Vaccine News

Sweden's Public Health Agency recently reported several severe influenza cases have occurred in Orebro County, located west of Stockholm. Complications can occur in connection with influenza infection, but this outbreak is unusual. 

The spread of influenza A and B is estimated to continue throughout the country as of March 17, 2023.

During week #10, there was roughly the same number of cases of influenza A (385 cases) as influenza B (364 cases). 

So far, eleven newly admitted patients with laboratory-confirmed influenza have been reported in intensive care during week 10, of which six with influenza A and five with influenza B. 

The current investigation aims to assess whether there are more influenza B cases with serious complications than expected and whether there is any common contributing cause. Therefore, the Public Health Authority has asked other infection control units to investigate whether there are similar cases in other regions.

Of the 21 countries that reported sentinel primary care specimen influenza virus positivity above the 10% epidemic threshold, France, Hungary, Romania, and Slovenia reported activity above 40%.

So far, sequencing of clinical specimens from severe cases in Sweden has identified B/Victoria viruses belonging to subgroup V1A.3a.2, which is the dominant influenza type B virus circulating across Europe and the northern hemisphere 2022-23 and 2023-24 influenza vaccine strain (B/Austria/1359417/2021-like virus).

When traveling abroad, the U.S. Centers for Disease Control and Prevention suggests getting a second flu shot if visiting an area with influenza activity.

Various flu shots are available in the U.S. at health clinics and travel pharmacies.

Vaccitech plc today announced topline interim data from the HPV001 Phase 1b/2 clinical trial of VTP-200 heterologous prime-boost immunotherapy in women with low-grade cervical human papillomavirus (HPV) lesions.

It is estimated that approximately 291 million women worldwide are carriers of HPV DNA.

Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 placebo-controlled study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint. Immunogenicity results showed high responses, defined as an average greater than 1,000 spot-forming units per million peripheral blood mononuclear cells in an ELISPOT assay, especially to the E1, E2, and E6 antigens.

VTP-200 was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs.

"These interim data are a promising step in the right direction, and we look forward to seeing the final data in early 2024," said Bill Enright, CEO of Vaccitech, in a press release on March 20, 2023.

"Currently, people with persistent HPV infections have no treatment options until they develop high-grade lesions. Being told to return for a repeat cervical screening every 6 to 12 months without a treatment option can be frustrating and anxiety-provoking."

"VTP-200 is intended to treat HPV infections, potentially before the virus causes these high-grade lesions."

VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions.

Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma.

Over 95% of cervical cancers are caused by HPV infection.

The American Cancer Society predicts that in 2022, approximately 14,100 new cases of invasive cervical cancer were diagnosed in the U.S., with over 4,280 women dying from the disease.

In the U.S., various HPV vaccines are authorized for women and men and available at most clinics and clinical pharmacies in March 2023.

AfricaNews recently reported the United Republic of Tanzania requested medical experts investigate a mysterious "communicable" disease that has already killed five people in the country in March 2023.

Outbreaks are not new in the east African country of Tanzania.

In July 2022, a disease whose symptoms included nosebleeds, fever, headaches, and fatigue, was detected in the Lindi region. A total of 13 patients were detected then.

The World Health Organization later confirmed 20 cases of leptospirosis in two districts in the Lindi Region, including three deaths. The majority of these cases were men who were farmers as of August 8, 2022.

And in 2019, a disease with Ebola-like symptoms killed one woman who had visited Uganda, where an Ebola outbreak was detected.

Tanzania was formed as a sovereign state in 1964 through the combination of Tanganyika and Zanzibar, reports Britannica.  

No U.S. CDC health notices are in effect for Tanzania, including Zanzibar, as of March 18, 2023.

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced an early-stage antiviral candidate (JNJ-1802) provides strong protection against dengue in non-human primates and mice.

The new data indicate JNJ-1802 is effective against all four dengue serotypes in mouse models and provides strong protection against two tested serotypes (DENV-1 and -2) in non-human primates.

The first-in-class antiviral, which was shown to be safe and well tolerated in a first-in-human clinical study, is progressing into Phase 2 clinical studies for the prevention and treatment of dengue.

"The unprecedented rise in dengue outbreaks throughout the past years offers a glimpse of what lies ahead ....." said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health R&D at Janssen Research & Development, LLC, in a press release on March 15, 2023.

"We know an antiviral will be critical to addressing the unmet needs today and tomorrow."

The peer-review journal Nature published this study: Blocking NS3–NS4B interaction inhibits dengue virus in non-human primates. These findings support the further clinical development of JNJ-1802, a first-in-class antiviral agent against dengue, which is now progressing in clinical studies to prevent and treat dengue.

The U.S. Centers for Disease Control and Prevention (CDC) Technical Report issued on March 17, 2023, stated that despite the geographic spread of highly pathogenic avian influenza (HPAI) A(H5N1) viruses, only a small number of 'bird flu' cases in people have been identified.

The CDC stated all reported human cases since 2022 have been associated with poultry exposures.

And no bird flu cases of human-to-human transmission have been identified, says the CDC.

However, because of the potential for influenza viruses to evolve rapidly, continued sporadic human infections are anticipated.

To date, more than 6,300 people in 52 jurisdictions have been monitored since 2022, and only one human case in Colorado has been identified.

However, there has been an upsurge in various mammals dying from bird flu in Canada and the U.S. during 2023.

The CDC presented some good news regarding bird flu vaccines.

An H5 candidate vaccine virus (CVV) produced by CDC is nearly identical or, in many samples, identical to the hemagglutinin (HA) protein of recently detected clade 2.3.4.4b HPAI A(H5N1) viruses in birds and mammals and could be used to produce a vaccine for people. 

This H5 CVV is available and has been shared with vaccine manufacturers.

One manufacturer, CSL Seqirus Inc., has already produced a U.S. FDA-approved vaccine, Audenz™.

Audenz is a monovalent, adjuvanted, cell-based inactivated influenza (H5N1) subunit vaccine designed to protect people from bird flu.

GSK plc recently announced positive results from a phase 3 clinical trial evaluating its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years.

GSK's MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY).

All primary endpoints were met, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response.

In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo.

Tony Wood, Chief Scientific Officer at GSK, commented in a press release on march 14, 2023, "These statistically significant phase III data are a very encouraging step toward reducing the incidence of meningococcal disease."

"In the U.S., routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease's incidence peak, could drive significant public health impact."

Invasive meningococcal disease (IMD), a significant cause of meningitis and septicemia, is an uncommon but serious illness that can cause life-threatening complications or even death, typically amongst previously healthy children and adolescents.

Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly all IMD cases worldwide.

Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment. 

As yet, no licensed combination vaccine offers protection against these serogroups in a single vaccine.

Currently, in the U.S., two separate vaccines needing four injections are required to protect against all five serogroups.

This immunization regimen and low awareness of the disease can lead to sub-optimal immunization coverage rates, particularly for MenB, with an estimated coverage of only about 31% of adolescents in the U.S.

GSK works closely with regulators to review the complete phase III data set, including the supplemental Biologics License Application for Bexsero.

This clinical trial was the confirmatory trial for Bexsero and the phase III trial for MenABCWY.

Detailed results from this phase III trial will be presented in a peer-reviewed publication and at upcoming scientific meetings.

The U.S. Food and Drug Administration (FDA) presented some good news last week regarding influenza vaccines. The FDA confirmed this season's influenza vaccination provided substantial protection against inpatient, emergency department, and outpatient illnesses among all ages.

On March 7, 2023, Lisa Grohskopf, MD, MPH, with the U.S. Centers for Disease Control and Prevention (CDC), presented to the FDA's Vaccines and Related Biological Products Advisory Committee updated vaccine effectiveness (VE) information through January 2023.

Dr. Grohskopf's presentation highlighted influenza vaccination significantly reduced disease by the following:

• 39% (95%CI: 31, 45) against adult hospitalizations,
• 44% (95%CI: 41, 47) against adult ED or UC visits, and
• VE was observed across age groups and immunocompromised.

Furthermore, this flu season's estimates are higher than VE estimates against hospitalization (25%) and ED or UC visits (25%) from the 2021–22 season.

As of March 15, 2023, the CDC says various flu shots remain available at most clinics and pharmacies in the U.S., and late-season vaccinations are advised for certain at-risk people.

Over 173 million influenza vaccines have already been distributed this flu season.