Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Jun 29, 2023 • 10:15 am CDT
WHO Influenza Map June 26, 2023

The U.S. Centers for Disease Control and Prevention (C.D.C.) today announced the current C.D.C. Director adopted the 2023-2024 Advisory Committee on Immunization Practices' (ACIP) recommendations on annual influenza (flu) vaccination for everyone six months and older in the U.S.

As of June 29, 2023, there are minor changes to the ACIP's flu shot recommendations, including, but not limited to, an acknowledgment of the updated flu vaccine composition for the 2023-2024 flu season.

And a change in the recommendations for vaccination of people with egg allergies.

Flu vaccination has many benefits. It has been shown to reduce the risk of getting sick with the flu and also to reduce the risk of more serious flu outcomes that can result in hospitalization or even death, says the CDC.

Rochelle P. Walensky, M.D., M.P.H.'s adoption of the ACIP recommendations makes them official C.D.C. policy. Providers should begin vaccinating patients according to C.D.C.'s recommended timing, which has not changed for the 2023-2023 influenza season in the U.S.

The C.D.C. says September and October are the best times for most people to get vaccinated.

Furthermore, flu vaccination in July and August is not recommended for most people, but there are several considerations for specific groups.

While influenza viruses are detected year-round, the exact timing and duration of flu seasons vary by country, says the World Health Organization (WHO). What happens in the Southern Hemisphere does not necessarily predict what will happen in the Northern Hemisphere, which includes the U.S.

The WHO recently published Influenza Update N° 448, which confirmed influenza detections remained low globally. Still, in the southern hemisphere, some countries reported variable changes in influenza detections in recent weeks, while detections in others seemed to have peaked as of June 26, 2023.

Additionally, Precision Vaccinations published an updated list of influenza vaccines and candidates conducting clinical trials.

Jun 29, 2023 • 8:54 am CDT
WHO COVID-19 Data Dashboard map June 28, 2023

The World Health Organization (WHO) today published an updated COVID-19 data dashboard indicating COVID-19 cases and related fatalities continue to decrease in most WHO Regions.

As of June 28, 2023, the African region reported a slight increase in COVID-19 fatalities but a 26% decrease in cases, while the other five WHO regions reported declines in both cases and deaths. 

At the regional level, the number of newly reported 28-day cases decreased across the South East Asia Region (-78%), the Eastern Mediterranean Region (-71%), the Region of the Americas (-70%), the European Region (-46%), and the Western Pacific Region (-33%).

As of June 29, 2023, various COVID-19 vaccines remain available in most countries and may be required to enter some countries.

Jun 28, 2023 • 3:36 pm CDT
by Gerson Vaz

The MedAfrica Times recently reported that the Republic of Brazil donated 80 thousand vaccines against HPV and yellow fever to Cabo Verde.

The Cape Verdean Ministry of Health announced on June 27, 2023, 50 thousand doses of HPV and 30 thousand doses of yellow fever arrived in Praia.

"The yellow fever vaccine is used to prevent yellow fever, a disease caused by an arbovirus. It is recommended for prevention in endemic areas or for travelers", said this article.

The U.S. CDC recently wrote that no (health) notices are currently in effect for Cape Verde.

However, the CDC suggests prospective visitors to Cape Verde speak with a healthcare provider regarding travel vaccinations, such as yellow fever and medicines.

Located 900 miles south of the Canary Islands and 350 miles from the African mainland, Cape Verde's nine inhabited islands offer vacationers many relaxing options.

Cabo Verde has witnessed significant economic progress since 1990, driven in large part by the rapid development of tourism (25% of GDP).

And remember to pack essential health supplies in case of travel delays, says the CDC.

Jun 28, 2023 • 2:24 pm CDT
by Alan Morris

The U.S. Department of State recently published an updated Level 2 Travel Advisory for the Republic of Maldives, a nation located in the Indian Ocean.

On June 22, 2023, the State Department confirmed visitors to the Maldives should exercise increased caution due to civil unrest at tourist locations, transportation hubs, markets/shopping malls, and local government facilities.

And attacks may occur on remote islands, which could lengthen the response time of authorities.

Furthermore, U.S. citizens can obtain assistance from the U.S. Embassy Colombo in Sri Lanka.

If you travel to Maldives in 2023, the U.S. government suggests enrolling in the Smart Traveler Program to receive alerts during an emergency.

Moreover, getting to the Maldives is now easier.

The capital city of Malé recently announced the launch of Saudi Arabia's airline Flynas.

In 2022, Maldives welcomed over 1.6 million tourists.

From a health perspective, the U.S. CDC says no notices currently exist for Maldives.

However, the CDC encourages visitors to be current on several travel vaccinations, such as yellow fever, measles, and typhoid.

 

Jun 28, 2023 • 9:23 am CDT
by Gordon Johnson

While most of the media attention has been focused on the state of Florida's recent malaria outbreak (4) on its west coast, another mosquito-transmitted disease continues its multi-year impact on Florida's southeastern coast.

As of June 24, 2023, Florida Weekly Arbovirus Report revealed another 18 travel-associated dengue cases had been confirmed.

This data increased Florida's dengue outbreak to 100 cases in 2023, led by Miami-Dade (64) and Broward (8) countries.

These dengue-infected travelers primarily originated in Brazil and Cuba.

Furthermore, 2 cases of locally acquired dengue have been reported this year.

In 2022, 903 travel-associated and 68 locally-acquired dengue cases were reported in Florida.

To notify residents and visitors, the Florida Department of Health issued a statewide mosquito-borne illness advisory on June 26, 2023.

Furthermore, Florida continues to conduct statewide surveillance for mosquito-borne illnesses, including West Nile virus, Eastern equine encephalitis, St. Louis encephalitis, and chikungunya. 

The Department confirmed aerial and ground mosquito spraying continues in these areas to mitigate the risk of further virus transmission.

There are approved vaccines for both dengue and malaria, but access is limited in the U.S. 

As of June 28, 2023, the U.S. Centers for Disease Control and Prevention nor the U.K. Foreign Office have issued travel advice when visiting Florida.

Jun 28, 2023 • 7:51 am CDT
by Pham Trung Kien

GSK plc today announced the U.S. Food and Drug Administration (FDA) had granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine (NgG).

Fast Track designation is intended to facilitate the development and expedite the review of potentially important new drugs and vaccines to treat or prevent serious conditions with unmet medical needs.

As of June 27, 2023, the vaccine candidate is conducting a Phase II clinical trial and aims to demonstrate proof of concept by assessing the efficacy of the NgG vaccine in healthy adults.

Phil Dormitzer, Global Head of Vaccines R&D, GSK, commented in a related press release, "This designation recognizes the potential for a vaccine that could help protect millions of people across the world against the serious health consequences of infection with a bacterium that is considered a 'high priority' pathogen by the World Health Organisation."

Gonorrhoea is the second most prevalent bacterial sexually transmitted infection worldwide, with an estimated 82 million new cases yearly. 

In the U.S., rates of reported gonorrhea have increased by 118% from 2009 to 2021.

Furthermore, antimicrobial resistance to gonorrhea has increased over the past 80 years, rendering many classes of antibiotics used to treat the disease ineffective.

Vaccines can play a critical role in the fight against AMR by helping prevent bacterial, viral, and other infections.

Currently, no gonorrhea-specific vaccines are approved anywhere in the world, says GSK.

However, in France, the meningococcal (MenB-4C) vaccine is recommended against gonorrhea.

And Intravacc's Avacc 11® is the prophylactic intranasal gonorrhea candidate vaccine.

As of June 28, 2023, gonorrhea vaccine and treatment news have been published by Precision Vaccinations.

Jun 27, 2023 • 1:50 pm CDT

The U.S. Centers for Disease Control and Prevention (CDC) today republished an expanded global polio outbreak Travel Health Notice.

On June 26, 2023, the CDC identified thirty destinations with circulating poliovirus.

And, before travel to any destination listed, adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of a polio vaccine.

In the U.S., the IPV vaccine has been offered since 2000. Oral polio vaccines are provided in various countries in 2023.

For example, the new nOPV2 vaccine has been administered over 620 million times in recent years.

The CDC says polio is a crippling and potentially deadly disease that affects the nervous system.

Because the virus that causes polio lives in the feces of an infected person, people infected with the disease can spread it to others when they do not wash their hands well after defecating.

People can also be infected if they drink water or eat food contaminated with infected feces.

Most people with polio do not feel sick. 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. Polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain, says the CDC.

Jun 27, 2023 • 12:40 pm CDT
WHO mpox map June 24, 2023

Xinhua recently reported Israel had detected a case of mpox for the first time in 2023.

In a statement on June 23, 2023, Israel's Health Ministry confirmed that a man who traveled from Portugal to Israel contracted mpox despite being vaccinated (JYNNEOS®, MVA-BN) against the virus.

An epidemiological investigation revealed that no other people had contact with the man and were exposed to the virus.

According to the ministry, vaccinated people may contract the mpox again if others around them have a high viral load.

Between May and October 31, 2022, Israel's ministry reported 262 mpox cases were diagnosed.

On June 24, 2023, the World Health Organization (WHO) published Situation Report #25 for the multi-country outbreak of mpox, which provides details on the latest epidemiology and recommendations for the care of pregnant women with mpox.

Between January 2022 and June 11, 2023, 58 mpox cases were reported by pregnant women.

Since June 19, 2023, 114 new confirmed or probable mpox cases and (1) recent death have been reported to WHO. 

Furthermore, 19 of the 112 affected countries have reported new mpox cases within the last 21 days. Six of these countries are in the Region of the Americas, and five are in the European Region.

In the U.S., the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices presented various mpox outbreak data and published Notes from the Field on June 23, 2023.

As of June 27, 2023, mpox breakthrough cases were recently confirmed in Chicago, Denver, New Jersey, and New York City.

Jun 27, 2023 • 11:29 am CDT
IAVI’s NY Vaccine Design and Development Lab

IAVI announced today that the initial participants had been vaccinated with a Sudan virus (SUDV) vaccine candidate in a first-in-human Phase I clinical trial in the U.S.

As of June 27, 2023, the IAVI C108 IAVI-sponsored trial is funded by the Biomedical Advanced Research and Development Authority (BARDA).

IAVI C108 will occur at two U.S.-based clinical trial sites, where the vaccine candidate will be administered intramuscularly at three dosage levels. 

This is essential news since there are no SUDV vaccines available.

Furthermore, like the Zaire Ebolavirus (ZEBOV), SUDV is responsible for recurring viral hemorrhagic fever outbreaks across sub-Saharan Africa.

In past Ebola outbreaks, the estimated case fatality ratios of SUDV disease have varied from 41% to 100%.

This study evaluates the safety and immunogenicity of an investigational SUDV vaccine candidate previously donated to IAVI by Merck. This investigational SUDV vaccine candidate was produced for IAVI from an existing investigational bulk drug substance previously manufactured by Merck.

IAVI is responsible for all aspects of the candidate’s future development, including demonstrating equivalence between this SUDV vaccine candidate and IAVI’s other SUDV vaccine candidate, which utilizes the same viral vector but is manufactured using a new production platform.

The SUDV vaccine candidate being evaluated in IAVI C108 uses the same recombinant vesicular stomatitis virus (rVSV) viral vector platform as ERVEBO®, Merck’s single-dose ZEBOV vaccine, which is licensed in the U.S., U.K., European Union, Canada, Switzerland, and 10 African countries.

“IAVI C108 represents an important first step toward generating the data needed for eventual licensure of an rVSV-SUDV vaccine. The development and licensure of ERVEBO® have resulted in an important tool in Ebola Zaire outbreak responses. If proven effective, we’re hopeful that a vaccine candidate built on the same viral platform will be similarly important in future SUDV outbreaks,” said Swati Gupta, Ph.D., vice president and head of emerging infectious diseases and epidemiology at IAVI, in a related press release.

The rVSV platform has been used extensively in adults and children. The underlying vesicular stomatitis virus is a common animal virus that does not cause serious illness in humans and has been investigated extensively as a vaccine vector.

In the vaccine platform, it is engineered to encode a surface protein from a target pathogen, in this case, SUDV, to prompt the body to mount an immune response.

Much of the research and development on IAVI’s rVSV platform is performed at the IAVI Vaccine Design and Development Lab in Brooklyn, New York.

Jun 27, 2023 • 10:10 am CDT
UK FCDO travel advice June 2023

The U.K. The Foreign, Commonwealth, and Development Office (FCDO) recently advised against all but essential travel to various states in Mexico as some areas of Mexico have a high crime rate and civil unrest.

On June 22, 2023, the FCDO stated that when considering travel to any of these areas in Mexico, including Cancun, please see the Safety and Security section for more detailed information on the risks.

Additionally, if you plan to pass through another country to return to the U.K., check the travel advice for your transiting country says the FCDO.

From a health perspective, the U.S. CDC issued a Disease Outbreak News, confirming an outbreak of suspected fungal meningitis associated with surgical procedures performed under spinal anesthesia.

The CDC suggests speaking with a healthcare provider about travel vaccine options, such as dengue, one month before visiting Mexico.

Jun 27, 2023 • 9:12 am CDT
U.S. NIH June 2023

Sanofi - Aventis Groupe today announced positive topline Phase 2b clinical data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody.

The primary endpoint was met in the Phase 2b study (STREAM-AD) of amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach.

Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator.

It can be a first-in-class treatment for various immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis and asthma.

By targeting OX40-Ligand, amlitelimab aims to restore immune homeostasis between pro-inflammatory and regulatory T cells.

Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation, Sanofi, commented in a press release on June 27, 2023, "While we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options."

"We believe that the results from this Phase 2b study with amlitelimab support our perspective that targeting OX40-Ligand has the potential to provide a first and best-in-class treatment option that addresses type 2 and non-type 2 inflammation to meet the individual needs of people living with atopic dermatitis and other chronic inflammatory diseases."

"We look forward to advancing into a larger Phase 3 clinical development program and continuing to drive momentum in our Immunology pipeline to deliver first or best-in-class treatments."

In this dose-ranging study, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied.

There were also improvements in key secondary outcome measures, and continued improvements were observed through week 24 in primary and key secondary outcomes.

Biomarker results support an effect on both type 2 and non-type 2 pathways.

Amlitelimab was well-tolerated in the study across all dose arms, and no new safety concerns were identified.

Furthermore, Amlitelimab is under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

The U.S. NIH says atopic dermatitis, often referred to as eczema, is a chronic (long-lasting) disease that causes inflammation, redness, and irritation of the skin. It is a common condition that usually begins in childhood.

However, anyone can get the disease at any age.

And atopic dermatitis is not contagious, so it cannot be spread from person to person.

Jun 27, 2023 • 7:16 am CDT
by D. Sandzhiev

AC Immune SA today announced that it had received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate, ACI-24.060, for the treatment of Alzheimer’s disease (AD).

Confirmed on June 27, 2023, this news follows FDA clearance of the Investigational New Drug (IND) application enabling expansion to the USA of the ongoing Phase 1b/2 ABATE study of ACI-24.060 in patients with AD and individuals with Down syndrome (DS).

Furthermore, the first individual with DS has been dosed in ABATE.

Dr. Michael Rafii, Medical Director of the Alzheimer’s Therapeutic Research Institute, Professor of Neurology at the Keck School of Medicine, and the Principal Investigator of the clinical trial, commented in a press release, “Despite representing the world’s largest population that is genetically at high risk for AD, individuals with DS are vastly underserved and underrepresented in clinical trials."

"I applaud AC Immune for seeking to address the urgent needs of this population and believe ACI-24.060 holds great promise as a novel therapy that can lower Abeta plaques to delay, or perhaps even prevent, the onset of clinical dementia symptoms in AD and DS-related AD."

"Moreover, I believe the potential safety, efficacy, and logistical advantages of a vaccine over monoclonal antibodies strongly support the development of therapeutics such as ACI-24.060 as the next generation of anti-Abeta therapies.”

Alzheimer's vaccine candidates are not FDA-approved as of June 27, 2023.

Jun 26, 2023 • 4:32 pm CDT
by Arek Socha

The journal Nature Communications recently published an article that concluded interim data from 2 parts of the phase 1/2 clinical trial support the continued development of mRNA-1010.

The mRNA-1010 vaccine candidate elicited either higher or comparable immune responses to a standard-dose, influenza quadrivalent inactivated vaccine

Overall, these first-in-human safety and immunogenicity findings highlight, on June 19, 2023, the potential of the mRNA platform to improve the effectiveness of influenza vaccines.

Vaccines using mRNA technology are readily amenable to antigenic drift and shift in influenza strains, allowing for rapid deployment of vaccines. In addition, mRNA-based platforms allow for the expression of multiple antigens, raising the possibility for an increased breadth of protective responses against seasonal influenza or multiple respiratory diseases.

However, approved cell-based influenza vaccines, such as Flucelvax® Quadrivalent (QIVc), currently produce an exact antigenic match for circulating flu trains.

Further, based on findings with mRNA-1273, an mRNA-based vaccine against SARS-CoV-2, mRNA vaccines may also induce strong cellular immune responses and prolonged germinal center reactions that can improve protection in older adults, a population at particular risk for infection and severe outcomes. 

While mRNA-1010 had an acceptable safety profile in this trial, transient solicited adverse reactions were more common after mRNA-1010 than with the active comparator.

Additional clinical trials are ongoing to assess further this vaccine candidate's safety, efficacy, and immunogenicity and a licensed influenza vaccine comparator (NCT05566639 and NCT05415462).

Moderna, Inc. was involved in the study design, data collection and analysis, and the writing of this manuscript. Moderna funded this study.

Jun 26, 2023 • 11:11 am CDT
by Cheryl Zelenka

The Colorado Sun today reported Dr. Rachel Herlihy, an epidemiologist at the Colorado Department of Public Health and Environment (CDPHE), confirmed three mpox cases were identified in June and one in May 2023.

Dr. Herlihy told John Ingold on June 26, 2023, that some cases involved out-of-state travel, and two patients were linked.

Herlihy confirmed of the four recent Colorado cases, two were in people who had received the complete two-dose JYNNEOS® (MVA-BN) vaccine regimen, and one was in someone who was unvaccinated. 

Additional mpox vaccine breakthrough cases, such as about 40 in Chicago, IL, have been confirmed.

CDPHE's press release on June 12, 2023, stated vaccination continues to be one of the most important preventive measures against mpox.

Mpox vaccination in Colorado remains limited to those currently most at risk for exposure to the virus. Go to CDPHE's website to find a vaccine provider or sign up for vaccination at a mobile clinic.

"There's always going to be the potential for re-introduction," Herlihy said. "For the time being, at least, I think we will continue to see sporadic (mpox) cases occurring."

The U.S. Centers for Disease Control and Prevention (CDC) updated the U.S. National Mpox Vaccination Strategy in 2023, continuing to recommend people exposed to the mpox virus and those more likely to contract the sexually transmitted disease should be vaccinated.

However, the CDC's Advisory Committee on Immunization Practices recently presented no recommendation for a third JYNNEOS dose, including for persons with advanced HIV or other severe immunocompromise.

Mpox vaccination and outbreak news was updated on June 26, 2023.

Jun 26, 2023 • 10:29 am CDT
Invivyd, Inc. pipeline June 26, 2023

Invivyd, Inc. today announced that it has reached general alignment with the U.S. Food and Drug Administration (FDA) on a pathway to potential emergency use authorization (EUA) for VYD222 and anticipated follow-on monoclonal antibody (mAb) candidates designed to prevent symptomatic COVID-19.

The company plans to leverage the pathway, which includes the use of serum-neutralizing titers as a correlate of protection in an immunobridging approach to a pivotal clinical trial of VYD222, to rapidly generate data to support a potential VYD222 EUA for the prevention of symptomatic COVID-19.

Based on FDA feedback, the use of a correlate of protection in an immunobridging approach to a pivotal EUA-directed clinical trial may be a reasonable approach for a new mAb candidate when clinical trial data from a "prototype" mAb is available, provided that the new mAb candidate:

  1. Is similar to the prototype mAb such that it leverages a consistent manufacturing platform and has limited structural and functional differences, and,
  2. Has supportive nonclinical data, such as favorable in vitro neutralization data against currently circulating SARS-CoV-2 variants.

"We are very encouraged by the recent feedback from the FDA and appreciate their commitment to exploring alternative strategies to expedite the development of mAbs for the prevention of symptomatic COVID-19, such as the use of a correlate of protection as the primary endpoint in a pivotal clinical trial, a strategy that we are pleased to see further advance following the joint EMA-FDA workshop last December where the approach was discussed," said Dave Hering, chief executive officer of Invivyd, in a press release on June 26, 2023.

"Given our previous work developing adintrevimab and our platform-based approach to rapid mAb discovery, we believe we are one of few companies positioned to rapidly and serially generate data for potential EUA submission for next-generation mAb candidates for the prevention of symptomatic COVID-19."

"This potential pathway supports the company's vision and strategy of establishing a platform and stream of optimized anti-SARS-CoV-2 mAb candidates that can be deployed to keep pace with viral evolution and protect the vulnerable."

COVID-19 antibody and antiviral news was updated on June 26, 2023.