Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Mar 29, 2024 • 9:36 am CDT
US CDC measles travel advisory map March 22, 2024

Measles outbreaks remain an ongoing health risk worldwide, and various health officials are taking action to limit this vaccine-preventable disease.

According to the U.S. Centers for Disease Control and Prevention (CDC), 49 countries are now reporting measles outbreaks.

The CDC stated on March 22, 2024, that travelers to these countries, including the United States, are at risk of measles if they have not been fully vaccinated at least two weeks prior to departure or have not had measles in the past and travel internationally.

The CDC says the majority of measles cases imported into the United States occur in unvaccinated U.S. residents who become infected during international travel.

According to the CDC's vaccination recommendations for international travel, all travelers, including most children, should be fully vaccinated against measles with a measles-mumps-rubella vaccine.

Measles vaccines are generally offered at health clinics and community pharmacies in the U.S.

Mar 28, 2024 • 11:40 am CDT
U.S. CDC India vaccination recommendations March 2024

Dr. Reddy's Laboratories Ltd. today announced that it has entered into an exclusive partnership with Sanofi Healthcare India Private Limited to promote and distribute its vaccine brands across private markets in India.

Under the arrangement confirmed on March 27, 2024, Dr. Reddy's will have exclusive rights to promote and distribute Sanofi's well-established and trusted pediatric and adult vaccine brands Hexaxim®, Pentaxim®, Tetraxim®, Menactra®, FluQuadri®, Adacel®, and Avaxim® 80U.

Sanofi will continue to own, manufacture, and import these brands into India.

These brands saw combined sales of approximately $51 million as of February 2024.

M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy's, commented in a press release, "We are happy to have the opportunity to leverage our strengths in promotion and distribution to considerably expand engagement with healthcare professionals and help widen access of Sanofi's well-established and trusted vaccine brands in India."

"The portfolio now gives Dr. Reddy's a strong presence in the vaccine segment, propelling us to the second position among vaccine players in India. Through each product and partnership, we aim to serve over 1.5 billion patients by 2030."

Dr. Reddy's was established in 1984 and has become a global pharmaceutical company headquartered in Hyderabad, India.

The U.S. CDC recommends visiting your healthcare provider at least a month before visiting India to get any vaccines or medicines you may need.

Additionally, the CDC included India in its recent Global Measles travel advisory.

Mar 28, 2024 • 10:52 am CDT
by Keith Johnston

Vaccines to protect people against Zaire Ebolavirus outbreaks have been used during outbreaks over the past few years.

According to the World Health Organization, two Ebola vaccines are available in 2024.

A recent study has confirmed that the prime-boost Ebola vaccine regimen is safe and effective for children and adults.

This phase 2 study assessed the long-term immunogenicity of the MVA-BN-Filo vaccine regimen and the safety of an immune memory response to an Ad26.ZEBOV booster vaccination.

These researchers concluded, in a paper published on March 26, 2024, that the vaccine regimen and booster dose were well tolerated.

These researchers wrote that a similar and robust humoral immune response was observed for participants boosted one year and two years after the first dose, supporting the use of the regimen and flexibility of booster dose administration for prophylactic vaccination in at-risk populations.

The other recommended Ebola vaccine is Merck's Ervebo®, which was approved in 2019.

However, no vaccines have been approved to protect people against the Sudan Ebolavirus. 

In 2024, ten years after the West African Zaire Ebola outbreak, the World Health Organization updated its guidelines on infection prevention and control for Ebola disease.

Mar 27, 2024 • 4:54 pm CDT
US CDC Dengue case map March 2024

In 2016, the Philippine Department of Health implemented a dengue vaccination program with a first-generation dengue virus (DENV) vaccine, which was discontinued because of safety concerns. 

A recent study assessed the relative risk of developing virologically confirmed dengue among children who did or did not receive a single dose of the Dengvaxia® (CYD-TDV) vaccine by previous DENV infections at baseline classified as none, one, and two or more infections.

This study published by The Lancet Infectious Diseases on March 22, 2024, concluded that a single dose of the Dengvaxia vaccine was ineffective in protecting against DENV among patients who had no prior history of infection or had only one prior infection.

One dose conferred significant protection against hospital admission for virologically confirmed dengue among participants who had two or more previous DENV infections at baseline during the first three years (70%, 95% CI 20–88; p=0·017) and the entire follow-up period (67%, 19–87; p=0·016).

However, young patients exposed to two or more prior DENV infections showed a significant decrease in the risk of DENV infection after receiving the first Dengvaxia dose. This protection continued for up to three years after the vaccination.

Since the study assessed the effect of only a single dose, this study's findings cannot inform public health officers' decisions on vaccination. However, the findings have implications for children who receive an incomplete vaccination regimen, and should prompt more detailed analyses in future trials on dengue vaccines.

Dengue outbreaks are a global health problem in 2024.

As of March 2024, the CDC has reported over two million dengue cases worldwide, with over 500 deaths. The U.S. CDC has issued a global alert regarding dengue outbreaks in various countries.

A person infected via a mosquito bite will have no symptoms or show clinical manifestations ranging from dengue fever, a mild flu-like syndrome, to dengue shock syndrome, a life-threatening condition.

The CDC recommends speaking with a healthcare provider before visiting dengue-endemic areas like Puerto Rico to discuss vaccination and treatment options.

Mar 27, 2024 • 7:51 am CDT
from Pixabay

Blackstone announced today a new collaboration with Moderna, Inc. through a development and commercialization funding agreement which will provide up to $750 million to fund Moderna's influenza vaccine program.

Under the terms of the agreement announced on March 27, 2024, Blackstone Life Sciences (BXLS) will be eligible to receive milestones and royalties on resultant Moderna's influenza products. 

Moderna will recognize the funding as a reduction in research and development expenses and will retain full rights and control of the Company's influenza program.

"Moderna has demonstrated a remarkable ability to impact human health through mRNA vaccines targeting respiratory illnesses. This landmark collaboration is another example of our long-standing strategy to partner with the world's leading life science companies to advance their critical path vaccines, medicines, and medical technologies to patients," said Nicholas Galakatos, Ph.D., Global Head of BXLA, in a press release.

Updated information about Moderna's flu program can be found at https://investors.modernatx.com/. 

In the United States, flu shot distributions have been decreasing.

As of March 2024, the U.S. CDC reported about 158 million flu vaccines, egg, cell, and nasal-based, had been distributed during the 2023-2024 season. This data compares with 173 million distributed during the 2022-2023 flu season and 194 million during the 201-2022 season.

Mar 26, 2024 • 9:29 am CDT
Accum™ Technology website 2024

Defence Therapeutics Inc. today announced the successful testing of a second-generation anti-cancer vaccine, ARM-002TM, using its lead anti-cancer molecule AccuTOX®.

When tested as a therapeutic vaccine in a melanoma cancer model, ARM-002TM led to an 80% complete response when combined with the anti-PD-1 immune checkpoint inhibitor.

The ARM-002TM vaccine was tested in vivo in the context of melanoma.

"AccuTOX® is an amazing molecule! AccuTOX® has the capacity to trigger cancer cell death when used as a direct cancer injectable, and AccuTOX®, the same molecule, converts mesenchymal stromal cells into potent antigen-presenting cells capable of priming potent anti-tumoral responses using 10-fold lower antigen preparation," commented Mr. Sébastien Plouffe, Chief Executive Officer and Director of Defence Therapeutics, in a media statement on March 26, 2024.

Vaccination can stimulate specific immune responses capable of potentially curing established tumors compared to current anti-cancer strategies.

In addition, developed immune cells can lead to a long-lasting memory response capable of further protecting the patient from subsequent cancer relapses, says the company.

According to Data Bridge Market Research, this vaccine segment is expected to reach revenues of about $900 billion by 2029.

Mar 26, 2024 • 7:32 am CDT
by Okan Caliskan

BioNTech SE's chief operating officer issued a U.S. Securities and Exchange Commission (SEC) filing on March 22, 2024, confirming that it previously disclosed that the Company was in discussions with the National Institutes of Health ("NIH") concerning royalties and other amounts allegedly owed on sales of the Company's COVID-19 vaccine since commercialization.

The NIH had delivered a communication threatening to send a notice of default under its license agreement with the Company, and the Company received a notice of default from the NIH relating to alleged amounts owed and breaches under such license.

As previously disclosed, the Company disagrees with the positions being taken by the NIH and intends to vigorously defend against all allegations of breach.

BioNTech's recent annual report filing (20-F) with the SEC disclosed an ongoing royalty disagreement with the NIH.

An SEC notice of default informs a contract partner that they have failed to fulfill an obligation and that legal action will be taken if they continue to default. 

Mar 26, 2024 • 7:11 am CDT
from Pixabay

Osivax, a biopharmaceutical company, today announced that all participants have completed their final visit in the Phase 2a clinical trial (NCT05734040) evaluating OVX836, a broad-spectrum influenza A vaccine candidate, in combination with Quadrivalent Influenza Vaccines (QIVs).

Topline results from this study are expected in the second half of 2024. OVX836 has been tested in 5 clinical trials with 1,200 participants, showing promising safety, immunogenicity, and efficacy read-outs. 

OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen.

Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response.

Osivax’s oligoDOMTM technology enables the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle and thus triggers powerful T- and B-cell immune responses.

“The need for more effective and safe flu vaccines remains high, and the conclusion of our trial, which evaluates OVX836 in combination with QIVs, brings us one step closer to providing improved protection,” said Alexandre Le Vert, CEO and Co-Founder of Osivax, in a press release on March 26, 2024.

According to various reports, most flu shots offered about 50% protection during the 2023-2024 influenza season in the U.S.

 

Mar 26, 2024 • 5:35 am CDT
Potential Zika virus risk areas

Valneva SE today announced the initiation of a Phase 1 clinical trial to investigate the the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV).

The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. Topline data from the trial are expected in the first half of 2025.

The initial Phase 1 study results from Valneva’s first-generation Zika vaccine candidate were reported in 2018, showing a favorable safety profile and immunogenicity in all tested doses and schedules.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release on March 26, 2024, “Valneva’s commitment to our vision – to live in a world in which no one dies or suffers from a vaccine-preventable disease – fuels our pursuit for preparedness solutions against the Zika virus."

There are currently no preventive vaccines or effective treatments available against ZIKV. However, there are over ten Zika vaccine candidates conducting research.

As such, this mosquito-borne disease remains a public health threat and is included in the Food and Drug Administration’s Tropical Disease Priority Review Voucher Program.

As of March 2024, over 1,100 Zika cases have been confirmed in the Americas this year. Ten countries accounted for about 89% of Zika outbreaks recorded between 2014 and 2023. 

Mar 25, 2024 • 2:38 pm CDT
by Robin Mur

A new tuberculosis (TB) vaccine candidate, MTBVAC, has started clinical trials in India. This vaccine is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human.

Bharat Biotech is conducting the clinical trials in collaboration with Biofabri, S.L.U, the vaccine's owner. The phase 3 clinical trials of the vaccine were announced on March 23, 2024, and plan to start in 2025.

The MTBVAC vaccine has passed several milestones before entering clinical trials in India. 

This is a significant development since India has a high incidence of TB cases.

Esteban Rodriguez, CEO of Biofabri, commented in a press release, "It is a giant step to test in adults and adolescents in the country where 28% of the world's TB cases accumulate."

"It should be remembered that the only vaccine in use today, Bacillus Calmette and Guérin (BCG), is an attenuated variant of the bovine TB pathogen. It has a very limited effect on pulmonary tuberculosis, which is responsible for transmitting the (respiratory) disease."

Unlike BCG, which lacks over 100 genes compared to the human pathogen, MTBVAC contains the complete set of antigenic targets of the original pathogen.

According to the World Health Organization (WHO), the number of people who fell ill with TB in 2021 was 4.5% higher than in 2020, with 10.6 million people diagnosed.

In 2023, India reported over 2.2 million TB cases.

Biofabri is part of the Zendal Group, a Spanish pharmaceutical company specializing in human and animal health. 

Mar 25, 2024 • 7:35 am CDT
by Mohamed Hassan

Invivyd, Inc. today announced that PEMGARDA™ (pemivibart, VYD222), a half-life extended monoclonal antibody (mAb), has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the pre-exposure prevention of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

PEMGARDA recipients should not be infected with or have had a known recent exposure to an individual infected with the SARS-CoV-2 coronavirus.

VYD222 was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for preventing and treating COVID-19. 

Dave Hering, CEO of Invivyd, commented in a press release on March 22, 2024, "PEMGARDA is the first authorized mAb from our proprietary platform approach. We are committed to ongoing process improvement while working with global regulatory agencies to increase the speed and efficiency of new mAb candidate development even further."

"Additionally, we plan to explore the protective clinical benefits of mAb prophylaxis for symptomatic COVID-19 disease in future studies."

As previously disclosed in December 2023, a potential early signal of clinical protection from symptomatic COVID-19 confirmed by RT-PCR was observed. Invivyd is now providing an update on the clinical cases of confirmed symptomatic COVID-19 through Day 90.

Beyond today's update, additional cases of COVID-19 have occurred in Cohorts A and B post-Day 90. These data are planned to be analyzed at Day 180 and presented when available.

The FDA says SARS-COV-2-targeting mAbs are laboratory-produced antibodies that can help the immune system attack SARS-COV-2.

These mAbs block entry of SARS-CoV-2 into human cells, thus neutralizing the virus. SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains.

Some virus variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19.

Mar 24, 2024 • 2:49 pm CDT
NoroSTAT-Participating States Per Week, 2012–2024

A clinical-stage biopharmaceutical company recently highlighted the progress and upcoming milestones for its investigational vaccine, HIL-214.

This vaccine aims to prevent moderate-to-severe acute gastroenteritis (AGE) caused by norovirus.

HilleVax, Inc. reported on March 20, 2024, topline data from the NEST-IN1 Phase 2B clinical study of HIL-214 in infants expected in mid-2024.

This is important news since no U.S. FDA vaccine is approved for AGE prevention. Noroviruses' genetic and antigenic diversity makes it difficult to develop a broadly effective vaccine. 

According to the U.S. CDC, norovirus is a common intestinal infection marked by watery diarrhea, vomiting, abdominal cramps, nausea, and sometimes fever that may lead to clinically significant dehydration.

According to the CDC, 1,020 norovirus outbreaks were reported between August 2023 and March 12, 2024, within the 2012–2020 seasonal years range.

According to the CDC, three confirmed norovirus outbreaks on cruise ships were under U.S. jurisdiction in 2024.

"Over the past year, we made significant progress with HIL-214, our vaccine candidate for preventing moderate-to-severe norovirus-related AGE. We have continued to progress the NEST-IN1 clinical trial and remain on track to report topline data by mid-2024," said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax, in a press release.

"We have also made good progress on our manufacturing activities for HIL-214 in support of continued development in subsequent registrational trials for infants and older adults."

According to HilleVax, HIL-214 is a virus-like particle-based vaccine candidate.

In late 2023, HilleVax initiated three clinical trials supporting the advancement of HIL-214, including NOR-109, a Phase 1 clinical trial of HIL-214 in Japanese infants, NOR-206, a Phase 2 clinical trial co-administering HIL-214 with other standard infant vaccinations, and NOR-215, a Phase 2 serology study of HIL-214 in adults.

As of October 2023, HilleVax has completed enrollment of subjects in all three clinical trials.

Globally, norovirus is estimated to result in approximately 700 million cases of AGE and 200,000 deaths per year, resulting in direct and indirect healthcare system and societal costs of $10 billion in the U.S. and $60 billion globally.

Mar 24, 2024 • 9:39 am CDT
Walgreens Flu Index - Week Ending March 16th, 2024

The Walgreens Flu Index® recently published information regarding flu activity compiled using retail prescription data for antiviral medications used to treat influenza across Walgreens locations nationwide.   

As of March 16, 2024, Walgreens listed the Top Designated Markets with Flu Activity were:

  1. Ft. Smith-Fayetteville-Springdale-Rogers, Ark.
  2. Omaha, Neb.
  3. Oklahoma City, Okla.
  4. El Paso, Texas (Las Cruces, N.M.)
  5. Little Rock-Pine Bluff, Ark.

Seperately the U.S. CDC reported five influenza-associated pediatric deaths during the 2023-2024 flu season during Week # 11. This data increases the flu season total to 121 pediatric deaths.

Last flu season, 184 influenza-associated pediatric deaths were reported.

As of March 24, 2024, various types of flu vaccines remain available at most community pharmacies. About 158 million flu vaccines had been distributed this season.

Note: The Walgreens Flu Index is not intended to illustrate levels or severity of flu activity but rather to illustrate which populations are experiencing the highest incidence of flu.

Mar 24, 2024 • 8:48 am CDT
Chicago Dept of Health March 2024

The Chicago Department of Public Health (CDPH) is responding to the first measles cases in the city since 2019 and a recent outbreak.

As of March 24, 2024, CDPH has identified 17 confirmed measles cases in Chicago, most of which have been found in the Pilsen new arrivals shelter on Halsted Street.

Of the 17 confirmed cases, 11 are in children below the age of 5.

CDPH has established vaccine operations at new arrival shelters and the landing zone. Since the measles outbreak began, about 4,000 people have received a measles-mumps-rubella (MMR) vaccine.

MMR vaccination remains the best and most effective way to prevent the spread of measles, and all Chicagoans should review their immunization records or contact their healthcare provider to ensure they are up to date on the vaccine.

MMR vaccinations are generally offered at health clinics and community pharmacies in Illinois. 

During 2024, a total of 64 measles cases were reported by 17 jurisdictions: Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, Virginia, and Washington.

In 2023, the U.S. CDC reported 58 measles cases in 20 jurisdictions.

Mar 23, 2024 • 5:31 am CDT
WHO March 2024

As World Tuberculosis Day approaches on March 24, everyone should focus on preventing this disease to reduce its impact on society.

According to GlobalData, an analytics company, various TB vaccines are in late-stage development and hold promise in containing the disease burden.

GlobalData reported today that there are currently 11 TB vaccine candidates in the late stages of development.

For example, the M72/AS01E vaccine candidate could be the first licensed TB vaccine in decades.

While the 100-year-old Bacillus Calmette-Guérin (BCG) vaccine is up to 80% effective at preventing TB infection in young children, it provides reduced protection against pulmonary TB.

This means there is a significant need for improved prophylactic vaccines.

Currently, there are about 16 approved TB vaccines in use worldwide.

Anaelle Tannen, Infectious Disease Analyst at GlobalData, commented in a press release on March 22, 2024, "Progress in this area has the potential to save countless lives as well as reduce the health and socio-economic burden associated with this disease."

Tannen added, "Prevention and early diagnosis are key to stopping the ongoing spread of the disease. The BCG vaccine is currently the only prophylactic on the market. It is given to babies in countries where TB is common."

"In areas where TB is less common, it is only given to those at high risk, including those that are more likely to be exposed to the bacterium."

TB remains a global pandemic, with 1.8 billion people estimated to be infected with the bacteria, according to the World Health Organization (WHO). India leads most countries in reporting TB cases and deaths.

The disease exists in both a latent and active form; the latent type does not express symptoms and is not transmissible unless it develops into the active type.

The lifetime risk for latently infected persons is about 5-10%.

Antibiotics are typically administered for at least six months, and ensuring the course is completed is vital to prevent antibiotic resistance, says the WHO.

In the United States, the TICE® BCG vaccine is available at most health departments but not retail pharmacies.