Vaccine News

GSK plc recently announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Arexvy for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

This is the first time an RSV vaccine for older adults has been authorized in Great Britain.

Neale Belson, GSK's Senior Vice President and General Manager UK, said in a press release on July 10, 2023, "Our ambition is to help protect adults 60 years of age and older in the U.K. who are at risk from RSV disease, including those with underlying medical conditions, who drive the majority of RSV hospitalizations."

"This authorization for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK's long history of vaccine innovation."   

RSV is a common, contagious respiratory virus that leads to an estimated 175,000 GP visits, 14,000 hospitalizations, and 8,000 deaths yearly in adults aged 60 and over in the U.K.

Recent studies indicate that the burden of RSV disease may be even greater than that of influenza in hospitalized older adults.

In the U.S., two RSV vaccines have been approved, and several RSV vaccine candidates are conducting late-stage clinical trials.

Precision Vaccinations publishes RSV seasonal trends for 2023.

Dengue fever outbreaks continue to confront numerous countries in 2023. To extend access to dengue vaccines, the U.S. Food and Drug Administration (FDA) recently approved a supplement Biologics License Application (sBLA) for Dengue Tetravalent Vaccine, Live (Dengvaxia®).

On June 30, 2023, the FDA issued to Michael F. Stirr, Sanofi Pasteur, Inc. BL 125682/40, to include safety and efficacy data that support the use of Dengvaxia in individuals 6 through 16 years of age, with laboratory-confirmed previous dengue infection and living in endemic areas.

This FDA expansion is important as no specific medication to treat dengue infection exists.

As of July 3, 2023, the FDA's review of this supplement was associated with the following National Clinical Trial numbers: NCT01373281, NCT01374516, NCT00842530, and NCT01983553.

The three-dose Dengvaxia's (CYD-TDV) original BLA was approved by the FDA on May 1, 2019. It was first licensed in Mexico in 2015 for use in individuals 9-45 years of age and is now licensed in over 20 countries. 

Dengvaxia is the only dengue vaccine recommended for routine use by the U.S. CDC's Advisory Committee on Immunization Practices.

Before being vaccinated with Dengvaxia, the CDC's vaccine committee says healthcare providers that if a patient has dengue symptoms or lives in or has recently traveled to an area with a risk of dengue and has not previously been infected, they are at increased risk for Severe Dengue disease when vaccinated and subsequently infected with the dengue virus. 

Dengue is caused by infection with any of the four dengue viruses.

According to the CDC, these viruses are transmitted in tropical and subtropical regions by infected  Aedes mosquito species.

During the summer of 2023, locally-acquired dengue cases have been reported in Florida, Texas, Puerto Rico, and Costa Rica.

Given an increase in outbreaks caused by different microorganisms associated with medical and health tourism, the Pan American Health Organization / World Health Organization (PAHO/WHO) recently announced it encouraged Member States to strengthen their capacity to detect and manage related infections.

On July 7, 2023, the PAHO/WHO stated in recent years, the Region of the Americas has experienced an exponential growth of international travel in search of health care. For example, millions of Americans travel to other countries for health care each year, primarily to Mexico, Canada, and other countries in Central America, South America, and the Caribbean.

It is estimated that for the United States alone, the annual number has increased from 750,000 to 1.4 million over ten years (2007 to 
2017). 

Additionally, the U.S. Centers for Disease Control and Prevention (CDC), the Mexican Ministry of Health, and U.S. state health departments are responding to a multinational fungal meningitis outbreak among 35 people who had procedures in Matamoros, Tamaulipas, Mexico.

Ten U.S. patients have confirmed cases of fungal meningitis, and eight have died, according to the U.S. CDC.

The CDC says anyone who had procedures under epidural anesthesia from January to May 13, 2023, is at risk for fungal meningitis.... and should go to the nearest emergency room as soon as possible to be evaluated for fungal meningitis, even if you do not currently have symptoms.

Fungal meningitis is a rare, life-threatening fungal infection that causes swelling of the areas around the brain and spinal cord. Starting treatment right away if you are found to have fungal meningitis greatly increases the likelihood of survival.

However, infections are not contagious and are not spread from person to person, says the CDC.

The U.S. Centers for Disease Control and Prevention (CDC) recently issued a statement confirming when and explaining how the new COVID-19 vaccines will be available after September 2023.

The CDC stated on July 6, 2023, the new monovalent XBB.1.5 composition vaccines will be the first COVID-19 vaccines to be available directly from the pharmaceutical manufacturers as part of the commercial market rather than through the United States Government (USG).

It is anticipated that USG will stop the regular threshold/replenishment ordering mechanism for all COVID-19 vaccines and ancillary supplies on August 3, 2023.

Providers are encouraged to place necessary orders before that cutoff date.

Suppose a provider requires additional supply to be responsive to demand after USG closes the current ordering mechanism. In that case, COVID-19 vaccines will remain available for ordering via the established out-of-cycle request process.

The public will continue to be directed to Vaccines.gov to find providers offering COVID-19 vaccines.

CDC will provide access to COVID-19 vaccines for uninsured individuals once COVID-19 vaccines become commercially available.

Uninsured children can receive COVID-19 vaccines through the existing Vaccines for Children program.

And uninsured adults can receive COVID-19 vaccines through a new temporary program called the Bridge Access Program for COVID-19 Vaccines and Treatments.

As of July 7, 2023, more than 304.7 million doses of COVID-19 vaccine have been administered and reported by Federal Retail Pharmacy Program participants in the US. This includes 8 million doses administered onsite to long-term care facilities in the early days of the COVID-19 vaccination program.

Furthermore, detail on the current recommended vaccine schedules for each age group can be found on the CDC website.

Vaxart, Inc. recently announced positive topline data from the dose-ranging Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate.

This study's preliminary results showed robust serum immune responses across all doses at Day 29 relative to Day 1.

Both doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms, and the mucosal and cell-based assay data will be available later.

Dr. James F. Cummings, Vaxart's Chief Medical Officer, commented in a press release on July 6, 2023, "These data, additional forthcoming data from this study, and the data we expect from our norovirus challenge study, will help inform our selection of dosage levels in a larger Phase 2b study."

"And support an End-of-Phase 2 meeting with the U.S. Food and Drug Administration."

"Our bivalent vaccine is designed to target the most important genogroups, GI and GII, and specifically to cover the important strains, GI.1 and GII.4. GII.4 currently causes the majority of norovirus disease in humans." 

This Phase 2 dose-ranging study demonstrated that the bivalent norovirus vaccine candidate was well tolerated, with a favorable safety profile.

This is the seventh clinical trial completed in Vaxart's norovirus program, and it supports previous findings of robust immunogenicity and benign tolerability. 

As of July 10, 2023, Vaxart's vaccine is one of several norovirus vaccine candidates conducting clinical research.

Norovirus is a very contagious virus that causes vomiting and diarrhea. Anyone can get infected and sick with norovirus. The U.S. Centers for Disease Control and Prevention (CDC) says norovirus cases generally occur most frequently during late fall, winter, and early spring.

The CDC publishes the Norovirus Outbreak Map and posts Norovirus National Trends.

The European Centre for Disease Prevention and Control recently published a Communicable Disease Threats Report (CDTR) for week #27, which included a mpox outbreak update.

The weekly number of mpox cases reported in the EU/EEA peaked in July 2022, and since then, a steadily declining trend has been observed.

Mpox is a viral disease, and the outbreak that began in May 2022 was driven by human-to-human transmission via close contact with infected individuals. 

As of July 8, 2023, this CDTR confirmed since the last monthly update, 13 cases of mpox have been reported by Portugal (12) and Norway (1).

Portugal reported in the latest epidemiological update (June 30, 2023) that following three months with no new mpox cases, information is available for seven of the 12 patients; all were male, five (71%) were 20–29 years old, five presented with exanthema, and four are HIV-positive.

Based on evidence from the current outbreak and the declining number of new infections in the WHO European Region, the CDTR says the overall risk of mpox infection is moderate for men with sex with men and low for the broader population in the EU/EEA.

As of July 9, 2023, the leading mpox vaccine is JYNNEOS®.

As of June 27, 2023, 1,237,235 JYNNEOS doses (1st and 2nd) had been administered in 57 U.S. Jurisdictions. The U.S. CDC's vaccine advisory committee recently presented no recommendation for a third Jynneos dose.

Other sexually transmitted disease vaccine news is posted at Precision Vaccinations.

As more countries reported measles outbreaks this year, the U.S. Centers for Disease Control and Prevention (CDC) is arming travelers with information on preventing this highly contagious, vaccine-preventable disease.

On June 29, 2023, the CDC updated its Travel Health Advisory that confirmed many international destinations are reporting increased numbers of cases of measles in 2023.

For example, Austria reported 130 cases of measles in 2023. Styria is the most affected region with 102 cases reported since the beginning of the outbreak in week 4, 2023.

And in Germany, 54 suspected and confirmed cases were reported as of July 2, 2023.

The CDC's Level 1 Global Measles advisory says travelers are at risk of measles if they have not been fully vaccinated two weeks prior to departure or have not had measles in the past and travel internationally to areas where measles is spreading.

And all international travelers, including infants 6–11 months of age and preschool-aged children, should be fully vaccinated against measles according to CDC's measles recommendations for international travel.

If you are not sure if you or your travel companions are fully protected against measles, schedule an appointment to see your clinician at least 1 month before traveling.

But, some people should not get a measles-containing vaccine. If you don’t think you can safely receive a measles-containing vaccine, talk to your clinician and consider making alternative travel plans.

Furthermore, international travelers should seek medical care if they develop a rash, high fever, cough, runny nose, or red, watery eyes. Travelers with suspected measles should notify the healthcare facility before visiting so staff can implement precautions to prevent the spread within the facility.

As of July 8, 2023, various measles prevention vaccines are available in the U.S. and worldwide.