SII). R21/Matrix-M was designed to improve the RTS, S/AS01 malaria vaccine. The University of Oxford Jenner Institute created R21. In 2017, Oxford published an abstract: High-level Efficacy in Humans of a next-generation Plasmodium falciparum anti-sporozoite vaccine: R21 in Matrix-M adjuvant. R21/Matrix-M is produced by Novavax AB, expressing recombinant HBsAg virus-like particles in Hansenula polymorpha, comprising the central repeat and the C-terminus of the circumsporozoite protein (CSP) fused to the N-terminal end of HBsAg10.

On October 2, 2023, the World Health Organization (WHO) recommended R21/Matrix-M to prevent malaria in children. The recommendation follows advice from the WHO's Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Group (MPAG). The R21 vaccine reduced symptomatic malaria cases by 75% during the 12 months following a 3-dose series. The WHO says a fourth dose given a year after the third maintains Efficacy. On December 21, 2023, the WHO added the R21/Matrix-M malaria vaccine to its list of prequalified vaccines, a prerequisite for UNICEF vaccine procurement and Gavi, the Vaccine Alliance, funding for deployment.

A perspective paper published by the Malaria Journal on January 12, 2024, examined the R21/Matrix-M malaria vaccine, its development, its potential impact on global malaria eradication efforts, and the challenges and opportunities it presents. On February 1, 2024, The Lancet published results from a phase 3 study of R21/Matrix-M, which was well tolerated and demonstrated high Efficacy against clinical malaria in African children. The Lancet reported on February 3, 2024, that over 3 million children in 20 countries will receive malaria vaccination in 2024. The follow-up data from a group of 409 children who received a fourth 'booster' dose at one year, with either a low (25 μg) or high (50 μg) dose of Novavax' Matrix-M adjuvant, used to boost the immune response to the R21 antigen, induced antibody concentrations that correlated with vaccine efficacy.

On November 24, 2025, Gavi and UNICEF announced a new agreement that will significantly increase the accessibility and affordability of the R21/Matrix-M™ malaria vaccines. The lower price of the vaccine at $2.99 per dose is anticipated to take effect in approximately one year. 

Oxford University's Jenner Institute is within the Nuffield Department of Medicine, located at the Old Road Campus Research Building in Headington, Oxford. Serum Institute of India Pvt. Ltd. is a significant vaccine manufacturer by the number of doses produced and sold globally (more than 1.5 billion doses), which includes Polio vaccine, Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps, Rubella, as well as Pneumococcal and Covid-19 vaccines. The Poonawalla Bio-Tech Park at Manjari, Pune, India, spans over 42 acres. On October 31, 2024, TIME awarded the R21/Matrix-M™ malaria vaccine a 'Best Inventions of 2024.'

R21/Matrix-M Vaccine Efficacy

The Lancet published results from a Phase 3 efficacy trial of the R21/Matrix-M™ malaria vaccine on February 1, 2024. The publication reported Efficacy of 75% when administered before the high transmission season: In areas with highly seasonal malaria transmission (where malaria transmission is mainly limited to 4 or 5 months per year), the R21/Matrix-M vaccine was shown to reduce symptomatic cases of malaria by 75% during the 12 months following a 3-dose series. Efficacy of 68% when administered in an age-based schedule in regions where malaria is present perennially during the 12 months following the first three doses. On September 26, 2023, a Phase III Randomised Controlled Trial concluded that R21/Matrix-M™ has a well-tolerated safety profile and offers high-level Efficacy against clinical malaria in African children at seasonal and perennial transmission sites.

Matrix-M Commercial Agreements

Serum Institute (SII) has the commercial rights to use Novavax Inc.'s Matrix-M in the vaccine and pay Novavax royalties. Additionally, Novavax has the commercial rights to sell and distribute the SII-manufactured malaria vaccine in certain countries and military vaccine markets. 

R21/Matrix-M Vaccine Availability 2025

As of 2025, NigeriaMozambiqueSouth Sudan, DR Congo, Central African Republic, Kenya, Cameroon, Chad, Malawi, Benin, Uganda, and Côte d'Ivoire received R21 vaccines. The Food and Drugs Authority of the Republic of Ghana licensed the R21/Matrix-MTM malaria vaccine on April 13, 2023. Nigeria issued its authorization on April 17, 2023. On July 24, 2023, Burkina Faso's Agence Nationale de la Regulation Pharmaceutique approved the use of R21. Previously, the Drugs Controller General of India granted permission on September 29, 2022, to send two lakh doses of the R21/Matrix-M vaccine manufactured by Serum Institute to the UK

R21.Marrix-M Vaccine Production

As of April 2024, the Serum Institute of India had manufactured about 25 million doses of the R21/Matrix-M vaccine. On October 12, 2023, UNICEF announced an agreement to secure supplies of R21/Matrix-M.

R21/Matrix-M Indication

The R21/Matrix-M Malaria Vaccine is indicated for the prevention of Plasmodium falciparum malaria, a mosquito-borne disease. The vaccine has been approved for use in certain countries in children aged 5 to 36 months. There were 229 million malaria cases worldwide in 2019, with an estimated 409,000 deaths. According to the WHO, children under five are the most vulnerable, accounting for 67% of malaria-related fatalities worldwide in 2019. On December 8, 2022, the WHO published the World Malaria Report 2022, which provides in-depth information on the latest trends in malaria control and elimination at global, regional, and country levels.

R21/Matrix-M Dosage

R21/Matrix-M Malaria vaccine is a three- or four-dose primary regimen.

R21/Matrix-M Side Effects

In a phase 3 clinical trial, the most common adverse events with the vaccine were fever (47%) and injection site pain (19%).

R21/Matrix-M Booster Dose

This phase 1/2b randomized controlled clinical trial reports the safety, immunogenicity, and Efficacy of the R21/Matrix-M malaria vaccine. The administration of a booster dose 12 months following the 3-dose primary series of R21/Matrix-M vaccinations shows the added benefit of a fourth dose when administered before the malaria season. Vaccine efficacy was maintained in the high-dose adjuvant group, at 80% following the booster vaccine over 12 months and 75% over 24 months after the prior three-dose regimen. Furthermore, vaccine efficacy against multiple episodes of clinical malaria was similar (78%) over two years of follow-up. R21/Matrix-M has a favorable safety profile and induces high levels of malaria-specific anti-NANP antibodies that correlate with the observed protection against clinical malaria.

R21/Matrix-M Vaccine Manufacturing

The University of Oxford has partnered with Serum Institute of India Pvt Ltd. (SIIPL) to manufacture R21/Matrix-M to ensure the provision of high volumes. The SIIPL has established a production capacity for 100 million doses per annum.

Matrix-M™ Adjuvant

Novavax Inc.'s Matrix-M adjuvant is derived from saponins, naturally occurring compounds found in the bark of the Quillaja saponaria tree. Saponins have a long history of being used for their medicinal properties.

R21/Matrix-M Vaccine Cost Effectiveness

The WHO stated that at prices of $2– 4 per dose, the cost-effectiveness of the R21 vaccine would be comparable to that of other recommended malaria interventions and other childhood vaccines.

R21/Matrix-M Vaccine News

April 2, 2025 - Uganda's Minister of Health, Dr Jane Ruth Aceng Ocero, said: "The introduction of the vaccine marks a significant milestone in our fight against malaria."

October 17, 2024: The Nigerian Federal Government received one million doses of the R21/Matrix-M malaria vaccine donated by Gavi, the Vaccine Alliance.

July 16, 2024 - "The nationwide rollout of the malaria vaccine marks a significant milestone in South Sudan's journey to reduce the devastating burden of malaria and save countless young lives.....," said Patience Musanhu, Gavi Senior Country Manager for South Sudan. 

July 15, 2024 - Professor Adrian Hill, Director of the Jenner Institute at Oxford University, said in a press release: "The (Côte d'Ivoire) rollout of the R21/Matrix-M™ malaria vaccine marks the start of a new era in malaria control interventions with the high efficacy vaccine now accessible at a modest price and very large scale to many countries in greatest need. We hope this vaccine can be provided to all African countries that wish to use it soon."

May 23, 2024 - Dr. Sania Nishtar, CEO of Gavi, the Vaccine Alliance, stated, "That is what matters most – that countries where our vaccines can be most impactful can access them, saving thousands of lives each year and offering relief to families, communities, and entire health systems."

February 1, 2024 - Article: Safety and Efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomized, phase 3 trial. Professor Adrian Hill, the chief investigator of the R21/Matrix-M™ phase 3 trial, said, "The continued high Efficacy of this new vaccine in field trials is very encouraging and consistent with the high Efficacy and excellent durability observed in a smaller four-year phase IIb trial. These data support an important role for the unique high-density nanoparticle display of the conserved repeat region of the malaria parasite circumsporozoite protein, a feature in the design of the R21 vaccine, in providing such high vaccine efficacy and, thereby, an important new tool for malaria control".

December 21, 2023 - Dr. Kate O'Brien, Director of WHO's Department of Immunization, Vaccines, and Biologicals, commented: "Today marks a massive stride in global health as we welcome the prequalification of R21/Matrix-M, the second malaria vaccine recommended for children in malaria-endemic areas.

December 13, 2023—The journal Nature published an article titled "Malaria fighter: this researcher paved the way for a game-changing vaccine."

April 13, 2023 - GAVI reported: Five things you need to know about the new R21 malaria vaccine.

December 1—022 - The Lancet Infectious Diseases published: Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after two years follow-up in children in Burkina Faso: a phase 1/2b randomized controlled trial.

September 7, 2022 - The peer-reviewed journal The Lancet published the findings from a booster dose clinical trial. These findings show that R21/Matrix-M has again reached the WHO-specified efficacy goal of 75% or greater over 24 months in the target population of African children. In children who received R21 with the higher dose of Matrix-M adjuvant, Efficacy was 80% at 12 months following the booster vaccination.

April 30, 2021 - BMC article: The new vaccine, R21, is very similar to RTS, S/AS01, in that it still contains the central repeat and the C-terminus of the circumsporozoite protein (CSP) fused to the N-terminal end of HBsAg. However, in contrast with RTS, S/AS01 does not contain the HBsAg in monomer form, only as fusion protein moieties, providing more surface for the CSP on the virus-like particle, making for a more specific immune response. In addition, R21 is mixed with a different saponin-based adjuvant called Matrix-M, which Novavax produces.

April 20, 2021 - The Lancet published a non-peer-reviewed study: High Efficacy of a Low Dose Candidate Malaria Vaccine, R21 in 1 Adjuvant Matrix-M™, with Seasonal Administration to Children in Burkina Faso. Interpretation: R21/Matrix-M appears safe and immunogenic in African children and demonstrates promising high-level Efficacy.

May 7, 2015 - A vaccine against malaria developed at Oxford University's Institute has shown promising results in its first field trial. The results are published in the journal Science Translational Medicine.

R21 / Matrix-M Malaria Vaccine Clinical Trials

R21/Matrix-M Malaria Vaccine candidate continues progressing through the Clinical Trial process.

Phase 3 (NCT04704830) Clinical Study Interpretation: R21/Matrix-M™ has a well-tolerated safety profile and offers high-level Efficacy against clinical malaria in African children at seasonal and perennial transmission sites. This low-cost vaccine, soon to be available at over 100 million doses a year and already licensed in three African countries (Burkina Faso, Ghana & Nigeria), could substantially reduce the burden of malaria and deaths in sub-Saharan Africa. Funding: The Serum Institute of India Pvt. Ltd, the Wellcome Trust, the UK National Institute for Health Research Oxford Biomedical Research Centre, and Open Philanthropy.

The Phase 1/2 trial was funded by the EDCTP2 program, supported by the European Union (grant number RIA2016V-1649-MMVC), the Wellcome Trust, and the NIHR Oxford Biomedical Research Centre. Oxford researchers and their partners reported from a Phase IIb trial that a booster dose of R21/Matrix-M at one year following a primary three-dose regime maintained high Efficacy against malaria and continued to meet the World Health Organization Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed 2021 results from the Phase-IIb trial, which reported that R21/Matrix-M demonstrated a high efficacy of 77%. Recent data from the pivotal phase III trial also show high Efficacy and a reassuring safety profile.

Phase 3 trial assesses large-scale safety and Efficacy in 4,800 children 5-36 months across Burkina Faso, Kenya, Mali, and Tanzania.

0 min read
Availability: 
UK, Nigeria, Ghana, Burkina Faso, Uganda
Generic: 
R21/MM
Drug Class: 
Vaccine
Condition: 
Last Reviewed: 
Tuesday, November 25, 2025 - 09:05
Brand: 
R21/Matrix-M
Status: 
Manufacturer Country ID: 
FDA First In Class: 
Yes

mRESVIA RSV Vaccine

mRESVIA® (mRNA-1345) RSV Vaccine Clinical Trials, Dosage, Efficacy, Side Effects

Moderna Inc.'s mRESVIA® (mRNA-1345) Respiratory Syncytial Virus (RSV) messenger RNA (mRNA) vaccine that encodes for a prefusion F glycoprotein and uses lipid nanoparticles (LNPs), eliciting a superior neutralizing antibody response. The prefusion conformation is a significant target of potent neutralizing antibodies, and the protein sequences are primarily similar across both RSV-A and RSV-B subtypes. This mRNA is entirely made in a laboratory and instructs your body to create small pieces of proteins. In addition, this RSV vaccine contains the mRNA code for the RSV glycoprotein F. It does not cause RSV infection but helps the body's immune system recognize and protect itself if it encounters the RSV virus. Furthermore, receiving Moderna's RSV vaccine prevents you from becoming infected with RSV.

Moderna initiated a rolling submission of a Biologics License Application (STN: 125796) for mRNA-1345 to the U.S. Food and Drug Administration (FDA). On May 31, 2024, the FDA approved mRESVIA. The FDA previously granted Fast Track and Breakthrough Designation designations for mRNA-1345 in adults older than 60. On August 23, 2024, the European Commission (EC) granted marketing authorization for mRESVIA in thirty European countries. On June 12, 2025, the FDA expanded the indications for individuals 18-59 years of age who are at increased risk for RSV. This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older.

On February 14, 2025, Moderna reported $15 million in mRESVIA sales in the fourth quarter of 2024, representing $25 million for the full year 2024.

Massachusetts-based Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing and has allowed the development of therapeutics and vaccines. To learn more, visit www.modernatx.com.

mRESVIA (mRNA-1345) Vaccine Availability

Moderna expects to have mRESVIA available in the U.S. and Europe for the 2024/2025 RSV season.

mRESVIA (mRNA-1345) Vaccine Indication

The mRNA-1345 RSV vaccine candidate is indicated for the prevention of illness caused by RSV, a leading cause of respiratory disease in young children and older adults (65 years and older). RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lungs) and pneumonia (infection of the lungs) in children under one year of age. According to the U.S. CDC, RSV leads each year, on average, to approximately 58,000 hospitalizations among children younger than five years old, 177,000 hospitalizations among adults 65 years and older, and 14,000 deaths among adults 65 years and older.

mRESVIA (mRNA-1345) Vaccine Dosage

The data from a Phase 1 study in older adults ages 65-79 showed that a single mRNA-1345 vaccination of 50 µg, 100 µg, or 200 µg boosted neutralizing antibody titers against RSV-A by approximately 14-fold and against RSV-B by about 10-fold. The U.S. FDA updated the data.

mRESVIA (mRNA-1345) Vaccine Efficacy

Moderna's presentation to the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) on June 26, 2024, disclosed that mRESVIA (mRNA-1345) showed about 81% efficacy after 3.7 months but only 50% efficacy in preventing the illness after 18 months. On October 25, 2023, the ACIP confirmed the Work Group was reviewing the safety and efficacy of Moderna's mRNA-1345 for use in adults 60 and older. On February 29, 2024, the ACIP committee reviewed the results of the Pivotal Phase 2/3 clinical trial (36,557 Participants Enrolled in 22 Countries). The mRNA-1345 vaccine was generally well tolerated in >19,500 individuals with no safety concerns. The ACIP reviewed a Phase 1 trial: Concomitant administration of influenza and COVID-19 vaccines.

mRESVIA (mRNA-1345) Vaccine Safety

The U.S. FDA published an updated Package Insert. The NEJM published an ORIGINAL ARTICLE in December 2023 - Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns. It led to a lower incidence of RSV-associated lower respiratory tract disease and RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434) Moderna announced in July 2023 that the vaccine candidate was well-tolerated and had a favorable safety profile. Most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. Moderna presented: Safety and Efficacy of mRNA-1345, an mRNA-based Vaccine Against RSV, in Adults 60 Years and Older on February 23, 2023, at the 7th ReSViNET Conference. Conclusion: mRNA-1345 was well tolerated and had an acceptable safety profile; solicited adverse reactions were mostly grade 1 or grade 2 in severity.

mRESVIA (mRNA-1345) Vaccine News

June 12, 2025 - Stéphane Bancel, Chief Executive Officer of Moderna, stated in a press release, "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV."

August 23, 2024 - The EC marketing authorization follows the Positive Opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. It is valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway.

June 28, 2024 - Moderna's chief Executive Officer said in a press release, "mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators' time and reducing the risk of administrative errors."

May 31, 2024 - Stéphane Bancel, Chief EStéphane Bancel, Chief Executive Officer of Moderna. "mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration, which can save healthcare professionals time and reduce administrative errors.

February 29, 2024 - Moderna Inc. presented an RSV vaccine update to the U.S. CDC's ACIP committee.

February 7, 2024 - Moderna Inc. posted: Respiratory Syncytial Virus (RSV): What You Need to Know.

July 5, 2023 - "We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the U.S. RSV is a major cause of lower respiratory tract infections in older adults and significantly burden to health systems through hospitalizations and emergency care admissions," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release.

March 24, 2022 - Moderna confirmed that a Phase 1 RSV trial (mRNA-1345) is ongoing, evaluating tolerability, reactogenicity, and immunogenicity in children, younger adults, older adults, and women of childbearing age. In an interim analysis, mRNA-1345 boosted RSV-neutralizing antibodies and was well-tolerated at all doses in younger and older adults.

August 3, 2021 - Moderna, Inc. announced that the U.S. FDA had granted Fast Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against RSV in adults older than 60.

April 14, 2021 - Moderna shared the first interim analysis of the Phase 1 study after 1-month post-vaccination of younger adults (18-49).

mRESVIA (mRNA-1345) Vaccine Clinical Trials

The pivotal ConquerRSV Phase 3 study of RSV in older adults (60+ years) the pivotal ConquerRSV study met both its primary efficacy endpoints, with vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. No Guillain-Barre Syndrome (GBS) cases have been reported with mRNA-1345 in the Phase 3 RSV trial. In addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in pediatric populations.

Clinical Trial NCT04528719: A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and Children Who Are Respiratory Syncytial Virus Seropositive. Estimated Completion Date: September 30, 2023. The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Phase 2 segment, 400 and 2,000 participants will be randomly assigned to receive a single injection of either the mRNA-1345 vaccine at the selected dose or a placebo in a 1:1 randomization ratio.

On December 14, 2023, the New England Journal of Medicines published an Original Article that concluded a single dose of the mRNA-1345 vaccine led to a lower incidence of RSV-associated lower respiratory tract disease and RSV-associated acute respiratory disease than placebo among adults 60 years of age or older in a phase2/3 clinical trial. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Serious adverse events occurred in 2.8% of the participants in each trial group. On December 14, 2023, a New England Journal of Medicine op-ed discussed these results.

0 min read
Availability: 
United States, Canada, EU, Norway, Iceland, Liechtenstein, the United Arab Emirates, Qatar and Taiwan
Generic: 
mRNA-1345
Clinical Trial: 
https://conquerrsv.com/
Drug Class: 
mRNA Vaccine
Last Reviewed: 
Sunday, June 15, 2025 - 07:10
Brand: 
mRESVIA
Status: 
Manufacturer Country ID: 
FDA First In Class: 
Yes
Location tags: 

VC2 HSV Vaccine

VC2 Vaccine Description 2023

Rational Vaccines VC2 vaccine candidate is a live-attenuated, engineered version of HSV-1. The VC2 vaccine targets facial, ocular, and genital herpes caused by HSV-1 but may also protect against genital herpes caused by HSV-2. 

"VC2 is unique in that it is engineered to prevent the virus from entering the neurons, " said Dr. Gus Kousoulas, who recently joined Rational Vaccines as Vice President of Scientific Affairs. HSV typically infiltrates a person's neurons and remains latent within the nervous system, and can reactivate to cause substantial disease. Some patients can even be asymptomatic carriers, spreading the virus through skin contact while showing no signs of infection themselves."

A clinical study: "A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease," will be led by Dr. Rajul Patel, consultant physician for genitourinary and HIV medicine at Southampton University Hospital, Southampton, England. The trial will be conducted at Southampton University Hospital and Chelsea and Westminster Hospital, London, England. Last Update Posted: August 12, 2022.

Rational Vaccines is focused on revolutionizing the treatment and prevention of herpes to eradicate the disease. Led by a team of scientists, the Company is headquartered in Woburn, MA, with locations in Miami, FL, and Oxford, UK. For more information, please visit www.rationalvaccines.com.

VC2 Vaccine Indication

The VC2 vaccine candidate has demonstrated promise in the treatment of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) as well as facial and ocular herpes in several animal model studies.

VC2 Vaccine News

August 15, 2022 - Rational Vaccines launched a clinical trial to determine the baseline characteristics of patients diagnosed with recurrent symptomatic HSV-2. In addition to assessing the typical baseline characteristics of the population, the purpose of this study is also to determine the acceptance of clinical trial procedures and understand the interest of the target patient population to participate in a therapeutic Phase 1/2 HSV-2 vaccine study.

April 5, 2021 - Rational Vaccines announces a licensing agreement with Louisiana State University for a vaccine technology VC2, demonstrating great promise in treating HSV1 and HSV2. "We are so very excited about adding this incredible science to the Rational Vaccines arsenal and partnering with Louisiana State University in the fight against HSV," said Rational CEO Agustin Fernandez.

March 7, 2018 - Intramuscular vaccination of guinea pigs with the live-attenuated human herpes simplex vaccine VC2 stimulates a transcriptional profile of vaginal Th17 and regulatory Tr1 responses. 'Kousoulas said his team's research has demonstrated that the live-attenuated HSV-1 VC2 vaccine strain cannot establish latency in vaccinated animals and produces a robust immune response capable of completely protecting mice against lethal ocular and vaginal HSV-1 or HSV-2 infections. In addition, he said the guinea pig represents the best small animal model for genital HSV-2 disease.'

VC2 Clinical Trial

ClinicalTrials.gov Identifier: NCT05500053 - Determine the baseline characteristics of patients with the recurrent symptomatic genital herpetic disease. Determine the acceptance of patients of clinical trial procedures. Determine interest in participation in genital herpes vaccine trials.

0 min read
Vaccine: 
Clinical Trial: 
https://clinicaltrials.gov/ct2/show/NCT05500053?term=NCT05500053&draw=2&rank=1
Drug Class: 
Vaccine
Condition: 
Last Reviewed: 
Tuesday, January 10, 2023 - 09:05
Brand: 
VC2
Status: 
Manufacturer Country ID: 

Hajj and Umrah Vaccinations

Hajj Umrah Vaccination Requirements 2025

The Saudi Ministry of Health established vaccine requirements for pilgrims to obtain an Entry Visa for Hajj and to perform Umrah in the Kingdom of Saudi Arabia (KSA). Health regulations and vaccination requirements were updated in 2024. On October 21, 2024, the World Health Organization (WHO) and the KSA announced a new effort to expand the Hajj health smart card initiative that summarizes critical health information, such as immunization status. In 2024, about 250,000 pilgrims from Indonesia, Malaysia, and Oman were issued Hajj health cards as part of the pilot collaboration between WHO and the KSA.

Hajj 1445 vaccinations include the following vaccines:

COVID-19: The Ministry of Health of Saudi Arabia recognizes the World Health Organization's Listed COVID-19 vaccines.

Influenza: The Saudi Ministry of Health recommends that pilgrims be vaccinated against seasonal flu before arriving in the Kingdom of Saudi Arabia. This is particularly important for those at increased risk of severe influenza, including pregnant women, children under five years of age, the elderly, and individuals with underlying health conditions.

Meningococcal: Adults and children 9 months or older arriving for Umrah, Hajj, or seasonal work must submit a vaccination certificate showing they received the (ACYW135) vaccine, issued no more than 3 years and no fewer than 10 days before arrival in Saudi Arabia. In April 2025, 11 cases of invasive meningococcal disease in the KSA were reported to the WHO.

Additional diseases underscore the need for rigorous surveillance and targeted vaccination strategies to mitigate the risk of transmission during the Hajj. Suggested vaccinations include:

Dengue and Zika Viruses: Aircraft, ships, and other means of transportation arriving in KSA from countries affected with the Zika virus and/or Dengue Fever. Valid certificate indicating that disinsection was applied per the methods recommended by WHO. They may be subjected to inspection as a condition of granting free pratique.

Polio: All visitors from polio-endemic countries and from countries with re-established transmission should receive one oral polio vaccine (OPV) dose, regardless of age and vaccination status. Proof of vaccination at least 6 weeks before departure is required for visitors from polio-endemic and re-established-transmission countries to apply for an entry visa to Saudi Arabia, and travelers will also receive one dose of OPV at border points upon arrival in Saudi Arabia. In addition, irrespective of previous immunization history, all visitors under 15 years old arriving in Saudi Arabia will receive one dose of OPV at border points.

Yellow Fever: Under the International Health Regulations 2005, all travelers arriving from countries or areas at risk of yellow fever must present a valid International Certificate of Vaccination or Prophylaxis showing that the were vaccinated with either FY-Vax or Stamaril at least 10 days before arrival. In the absence of such a certificate, the individual will be placed under strict surveillance.

General Precautions: It is recommended that all pilgrims update their immunizations against vaccine-preventable diseases. These usually include diphtheria, tetanus, pertussis, measles, and mumps. Pilgrims planning travel to malaria-risk areas in Asia, Africa, and Latin America before or after Hajj or Umrah should seek advice.

Vaccinations for Pilgrims Within the Kingdom

Primary healthcare centers located in the Kingdom offer vaccinations.

Travel Vaccinations Saudi Arabia

The U.S. Department of State confirms that those wishing to travel to Saudi Arabia to visit Medina or perform Hajj/Umrah should review the U.S. Centers for Disease Control and Prevention (CDC) vaccine recommendations. If you travel to Saudi Arabia, ensure you are fully vaccinated before travel, says the CDC. The ECDC reported in 2023 that returning travelers from the Hajj should seek medical attention immediately if they experience symptoms suggestive of any infection.

4 min read
Last Reviewed: 
Thursday, December 11, 2025 - 15:05
Description: 
Hajj and Umrah pilgrims are required to be vaccinated before visiting the Kingdom of Saudi Arabia.
Travel: 

Rabies Vaccines

Rabies Vaccines 2025

Rabies is a vaccine-preventable viral disease found in more than 150 countries and territories, according to the World Health Organization (WHO). Two types of vaccines protect people against Rabies: nerve tissue and cell culture vaccines. Cell culture vaccines, which are more affordable and require less vaccine, have been developed recently. Unlike conventional, inactivated rabies vaccines, live-attenuated viruses are genetically modified viruses that can replicate in a vaccinated person without causing adverse effects while eliciting robust and effective immune responses against viral infection.

As of 2025, according to the WHO, intradermal immunization using cell-culture-based rabies vaccines is an acceptable alternative to standard intramuscular administration. In the United Kingdom, rabies vaccines must be inactivated or recombinant and approved for use in the country. 

Rabies Vaccines Approved

As of 2025, the WHO has pre-qualified rabies vaccines, including Bavarian Nordic's RabAvert vaccIVAX-S by Serum Institute of India Pvt. Ltd., VaxiRab N by Zydus Lifesciences Limited, and VERORAB by Sanofi Pasteur.

RabAvert is a vaccine that contains an inactivated rabies antigen, indicated for preexposure vaccination, primary and booster doses, and post-exposure prophylaxis against Rabies in all age groups.

Chirorab®, previously known as Rabipur, is an inactivated rabies virus of Flury LEP. Chiron Behring Vaccines is relaunching Rabipur, a purified chick-embryo-celline. It will continue manufacturing at its WHO-prequalified facility in Ankleshwar, Gujarat, India.

Rabipur is an inactivated rabies vaccine produced by Valneva SE, which has over 35 years of worldwide clinical experience.

Rabivax-S is a lyophilized vaccine manufactured by Serum Institute of India Pvt. Ltd. It contains inactivated, purified rabies antigen and was developed using Vero cells (ATCC CCL81), derived from the Pitman-Moore strain. The inactivated vaccine is freeze-dried until ready for immunization.

Rabies Vaccine Candidates

Rabies vaccine candidates are seeking participants for various clinical trials in 2025. 

YS Biopharma Co., Ltd. PIKA Rabies Vaccine utilizes the company's proprietary PIKA adjuvant technology, designed to produce a more robust immune response in a shorter timeframe than traditional rabies vaccines. On April 9, 2024, YS Bio announced positive interim results from the ongoing Phase 3 clinical trial, indicating that the PIKA Rabies Vaccine has successfully met the primary endpoints and has the potential to achieve best-in-class accelerated protection and meet the WHO's goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. On June 1, 2023, the Food and Drug Administration of the Philippines approved a Phase 3 clinical trial, and on May 16, 2023, Pakistan issued study approval.

Replicate Bioscience announced on September 12, 2023, the dosing of the first participant in a Phase 1 trial of its RBI-4000 vaccine candidate for rabies prevention. The Trial marks the first time a human has been dosed with Replicate's next-generation srRNA technology, which will be a benchmark for its utility in this indication.

VitriVax, Inc. received a grant of up to $5 million from the Coalition for Epidemic Preparedness Innovations to develop further Atomic Layering Thermostable Antigen and Adjuvant (ALTA) technology, using Rabies as a vaccine target. ALTA® could replace multi-dose vaccines for protection against infectious diseases with a single-administration alternative.

Rabies Vaccine Preexposure Prophylaxis (PrEP)

The WHO recommends preexposure prophylaxis (PrEP) for individuals at high risk of exposure. The WHO position paper on rabies vaccines recommends a one-week, two-site intradermal post-exposure prophylaxis (PEP) schedule with 0.1 mL of vaccine injected on days 0, 3, and 7. The U.S. Centers for Disease Control and Prevention (CDC) updated its recommendations for rRabies post-exposure prophylaxis (PrEP) for humans, replacing the three-dose vaccination schedule with a two-dose program intended to protect people for at least three years. On May 6, 2022, the U.S. CDC published Use of a Modified Preexposure Prophylaxis Vaccination Schedule to Prevent Human Rabies: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022. 

Rabies Vaccine Breakthrough Infections

A case report by Holzbauer et al. in the March 2023 issue of Clinical Infectious Diseases is not a situation of inappropriate prophylaxis; rather, it represents a textbook response to accurate exposure to Rabies. An 84-year-old awoke to a bat biting his finger. The man washed his finger with soap and water, as recommended. Post-exposure prophylaxis was initiated three days after exposure. He received a complete four-vaccine regimen and more than the recommended 20 IU/kg of human rabies immunoglobulin (the actual dose was reportedly 30.9 IU/kg, as determined by potency testing of the immunoglobulin used), partially injected into the bite site, with the remaining amount given intramuscularly. Yet, five months later, he developed clinical Rabies and succumbed to it.

Importation of Dogs Without Rabies

In the U.S., stray dog control programs were initiated in the 1940s, and routine rabies vaccination of owned dogs eliminated the canine rabies virus variant from circulation by 2008. The American Animal Hospital Association Canine Vaccination Guidelines were updated in 2022. As of August 2023, a valid CDC Rabies Vaccination and Microchip Record is needed to obtain a permit or make a reservation. The CDC does not accept foreign-issued pet passports or other certificates for rabies vaccinations administered outside the United States. Rabies-vaccinated dogs vaccinated in the U.S. by a U.S.-licensed veterinarian may re-enter the country from a high-risk country without a CDC Dog Import Permit if the dog has a current, valid U.S.-issued rabies vaccination certificate and an ISO-compatible microchip. The CDC has temporarily suspended the importation of dogs from high-risk countries with Rabies until July 31, 2024.

Rabies Vaccines Raccoons

The U.S. Department of Agriculture's Animal and Plant Health Inspection Service announced on August 4, 2023, that it will begin its annual distribution of RABORAL V-RG®, an oral rabies vaccine bait, in select areas in the eastern United States to prevent the spread of raccoon rabies. Raccoons, foxes (including red and gray varieties), skunks, and bats are considered primary carriers of the rabies virus in the United States.

5 min read
Last Reviewed: 
Wednesday, November 12, 2025 - 05:55
Description: 
Rabies vaccines are approved and offered worldwide in 2025
Condition: 

HSV-2 Vaccine (GSK4108771A)

HSV-2 Vaccine (GSK4108771A)

The herpes simplex virus type 2 (HSV-2) vaccine candidate (GSK4108771A) utilizes self-amplifying messenger RNA, "SAM" technology. To develop a SAM-based vaccine, GlaxoSmithKline (GSK) scientists designed a SAM molecule synthetically in a laboratory, using portions of the genetic code of a virus. However, in the SAM molecule, the genes linked to the virus's ability to cause infection are deleted and replaced with genes from target viruses that will produce the antigens for desired vaccines. 

The transport of nascent HSV particles from neuron cell bodies into axons and along axons to axon tips in the periphery is an essential component of this reactivation and reinfection. Two HSV membrane proteins, gE/gI, and US9, play a crucial role in these processes. Tiny balls of fat called lipid nanoparticles or LNPs will deliver the vaccine.

Using the body's cells to produce the vaccine means that GSK would only produce the SAM genetic platform and its delivery systems. Volumes may be much smaller than with traditional vaccines. The production process would be very similar for a wide variety of different vaccines, says GSK, potentially leading to substantial streamlining of the vaccine R&D process.

England-based GSK is the world's largest vaccine company by revenue, delivering vaccines that help protect people at all stages of life. Their R&D focuses on developing vaccines against infectious diseases that combine high-medical needs and strong market potential. The GSK vaccine portfolio has been helping to protect people from serious diseases for well over 100 years, with our Marietta (US) site dedicated to smallpox vaccine production since 1882.  

HSV-2 Vaccine (GSK4108771A) Indication

HSV-2 Vaccine (GSK4108771A) is indicated to prevent HSV.

HSV-2 Vaccine (GSK4108771A) Dosage

HSV-2 Vaccine candidate (GSK4108771A) dosage is being tested in a Phase 1 clinical trial. Four doses of the formulation will be administered intramuscularly on day one and day 57.

HSV-2 Vaccine (GSK4108771A) News

June 28, 2021 - GSK has terminated its phase 1 clinical trial to enable the development of an enhanced vaccine version.

May 5, 2021 - The U.S.-based Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety, and Immune Response of an HSV Vaccine in Healthy (~60) Participants Aged 18-40 Years was last updated. Women of non-childbearing potential may be enrolled in the study. Women with childbearing potential may be enrolled in the study under certain conditions.

March 23, 2021 - GlaxoSmithKline (GSK) launched a limited phase 1 clinical trial for a herpes simplex virus type 2 (HSV-2) candidate known as HSV vaccine (GSK4108771A). This USA-based study will include sixty participants and was last updated on March 18, 2021. This first-time-in-human study intends to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental HSV-2 vaccine administered intramuscularly on a 0, 2-month schedule to healthy participants aged 18-40.

HSV-2 Vaccine (GSK4108771A) Clinical Trial

Clinical Trial NCT04762511: This clinical trial has been terminated. This Phase 1 study aims to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine when administered intramuscularly on a 0, 2-month schedule. 

0 min read
Generic: 
GSK4108771A
Clinical Trial: 
https://us.gsk.com/en-us/research-and-development/clinical-trials/
Drug Class: 
Vaccine
Condition: 
Last Reviewed: 
Wednesday, June 19, 2024 - 05:35
Brand: 
HSV-2 vaccine (GSK4108771A)
Abbreviation: 
HSV-2
Status: 
Manufacturer Country ID: 
FDA First In Class: 
Yes

Travel Vaccine Certificates, Passports, Visa

Travel Vaccine Certificates, Passports, Visa, Green Card 2025

Various countries require proof of immunization as a prerequisite for obtaining a visa or entering their territory. Vaccine passports are digital credentials that confirm a person has been vaccinated against particular diseases. The World Health Organization (WHOGlobal Digital Health Certification Network (GDHCN) became effective in Europe on July 1, 2023. The GDHCN's digital capabilities may include verification of vaccinations, the International Patient Summary, verification of vaccination certificates within and across borders, and certification of public health professionals through the WHO Academy. The WHO published the Digital Documentation of Certificates: Vaccination Status and Test Results in 2021 and 2022, respectively.

In 2023, the WHO endorsed the European Union (EU) digital certification system. The EU Digital Certificate has been issued across 51 countries.

U.S. Passport, Security Notices, Health Advisories

The U.S. Department of State publishes information for visa and passport applications, as well as for countries, to help travelers assess their risks. If Americans are overseas and need emergency assistance, they should contact the nearest U.S. embassy or consulate, says the State Department. From Overseas, call +1 202-501-4444. Updated FAQs about U.S. passport and visa operations are on this State Department webpage. In addition, view travel requirements for countries edited by Sherpa. Choose a country on this map to begin your search.

The State Department launched the Bureau of Global Health Security and Diplomacy on August 1, 2023. The Bureau's overarching mission is to fortify the global health security architecture to effectively prevent, detect, control, and respond to infectious diseases, including HIV/AIDS. By leveraging and coordinating U.S. foreign assistance, the Bureau aims to foster robust international cooperation and enhance protection for the United States and the global community against health threats through strengthened systems and policies.

U.S. Transportation Security Administration

The U.S. Transportation Security Administration (TSA) provides a range of customer service resources to support travelers. PreCheck lanes are available at your airport; you can search for them using this link. The TSA has a team dedicated to answering questions related to prohibited and permitted items, identification requirements, and other related topics. AskTSA is available 365 days a year on these social media networks: X (@AskTSA), Facebook Messenger (www.fb.com/AskTSA), Apple Business Chat (AskTSA), and by texting "Travel" to AskTSA (275-872).

On May 6, 2025, the Turkish Directorate General of Civil Aviation issued a statement (UOD-2025/01warning airline passengers that standing up before the plane has come to a complete stop and vaping or smoking on board are prohibited. Turkish Airlines may fine violators around $70 per violation.

A 2023 report from the International Air Transport Association indicates an increase in the rate of reported unruly passenger incidents. Based on over 24,500 incident reports from more than 50 operators globally, there was one incident for every 480 flights in 2023, compared to one incident for every 568 flights in 2022.

U.S. Visa Waiver Program

The U.S. Visa Waiver Program is an international travel facility that allows citizens of select countries to visit the U.S. without requiring a traditional visa. Under this program, a person can stay in the U.S. for a maximum of 90 days. Under this program, even without a visa, there are certain conditions, such as possessing an e-passport and obtaining prior permission online through the Electronic System for Travel Authorization. Visitors must meet all of the requirements to travel to the United States on the VWP.

U.S. Green Card Applications

Effective January 22, 2025, the United States Citizenship and Immigration Services (USCIS) waived the requirement that applicants for adjustment of status to lawful permanent resident present documentation on their Form I-693, Report of Immigration Medical Examination and Vaccination Record, indicating that they received the COVID-19 vaccination. USCIS will not issue any Request for Evidence or Notice of Intent to Deny related to proving a COVID-19 vaccination. USCIS will not deny any adjustment of status application based on the applicant's failure to present documentation showing receipt of the COVID-19 vaccination.

International Certificates of Vaccination or Prophylaxis

The International Certificate of Vaccination or Prophylaxis (ICVP), also known as the yellow card, is required to enter various countries internationally. The WHO published a Country List to identify which countries require an ICVP.

REAL ID Act

All U.S. states, the District of Columbia, and four of five U.S. territories covered by the REAL ID Act and related regulations are issuing REAL ID-compliant licenses and identification cards. In addition, the Department of Homeland Security (DHS) announced in December 2022 its intent to extend the REAL ID full enforcement date by 24 months, from May 3, 2023, to May 7, 2025. The REAL ID Act establishes minimum security standards for state-issued driver's licenses and identification cards. Under the new regulations, beginning May 7, 2025, every traveler 18 years or older will need a REAL ID-compliant license or identification card, a state-issued enhanced license, or another TSA-acceptable form of identification at airport security checkpoints for domestic air travel. 

U.S. Customs and Border Protection

If you are a U.S. citizen planning to travel abroad, you must comply with the document requirements for that country. Each individual arriving in the U.S. must complete the CBP Declaration Form 6059B. Examples and a sample declaration form can be found on the Customs Declaration Form. Additionally, the U.S. Customs and Border Protection (CBP) One app serves as a single portal for mobile applications and services. 

As a result of the Bipartisan Budget Act of 2018, the Electronic System for Travel Authorization (ESTA) travel promotion fee was increased from $10 to $17, in addition to a $4 operation fee. CBP began collecting the new fee amount on May 26, 2022. Individuals with an approved ESTA do not have to reapply, as an ESTA is valid for up to two years. ESTA is an automated system that determines the eligibility of visitors to travel to the United States under the Visa Waiver Program (VWP). Authorization via ESTA does not determine whether a traveler is admissible to the United States. Instead, U.S. CBP officers determine the admissibility of travelers upon their arrival.

Global Entry Program

Global Entry is a U.S. Customs and Border Protection program that allows expedited clearance for pre-approved, low-risk travelers upon arrival in the USA. Members enter through automatic kiosks at select airports. Additionally, the Enrollment on Arrival (EoA) program enables Global Entry applicants who are conditionally approved to complete their interviews upon arrival in the United States. A list of participating EoA airports is posted on this webpage. While Global Entry aims to speed travelers through the process, members may still be selected for further examination when entering the USA.

United Kingdom Electronic Travel Authorization 2025

As of June 2025, the UK Global Health Insurance Card (GHIC) enables UK residents to access necessary state healthcare in the European Economic Area (EEA) and certain other countries on the same basis as a resident of those countries. In 2025, all individuals wishing to travel to and through the United Kingdom, except British and Irish citizens, will be required to obtain an Electronic Travel Authorization (ETA). You can get an ETA instead of a visa if you're coming to the UK for up to six months for tourism, visiting family and friends, or business purposes, or if you're transiting through the UK for up to three months. ETAs for the last two years, enabling you to travel to the UK as often as possible. Prospective travelers should apply for the United Kingdom ETA using this IVISA link. The application costs £10 (about $12.50) to apply. As of 2025, the UK offers information on passport eligibility, fees, and the application process, including renewal and update procedures.

Western Hemisphere Travel Initiative

The Western Hemisphere Travel Initiative (WHTI) is a joint plan between the U.S. Department of State and the Department of Homeland Security to implement the recommendations of the 9/11 Commission and the statutory mandates of the Intelligence Reform and Terrorism Prevention Act of 2004. As a result, U.S. citizens can present a passport, a Passport Trusted Traveler Program card (such as NEXUS or SENTRI), or a U.S. military ID. Military identification card when traveling on official, oral orders; U.S. Merchant Mariner Document when traveling with official maritime business.

Note that children must also present their passports when traveling by air. Lawful permanent residents must continue to carry a valid Permanent Resident Card. A visa is not required. However, the Indian tribal card cannot be used for air travel.

Pet Passport and Tips

An EU Pet Passport is a universal document issued by an official veterinarian in a European Union (EU) Member State or another designated country, containing official health information related to a specific pet. A passport is issued to a dog, cat, or ferret after it has been taken to an EU veterinarian and vaccinated. The purpose of the EU Pet Passport is to simplify travel between the EU Member States. An EU Pet Passport cannot be obtained in the U.S.

On December 14, 2022, the TSA offered tips for traveling with small pets through security checkpoints this holiday season. Furthermore, the USDA has requirements for importing pet dogs from foreign countries. In particular, dogs traveling to the U.S. from countries affected by specific diseases may need additional inspection and/or quarantine. Use this digital menu to determine if your destination State has particular import requirements.

Airline Compensation Policies

Issued by the U.S. on August 29, 2022, a digital dashboard ensures that travelers have access to U.S. airlines' services to mitigate passenger inconveniences when the cause of a cancellation or delay was due to circumstances within the airline's control.

Traveler-based Genomic Surveillance

The CDC's Traveler-based Genomic Surveillance (TGS) program anonymously collects two nasal swab samples from consenting international travelers arriving at U.S. airports. The nasal sampling multipathogen pilot program tests people for Flu A/B, RSV, SARS-CoV-2, and 30 additional priority pathogens. As of September 2023, the TGS program had enrolled more than 360,000 air travelers from more than 135 countries. As of November 6, 2023, Ginkgo Bioworks and XpresCheck will implement the program in selected airports. 

9 min read
Last Reviewed: 
Wednesday, October 1, 2025 - 04:00
Description: 
Vaccine certificates, digital passports and visas are required in 2025
Condition: 

Content Creation Staff

Content Creation Team

The Precision Vax LLC Fact-Checkers and Contributing Experts have been led by medical director Dr. Robert Carlson and publisher Donald Hackett since 2016.

  • Holly Lutmer, PharmD, Senior Editor
  • Michelle Beall, PharmD
  • Beth Bolt, RPh
  • Chris Felton, PharmD
  • Lytle Germann, PharmD
  • Natasha Gildersleeve, PharmD
  • Ashton L. Goode, PharmD
  • Allison Hall, PharmD
  • Shane Kyral, PharmD
  • Kelley Lu, PharmD
  • Cynthia N Nguyen, PharmD
  • Paul Nguyen, PharmD
  • Lauren Ragan, PharmD
  • Danielle Reiter, RN
  • Kim Robenson, RPh
  • Chelsea K Sanchez, PharmD
  • John Paul Sanchez, PharmD
1 min read
Last Reviewed: 
Monday, March 6, 2023 - 04:55
Description: 
PVax founders deployed fact checking of doctor, pharmacist, and nurse reviewed health information in 1998.
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Zoonotic Influenza Vaccines 2023

Zoonotic Influenza Vaccines August 2023

Zoonotic influenza infections are caused by harmful germs, bacteria, parasites, and fungi, says the U.S. Centers for Disease Control and Prevention (CDC). These germs cause illnesses in people, birds, and animals, ranging from mild to severe infections, according to the World Health Organization (WHO). As of August 2023, the CDC says annual 'flu shots' do not prevent zoonotic influenza infections such as swine flu (H3N2) or Avian influenza (Bird Flu). In September 2023, the U.S. CDC published Volume 29, Number 9, Research: Interspecies Transmission of Swine Influenza A Viruses and Human Seasonal Vaccine-Mediated Protection Investigated in a Ferret Model - results reaffirm the need for continuous influenza A virus surveillance in pigs and identification of candidate human vaccine viruses.

The WHO's Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted in 2011 as a global approach to pandemic influenza preparedness and response. If a pandemic influenza A virus changes and becomes transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be significant. The CDC says the severity is unpredictable because human immune systems have not established natural defenses. The most recent pandemic occurred in 2009, caused by an influenza A (H1N1) virus. Estimates indicate that the pandemic caused up to 400,000 deaths globally, with about 12,000 people in the U.S. 

Pandemic Influenza Vaccine

In April 2007, the U.S. Food and Drug Administration (FDA) licensed the first inactivated influenza vaccine for people at increased risk of exposure to the H5N1 influenza virus subtype. It was derived from the A/Vietnam/1203/2004 influenza virus a, manufactured by Sanofi Pasteur Inc. Furthermore, four pandemic preparedness vaccines are authorized in Europe, which can be modified into pandemic influenza vaccines. The EMA conditionally Authorized AstraZeneca's Pandemic influenza vaccine H5N1 (P/LAIV) in May 2017 to prevent pandemic influenza in children and adolescents. Companies operating in the global swine flu vaccine market are Novartis AG, CSL Limited, Zydus Cadila, AstraZeneca plc, MedImmune, GlaxoSmithKline, Sanofi SA, Baxter, and Sinovac Biotech Ltd.

Bird Flu Vaccine

Avian influenza vaccine news is published on this webpage.

Swine Influenza (Swine Flu)

When a swine influenza virus (H3N2) is detected in a person, it is called a "variant influenza virus," says the CDC. When animal influenza viruses infect their natural host, they are named for that host, as in avian influenza viruses, swine influenza viruses, equine influenza viruses, etc. In 2005, human infection with the novel flu A virus became nationally notifiable in the United States. The term "swine flu" refers to swine influenza viruses infecting swine. There are different swine influenza virus subtypes and strains, some of which infect other animal species, including (rarely) humans. Most human infections with variant influenza viruses occur following proximity to swine. However, human-to-human transmission can occur, says the CDC. For recommendations on safe trade in animals and related products from countries affected by these influenza viruses, refer to WOAH guidance

The first swine influenza virus was found in pigs in 1918. Since 2005, 512 variant influenza virus infections (of different influenza A virus subtypes), including 37 (human infections with influenza A (H1N2)v viruses, were reported in the U.S. The CDC published an interactive analysis of Novel Influenza A Virus Infections in the U.S. A study (Volume 29, Number 9) published by the CDC in September 2023, results reaffirmed the need for continuous influenza A virus surveillance in pigs and identification of candidate human vaccine viruses.

On September 2, 2023, the Ministry of Health, Welfare, and Sport of the Netherlands notified the WHO of a laboratory-confirmed human infection with a swine-origin influenza A(H1N1) variant virus. On August 4, 2023, the CDC reported the first two U.S. human infections with swine flu viruses who attended different agricultural fairs in Michigan in 2023 and had exposure to pigs. On June 7, 2023, Brazil notified the WHO of a fatal laboratory-confirmed human case of infection with a swine-origin influenza A(H1N1) variant (v) virus in the inner state of Paraná. It's the third swine flu fatality. Taiwan's CDC reported its third H1N2 variant (H1N2v) influenza virus case in May 2023 involving girls who had contact with pig farms in central Taiwan. India reported 451 cases of H3N2 from January to March 5, 2023.

African Swine Fever

African Swine Fever (ASF) is a highly contagious and deadly viral disease affecting domestic and feral swine of all ages. The U.S. Department of Agriculture and the FDA say ASF cannot be transmitted from domestic and wild pigs to humans.

Langya Henipavirus

Langya henipavirus (LayV), also known as Langya virus, is a species of henipavirus detected in China's Shandong and Henan provinces. Media reports indicated that 35 people were infected from 2018 to August 2022. Hendra virus and Nipah virus from this genus are known to infect humans, with fruit bats as the natural host of both viruses.

5 min read
Last Reviewed: 
Thursday, September 14, 2023 - 11:25
Description: 
Zoonotic diseases such as swine and bird influenza pandemic in 2023.
Condition: