Vaccine News

While the 2023-2024 flu season has yet to begin in the United States, influenza-related cases and fatalities continue to be reported from last season.

During week #28, 689 patients with laboratory-confirmed influenza were admitted to a hospital in the U.S., reported the Centers for Disease Control and Prevention (CDC).

And 1.2% of patient visits reported through ILINet were due to respiratory illness, including fever plus a cough or sore throat.

On July 21, 2023, the U.S. CDC reported the National Center for Health Statistics Mortality Surveillance data showed eight death certificates listed influenza as the underlying cause.

Additionally, the CDC reported one additional influenza-associated pediatric death occurred during the 2022-2023 flu season. This death was associated with an influenza B virus with no lineage determined and occurred during week #28 (the week ending July 15, 2023).

A total of 163 influenza-associated pediatric deaths occurred during the 2022-2023 flu season, which surpasses the 47 deaths reported for the 2021-2022 season in the U.S.

The CDC says an annual flu shot is the best way to prevent influenza infection. 

The recommended timing of vaccination is similar to last flu season. September and October are generally good times to get vaccinated.

For most people who need only one dose for the 2023-2024 season.

Note: All data in this CDC report are preliminary and may change as more reports are received.

GC Biopharma recently announced that its flu vaccine GC FLU Quadrivalent Pre-filled syringe Intramuscular was approved by the Egyptian Drug Authority (EDA).

As of July 18, 2023, this is the first approval the South Korea-based company had obtained for its flu vaccine from the Arab Republic of Egypt on the African continent. Egypt has one of the largest pharmaceutical markets in the African region.

Taking this EDA approval as an opportunity, GC Biopharma plans to expand its global presence further, which has been centering on Southeast Asia and Latin American regions to Africa and the Middle East.

Based on GC Biopharma's internationally recognized seasonal flu vaccine production technology, GC FLU has been expanding its export volume and number of markets yearly.

At the same time, the company will push ahead with entering into the private markets of individual countries based on its successful presence in the procurement markets of international organizations.

"The trend of moving away to quadrivalent flu vaccines is clear not only in the procurement market led by international organizations but also in the individual private markets," points out GC Biopharma in a press release on July 21, 2023, and further emphasizes, "We will target both international organizations' procurement markets as well as the private markets to draw synergy and boost our sales and profitability."

According to the company, the flu vaccine market divides into two parts: the procurement market of international organizations represented by the PAHO of WHO and the UNICEF; and the private markets of each country that supplies pharmaceuticals based on the approvals of respective authorities.

The WHO prequalified the GC FLU vaccine in 2016. There are nine manufacturers of WHO-prequalified influenza vaccines in 2023.

The journal Vaccines recently published the results from a study led by University of Pittsburgh scientists that found both recombinant influenza vaccine (RIV4) and standard-dose influenza vaccine (SD-IIV4) effectively prevent influenza hospitalization.

Of the 14,590 individuals included in the primary analysis, the overall RIV4 relative vaccine effectiveness (rVE) was significant when adjusted for propensity scores with inverse probability weights (rVE = 31; 95 % CI = 11 %, 46 %).

Among younger adults (18–64 years-old), overall rVE of RIV4 was significant (rVE = 29; 95 % CI = 4 %, 47 %).

These scientists wrote, "Both RIV4 and SD-IIV4 were significantly effective among all adults against influenza-related hospitalizations during the 2018–2019 and 2019–2020 influenza seasons."

"Relative vaccine effectiveness of RIV4 compared with SD-IIV4 was significant for all adults and younger and healthier recipients."

On June 27, 2023, the CDC Director adopted the 2023-2024 Advisory Committee on Immunization Practices’ recommendations on annual influenza vaccination for everyone six months and older in the United States.

The CDC's recommended timing of flu vaccination has not changed.

September and October are the best times for most people to get vaccinated. Flu vaccination in July and August 2023 is not recommended for most people.

Disclosures: The University of Pittsburgh Institutional Review Board approved this retrospective study using EMR databases. Drs. Zimmerman, Raviotta, Nowalk, and Balasubramani received investigator-initiated grant funding from Sanofi for this project. Drs. Nowalk and Balasubramani have grant funding from Merck & Co., Inc. for an unrelated project. 

The World Health Organization (WHO) today published its Weekly Epidemiological Update on COVID-19 Edition #152, which stated during this recent 28-day period, 56% (131 of 234) of countries and territories reported at least one case.

As of July 20, 2023, the WHO reported that while five WHO regions confirmed decreases in COVID-19 cases and deaths, the Western Pacific Region has reported a decline in cases but an increase in fatalities.

At the country level, the highest numbers of new 28-day cases were reported from the Republic of Korea (372 557 new cases; -22%), Australia (62 748 new cases; -59%), Brazil (56 744 new cases; -50%), New Zealand (38 949 new cases; +12%), and Singapore (28 333 new cases; -59%).

From a prevention perspective, about 12 COVID-19 vaccines and monoclonal antibody therapies are in use globally.

Pfizer Inc. today announced data from a Phase 2 clinical study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6.

This vaccine candidate is being developed for maternal administration to protect infants against invasive GBS disease.

In stage two of the three-part study, GBS6 generated robust maternal antibody responses against the six GBS CPS serotypes included in the vaccine, and these antibodies were efficiently transferred to infants at ratios of ~0.4-1.3 depending on the GBS6 group.

Based on a parallel natural history study conducted in South Africa, the Phase 2 study immunogenicity data suggest that GBS6 may offer meaningful protection against invasive GBS disease in newborns and young infants.

The results were published in an Original Article in The New England Journal of Medicine on July 20, 2023, and will inform a planned Phase 3 clinical development program.

“Group B Streptococcus can cause potentially devastating diseases in infants, including sepsis, pneumonia, and meningitis. Annually, there are nearly 400,000 cases of infant disease and approximately 138,000 stillbirths and infant deaths worldwide due to GBS,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on July 19, 2023.

“Building on decades of expertise and knowledge in vaccines, we are committed to helping protect newborns and young infants through maternal immunization.”

The U.S. CDC says bacteria called group B Streptococcus cause GBS disease.

GBS bacteria commonly live in people’s gastrointestinal and genital tracts. The genital tract is the part of the body involved in reproduction and includes the vagina in women.

Sometimes the bacteria invade the body and cause certain infections, which are known as GBS disease.

Vir Biotechnology, Inc. today announced that the Phase 2 clinical trial (PENINSULA) evaluating VIR-2482 for preventing symptomatic influenza A illness did not meet primary or secondary efficacy endpoints.

In participants who received the highest dose of the investigational hemagglutinin-targeting monoclonal antibody (mAb) VIR-2482 (1,200 mg), a non-statistically significant reduction of approximately 16% in influenza A protocol-defined illness was observed.

And participants who received the highest dose showed an approximately 57% reduction in symptomatic influenza A illness when defined according to U.S. CDC influenza-like-illness criteria, which was one of two secondary endpoints.

VIR-2482 was generally well tolerated, and no safety signals were identified.

“We are grateful to all who participated in this trial, and we remain committed to the pursuit of novel therapies that have the potential to address some of the world’s most serious infectious diseases,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer, in a press release issued on July 2023.

The PENINSULA trial has been supported in whole or in part with federal funds from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority.

As of July 20, 2023, about 95 million influenza vaccines were being distributed in the U.S. The U.S. CDC recommends an annual flu shot for most people, which is offered at most health clinics and community pharmacies in the U.S.

Since the beginning of 2023, dengue outbreaks of significant magnitude have been recorded in the WHO Region of the Americas, with close to three million suspected and confirmed cases of dengue reported as of July 19, 2023.

This total surpassed the 2.8 million cases of dengue registered for the entire year of 2022.

The WHO has assessed the risk of dengue as high at the regional level since all four dengue virus serotypes are present in the Region of the Americas.

One example of these dengue outbreaks is Costa Rica.

As of EW #25, there have been 2,712 reported dengue cases, which is 16% higher compared to the same period in 2022 and 19% higher compared to the average of the last five years.

Almost half of the world’s population, about 4 billion people, live in areas with a risk of dengue. Dengue is often a leading cause of illness in areas with risk, says the U.S. CDC.

In the U.S., Florida continues to report both locally-acquired and travel-related dengue cases in July 2023.

Symptoms can be mild or severe for people who get sick with dengue. However, severe dengue can be life-threatening within a few hours and often requires care at a hospital.

Dengue viruses are spread to people through the bite of an infected Aedes mosquito.

The WHO does not recommend travel restrictions for countries in the Americas experiencing dengue epidemics based on the currently available information.

From a disease prevention perspective, two approved dengue vaccines (Qdenga and Dengvaxia) are available in certain countries in 2023.