Travel Vaccine Breaking News

Moderna, Inc. recently announced that the first participant has been dosed in a Phase 3 study of the Company's combination vaccine candidate against influenza and COVID-19 (mRNA-1083) in the U.S.

As of October 24, 2023, the Phase 3 study is expected to enroll approximately 8,000 adults and will evaluate the immunogenicity, safety, and reactogenicity of mRNA‐1083 as compared with active control, co‐administered licensed influenza and SAR‐CoV‐2 vaccines in two independent age‐group sub‐study cohorts.

The mRNA-1083 candidate selected to advance to Phase 3 achieved hemagglutination inhibition antibody titers similar to or greater than those of both licensed quadrivalent influenza vaccines and SARS-CoV-2 neutralizing antibody titers similar to those of the Spikevax bivalent booster in the Phase 1/2 study.

mRNA‐1083 has the potential to efficiently reduce the overall burden of acute viral respiratory diseases by providing simultaneous protection against influenza and SARS‐CoV‐2 viruses in a single injection.

mRNA‐1083 offers greater convenience and has the potential to lead to increased compliance with vaccine recommendations.

This approach could benefit public health by synergistically increasing coverage rates against influenza and SARS‐CoV‐2 viruses.

The Company continues to target a potential initial regulatory approval for the combination vaccine in 2025.

Pfizer Inc. and BioNTech SE today announced positive topline results from a Phase 1/2 clinical study evaluating the safety, tolerability, and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults.

The data from the trial showed that the companies' lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains.

The topline results of the ongoing trial demonstrated that the combination formulations evaluated had a safety profile consistent with the safety profile of the companies' COVID-19 vaccine.

In the Phase 1/2 clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit.

A pivotal Phase 3 trial evaluating these lead formulations is expected to be initiated in the coming months.

"Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases. Co-infections and consecutive respiratory infection during this period can further increase the risk of severe illness," said Prof. Ugur Sahin, MD, CEO and Co-founder of BioNTech, in a press release on October 26, 2023. 

"Combination vaccines have the potential to become a mainstay of routine vaccination against respiratory diseases, especially for the vaccination of populations with a higher risk of severe illness."

Immunogenicity results induced by lead formulations in the companies' phase 1/2 trial showed point estimates for Geometric Mean Titer (GMT) ratios consistent with the criteria applied to regulatory-approved vaccines against the respective influenza and SARS-CoV-2 strains.

Point estimates for GMT ratios for all matched influenza vaccine strains with lead formulations were >1 relative to a licensed Quadrivalent Influenza Vaccine given concomitantly with the Pfizer-BioNTech COVID-19 vaccine.

Pfizer and BioNTech previously announced that their mRNA-based combination vaccine candidate for influenza and COVID-19 received Fast Track Designation from the U.S. Food and Drug Administration.

For the 2023-2024 flu season in the U.S., 136.94 million influenza vaccine doses had been distributed as of October 14, 2023.

In a study published in The New England Journal of Medicine, clinicians and researchers show that passive immunization by administering plasma taken from convalescent donors after infection with the SARS-CoV-2 coronavirus to patients suffering from acute respiratory distress syndrome requiring artificial mechanical ventilation significantly reduced mortality by 10%.

The effect on reducing mortality was more specifically observed in patients who received convalescent plasma during the first 48 hours after being put on artificial respiratory assistance.

The randomized phase 2 clinical trial involved 17 intensive care units in Belgian hospitals. It included a total of 475 patients from October 2020 to March 2022. 

Thanks to the collaboration of the Belgian Red Cross and the laboratories of the KULeuven, UAntwerpen, and ULiège, the intensive care units of the study's partner hospitals were able to use convalescent plasma with high neutralizing antibody titres of 1/320 for 82.3% of patients and 1/160 for the remaining 17.7%.

"For the first time, we have demonstrated the therapeutic value of convalescent plasma in improving these patients' very poor vital prognosis. The reduction in mortality, of the order of 10%, is particularly noticeable in patients who were given convalescent plasma rapidly after the start of artificial respiratory ventilation", explains Dr. Benoît Misset, head of the intensive care unit at the CHU of Liège and Assistant Professor at the Faculty of Medicine at the University of Liège, who is responsible for and first author of this study.

"This study documents and confirms the value of convalescent plasma for passive immunization, but also against possible pathogenic variants and possibly in the event of future pandemics," wrote these researchers on October 25, 2023.

GSK plc today announced positive preliminary results from its phase III clinical trial evaluating the immune response and safety of the AREXVY™ respiratory syncytial virus (RSV) vaccine in adults aged 50 to 59, including those at increased risk of RSV lower respiratory tract disease (LRTD) due to certain underlying medical conditions.

In this study, the vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that were non-inferior to that observed in adults aged 60 and above, meeting the trial's primary co-endpoint.

Vaccine efficacy has previously been demonstrated in adults aged 60 and above.

The co-primary endpoint was also met for the broader group of adults aged 50 to 59 also enrolled in the trial. Safety and reactogenicity data were consistent with results from the initial phase III program.

The most common local adverse event was pain, and the most common systematic adverse events were fatigue and headache, most of which were transient and mild in intensity.

These results will be presented at the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices meeting on October 25, 2023.

AREXVY is currently approved in the United States, Europe, Japan, and several other countries for active immunization for the prevention of RSV-LRTD in adults 60 years of age and older. 

AREXVY recombinant, AS01E adjuvanted, single dose, RSV vaccine contains a recombinant subunit pre-fusion RSV glycoprotein antigen (RSVPreF3) combined with GSK's proprietary ASO1 adjuvant. 

Tony Wood, Chief Scientific Officer, GSK, said in a press release on October 25, 2023, "This trial reinforces our confidence in our RSV vaccine's ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD."

"We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time."

There is a substantial burden of RSV-associated illness for adults at increased risk for RSV disease due to advanced age, immunocompromised status, or underlying medical conditions, such as chronic obstructive pulmonary disease, asthma, and chronic heart failure. RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.

The final results from this trial will be presented at an upcoming medical conference and submitted for peer-reviewed publication. The data will also be submitted to the US Food and Drug Administration and other regulators to support potential label expansions.

The Federal Republic of Nigeria today announced the introduction of the human papillomavirus (HPV) vaccine into its routine immunization system.

The west African country of Nigeria aims to reach 7.7 million girls aged 9–14 in a vaccination drive against HPV types 16 and 18 that cause most cervical cancer cases. 

As of October 24, 2023, this is the most significant number in a single round of HPV vaccination in the African region. 

The second phase of the vaccination introduction is set to start in May 2024.

"The loss of about 8,000 Nigerian women yearly from a preventable (sexually transmitted) disease is completely unacceptable," says Muhammad Ali Pate, the Coordinating Minister of Health & Social Welfare, in a related press release.

A five-day mass vaccination campaign in schools and communities will be carried out during the inaugural rollout in 16 Nigerian states and the Federal Capital Territory.

The Federal Ministry of Health provides the vaccine for free through the National Primary Health Care Development Agency with support from Gavi, the Vaccine Alliance, United Nations Children's Fund (UNICEF), World Health Organization (WHO), and other partners.  

WHO recommends that HPV vaccination be included in the national immunization programs of countries where cervical cancer is a public health priority and its cost-effective and sustainable implementation is feasible.

The Lancet Oncology reported in September 2023 that African countries are home to 19 of 20 countries with the highest burden of cervical cancer. 

However, global supply shortages have slowed Gavi-supported HPV vaccine introductions.

These supply issues are now easing thanks to years of market-shaping efforts to develop a more robust HPV vaccine market and the single dose recommendation.

The Gavi board recently approved revitalizing its HPV vaccine program with an investment of over US$ 600 million by the end of 2025. With the additional funding, Gavi and its partners have set an ambitious goal to reach over 86 million girls by 2025, aiming to avert over 1.4 million future deaths from cervical cancer.

The WHO currently supports a one-dose regimen of the HPV vaccine for certain people.

The WHO's vaccine advisors recommend updating HPV dose schedules as follows: one or two-dose program for the primary target of girls aged 9-14, one or two-dose plan for young women aged 15-20, two doses with a 6-month interval for women older than 21, and immunocompromised individuals, including those with HIV, should receive three doses if feasible. 

As of October 2023, there are effective HPV vaccines that protect men and women against cancers caused by HPV. These approved vaccines include 9vHPV, 4vHPV, and/or 2vHPV.

The number of new HIV infections remains unacceptably high, and urgent new approaches are needed to advance HIV vaccine science. However, developing a preventive HIV vaccine has proven to be an intractable scientific challenge, wrote Prof Alexandra Trkola, PhD, and Prof Penny L Moore, PhD, in an article published by The Lancet Infectious Diseases.

This view was published on October 23, 2023, and stated, 'Recent advances in HIV immunogen design have taken the field closer to triggering the rare precursors of broadly neutralizing antibodies, which are widely assumed to be necessary for a vaccine.

Nonetheless, these same studies and previous studies in people living with HIV have also highlighted the significant hurdles that must be overcome to boost the cross-reactivity and potency of these responses to sufficient levels.

Here, we describe an opportunity for fast-tracking the evaluation of candidate preventive and therapeutic vaccines by immunizing people with HIV who are antiretroviral therapy suppressed.

We argue that such studies, unlike traditional studies of vaccines in participants not infected with HIV, will be faster and more informative and will allow the vaccine field to bypass multiple hurdles.

This approach will accelerate the process of defining the capacity of immunogens to trigger relevant antibodies, currently an extremely slow and expensive pathway, and provide a quick path to creating an HIV vaccine.'

The full, unedited article is posted at this link.

Following the discovery of HIV as a causative agent of AIDS, multiple HIV vaccine clinical trials have been conducted globally over the past 35 years. As of October 24, 2923, there are several HIV vaccine candidates conducting research. 

According to the U.S. National Institutes of Health, HIV vaccine candidates can not cause an HIV infection. 

Health experts recently warned of additional measles outbreaks occurring in 2023 after measles cases increased by about 80% worldwide last year.

Since measles is a very contagious virus, the threat to the United States continues to be closely monitored. 

Recently, the Illinois Department of Public Health (IDPH) reported a suspected case of measles was confirmed by Cook County Department of Public Health to IDPH. 

This unvaccinated individual was exposed to the measles virus internationally, and the infectious period would be between October 5 through October 13, 2023. IDPH says people can spread measles up to four days before and four days after a rash appears.

Before this case, the last measles case in Illinois was identified in 2019, when 9 cases were confirmed.

"This first reported case of measles in Illinois since 2019 is a reminder that this disease can be prevented with up-to-date vaccination," said IDPH Director Dr. Sameer Vohra in a press release.

"Two doses of measles vaccine are 97% effective in preventing measles. However, as we saw this week, it still can affect unvaccinated people."

"I urge everyone to make sure they and their family members are up-to-date on measles/mumps/rubella (MMR) vaccine and all other age-appropriate immunizations."

Measles is easily spread through the air when someone coughs or sneezes. People can also get sick when they come in contact with mucus or saliva from an infected person. Measles can cause serious complications such as pneumonia and encephalitis.  

In the U.S., the Centers for Disease Control and Prevention (CDC) reported 29 measles cases in 16 jurisdictions.

Internationally, the CDC listed the Top 10 Countries with Global Measles Outbreaks as of October 19, 2023. India, with 36,154 cases, and Yemen, with 28,271, lead this list.

 To alert international travelers, the CDC published an updated list of measles outbreak countries, travel vaccine recommendations, and issued a Level 1 - Practice Usual Precautions, Travel Health Advisory in September 2023.