Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Dec 18, 2024 • 4:26 am CST
from Pixabay

Merck today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab, the company’s investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.

The FDA has set a Prescription Drug User Fee Act date of June 10, 2025.

Dr. Paula Annunziato, senior vice president of infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, commented in a press release on December 17, 2024, “We look forward to working alongside the FDA on the review of clesrovimab, which, if approved, would be the first and only single-dose immunization for infants regardless of weight designed to protect them for the duration of their first RSV season.”

If approved, Merck anticipates that clesrovimab shipments will arrive in time for the 2025 RSV season.

Currently, Beyfortus™, an FDA-approved extended half-life monoclonal antibody, is available in the U.S.

Dec 18, 2024 • 3:43 am CST
US CDC Dec. 2024

The Democratic Republic of Congo (DRC) Health Ministry informed the media that a previously unidentified disease detected in the Kwango province has been determined to be a form of severe malaria.

The WHO previously reported cases were from nine out of 30 health areas in the Panzi health zone.

"The mystery has finally been solved. It's a case of severe malaria in the form of a respiratory illness," the Health Ministry announced on December 17, 2024. The statement also said that 592 cases had been reported since October 2024, with a fatality rate of 6.2%.

Children aged 0-14 years represent 64.3% of all reported cases.

On December 11, 2024, The Lancet published a Comment that stated, 'the rapid spread of artemisinin partial resistance across east Africa, the Horn of Africa, and southern Africa threatens to undermine malaria control and elimination efforts, potentially increasing deaths.'

The WHO wrote on December 8, 2024, that the overall risk level to the affected communities is assessed as high.

At the regional and global levels, the risk remains low. However, the proximity of the affected area to the border with Angola raises concerns about potential cross-border transmission, and continued monitoring and cross-border coordination will be essential to mitigate this risk. 

Two malaria vaccines are currently available in Africa but have yet to be deployed in this area of the DRC.

The U.S. CDC says to visit your healthcare provider at least a month before your trip to the DRC to get vaccines or medicines, as there are current reports of measles, mpox, and polio disease.

Dec 17, 2024 • 2:05 pm CST
from Pixabay

The World Health Organization recently reported that measles outbreaks have been reported in 103 countries over the last five years. There were an estimated 10.3 million measles cases in 2023, a 20% increase from 2022.

According to new data from the U.S. Centers for Disease Control and Prevention (CDC), 59 countries outside the Region of the Americas, which includes Canada and the U.S., have reported measles outbreaks this year.

In 2024, the CDC reported 283 measles cases (49 imported) in 32 U.S. jurisdictions, led by Minnesota, with 70 patients.

Additionally, recent bursts of measles cases in Ontario and New Brunswick have increased Canada's total to 160, the highest number in nearly a decade.

On December 16, 2024, the CDC republished its Level 1 - Practice Usual Precautions, Global Measles Outbreak Advisory. The CDC wrote that all international travelers should be fully vaccinated against measles with the measles-mumps-rubella (MMR) vaccine, including an early dose for infants.

Insurance policies generally fund MMR vaccines, available at travel clinics and pharmacies in the U.S.

Furthermore, travelers to at-risk areas should seek medical care if they develop measles symptoms. However, they should alert their healthcare provider before visiting a clinic.

Dec 17, 2024 • 9:29 am CST
US CDC Dengue Map; Dec. 16, 2024

The U.S. Centers for Disease Control and Prevention (CDC) today reissued its Level 1—Practice Usual Precautions, Travel Health Advisory, which highlights Dengue virus outbreaks.

On December 16, 2024, the CDC confirmed that Dengue is mosquito-transmitted and identified 23 countries reporting increased disease cases this year. However, not all countries with Dengue transmission are on this updated CDC list.

Therefore, since Dengue is a year-round risk, international travelers should practice prevention measures for all outbreak areas.

For example, the United States' southern neighbor, Mexico, has reported over 543,000 Dengue cases in 2024.

Within the U.S., the CDC recently confirmed 8,270 travel-related and locally-acquired Dengue cases from 52 jurisdictions, led by Florida (Miami), California (Los Angeles), New York, and Texas.

Although Dengue is a vaccine-preventable disease, no U.S. FDA-approved vaccine was available in late December 2024. However, several vaccine candidates, such as Butantan Institute Butantan-DV, are approaching approval in various countries.

Dec 17, 2024 • 5:31 am CST
Source dataset: hlth_ps_immu

During the peak influenza season in the Northern Hemisphere, health officials strongly encourage most people to get an annual flu shot for protection against respiratory disease.

In Europe, influenza vaccination rates have varied over the years.

Eurostat reported on December 16, 2024, that 48.2% of individuals aged 65 or over in the EU were vaccinated against influenza in 2022.

Among EU countries in 2022, Denmark reported the highest vaccination rate for people aged 65 and older at 78.0%, followed by Portugal (75.8%) and Ireland (75.4%). In contrast, Slovakia (5.6%), Poland (8.6%) and Bulgaria (10.4%) had the lowest rates.

The U.S. CDC recommends getting a flu shot before visiting Europe during the 2024-2025 influenza season. Various vaccines are offered at travel clinics and pharmacies in the U.S.

Dec 17, 2024 • 4:51 am CST
by Kerry Wilson

The JAMA Network Open recently published results from an Original Investigation demonstrating respiratory syncytial virus (RSV) vaccine effectiveness in older adults of 90% for RSV–related hospitalization and emergency department visits.

This study provides real-world VE data from the 2023-24 RSV season.

Published on December 13, 2024, these researchers wrote, 'These data (based on data from Kaiser Permanente of Southern California) supports the use of this vaccine (ABRYSVO™) in older adults.'

Pfizer Inc.'s ABRYSVO™ RSVpreF bivalent prefusion F subunit vaccine is a U.S. Food and Drug Administration-approved vaccine.

Dec 16, 2024 • 12:01 pm CST
from Pixabay

Stanford University scientists recently reported findings in a mouse study that could lead to a needle-free vaccination approach that eliminates reactions such as fever, swelling, and pain.

Published in the journal Nature on December 11, 2024, Fischbach and colleagues stated the ubiquitous skin colonist  Staphylococcus epidermidis elicits a CD8+ T cell response pre-emptively in the absence of an infection.

They wrote that this colonist also induces a potent, durable, and specific antibody response that is conserved in humans and non-human primates.

These specialized proteins can stick to specific biochemical features of invading microbes, often preventing them from getting inside cells or traveling unmolested through the bloodstream to places they should not go.

The initial experiments included dipping a cotton swab into a vial containing S. epidermidis. Rub the swab gently on the head of a regular mouse — no need to shave, rinse, or wash its fur — and put the mouse back in its cage. Draw blood at defined time points over six weeks, asking: Has this mouse’s immune system produced antibodies that bind to S. epidermidis?

The mice’s antibody response to S. epidermidis was “a shocker,” Fischbach said.

“Those antibodies’ levels increased slowly, then some more — and then even more.” At six weeks, they’d reached a higher concentration than expected from a regular vaccination — and they stayed at those levels.

“It’s as if the mice had been vaccinated,” Fischbach said. Their antibody response was as strong and specific as if it had been reacting to a pathogen.

“The same thing appears to be occurring naturally in humans,” Fischbach said. “We got blood from human donors and found that their circulating levels of antibodies directed at S. epidermidis were as high as anything we get routinely vaccinated against.”

That’s puzzling, he said: “Our ferocious immune response to these commensal bacteria loitering on the far side of that all-important anti-microbial barrier we call our skin seems to have no purpose.”

“We think this will work for viruses, bacteria, fungi, and one-celled parasites,” he said. If things go well, he expects this vaccination approach to enter clinical trials within two or three years.

The completed, unedited Stanford news article written by Bruce Goldman is posted at this link.

Dec 16, 2024 • 11:17 am CST
from Pixabay

Sinovac Biotech Ltd. today announced the enrollment for a Phase Ⅲ clinical trial on a bivalent vaccine candidate to prevent Hand, Foot, and Mouth Disease (HFMD) caused by both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16).

As of December 16, 2024, no multivalent vaccines against HFMD have been approved for marketing worldwide.

SINOVAC is also developing a vaccine to prevent HFMD caused by EV71, CA16, CA10, and CA6.

According to the U.S. CDC, non-polio enteroviruses cause about 10 to 15 million infections and tens of thousands of hospitalizations each year in the United States.

HFMD can be caused by several enteroviruses, which often exhibit low cross-immunogenicity, leading to insufficient protection. HFMD is very contagious and mainly affects children under 5 years old, accounting for at least 90% of the total HFMD patients. Most people recover on their own in 7 to 10 days.

Dec 16, 2024 • 9:24 am CST
US CDC 2024

To ensure the United States is well stocked with Anthrax vaccines, the Biomedical Advanced Research and Development Authority (BARDA) today announced a $50 million option to Emergent BioSolutions Inc. for the acquisition of CYFENDUS® (Anthrax Vaccine Adsorbed, Adjuvanted), a U.S. FDA approved vaccine.

Vaccine deliveries will begin in late 2024 and be complete by April 2025.

While Anthrax is rare in the U.S., occasional outbreaks happen in wild and domestic grazing animals such as cattle or deer, says the U.S. CDC. 

Most people will never be exposed to any of the four types of Anthrax. However, jobs, hobbies, and activities can put some people at higher risk of exposure.

Furthermore, the U.S. government remains concerned about the exposure to Bacillus anthracis, the cause of Anthrax, which is a likely agent for bioterrorism. In 2001, letters with powdered anthrax spores were mailed in the U.S., causing 22 infections and five related fatalities.

“An anthrax emergency continues to be a significant public health threat due to its ability to be easily disseminated, lethality, and potential for widespread impact,” said Paul Williams, senior vice president, products head at Emergent, in a press release on December 16, 2024.

“This procurement award further bolsters anthrax preparedness and demonstrates Emergent’s commitment to public health preparedness.”

This new BARDA award follows a previously announced contract modification of $30 million to supply CYFENDUS.

Dec 16, 2024 • 4:18 am CST
by Gerd Altmann

Bavarian Nordic A/S today announced an agreement with Serum Institute of India Pvt. Ltd. ("SII") for its MVA-BN® mpox vaccine.

Under the agreement revealed on December 16, 2024, the companies will undertake a technology transfer of the current manufacturing process for MVA-BN (JYNNEOS®) to SII to enable the supply of the mpox vaccine for the Indian market. Furthermore, upon the relevant regulatory approvals, SII will perform contract manufacturing of MVA-BN, ensuring global access even during outbreaks of mpox.

SII's multifunctional production and one of the most extensive facilities in Pune, India, has an annual capacity of 4 billion doses.

In a press release, SII's CEO Adar Poonawalla said, "The recent mpox outbreak underscores the critical need for a swift and coordinated response. Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox."

Bavarian Nordic continues to explore additional opportunities to establish partnerships, including with local African manufacturers, to ensure equitable access to MVA-BN.

Local media recently reported that since 2022, 33 confirmed cases of Mpox have been reported in India. And a Surveillance Program has been recently instructed to intensify surveillance of Mpox patients at airports. India confirmed its first case of the clade Ib mpox strain in late September 2024.

Since it was approved to protect people from smallpox in 2019, the JYNNEOS brand is now commercially available at many clinics and pharmacies.

From an efficacy perspective, U.S. CDC research published in the journal Emerging Infectious Diseases, Volume 30, Number 10—October 2024, concluded the estimated effectiveness of the 2-dose JYNNEOS vaccine was about 80% against clade 2.

A study announced in March 2024 showed that JYNNEOS antibodies waned within a year.

Vaccine efficacy data against clade I mpox is pending.

Dec 15, 2024 • 5:45 am CST
Google Maps December 15, 2024

As many winter vacationers are finalizing plans to visit warm Central American beaches, the U.S. Department of State issued a high-level advisory for the Republic of Honduras.

As of December 10, 2024, the State Department's Level 3 advisory warns against traveling to the Gracias a Dios Department, Honduras's most eastern department, due to civil unrest. This department's infrastructure is weak, government services are limited, and police and military presence is scarce.

In December 2022, the Government of Honduras declared a "State of Exception." That declaration remains in effect in 2024 and has been modified to include more cities.

However, some locations in Honduras were found welcoming for visitors this winter.

The State Department's advisory states: "There is a concentration of resources around resort areas in the Bay Islands, which include Roatan, Utila, and Guanaja, and these areas are better policed."

If you visit Honduras, enroll in the Smart Traveler Enrollment Program to receive digital alerts and make locating you in an emergency easier. If U.S. citizens need assistance while in Honduras, the U.S. Embassy in Tegucigalpa is located at Avenida La Paz, Tegucigalpa, M.D.C.

From a health perspective, the Honduran Ministry of Health declared a national emergency in Honduras due to the increased risk of the mosquito-transmitted dengue virus in June 2024.

As of December 15, 2024, over 175,000 dengue cases and 153 related fatalities have been reported this year.

Additionally, Honduras has reported chikungunya and zika patients in 2024.

For disease prevention, an approved chikungunya vaccine (Valneva SE's IXCHIQ®) is available at many travel clinics and pharmacies in the U.S., but no vaccine is offered for dengue or zika.

Dec 14, 2024 • 5:49 am CST
by Ahmad Ardity

Novavax, Inc. today announced progress in advancing its corporate growth strategy through its partnership with Sanofi, a Paris, France based company.

Novavax has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering Sanofi's first $50 million milestone payment.

Novavax's COVID-19 vaccine is included in Sanofi's two combination vaccine candidates for the prevention of influenza and COVID-19, for which Phase 1/2 trials were initiated, and the U.S. FDA Fast Track designation was recently granted in the U.S.

n addition to milestones for the stand-alone COVID-19 vaccine, the agreement also includes combination products developed by Sanofi including Novavax's COVID-19 vaccine, which present a potential opportunity of up to an additional $350 million for Novavax in future milestones.

In addition, stand-alone COVID-19 sales and potential sales of any Sanofi combination products would net Novavax ongoing tiered royalties.

Further, Novavax is eligible to receive up to $200 million for the first four products created by Sanofi utilizing its Matrix-M adjuvant and up to $210 million in milestone payments for each product, including Matrix-M thereafter, plus ongoing royalties for all Sanofi products utilizing Matrix-M.

Dec 14, 2024 • 4:40 am CST
Google Maps Dec. 2024

The Queensland Public Health and Scientific Services, Communicable Diseases Branch, recently issued a public health alert about measles outbreaks.

As of December 13, 2024, measles cases have been reported among travelers to Victoria, Western Australia, and Queensland this year.

This alert stated clinicians in Australia should be alert for signs and symptoms of measles, particularly in international travelers or those close contacts potentially exposed to measles.

To alert the global community, the U.S. CDC reissued a Level 1 - Practice Usual Precautions, Travel Health Advisory, regarding measles outbreaks in 56 countries. As of late November 2024, this CDC alert did not include Australia.

As of December 6, 2024, the U.S. CDC reported 283 measles cases in 32 jurisdictions this year.

The CDC wrote that travelers are at risk of measles if they have not been fully vaccinated at least two weeks before departure or have not had measles in the past and have traveled internationally. In the U.S., measles vaccines are generally available at travel clinics and pharmacies.

Dec 13, 2024 • 2:35 pm CST
Google Maps Dec. 13, 2024

The European CDC today reported that the United Kingdom confirmed the notification of circulating vaccine-derived poliovirus type 2 (cVDPV2) isolated from environmental samples. 

As of December 13, 2024, the ECDC stated that cVDPV2 was isolated from environmental samples collected in Leeds, London, and East Worthing over the past few months. However, no human cases of polio have been reported in the U.K. in 2024.

Regarding polio preventive vaccines, a recent report from the September Strategic Advisory Group of Experts on Immunization meeting recommended the concomitant use of IPV and type 2 novel oral polio (nOPV2) vaccines in initial outbreak response vaccination campaigns.

Since 2000, the IPV vaccine has been offered in the United States.

And over the past few years, about 1.1 billion nOPV2 vaccine doses have been administered in Africa.

Since August 2024, the U.S. CDC has issued a Level 2—Practice Enhanced Precautions, Travel Health Advisory, listing 37 countries reporting poliovirus detections this year. The CDC writes that adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of polio vaccine before traveling to any destination listed.

The U.K. is not included in the CDC's current list.

Dec 13, 2024 • 1:04 pm CST
US CDC December 11, 2024

The U.S. Centers for Disease Control and Prevention (CDC) issued a Level 2 Travel Health Notice for people visiting Brazil’s Espirito Santo state due to an Oropouche virus outbreak.

Over the past weeks, Brazil has reported more than 1,300 Oropouche cases, mainly in Espirito Santo.

On December 11, 2024, the CDC stated that travelers to this southeastern Brazil state should prevent bug bites during travel to protect themselves from infection. They should also prevent bug bites for three weeks after travel to avoid possibly spreading the virus to others.

Symptoms of Oropouche include headache, fever, muscle aches, stiff joints, nausea, vomiting, chills, or sensitivity to light. Severe cases may result in neuroinvasive diseases such as meningitis.

Additionally, pregnant women should reconsider non-essential travel to Espírito Santo, Brazil. If travel is unavoidable, these travelers should strictly follow Oropouche prevention recommendations.

Recent reports indicate that Oropouche can be spread by sex contact.

In August 2024, an infant with microcephaly associated with Oropouche virus infection was reported in Brazil. The infant, born in June 2024, who later died at 47 days of life, had tested positive for Orepouche virus IgM.

Previously, the CDC had a Level 1 travel notice for other parts of Brazil, Bolivia, Colombia, Cuba, the Dominican Republic, Ecuador, Guyana, and Peru.

In the United States, Florida has reported over 90 travel-related Oropouche cases in 2024.

As of December 13, 2024, no Oropouche vaccine is available.