Cancer Vaccine Breaking News

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May 18, 2023 • 1:29 pm CDT
by Ingela Skullman

The U.K. Health Security Agency (UKHSA) recently detected influenza A (H5) virus in two poultry workers who have recently worked on an infected poultry farm in England.

Neither person has experienced any avian influenza (bird flu) symptoms, and both have since tested negative.

Professor Susan Hopkins, Chief Medical Advisor at UKHSA, stated in a press release on May 16, 2023, "Current evidence suggests that the avian influenza viruses we're seeing circulating in birds around the world do not spread easily to people."

"However, we know already that the virus can spread to people following close contact with infected birds, and this is why, through screening programs like this one, we are monitoring people who have been exposed to learn more about this risk."

"Globally, there is no evidence of the spread of this strain from person to person, but we know that viruses evolve all the time, and we remain vigilant for any evidence of changing risk to the population."

"It remains critical that people avoid touching sick or dead birds."

In the U.S., one bird flu vaccine is approved by the U.S. FDA.

Precision Vaccinations posts updated news on the global avian influenza outbreak in birds, mammals, and humans.

May 18, 2023 • 12:41 pm CDT
WHO May 18, 2023

The World Health Organization (CDC) Technical Advisory Group for COVID-19 Vaccine Composition today announced its advice on the composition of future formulations of COVID-19 vaccines.

The objective of an update to COVID-19 vaccine antigen composition is to enhance vaccine-induced immune responses.

Updating the vaccine composition considers the evolution of the SARS-CoV-2 beta coronavirus variants and aims to improve protection against symptomatic disease.  

The Group suggests that future formulations of COVID-19 vaccines use newer variants in their composition, i.e., XBB.1 descendant lineages.  

As of May 2023, the XBB.1 descendent lineages currently predominate globally (i.e., XBB.1.5, XBB.1.16, XBB.1.9).

Furthermore, estimates of vaccine efficacy (VE) against currently circulating SARS-CoV-2 variants, including XBB.1 descendent lineages, are very limited in terms of the number of studies, vaccine products evaluated, and populations assessed; some studies show similar VE against BA.5 descendent and XBB.1 descendent lineages, while others suggest reduced VE during periods of the predominance of XBB.1 descendent lineages.

Additionally, the TAG-CO-VAC continues to encourage the further development of vaccines that enhance mucosal immunity because they may improve protection against infection and reduce transmission of SARS-CoV-2, in alignment with the WHO Global COVID-19 Vaccination Strategy, published in July 2022. 

On May 18, 2023, the WHO stated the current COVID-19 vaccines continue to be highly protective against severe disease and death. 

And the WHO strongly encourages the use of available authorized COVID-19 vaccines, which include the index SARS-CoV-2 virus, according to recommendations from the Strategic Advisory Group of Experts on Immunization, updated in March 2023.

May 18, 2023 • 11:51 am CDT
US CDC COCA Call May 18, 2023 - mpox vaccinations

During the U.S. Centers for Disease Control and Prevention COCA Call today, experts confirmed new mpox cases have occurred in some vaccinated men in Chicago, Illinois. 

These mpox patients were vaccinated less than one year ago.

On side #46, the COCA call presented from March 18 through May 15, 2023:

  • 21 men reported mpox infections to the Chicago Dept. of Public Health,
  • 17 cases (of 21 with information) were vaccinated,
  • 11 with two doses of the JYNNEOS® vaccine, 5 with one dose, and 1 with the smallpox vaccine ACAM2000,
  • 5 had well-controlled HIV,
  • And none were hospitalized.

'It is important that clinicians quickly identify cases to limit a possible mpox resurgence this summer in the United States,' wrote these CDC experts.

A replay of the COCA Call on May 18, 2023, will be accessible on this CDC webpage https://emergency.cdc.gov/coca/calls/2023/callinfo_051823.asp

May 17, 2023 • 6:18 pm CDT
U.S. FDA May 17, 2023

The U.S. Food and Drug Administration (FDA) today published the Briefing Document for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) review of ABRYSVO™, a respiratory syncytial virus (RSV) vaccine.

Pfizer Inc.'s ABRYSVO is a bivalent vaccine candidate comprised of two preF proteins selected to optimize protection against RSV A and B. 

This digital meeting is scheduled for May 18, 2023, and starts at 8:30 AM ET and is open to the public.

The VRBPAC provides independent expert advice to the FDA on broad scientific topics or certain products to help the agency make sound decisions based on the available science.

GSK's AREXVY™ RSV OA single-dose RSV vaccine was previously approved by the FDA for seniors.

Furthermore, there are several other RSV vaccine candidates conducting late-stage studies.

Update May 18, 2023 - EXECUTIVE SUMMARY - This document summarizes the favorable benefit-risk profile for Pfizer’s RSVpreF (Abrysvo), a bivalent respiratory syncytial virus (RSV) stabilized prefusion F subunit vaccine (RSVpreF) for the proposed indication for prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age, by active immunization of pregnant individuals.

May 17, 2023 • 4:04 pm CDT
U.S. Dept. of State Haiti May 17, 2023

The U.S. Department of Stated today reissued its Level 4: Do Not Travel for the Republic of Haiti due to civil unrest.

Announced on May 17, 2023, the Department of States says U.S. citizens in Haiti should consider departing Haiti by commercial or other privately available transportation options in light of the current security situation and infrastructure challenges.

The U.S. Embassy in Port-au-Prince suspended employee travel to Cap Haitien from May 17-21, 2023.

And U.S. citizens wishing to depart Port-au-Prince should monitor local news and only do so when considered safe.

Furthermore, U.S. government personnel are discouraged from walking in Port-au-Prince.

And only family members over the age of 18 are permitted to accompany U.S. government employees assigned to the U.S. Embassy in Port-au-Prince.

From a health perspective, the Haitian Ministry of Health and Population recently confirmed an ongoing cholera outbreak.

Additionally, the U.S. CDC recommends various travel vaccinations, such as typhoid and yellow fever.

Other Disease Hot Spots are posted by Vax-Before-Travel.

May 16, 2023 • 3:35 pm CDT
U.S. CDC Measles Outbreak May May 16, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today reissued its Watch - Level 1, Practice Usual Precautions notice regarding the ongoing worldwide measles outbreak.

As of May 16, 2023, the CDC has compiled an extensive list of countries reporting measles outbreaks in 2023.

This list is led by India, with about 68,000 measles cases.

Measles is caused by a highly contagious virus that spreads through the air by direct contact with infectious droplets or by airborne spread when an infected person breathes, coughs, or sneezes.

The measles virus can live for up to two hours in airspace after an infected person leaves an area.

Furthermore, people can spread measles up to four days before and four days after a rash.

While there have only been ten measles cases in the U.S. this year, this virus remains a risk to anyone under-vaccinated.

The CDC says all international travelers, including infants and preschool-aged children, should be protected against measles before traveling abroad.

Various measles vaccines are offered in the U.S. at clinics and community pharmacies.

May 16, 2023 • 11:58 am CDT
U.S. NIH May 2023

A clinical trial of an experimental universal influenza vaccine candidate developed by researchers at the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center (VRC) has begun enrolling volunteers.

This Phase 1 trial will test the experimental vaccine, known as H1ssF-3928 mRNA-LNP, for safety and its ability to induce an immune response.

“A universal influenza vaccine would be a major public health achievement and could eliminate the need for both annual development of seasonal influenza vaccines, as well as the need for patients to get a flu shot each year,” said Acting NIAID Director Hugh Auchincloss, M.D., in a press release on May 15, 2023. 

“Moreover, some strains of the influenza virus have significant pandemic potential. A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic.”

A similar vaccine developed by researchers at NIAID’s VRC has already shown positive results in early clinical trials.

Both vaccines use a specific portion of a flu protein, hemagglutinin (HA), to induce a broad immune response against influenza.

While one portion of the HA protein, known as the head, tends to change as the flu virus spreads and evolves, a more stable portion, known as the stem, evolves very slowly and is very similar across many different types of the flu virus.

Researchers hope to induce long-term immunity against a broad range of flu viruses by using the HA stem as the basis for a vaccine.

Unlike the VRC’s earlier vaccine, the H1ssF-3928 mRNA-LNP vaccine candidate uses an mRNA platform.

By developing and testing various platforms for a universal flu vaccine, researchers are more likely to find one that is safe and provides strong and broad immunity against various strains.

Additional flu shot and influenza vaccine development news is posted at Precision Vaccinations.

May 16, 2023 • 10:18 am CDT
U.S. CDC wild rabies 2023

YS Biopharma Co., Ltd. today announced its PIKA Rabies Vaccine candidate received Phase 3 clinical trial approval from the Drug Regulatory Authority of Pakistan.

The PIKA Rabies Vaccine has the potential to become the first accelerated three-visit one-week regimen, superior to the currently available vaccine with a five-visit one-month or three-visit three-week regimen.

Dr. Zenaida Mojares, Chief Medical Officer of YS Biopharma, commented in a press release on May 16, 2023, "Our progress enables us to advance towards our mission of providing innovative and efficacious vaccines in the fight against a vaccine-preventable rabies disease, with almost 100% case fatality rate."

Rabies is a zoonotic infection that is a vaccine-preventable viral disease. Unfortunately, almost 60,000 people worldwide die from rabies each year.

The number of human rabies deaths in the United States has been steadily declining since the 1970s thanks to animal control (bats and dogs) and vaccination programs, says the U.S. CDC.

Up to 95% of human deaths occur in Africa and Asia, where dog rabies is poorly controlled, says the WHO.

The Company has completed Phase 1 and 2 clinical trials of its PIKA Rabies Vaccine in Singapore. Another Phase 1 trial was also conducted in China. All three trials have shown that the PIKA rabies vaccine is safe, tolerable, and immunogenic.

In the U.S., various rabies vaccines are available at clinics and community pharmacies.

Note: Starting February 1, 2023, the temporary suspension for dogs entering the U.S. from high-risk countries for dog rabies was extended. This includes dogs arriving from countries without a high risk of rabies if the dogs have been in a high-risk country in the past six months. 

May 16, 2023 • 5:26 am CDT
by Nel Botha

Emergent BioSolutions today announced it had completed the sale of its travel health business to Bavarian Nordic and may receive up to $380 million in potential future payments.

Bavarian Nordic acquired the rights to Vivotif®, the licensed typhoid vaccine, and Vaxchora®, the licensed cholera vaccine, and the development-stage chikungunya vaccine candidate CHIKV VLP.

These travel-related vaccines are part of an estimated international market growth rate (9.9%) thru 2028. This data indicates millions of travelers are under-vaccinated before visiting disease-endemic countries. 

Bavarian Nordic also acquired manufacturing facilities in Bern, Switzerland, and development facilities in San Diego, California.

"This deal achieves two significant outcomes key to our mission and future success," said Robert G. Kramer, Emergent president, and chief executive officer, in a press release on May 15, 2023.

Other market research reports indicate an uplift in international travel is coming. 

Such as the Expedia Group's Traveler Insights reveals traveler searches increasing globally by 25% in Q1 2023, which means travelers are looking toward mid-year getaways.

May 15, 2023 • 1:40 pm CDT

The Timatic interactive world map is designed to guide you through identifying requirements and is made available for information purposes only as of May 15, 2023.

This COVID-19 map is updated regularly, and due to the ever-changing nature of the regulations, we strongly advise that you check with your airline before you travel.

Recently, the World Health Organization (WHO published its weekly epidemiological update #142, which confirmed over 2.7 million new cases and over 17 000 deaths were reported in the last 28 days.

This data indicates a decrease of 14% and 17%, respectively, compared to the previous period. 

The WHO says the global picture is mixed at the regional level, with increases in reported cases seen in the South-East Asia and Western Pacific regions and decreases in other areas.

As of May 7, 2023, over 765 million confirmed cases and over 6.9 million deaths have been reported globally.

Furthermore, various COVID-19 vaccines remain available in most countries.

May 15, 2023 • 10:07 am CDT
U.S. CDC HAN May 15, 2023

The U.S. Centers for Disease Control and Prevention (CDC) announced a Health Alert Network Health Update today to inform clinicians and public health agencies that the mpox outbreak is not over.

As of May 15, 2023, the CDC continues to receive reports of mpox cases that reflect ongoing community transmission in the U.S. and Europe (France).

For example, from April 17 to May 5, 2023, a total of 12 confirmed and one probable mpox case was reported to the Chicago Department of Public Health.

Unfortunately, nine (69%) of 13 cases were among men who had received both doses of the U.S. FDA-approved JYNNEOS® (MVA-BN) vaccine.

The travel history was available for nine men; 4 recently traveled (New York City, New Orleans, and Mexico).

Although vaccine-induced immunity is not complete, vaccination continues to be one of the most important prevention measures, says the CDC.

However, data posted by the CDC on December 8, 2022, indicates the effectiveness of one JYNNEOS dose was 37%, two doses were 69%, and the duration of immunity is unknown. 

The CDC announced on February 22, 2023, the Interim Clinical Considerations mpox vaccination should continue to be offered to people with the highest potential for exposure to mpox.

Furthermore, the CDC expects additional mpox cases among previously vaccinated people to occur during the spring and summer seasons in 2023 as people gather for festivals and other events.

Additional mpox outbreak news is posted by Precision Vaccinations.

May 15, 2023 • 9:14 am CDT
by Tumisu from Pixabay

VBI Vaccines Inc. today announced the expansion of its 3-antigen hepatitis B vaccine and increased sales. PreHevbrio™ is the only 3-antigen hepatitis B vaccine available as of May 15, 2023, comprised of the three surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2.

This innovative vaccine is approved for use in the U.S., European Union/European Economic Area, United Kingdom, Canada, and Israel under the brand names PreHevbrio™ (U.S./Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel).

In the U.S., PreHevbrio is now available for purchase at six retail pharmacy chains, including Costco, RiteAid, Walmart, and three of the top 10 regional retail pharmacy networks, as well as through the U.S. Department of Veterans Affairs, Federal Bureau of Prisons, and at certain military treatment facilities.

PreHevbrio increased the total number of customer orders in Q1 2023 by 170% compared to Q4 2022.

In a press release, Jeff Baxter, VBI's President, and CEO, commented, "We continue to make good progress across all three endeavors, and I am especially excited to note the increase in the use of PreHevbrio in the U.S."

"With an ever-expanding access and distribution network in place and our focus on commercial execution, we expect to see this momentum continue throughout 2023 and beyond."

Furthermore, the Fance-based specialty vaccine company Valneva SE distributes PreHevbri throughout select European countries, which includes the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands.

May 15, 2023 • 5:09 am CDT
HIV.gov May 2023

Theratechnologies Inc. recently presented data from a study in which the use of Trogarzo® (ibalizumab), a monoclonal antibody antiretroviral therapy (ART), was associated with favorable virologic outcomes compared to non-ibalizumab regimens used in routine care in heavily treatment-experienced people with HIV.

In the new study, using ibalizumab resulted in a statistically significant doubling of the likelihood of viral undetectability and a much longer duration of undetectability and viral suppression compared to a real-world, non-ibalizumab control group from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA®) database.

The ibalizumab study is thought to be the first matching-adjusted indirect treatment comparison study in HIV, an approach designed to facilitate a closely matched comparison from a synthesized, real-world population when randomization to a control arm would be impractical or unethical.

Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies, stated in a press release on May 4, 2023, “This is the largest dataset and longest follow-up for Trogarzo® since our Phase 3 study, and reinforces its importance in a patient population that historically has had limited novel treatment options.”

The study evaluated data from 76 participants in two clinical trials (Phase 2b and Phase 3) who received 800 mg of ibalizumab every two weeks (treatment arm) and compared those data to outcomes from 65 individuals treated with non-ibalizumab-containing regimens as routine care in the OPERA® cohort (control arm).

Standardized mortality rate weighting ensured a balance between the treatment and control groups regarding baseline age, CD4 cell count, viral load, and susceptibility to specific ART agents.

At 24 weeks, investigators observed a statistically significant doubling of the likelihood of viral undetectability (defined as VL <50 c/mL) in the treatment arm versus the control arm (SMR-weighted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.02, 3.69).

Achievement of viral suppression (defined as VL <200 c/mL) was also more likely with ibalizumab, though this finding did not reach statistical significance (SMR-weighted HR: 1.28; 95% CI: 0.82, 2.06).

Among those who achieved undetectability on ibalizumab, 95% maintained undetectability through the end of follow-up.

Additionally, the exact significance emerged for maintaining viral suppression, which was 18 times lower for real-world non-ibalizumab regimens.

For both durability analyses, confidence intervals were wide but statistically significant (SMR-weighted HR: 18.36; 95% CI: 2.48, 135.68).

Note: Monoclonal antibody antiretroviral therapy is not an HIV vaccine candidate.

May 15, 2023 • 4:33 am CDT
WHO Afghanistan health services May 2023

Kamal Shah, with the United Nations Children's Fund Polio Eradication Program in Afghanistan, told Azadi Radio on May 11, 2023, that a four-year-old child was infected with polio in Nangarhar. 

He added, "There is a risk that the polio virus will spread to other regions of the country. That's why we request all people to vaccinate their children in the upcoming campaign that will start next Monday to save them from contracting polio."

According to the Afghanistan Ministry of Health, two polio patients were confirmed in 2022, four in 2021, and 56 in 2020.

As of March 2023, over 500,000 people were served in health facilities and hospitals supported by WHO in Afghanistan. 

The U.S. CDC confirmed on March 22, 2023, polio continued to be an international concern and issued a Level 2 Travel Advisory.

Before traveling to any destination listed, the CDC recommends that adults who previously completed the full, routine polio vaccine series receive a single, lifetime booster dose of a polio vaccine.

Various polio vaccines are available in 2023.

 

May 14, 2023 • 8:37 am CDT
U.S. CDC Equatorial Guinea Marburg outbreak map May 12, 2023

The U.S. Centers for Disease Control and Prevention (CDC) reissued its Alert - Level 2, Practice Enhanced Precautions notice regarding the ongoing Marburg virus disease (MVD) outbreak in the Republic of Equatorial Guinea.

As of May 12, 2023, the CDC says, 'Reconsider non-essential travel to mainland Equatorial Guinea.'

If you travel to Equatorial Guinea, you should:

  • Avoid contact with sick people with fever, muscle pain, and rash symptoms.
  • Avoid contact with blood and other body fluids.
  • Avoid contact with dead bodies or items that have been in contact with dead bodies, participate in funeral or burial rituals, or attend a funeral or burial.
  • Avoid visiting healthcare facilities in the outbreak area for nonurgent medical care or non-medical reasons.
  • Avoid visiting traditional healers.
  • Avoid contact with fruit bats and the caves and mines where they live.
  • Avoid nonhuman primates (e.g., chimpanzees, gorillas).

Furthermore, visitors should watch their health for symptoms of Marburg, a viral hemorrhagic fever, while in the outbreak area and 21 days after leaving the outbreak area.

As of May 14, 2023, other Marburg outbreak alerts have been issued this year for Africa. 

Unfortunately, there are no Marburg vaccines available.