Vaccine News

A new World Health Organization (WHO) project aims to accelerate the development and accessibility of human avian influenza (H5N1) messenger RNA (mRNA) vaccine candidates.

The Argentinian manufacturer Sinergium Biotech is leading this effort, leveraging the WHO and the Medicines Patent Pool mRNA Technology Transfer Programme.

Sinergium Biotech has developed candidate H5N1 vaccines and aims to establish proof-of-concept in preclinical models. Once the preclinical data package is concluded, the technology, materials, and expertise will be shared with other vaccine manufacturing partners, accelerating the development of H5N1 vaccine candidates and bolstering pandemic preparedness efforts.

The mRNA Technology Transfer Programme, jointly developed by WHO and MPP, was launched in July 2021.

"This initiative exemplifies why WHO established the mRNA Technology Transfer Programme – to foster greater research, development, and production in low- and middle-income countries so that when the next pandemic arrives, the world will be better prepared to mount a more effective and more equitable response," said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release on July 29, 2024.

Avian influenza viruses are a public health risk due to their global circulation in birds and mammals. According to the WHO, they have the potential to cause a future human pandemic.

However, the WHO says avian influenza viruses are currently a low risk for most people.

In the United States, avian influenza vaccines have been developed, candidates are under development, and one has been U.S. FDA-approved.

The U.S. Department of Health and Human Services recently published an amendment to a 2013 emergency declaration under the Food, Drug, and Cosmetic Act that broadens the scope of the agency's assistance in facilitating certain medical countermeasures in response to a public health emergency, such as a pandemic.

The new declaration enables the U.S. Food and Drug Administration (FDA) to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices, or products, among other actions, including vaccines.

As of July 18, 2024, the amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of avian influenza (bird flu, cow flu).

Previously, the declaration specifically covered just the H7N9 strain.

In June 2024, the U.S. Administration for Strategic Preparedness and Response announced the Pandemic Influenza Preparedness and Response Strategy. The Strategy outlines how the U.S. government will leverage existing infrastructures and capabilities to respond to the current Highly Pathogenic Avian Influenza H5N1.

In April 2024, the FDA's Dr. Peter Marks informed the media that the U.S. stockpile of avian influenza-specific vaccines would work well if deployed. Over the past few years, the U.S. has invested hundreds of millions of dollars in various bird flu vaccines.

As of July 27, 2024, FDA-approved avian influenza vaccines are not commercially available in the U.S.

The Minnesota Department of Health (MDH) recently confirmed three additional measles cases in unvaccinated children in Anoka, Hennepin, and Ramsey counties.

MDH stated that based on current information, these cases are not directly linked and have not traveled, so there is concern for the possible spread of measles in the community.

As of July 26, 2024, Minnesota has confirmed 15 measles cases in 2024, and is an increase compared to other years. All the cases have occurred among unvaccinated children.

Minnesota isn’t the only state to have seen an increase in measles cases. Just to the south, Chicago, Illinois, reported a significant outbreak (64 cases) this year.

MDH is working with local health departments and other locations to notify people who may have been exposed directly. However, health officials note that anyone not vaccinated against measles could be at risk and should watch for symptoms of measles.   

“Measles spreads easily, and it finds those who are vulnerable,” said Jessica Hancock-Allen, infectious disease division director at MDH, in a press release.

“That is why families need to ensure their children are up to date on their immunizations to protect them from this potentially serious disease.” 

"The best way to prevent measles is through immunization."

Measles vaccines are generally available at clinics and pharmacies throughout the U.S.

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.

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.

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. 

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.