Vaccine News

The U.S. Centers for Disease Control and Prevention (CDC) recently reported that fall 2023 respiratory hospitalization 'triple-demic' may not actually occur this year.

On October 26, 2023, the CDC stated it continues to anticipate that the upcoming fall and winter respiratory disease season will likely result in a similar number of hospitalizations as last season.

The CDC wrote .....We continue to have low-to-moderate confidence in this assessment due to uncertainties anticipating the timing and levels of peak disease activity. As of October 20, 2023, respiratory virus activity in the U.S. is low nationally.

Although COVID-19 activity continues to decline in many areas of the United States and globally, it remains the cause of most new respiratory virus hospitalizations and deaths.

Additionally, sustained increases in RSV activity in the southern U.S. indicate the start of the 2023-2024 RSV season, with the mid-Atlantic and Northeastern regions also experiencing elevated activity.

RSV activity remains in line with normal seasonal patterns before the emergence of the SARS-CoV-2 coronavirus.

Furthermore, influenza activity remains low in most areas of the country, but small increases were reported in some places.

According to recent influenza outbreak modeling by the Scenario Modeling Hub, influenza hospitalizations will likely fall within the range observed from 2010 – 2020.

The World Health Organization's (WHO) recent report indicates the CDC's revised forecast is on-target. On October 16, 2023, the WHO published Influenza Update N° 456, showing that influenza and RSV detections remained low globally.

According to the CDC, vaccination remains the best way to protect yourself and your loved ones against serious disease outcomes. As of October 30, 2023, various flu shots and other vaccines are generally available at health clinics and pharmacies in the U.S.

To mark World Polio Day on October 24, 2023, supporters from over 30 countries joined the Make Polio History campaign to tell governments that eradication is possible and urgently needed. 

According to the U.S. Centers for Disease Control and Prevention (CDC), there are thirty-one countries reporting polio cases in 2023.

The CDC says polio is a crippling and potentially deadly disease that affects the nervous system. Some people have only minor symptoms, such as fever, tiredness, nausea, headache, nasal congestion, sore throat, cough, stiffness in the neck and back, and pain in the arms and legs.

In rare cases, polio infection causes permanent loss of muscle function (paralysis). Polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain.

Countries are deploying an innovative, novel oral polio vaccine type 2 (nOPV2) to better address the evolving risk of type 2 circulating vaccine-derived poliovirus (cVDPV2).

The vaccine is a modified version of the type 2 monovalent OPV vaccine, which clinical trials have shown provides comparable protection against poliovirus while being more genetically stable and less likely to be associated with the emergence of cVDPV2 in low immunity settings.

Thus, nOPV2 can be a significant tool for more sustainably stopping polio outbreaks.

As of October 29, 2023, approximately 820 million doses of nOPV2 had been administered across 35 countries. An additional 16 countries have met the requirements for using nOPV2 in the event of a polio outbreak.

However, the nOPV2 is not authorized by the U.S. Food and Drug Administration.

Since 2000, the only polio vaccine used in the U.S. is the inactivated polio vaccine (IPV), which protects against severe disease, including paralysis. IPVs are generally available at clinics and pharmacies in the U.S.

While the World Health Organization (WHO) Influenza Update N° 456 says respiratory syncytial virus (RSV) activity was generally low or decreasing globally, new data indicates the United States is seeing measurable increases.

The U.S. Centers for Disease Control and Prevention (CDC) RSV detection graphs showed increases throughout the U.S. as of October 27, 2023.

The National Respiratory and Enteric Virus Surveillance System (NREVSS) reports that the weekly percentage of RSV polymerase chain reaction (PCR) test positivity was 10.9% as of October 21, 2023.

During the 2022–2023 RSV season, positive test results peaked in November.

From an age perspective, the Weekly Emergency Department Visits chart clearly indicates that the most affected by this RSV season have been children under one-year-old.

In 2022, the JAMA Network conducted an Original Investigation that found 96 (95% CI, 92-99) RSV deaths among children younger than one year. And a study published by the Journal of Infectious Diseases determined that RSV-related deaths in infants <1 year peaked at about one month.

Furthermore, a meta-analysis of eleven studies published in October 2023 found that the meta-estimate of RSV-positive tests among pregnant women was  3.4%  (95% CI: 1.9; 54).

According to the CDC, RSV has geographic trends in the U.S.

Florida's RSV season is longer than the rest of the country and has distinct regional patterns.

The Florida Department of Health reported as of week #42, October 21, 2023, RSV activity was increasing in hospital admissions and emergency room rates, with current outbreaks in Martin (1), Pinellas (2), and Volusia (1). 

Fortunately, for the first time, there are approved RSV vaccines and passive immunizations available in the U.S. this season.

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.