Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Jul 26, 2024 • 1:13 pm CDT

High-Dose Quadrivalent Vaccine Remains Preferentially Recommended to Protect Seniors in Canada

by Tung Lam

As flu shots arrive in local pharmacies next month, Canadians will have different vaccines to choose which is best for their needs.

To assist this decision process, the Canadian National Advisory Committee on Immunization’s (NACI) annual Statement on Seasonal Influenza Vaccines for 2024-2025 recommends Fluzone® High-Dose Quadrivalent among the preferential influenza vaccines over standard-dose influenza vaccines.

According to NACI on July 26, 2024, Fluzone® High-Dose Quadrivalent has the most substantial body of supporting evidence among preferentially recommended vaccines for adults 65 years of age and older.

Dr. Angel Chu MD, FRCPC, Infectious disease specialist, Clinical Assistant Professor, University of Calgary, STI Clinic Calgary, and Vice-Chair of Immunize Canada, commented in a press release, “In the newest NACI statement, Fluzone® High-Dose continues to be recommended for adults 65 years of age and older. NACI also recognizes Fluzone® High-Dose has the most substantial body of supporting evidence among flu vaccines for seniors.”

Influenza can cause mild to severe illness. Some populations, especially young children and adults 65 and older, are at a higher risk for serious influenza complications.

Sanofi says vaccination is the most effective way to prevent influenza and its complications.

Earlier this year, the WHO recommended that trivalent vaccines be deployed during the 2024-2025 northern hemisphere influenza season.

On June 27, 2024, the U.S. Centers for Disease Control and Prevention vaccine committee meeting included presentations focused on Considerations and Proposed Recommendations for the 2024-25 Influenza Season in the United States. Physicians, nurses, and pharmacists can offer patients up to nine different influenza vaccines for the 2024 - 2025 flu season.

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Don Ward Hackett

Jul 26, 2024 • 6:32 am CDT

Universal Immunization Program for Infants During Ontario's RSV Season

by Scott Webb

The Ontario Ministry of Health has announced the first publicly funded universal program with Beyfortus® (nirsevimab) for all newborns and infants born in 2024 and through the 2024-2025 respiratory syncytial virus (RSV) season in the Northern Hemisphere.

Beyfortus single-dose administration can be timed to the start of the RSV season.

RSV is a common respiratory virus that often impacts children and can lead to lung infections such as bronchiolitis and pneumonia.

As of July 25, 2024, this new passive immunization program also includes some high-risk children up to 24 months old.

Beyfortus is administered directly to newborns and infants and offers rapid protection via an antibody without requiring immune system activation.

Delphine Lansac, General Manager, Vaccines, Sanofi Canada. commented in a press release on July 25, 2024, "Today's announcement by the Government of Ontario is a significant milestone. Providing universal access to Beyfortus® to help protect all infants in Ontario means that parents can focus on the joys of a new baby and worry less about experiencing a severe RSV infection."

"This new program builds on our 110-year heritage as a committed partner supporting public health in Canada. Our objective continues to be protecting the health of Canadians with innovative solutions and introducing Beyfortus® is a step forward to protect babies and make a positive difference for families and the healthcare system."

Health Canada issued a Notice of Compliance for Beyfortus in April 2023. Additionally, the single-dose, extended half-life monoclonal antibody was approved by the U.S. FDA in July 2023 and the European Union in October 2022.

According to media reports, access to Beyfortus is expected to meet demand in the United States during the second half of 2024.

AstraZeneca, responsible for Beyfortus manufacturing, confirmed regulatory applications for two additional filling lines have been submitted to health authorities to expand supply. This production expansion is anticipated to augment capacity compared to the one licensed line.

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Karen McClorey Hackett

Jul 26, 2024 • 5:50 am CDT

2-Dose Mpox Vaccination Up to 90% Effective

by Pete Linforth

Bavarian Nordic A/S today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the approval of a type II variation for IMVANEX® (MVA-BN, JYNNEOS®) smallpox and mpox vaccine.

This EMA recommendation includes real-world effectiveness data from the use of the vaccine during the global 2022 mpox outbreak in the marketing authorization.

In real-world studies, vaccine effectiveness against mpox disease was demonstrated at least 14 days after vaccination, with adjusted vaccine effectiveness estimates ranging from 35% (95% CI, -2-59) to 89% (95% CI, 76-95) after one MVA-BN dose and from 66% (95% CI, 47-78) to 90% (95% CI, 86-92) after two MVA-BN doses.

Furthermore, in a surveillance study, MVA-BN reduced the risks of mpox-related hospitalization.

Compared with unvaccinated mpox patients, the odds of hospitalization were 0.27 (95% CI, 0.08-0.65) after one MVA-BN dose and 0.20 (95% CI, 0.01-0.90) after two MVA-BN doses. The estimated relative risk reduction was 73% after one MVA-BN dose and 80% after two MVA-BN doses.

“The 2022 global mpox outbreak provided an opportunity to assess the effectiveness of our vaccine in at-risk populations across different geographies, both before and after exposure to the mpox virus, and we are pleased to receive the recommendation to include real-life data in our marketing authorization in Europe, which confirm a high effectiveness of up to 90% after two doses of the vaccine as recommended by the authorities. It is furthermore encouraging that data show the vaccine to reduce the risk of hospitalizations significantly, thus confirming our vaccine as an important and versatile tool in the fight against mpox globally,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, in a press release on July 26, 2024.

As of July 2024, the JYNNEOS vaccine is commercially available in the United States.

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Don Ward Hackett

Jul 25, 2024 • 9:08 am CDT

RSV Monoclonal Antibody Sales Surpass $19 Million

by Ray Shrewsberry

Sanofi today announced strong performance and increasing sales growth. In Q2 2024, Sanofi's sales were €10,745 million, up 10.2%.

In a press release on July 25, 2024, Paul Hudson, CEO, commented, “We are continuing our strong performance in 2024 and delivered broad-based, double-digit sales growth in the second quarter."

However, its very popular single-dose, extended half-life monoclonal antibody Beyfortus™ (Nirsevimab) offers passive immunization to prevent lower respiratory tract infections caused by the respiratory syncytial virus (RSV) to newborns and infants experiencing slow sales growth.

Beyfortus sales were limited to €18 million (USD $19.6), reflecting the global vaccine seasonality towards the second half-year. In the first quarter of 2024, Beyfortus produced €200 in sales.

In collaboration with AstraZeneca, responsible for Beyfortus manufacturing, the regulatory applications for two additional filling lines have been submitted to health authorities to expand supply for the Northern Hemisphere ahead of the 2024 - 2025 RSV season.

This production expansion is anticipated to augment capacity compared to the one licensed line.

According to media reports, access to Beyfortus is expected to meet demand in the United States during the second half of 2024.

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Don Ward Hackett

Jul 25, 2024 • 8:38 am CDT

Gavi 5.0 Strategy Targets Zero-Dose Children

Gavi 5.0 Strategy 2024

About 10% of children in Gavi-supported countries do not receive a single dose of routine vaccines.

To reach these missing millions, Gavi announced on July 11, 2024, that the 5.0 Strategy intends to reduce the number of zero-dose children by 25% by 2025 and 50% by 2030.

The new strategy will focus on reaching the most marginalized by strengthening primary healthcare systems, building and sustaining community demand, addressing gender barriers, and using innovation to ensure immunization services reach these children.

Available data suggests the largest disruptions were concentrated in Q2 2020, with the majority of countries restoring routine immunization services in the second half of the year. Over 75% of under-immunised children are now zero-dose, heightening the risk of child deaths, disease outbreaks, and medical impoverishment.

In 2000, just 47% of children in lower-income countries received essential vaccines.

In Gavi-eligible countries, coverage of critical vaccines increased by three percentage points from 2015 to 2019, and the number of zero-dose children was reduced by 14%.

In 2019, coverage for the same countries reached 82% before sliding back to 78% due to the pandemic.

According to data published by the World Health Organization and UNICEF, in 2022, 20.5 million children in India missed out on one or more vaccines delivered through routine immunization services.

Gavi wrote, 'The importance of immunization reaching all children is paramount and ensures all children have an equal chance of being healthy and productive members of society.'

'Vaccination, because of its preventative nature, averts illness and provides particularly significant benefits to zero-dose communities which may lack access to affordable, quality curative care while being at higher risk of vaccine-preventable diseases.'

'Immunised children are also more likely to grow up healthy and enjoy their survival and development rights. Vaccinated children have higher cognitive abilities, miss school less and are in school for longer, and have better nutrition and education outcomes – all of which translates into better-earning potential and productivity as an adult.'

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Karen McClorey Hackett

Jul 25, 2024 • 5:45 am CDT

JN.1 mRNA COVID-19 Vaccine for Adults and Children Approved in the U.K.

by Liza Popova

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) today approved an adapted Pfizer/BioNTech mRNA COVID-19 vaccine (Comirnaty) targeting the JN.1 COVID-19 subvariant.

On July 24, 2024, the MHRA announced four forms of this adapted Comirnaty JN.1 vaccine have been approved by the MHRA under the International Recognition Procedure after they were found to meet the U.K. regulator’s safety, quality, and effectiveness standards.

The MHRA confirmed that the vaccine administration differs between adults and children from infancy, depending on their age at the time of vaccination.

These forms are as follows:

Comirnaty JN.1 30 micrograms/dose dispersion for injection and Comirnaty JN.1 30 micrograms/dose dispersion for injection in a pre-filled syringe for use in adults.

Comirnaty JN.1 10 micrograms/dose dispersion for injection, single-dose vial for use in children from 5 to 11 years of age.

Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial for use in infants and children from 6 months to 4 years of age.

If a patient experiences any Comirnaty-related side effects, they should talk to their doctor, pharmacist, or nurse. A full list of all side effects reported with this medicine is available in the patient information leaflet, which can be obtained from the pharmacy or the product information published on the MHRA website.

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Karen McClorey Hackett

Jul 24, 2024 • 12:36 pm CDT

140% Increase in Measles Cases Confirmed

US CDC measles outbreak map July 2024

The International Journal of Infectious Diseases recently published a new study conducted by Columbia University that revealed a 140% surge in measles cases worldwide from 2010 to 2019 across 194 member countries of the World Health Organization.

In a Short Communication dated July 22, 2024, the researchers highlighted that decreasing vaccination rates in 59 of the 194 nations were attributed to socio-economic issues in some less developed countries and vaccine hesitancy in wealthier nations.

In July 2024, the U.S. Centers for Disease Control and Prevention (CDC) listed the top ten international measles outbreaks led by Azerbaijan, Kazakhstan, Iraq, and India. In total, the CDC listed 52 countries.

"Our analysis also suggests vaccine hesitancy may substantially contribute to the recent increases in measles incidence in wealthier countries. For instance, recent measles outbreaks in Europe and the United States have been linked to international travel and communities with prevailing vaccine skepticism,' wrote these researchers.

As of July 11, 2024, a total of 167 measles cases were reported by Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New Mexico, New York City, New York State, Ohio, Oregon, Pennsylvania, Vermont, Virginia, Washington, West Virginia, and Wisconsin.

The CDC reports 13 measles outbreaks in 2024, compared to 4 outbreaks reported in 2023.

Various U.S. FDA-approved measles vaccines are generally available at pharmacies in the United States.

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Don Ward Hackett

Jul 24, 2024 • 11:02 am CDT

Lenacapavir Shows 100% Efficacy and Zero Infections in HIV Prevention

by Mircea Iancu

Gilead Sciences, Inc. today announced full efficacy and safety results from its pivotal HIV-1 Phase 3 clinical trial.

Detailed data from the trial’s interim analysis announced in June 2024 showed that lenacapavir, the company’s twice-yearly injectable HIV-1 capsid inhibitor, demonstrated zero infections, 100% efficacy, and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women.

Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada.

The new data provide details on the efficacy, safety, and tolerability of twice-yearly lenacapavir injections; drug adherence among trial participants, including poor levels of adherence to daily oral pre-exposure prophylaxis (PrEP) and high levels of adherence to lenacapavir; and demographic and behavioral characteristics of trial participants, including pregnant women and adolescents.

The data were published today in The New England Journal of Medicine.

“These stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,” said Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and former President of the International AIDS Society, in a press release on July 24, 2024.

“PURPOSE 1 also sets a new standard for person-centered HIV prevention trials, demonstrating what can happen when a thoughtful scientific and community-focused trial design, a promising drug candidate, and an inclusive trial implementation plan come together.”

Gilead expects results in late 2024/early 2025 from the program’s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP among men.

Currently, there are no cures for HIV or AIDS or preventive vaccines available.

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Karen McClorey Hackett

Jul 24, 2024 • 7:10 am CDT

Quebec Recommends RSV Vaccines Including AREXVY

by Claudia Peters

The Committee on Immunization of Quebec (CIQ) today recommended using RSV (respiratory syncytial virus) vaccines, including AREXVY™, to prevent RSV among older adults at increased risk of severe outcomes from the virus.

Specifically, CIQ recommends vaccination for older adults living in residential and long-term care centers, intermediate resources, adults aged 75 and older living in private seniors’ residences, and those living in the community with chronic illnesses.

The CIQ recommendations for RSV vaccination follow those issued by the National Advisory Committee on Immunization, published earlier in July 2024.

Marni Freeman, Country Medical Director, GSK Canada, said in a press release on July 24, 2024, “As our immune system ages, we all become more vulnerable to severe consequences of RSV disease."

"Older adults who are immunocompromised or suffer from underlying medical conditions, such as chronic heart or lung disease, are at an even greater risk.

"The CIQ recommendation reflects the important role AREXVY can play in reducing the incidence and overall burden of respiratory syncytial virus among Quebec’s older adult population, and we look forward to collaborating with public health officials, healthcare professionals, and payers to ensure optimal vaccine access in the province.”

AREXVY was approved in Canada in August 2023 and is indicated for preventing lower respiratory tract disease caused by RSV in individuals 60 and older.

This vaccine (May 2023), two other RSV vaccines, and one monoclonal antibody for infants have been approved for use in the United States.

RSV is a common, contagious virus that affects the lungs and respiratory airways. For most people, the virus causes cold-like symptoms. Still, for older adults and adults with certain health conditions, it can lead to more serious infections and complications such as pneumonia, hospitalization, and even death, says the CIQ.

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Karen McClorey Hackett

Jul 23, 2024 • 2:48 pm CDT

Pertussis Cases Increase 300% in 2024

PAHO Epidemiological alert - Pertussis - July 22, 2024

The Pan American Health Organization (PAHO) reported yesterday a significant increase in pertussis (whooping cough) cases in the Region of the Americas.

On July 22, 2024, the PAHO confirmed that 7,251 pertussis cases were reported in the United States in 2024, a 300% increase from last year.

Pertussis cases in Mexico are 242% higher than reported in 2023. Brazil and Peru are also reporting measurable case increases.

In the Region of the Americas, 2012 was the year with the highest number of cases reported during the decade, with 72,328 reported cases of pertussis. Since then, there has been a progressive annual decrease in the reported cases, reaching the lowest number reported in 2022, with 3,283 pertussis cases.

The first and third doses of diphtheria, tetanus, and pertussis vaccines (DTP1 and DTP3) are commonly used as tracers of immunization coverage. The coverage trend for both first and third doses has shown a significant decline.

The year 2021 was the lowest coverage year in the Region of the Americas compared with the previous 20 years. However, updated vaccine coverage data for 2023 reported a recovery of 90% for DTP1 and 88% for DTP3.

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Don Ward Hackett

Jul 23, 2024 • 2:32 pm CDT

Six Oropouche Virus Disease Cases Confirmed in Europe

WHO Cuba map 2024

According to the European CDC, Italy and Spain each reported three confirmed cases of Oropouche virus disease in travelers returning from Cuba.

The ECDC stated on July 12, 2024, that the likelihood of secondary transmission of the Oropouche virus within continental Europe is considered very low due to the absence of known competent vectors, midges (small flies), and mosquitoes, commonly found in the Region of the Americas.

To alert international travelers, the U.S. CDC issued a Level 1 Travel Health Advisory in June 2024. This advisory stated that people should seek medical care if they develop high fever, headache, muscle aches, stiff joints, nausea, vomiting, chills, or sensitivity to light during or after travel.

As of July 23, 2024, no U.S. FDA-approved vaccines for Oropouche virus disease exist.

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Don Ward Hackett

Jul 23, 2024 • 10:31 am CDT

Another RSV Monoclonal Antibody Candidate Protects Infants

by Tung Lam

Globally, respiratory syncytial virus (RSV) is the leading cause of hospitalization for healthy infants under a year old and causes an estimated 101,000 deaths a year in children under five.

To address this significant health risk, Merck today announced positive topline results from its Phase 2b/3 clinical trial evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody (mAb) designed to protect infants from respiratory syncytial virus (RSV) disease.

Clesrovimab met its primary safety and efficacy endpoints in the trial, including reducing medically attended lower respiratory infections caused by RSV through Day 150.

Clesrovimab is being studied in infants (pre-term and full-term) to provide rapid, durable protection through their first RSV season with a single, fixed-dose administration.

“RSV is highly contagious and can cause inflammation in the airways of infants, leading to difficulty breathing. As a widespread illness globally, RSV is the leading cause of hospitalization for healthy infants,” said Dr. Paula Annunziato, senior vice president of infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, in a press release on July 23, 2024.

“We are encouraged by these findings and look forward to working with regulators to provide a new option to help address the impact of RSV on infants and their families."

For the 2024-2025 RSV season, the U.S. FDA-approved Beyfortus™ (Nirsevimab) mAb offers passive immunization to prevent lower respiratory tract infections caused by the RSV to infants experiencing their first or second RSV season and those with congenital heart disease or chronic lung disease.

Additionally, one vaccine has been approved for pregnant women, which offers RSV protection to newborns.

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Karen McClorey Hackett

Jul 22, 2024 • 2:01 pm CDT

Local Dengue Cases Increase in the Islamic Republic of Iran

US CDC map 2024

In the WHO Eastern Mediterranean Region, dengue outbreaks continue to be reported in 2024. The Ae. aegypti and some Ae. albopictus dengue virus-carrying mosquitoes have been identified in most of the countries in this region.

On July 17, 2024, the WHO Disease Outbreak News reported 12 autochthonous (local) cases of dengue documented in Iran, all of which were reported in Bandar-Lengheh, Hormozgan Province.

Additionally, there have been 137 travel-related dengue cases in 2024.

Iran reported an average of 20 imported dengue cases annually between 2017 and 2023.

Furthermore, WHO does not recommend any general travel or trade restrictions in Iran based on the available information.

The WHO recommends that vaccination against dengue be part of an integrated strategy to control the disease, including vector control, proper case management, community education, and community engagement.

WHO recommends that countries consider introducing the second-generation QDENGA® (TAK-003) vaccine into their routine immunization programs in locations where high transmission intensity of dengue poses a significant public health problem.

WHO does not currently recommend the programmatic use of TAK-003 in young children.

As of July 22, 2024, the QDENGA vaccine is not authorized for use in the United States.

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Don Ward Hackett

Jul 22, 2024 • 1:19 pm CDT

U.S. Spends $113 Million for Oral Mpox Smallpox Treatment

by Pete Linforth

The U.S. government recently exercised a procurement option to enhance orthopoxvirus preparedness against mpox and smallpox outbreaks.

On July 19, 2024, SIGA Technologies, Inc. announced that the U.S. Department of Health and Human Services (HHS) ordered the delivery of approximately $113 million of oral TPOXX® (tecovirimat) treatment courses.

“Building on the orders received in 2023 from the U.S. government and 15 international customers, this $113 million order from the U.S. government will enhance orthopoxvirus preparedness and support sizable and consistent action when needed to help ensure public health from natural, accidental, or intentional threats,” said Diem Nguyen, Chief Executive Officer, in a press release.

TPOXX is an antiviral medicine approved by the U.S. Food and Drug Administration (July 2018) specifically for treating smallpox disease in adults and pediatric patients weighing at least 13 kg.

Following U.S. approval, Health Canada also authorized TPOXX for the treatment of mpox and smallpox and authorized in Europe and the UK to treat smallpox, mpox, cowpox, and vaccinia complications.

As of July 22, 2024, mpox vaccines were also approved by the U.S. FDA and are available in the United States, Canada, and various countries.

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Don Ward Hackett

Jul 20, 2024 • 2:09 pm CDT

95% of Prenatal Zika Infections Could Be Undiagnosed in Infants

from Pixabay

With over 24,600 Zika virus cases already confirmed in the Region of the Americas in 2024, a new study published by the journal eBioMedicine, part of The Lancet, disclosed new, unsettling insights.

The Cleveland Clinic announced that this study revealed that maternal Zika virus infections can reprogram fetal immune development, leading to long-term consequences in children's immunity.

On July 18, 2024, the Clinic stated that these changes may occur in children born without the physical characteristics associated with congenital Zika syndrome, such as microcephaly.

This finding suggests that 95% of babies born from Zika-infected pregnancies who did not exhibit symptoms may have been affected by the virus with long-term immunological repercussions.

Additionally, heightened inflammation was observed in Zika-exposed infants with abnormalities at birth, while children exposed to Zika later maintained a chronic Th1-biased immune profile. The impaired response to Th2-biased vaccines raises concerns about the lasting effects of Zika virus exposure on immune responses.

Suan-Sin (Jolin) Foo, PhD, an expert in maternal-fetal virology and the Zika virus, says babies without symptoms are deemed healthy and do not receive any follow-up medical care or attention.

“Studies have only really focused on what’s happening with the children who were born with visible physical conditions like microcephaly or neurological complications,” Dr. Foo commented in a press release.

“The rest of these kids may not even have a note on their chart mentioning that their mother was infected during pregnancy. Unless they’re part of our study, they’re essentially lost to the medical field.”

Dr. Foo added, “Our study clearly shows there’s much more to this condition than meets the eye. We need to expand diagnostic criteria and conduct more research to ensure these immunologically vulnerable children get the necessary care.”

From a prevention perspective, no Zika vaccine candidate has been approved by the U.S. FDA as of July 2024.

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Karen McClorey Hackett