Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Oct 29, 2024 • 12:38 pm CDT
from Pixabay

Bavarian Nordic A/S today announced the initiation of a clinical study of the MVA-BN® (JYNNEOS) mpox/smallpox vaccine in children 2 to 11 years of age, partially funded with $6.5 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

The phase 2 study is currently enrolling children in the Democratic Republic of Congo, with plans to include sites in Uganda. Results from this study could support an extension of the current approval of MVA-BN to include young children.

Last month, the WHO prequalified MVA-BN for adolescents 12 to 17 years of age, adopting the recent approval from the European Medicines Agency (EMA) for this age group.

While this study represents the first investigation of MVA-BN as a mpox/smallpox vaccine for younger children, a recombinant version of MVA-BN (Mvabea®) was approved by EMA in 2020 as part of a prime-boost vaccine regimen or the prevention of disease caused by Zaire Ebolavirus.

Paul Chaplin, President and CEO of Bavarian Nordic, said in a press release, “Following the recent approval of MVA-BN for adolescents, we are pleased to initiate this study, which could provide additional data to extend the indication to include children. We thank CEPI and our partners in Africa for their support of this important work.”

From an access perspective, Bavarian Nordic announced an agreement with UNICEF on September 26, 2024, to supply 1 million doses of the MVA-BN® mpox vaccine for African countries impacted by the ongoing mpox outbreak. 

As of late October 2024, there have been about 2,230 clade 2 mpox cases reported to the U.S. CDC this year.

The JYNNEOS vaccine is commercially available in the United States at various clinics and pharmacies.

Oct 29, 2024 • 4:44 am CDT
DSN October 2024

Sandra Levy, senior editor of Drug Store News, conducted a digital conversation with Tim Ducharme, vice president of Immunization Growth and Strategy at CVS Health®.

This discussion, posted on YouTube on October 28, 2024, centered around the company’s vaccination business and its offerings for the respiratory virus season, and how it is working with patients to help them schedule any immunizations ahead of time.

Ducharme highlighted three areas of focus: appointment scheduling, vaccine availability, patient access issues and opportunities.

He also discusses how CVS is working to educate patients about the 2024-2025 respiratory season, which includes RSV and influenza. Various vaccines are available for these diseases.

Product delivery, available through the more than 9,000 CVS Pharmacy locations across the U.S., is a core component of the company’s digital offerings and efforts to meet consumers’ unique health and wellness needs.

Oct 29, 2024 • 4:18 am CDT
Lassa Fever - isaric.org

The Iowa Department of Health and Human Services (IDHHS) today announced the death of an Iowa resident from Lassa fever, a rare, often fatal, viral hemorrhagic fever.

There have been eight travel-associated cases of Lassa fever in the U.S. in the past 55 years.

If confirmed, the Iowa case would be the ninth known occurrence of travelers returning to the U.S. since 1969.

This individual had recently returned from travel to West Africa, where ISHHS believes the person contracted the virus. About 5,000 Lassa fever-related deaths occur in West Africa each year.

Dr. Robert Kruse, State Medical Director of the IDHHS, stated in a press release on October 28, 2024, "I want to assure Iowans that the risk of transmission is incredibly low in our state. We continue investigating and monitoring this situation and are implementing the necessary public health protocols."

Lassa fever is carried by rodents and is transmitted to humans who may come in contact with the urine or feces of the infected rodents. Approximately 80% of Lassa fever patients have mild or no symptoms.

The U.S. Centers for Disease Control and Prevention posted a statement emphasizing that the overall risk to the public from this case is very low. 

Lassa is included in the World Health Organization's R&D Blueprint of priority pathogens, for which there is an urgent need for accelerated research, vaccine development, and countermeasures. 

As of October 2024, several Lassa fever vaccine candidates are conducting research, but the U.S. FDA has approved none.

Oct 28, 2024 • 3:38 pm CDT
WHO Malaria case map October 2024

Although the risk for locally acquired malaria in the United States remains very low, its reemergence highlights the importance of vectorborne disease preparedness and response.

On October 24, 2024, the U.S. CDC published MMWR 73(42);946–949 confirmed ten local cases identified in Arkansas, Florida, Maryland, and Texas in 2023.

So far, in 2024, the CDC has confirmed 1,576 travel-related malaria cases, with New York City leading with 220. About 240 people with malaria are reported each year in NYC.

However, the CDC has not reported any local malaria cases this year.

The WHO African Region shoulders the heaviest burden of malaria disease. When visiting malaria-endemic areas, the CDC recommends avoiding mosquito bites and bringing appropriate medications on your trip.

As of October 28, 2024, malaria vaccines are offered in Africa and Europe.

Oct 28, 2024 • 12:57 pm CDT
Vaxxas HD-MAP 2024

Vaxxas today announced that the U.S. National Institutes of Health (NIH) has granted the company a license to a next-generation vaccine antigen (DS2) designed for use in prophylactic vaccines against Respiratory Syncytial Virus (RSV).

DS2 has been found to prompt a more robust and durable immune response against RSV than the antigen used in globally approved vaccines (DS-Cav1).

There are three RSV vaccines currently approved for use in the U.S.

"Published preclinical results show the potential immunogenic advantages of this next-generation antigen as the basis for an RSV vaccine that could offer more robust and durable protection against the virus, compared to vaccines already on the market,” David L. Hoey, President and CEO of Vaxxas, in a press release on October 28, 2024.

Furthermore, Vaxxas’ proprietary HD-MAP offers the potential for the first needle-free, room-temperature stable RSV vaccine.

The Vaxxas HD-MAP comprises thousands of microscopic projections molded into a small patch. Each microprojection is coated with a small dose of vaccine in a dried formulation. When applied to the skin using a proprietary applicator, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface.

The company says, 'Ultimately, HD-MAPs could enable a future in which vaccine patches could be shipped directly to people, avoiding the delay, inconvenience, and safety challenges associated with traditional needle-and-syringe vaccine scheduling and administration.'

Oct 28, 2024 • 9:28 am CDT
US CDC October 25, 2024

The U.S. CDC's Influenza Surveillance Report: Key Updates for Week #42 says, 'Season influenza activity remains low nationally.'

Influenza is among several respiratory diseases, such as respiratory syncytial virus, currently circulating in the 2024-2025 flu season.

As of October 25, 2024, of the 97 viruses reported by public health laboratories, 94 were influenza A and 3 were influenza B. Of the 63 influenza A viruses subtyped during Week 42, 37 (58.7%) were influenza A(H1N1)pdm09, and 26 (41.3%) were A(H3N2).

The CDC recommends that everyone six months and older get an annual flu shot, ideally by the end of October. Over 92 million flu shots have been distributed in the U.S. and are offered at local pharmacies.

Oct 28, 2024 • 5:18 am CDT
US CDC October 25, 2024

During the summer and fall of 2024, the Pan American Health Organization (PAHO) issued several epidemiological alerts about Oropouche cases, including deaths, in the Region of the Americas.

Significant outbreaks have been reported in Brazil and Cuba.

On October 25, 2024, the U.S. CDC reaffirmed it is working with PAHO and other international partners to learn more about the potential risks of Oropouche.

The CDC's Level 1 - Practice Usual Precautions, Travel Health Advisory, says Oropouche is spread primarily by the bite of infected midges and mosquitoes.

Oropouche symptoms include headache, fever, muscle aches, stiff joints, nausea, vomiting, chills, and sensitivity to light. They typically start 3–10 days after being bitten and last 3–6 days, and most people recover without long-term effects.

The CDC says there is no specific treatment or vaccine for Oropouche.

Oct 27, 2024 • 9:57 am CDT
Google Maps Oct. 27, 2024

Throughout 2024, the world has faced a record number of dengue virus outbreaks. To alert international travelers, the World Health Organization has classified dengue as a grade 3 emergency.

However, the continental United States has remained largely unaffected by this mosquito-borne outbreak.

In the U.S., Florida has reported local dengue cases for several years, while California had only two cases in 2023.

In recent months, Los Angeles has confirmed nine local dengue cases, and San Diego has reported two, bringing the total to eleven cases in California this year.

As reported by the San Diego HHS Agency on October 25, 2024, the second locally acquired dengue case in San Diego County has been confirmed in a Vista resident who became sick and was hospitalized. This person is not associated with the Escondido case.

Nationwide, the U.S. CDC has confirmed 6,494 travel and local-related cases in 50 states this year. Many of these local dengue cases (3,877) have been reported in Puerto Rico, with the San Juan region reporting about 1,400 cases.

And in the Region of the Americas, which includes the U.S., over 12 million cases and 7,289 related deaths in the Americas in 2024.

While Dengue is a vaccine-preventable disease, the U.S. is one of a limited number of countries not offering a vaccine at the end of 2024.

Oct 27, 2024 • 8:05 am CDT
US CDC October 25, 2024

The U.S. CDC announced an essential update to its Level 2 travel advisory regarding the ongoing Oropouche virus outbreak in Cuba.

As of October 25, 2024, the CDC confirmed multiple cases of Oropouche have recently been reported in U.S. travelers returning from Cuba, indicating there is a detectable risk of infection.

The CDC recently confirmed 91 cases from five states, led by cities along Florida's southeast coast.

The CDC has also issued a Level 1 Travel Health Notice for Oropouche outbreaks in the Region of the Americas, such as in Bolivia, Brazil, Colombia, Dominican Republic, Ecuador, Guyana, and Peru.

From the beginning of the year to early October, 10,275 confirmed cases of Oropouche were reported in nine countries in the Region.

Historically, Oropouche has been confirmed to spread to people following a bite of infected midges (small flies) and mosquitoes.

Recently, Oropouche virus has been found in semen, but it is unknown if it can be spread through sex, says the CDC.

Additionally, pregnant women should reconsider non-essential travel to Cuba since there are concerns about an increase in possible cases of the Oropouche virus being passed from a pregnant person to their fetus associated with fetal deaths and congenital abnormalities. 

Since no Ocopouche vaccines are available, the CDC says travelers to Cuba should prevent bug bites during travel to protect themselves from infection.

Oct 26, 2024 • 5:59 am CDT
US CDC

Recently, the World Health Organization and the Africa Centres for Disease Control and Prevention identified Rift Valley fever as a priority disease.

To address this need, a promising vaccine candidate against the potentially deadly Rift Valley fever is set to begin Phase II trials in Kenya. ChAdOx1 RVF is the most advanced stage of testing a human Rift Valley fever vaccine candidate.

While Rift Valley fever vaccines have been registered for animals, no vaccines are available for human use.

ChAdOx1 RVF has already shown positive results in the first stage of clinical trials conducted in the UK. The trial demonstrated that the vaccine was safe and well-tolerated in volunteers who received a single shot of the vaccine, and that it elicited high levels of neutralising antibodies which block viral infection and mediate protection against the virus.

Studies have also shown that the vaccine protects against Rift Valley fever in multiple livestock species, suggesting that it could be used for both people and livestock.

“Rift Valley fever disproportionately affects the lives and livelihoods of vulnerable pastoral communities, potentially causing both human fatalities and large-scale livestock losses,” said Dr. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), in a press release.

Rift Valley fever, a mosquito-borne disease, usually occurs in people following direct contact with infected animals or bites from infected mosquitoes. The virus spreads from the female mosquitoes to the eggs. As more mosquitoes hatch, the potential for the virus to spread directly to animals and people increases.

While the majority of people infected experience mild disease, a small proportion develops the severe hemorrhagic form, which can cause blindness, convulsions, encephalitis, and bleeding, and mortality rates of up to 50%.

CEPI and the University of Oxford are committed to enabling access to vaccine outputs developed through this partnership, which aligns with CEPI’s Equitable Access Policy. 

Oct 25, 2024 • 2:39 pm CDT
from Pixabay

While monoclonal antibody (mAbs) treatments for infants have been available for many years, the recently approved version has become widely accepted.

Sanofi today announced its third-quarter earnings report, which included sales of its newly approved mAbs. This innovative product delivers long-term passive immunization to protect infants from respiratory syncytial virus (RSV)- related lower respiratory tract infections.

Beyfortus™ sales in the third quarter far exceeded Wall Street analyst projections.

After a second external filling line was licensed, additional capacity enabled increased supply in collaboration with AstraZeneca, which is responsible for manufacturing.

The company stated in a press release that sales were €645 million ($696m), driven by early deliveries in the U.S. and rollout in several countries, including Canada, France, Germany, Spain, Portugal, Belgium, and Ireland.

Sanofi confirmed that Beyfortus is available for the 2024-2025 RSV season in about 20 countries. In the United States, Beyfortus has become generally available.

The U.S. FDA-approved Beyfortus in 2023.

In October 2024, The Lancet published a study estimating Beyfortus's effectiveness against RSV-associated hospitalizations for bronchiolitis at 73%.

Oct 25, 2024 • 5:37 am CDT
US CDC

According to the U.S. government, malaria was eliminated from the United States in 1951, and almost all recent cases in the U.S. have been travel-associated.

As of the week ending October 19, 2024 (#42), the U.S. Centers for Disease Control and Prevention confirmed 1,576 travel-related malaria cases this year.

Most malaria cases are confirmed in New York, Florida, California, and Texas.

These cases were associated with travel to 85 countries where malaria remains endemic, such as Africa, and could represent a potential source of Plasmodium infection for locally acquired mosquito-transmitted cases in the U.S.

On October 24, 2024, the CDC reported (73(42);946–949) ten local malaria cases from May to September 2023. In Florida, seven locally acquired malaria cases were reported near Sarasota in 2023.

The CDC says that before traveling internationally to areas where malaria is endemic, travelers should consult with their healthcare provider regarding recommended malaria prevention measures to reduce personal and community risks.

While two malaria vaccines are WHO-recommended, neither are available in the U.S. in 2024.

Oct 24, 2024 • 12:22 pm CDT
from Pixabay

During today's U.S. CDC's Advisory Committee on Immunization Practices (ACIP), Michael Melgar, M.D. presented a summary focused on a small number of Guillain-Barré syndrome (GBS) cases observed in clinical trials within 42 days after U.S. FDA-approved protein subunit RSV vaccinations (GSK Arexvy, Pfizer Abrysvo).

The ACIP Work Group concluded on October 24, 2024, that 'available data support the existence of an increased risk of GBS after protein subunit RSV vaccination. GBS risk following RSV vaccination is rare, with less than 10 cases per 1 million vaccinations.'

However, Moderna’s newly approved mResvia mRNA vaccine has not been associated with an increased risk of GBS. Post-licensure safety surveillance for mResvia began recently in June 2024.

Dr. Melgar's presentation stated, 'Due to the small number of cases (in older adults), it was unclear whether they represented a genuine association between RSV vaccination and GBS.'

The CDC says GBS syndrome happens when a person’s immune system harms their nerves. This harm causes muscle weakness and sometimes paralysis. CDC estimates that only about 3,000–6,000 people develop GBS annually in the United States.

Oct 24, 2024 • 11:05 am CDT
from Pixabay

GSK's Susan Gerber, M.D., Medical Director, today confirmed that about 9 million people in the United States have been vaccinated with AREXVY, a vaccine indicated for active immunization to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).

During the CDC's Advisory Committee on Immunization Practices meeting on October 24, 2024, Dr. Gerber reaffirmed that protecting vulnerable individuals at high risk for severe RSV disease is essential ahead of this year's RSV season.

GSK also announced new preliminary data for AREXVY in adults aged 18-49 at increased risk for LRTD caused by RSV due to certain underlying medical conditions and in adults who are immunocompromised.

These data show the vaccine’s potential to help protect a broader group of adults at risk from the potentially serious consequences of RSV.

This U.S. FDA-approved RSV vaccine has been approved to prevent RSV-LRTD in individuals 60 years of age and older in more than 50 countries, including Europe and Japan.

Oct 24, 2024 • 5:13 am CDT
US CDC

The U.S. Centers for Disease Control and Prevention (CDC) Director today endorsed the Advisory Committee on Immunization Practices (ACIP) recommendation that people 65 years and older and those who are moderately or severely immunocompromised receive a second dose of the 2024-2025 COVID-19 vaccine six months after their first dose.

Announced on October 23, 2024, these updated recommendations also allow for flexibility for additional doses (3 or more) for moderately or severely immunocompromised people in consultation with their healthcare provider, known by the CDC as shared clinical decision-making.

 In a press release, CDC Director Dr. Mandy Cohen stated, "This vote allows people to make the best decisions possible to keep themselves and their loved ones safe from COVID-19. CDC will continue to educate the public on how and when to get updated vaccinations so they can risk less severe illness and do more of what they love."