Vaccine Breaking News

Oct 3, 2023 • 5:13 am CDT

Inverse Association Between Shingles Vaccination and Dementia Disclosed

by Nancy Jane

In a new study published by BMC Public Health, researchers investigated the effect of zoster vaccination on dementia risk in an extensive UK population-based data set,

On October 2, 2023, these researchers disclosed an inverse association between zoster vaccination and dementia outcome in a fully adjusted model (HR 0.78, 95% CI: 0.77–0.79).

For Alzheimer's disease, the effect size is smaller (HR 0.91, 95% CI: 0.89–0.92); however, this result is likely only significant because of the large sample size involved.

To investigate if the result seen was exclusive to HZ vaccination, we also explored the effect of influenza vaccine and dementia/Alzheimer's disease.

They found a slight decreased hazard risk with HR of 0.96 (95% CI: 0.94–0.97) for dementia and HR of 1.10 (95% CI: 1.07–1.12) for Alzheimer's disease.

It has been estimated that the number of people with dementia could increase from 57 million cases in 2019 to 152 (130.8–175.9) million cases worldwide in 2050.

These researchers wrote, 'Several population-based studies have suggested a link between herpes zoster infection or vaccine against shingles and dementia. However, other population-based studies did not show any association between zoster infection and dementia risk.'

Globally, there are several approved shingles (herpes zoster) vaccines.

In the United States, GlaxoSmithKline plc Shingrix® is generally available at health clinics and pharmacies and has been reported up to 90% effective against shingles infection in various clinical trials.

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Oct 2, 2023 • 1:47 pm CDT

Second Malaria Vaccine Recommended to Meet Consumer Demand

US CDC malaria map

Malaria vaccines have been in development since the 1960s, with substantial progress in the last decade, says the World Health Organization (WHO). Today, the WHO announced it has recommended a second vaccine, R21/Matrix-M, for preventing malaria in children.

As of October 2023, the R21 vaccine is the second malaria vaccine recommended by WHO, following the Mosquirix™ (RTS,S/AS01) vaccine, which received a WHO recommendation in 2021.

Demand for malaria vaccines is unprecedented in 2023. However, the available supply of RTS,S is limited.

The addition of R21 to the WHO's recommended malaria vaccine list is expected to result in sufficient vaccine supply in various countries.

The following steps for R21/Matrix-M, include completing the ongoing WHO prequalification and enabling international vaccine procurement for a broader rollout in malaria outbreak countries.

The WHO's Director-General endorsed the recommendation following its regular biannual meeting on 25-29 September 2023.

"As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria. Now we have two," commented Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release on October 2, 2023.

"Demand for the RTS,S vaccine far exceeds supply, so this second vaccine is a vital additional tool to protect more children faster and to bring us closer to our vision of a malaria-free future."

The R21 vaccine has been shown to reduce symptomatic malaria cases by 75% during the 12 months following a 3-dose series. A fourth dose given a year after the third maintained efficacy. 

This efficacy is similar to that demonstrated when RTS,S is given seasonally. 

The WHO says that at US $2 – US $4 per dose, the cost-effectiveness of the R21 vaccine would be comparable with other recommended malaria interventions and other childhood vaccines.

Malaria is a disease caused by four species of protozoan parasites of the genus Plasmodium and is transmitted to people by Anopheles mosquitoes.

According to the WHO's recent World Malaria Report, the global number of malaria cases reached about 240 million, with over 600,000 related fatalities.

As of October 2023, neither malaria vaccine is available in the United States.

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Oct 2, 2023 • 12:30 pm CDT

New Dengue Vaccine Gains WHO Recommendations

US CDC dengue map September 27, 2023

Dengue outbreaks continue to pose significant public health burdens in endemic countries and, unfortunately, may continue to increase in incidence as disease-carrying mosquitoes expand geographically, according to the World Health Organization (WHO).

To reduce the severity of dengue outbreaks, the WHO today announced the live-attenuated quadrivalent dengue vaccine Qdenga® (TAK-003) developed by Takeda has been confirmed to demonstrate efficacy against all four serotypes of the dengue virus in baseline seropositive children (4-16 years) in endemic countries.

And against serotypes 1 and 2 in baseline seronegative children.

The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) recommended on October 2, 2023, that Qdenga be considered for introduction in settings with high dengue disease burden and high transmission intensity to maximize the public health impact and minimize any potential risk in seronegative persons.

The SAGE now recommends introducing Qdenga to children aged 6 to 16.

The vaccine should be introduced within this age range about 1-2 years before the age-specific peak incidence of dengue-related hospitalizations.

Qdenga should be administered in a 2-dose schedule with a 3-month interval between doses.

While approved for use in Brazil and various European countries, Qdenga is unavailable in the U.S.

On July 11, 2023, Takeda announced that the Company has voluntarily withdrawn Qdenga's U.S. Biologics License Application following discussions with the U.S. Food and Drug Administration on aspects of data collection.

However, the Dengvaxia® vaccine is both FDA and WHO-recommended where appropriate.

As of September 13, 2023, 44 U.S. jurisdictions had reported about 997 dengue cases this year. Throughout the summer of 2023, dengue outbreaks have been reported in southern Florida and Puerto Rica.

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Oct 2, 2023 • 9:09 am CDT

Next-Generation Lithium Therapeutic Drug Candidate in Bipolar Disorder Proceeds to Phase IIA

from Pixabay

Without an approved Alzheimer's disease vaccine available, several bipolar disorder (BD) candidates are following U.S. Food and Drug Administration (FDA) policies to accelerate clinical research.

In the U.S., about 2.8% of the population is estimated to be affected by BD during the past year, says the U.S. NIH.

For example, Alzamend Neuro, Inc. today announced receipt of a “Study May Proceed” letter from the U.S. FDA for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD type 1.

AL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium, a chemical entity well known for efficacy in BD type 1.

Alzamend’s goal is to revive the utility of lithium treatment by importantly improving the benefit-to-risk relationship of lithium treatment in clinical practice.

“Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option for BD type 1,” said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on Octobe 2, 2023.

“If we are able to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the seven million Americans afflicted with BD."

"We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024"

Based on the favorable safety profile observed in the recently completed study and extensive safety data on the drug’s constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application pathway for FDA approval, which is available to new formulations of an approved drug.

BD is a mood disorder characterized by periods of depression and periods of abnormally elevated happiness.

The condition is classified as BD Type 1 if there has been at least one manic episode, with or without depressive episodes.

And can be classified as BD Type 2 if there has been at least one hypomanic episode (but no full manic episodes) and one major depressive episode.

As of October 2023, there are several Alzheimer's disease vaccines and therapies conducting clinical trials which are seeking participants.

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Oct 2, 2023 • 6:13 am CDT

About 2 Million Updated mRNA COVID-19 Vaccines Administered

US CDC pharmacist

According to Reuters reporting, about 1.8 million people in the United States received an updated mRNA COVID-19 vaccine during the week ended September 22, 2023, according to data compiled by IQVIA Holdings Inc.

Moderna Inc. and Pfizer, Inc.'s newly approved vaccines are meeting pent-up consumer demand who are preparing for the forthcoming respiratory disease season in the U.S.

These mRNA vaccines are generally available in U.S.-based pharmacies and health clinics.

Pharmacies such as Walgreens have recently updated their vaccine appointment scheduling capabilities and related information.

As of October 2, 2023, U.S. agencies have not approved Novavax Inc.'s protein-based COVID-19 Vaccine Adjuvanted (Nuvaxovid™).

These innovative vaccines aspire to prevent the fading COVID-19 pandemic from further impacting the global society.

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Sep 30, 2023 • 1:11 pm CDT

Meningococcal Vaccine Found Effective Against Gonorrhea Again

by K. Johnston

Recent research assessed whether the off-label use of meningococcal group B vaccines (MBV) was associated with subsequent lower gonorrhea prevalence.

A Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded the outer membrane vesicle OMV-based MBV was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29 years.

These results are consistent with other study findings that OMV-based vaccines offered 31% (95% CI 21-39) protection against gonorrhea.

Two meningococcal vaccines are available in the U.S.: MenB-4C (OMV-based) and MenB-FHbp.

This study's finding is good news since gonorrhea infection rates increased by about 4%, reaching 710,151 in 2022.

As of September 30, 2023, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency have not approved vaccines for preventing gonorrhea infection.

However, the FDA recently granted Fast Track designation for GSK's Neisseria gonorrhea investigational vaccine (NgG) candidate.

GSK announced on June 27, 2023, that Phase II of an ongoing study aims to demonstrate Proof of Concept by assessing the NgG vaccine's efficacy in healthy adults at risk of gonorrhea.

This study started in November 2022 in the U.S., UK, France, Germany, Spain, Brazil, Philippines, and South Africa.

According to the U.S. Centers for Disease Control and Prevention, gonorrhea is now the second most common sexually transmitted infection (STI) in the U.S. Most women infected with gonorrhea do not have any symptoms.

Other STI vaccine news (herpes, syphilis, HPV, mpox) is posted at this link.

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Sep 30, 2023 • 11:28 am CDT

Future Flu Shots Drop One Component

WHO Influenza zones map September 2023

The World Health Organization (WHO) today announced its vaccine recommendations for the 2024 influenza season in the southern hemisphere.

For countries in tropical and subtropical regions, the WHO recommendations for influenza vaccine composition (NH or SH) are available on the WHO Global Influenza Programme website as of September 29, 2023.

The WHO also recommended removing the influenza B/Yamagata/16/88 lineage component, which has not been detected since early 2020.

While influenza vaccines are safe and effective, manufacturing and using inactivated and live attenuated vaccines containing B/Yamagata lineage viruses pose a theoretical risk of reintroducing the B/Yamagata lineage virus into the population.

This risk can be mitigated by removing B/Yamagata lineage viruses from the vaccines.

Therefore, the WHO Influenza Vaccine Composition Advisory Committee believes that including a B/Yamagata antigen as a component of influenza vaccines is no longer warranted, and every effort should be made to exclude it as soon as possible, wrote the WHO.

Furthermore, when the WHO recommends viruses for inclusion in influenza vaccines twice each year, it is up to national or regional authorities to approve the composition and formulation of vaccines used in each country.

These new WHO recommendations do not impact the 2023-2024 flu shots currently offered in the United States.

As of September 16, 2023, 83.59 million influenza vaccine doses had been distributed in the U.S. Annual flu shots, which the U.S. CDC recommends for most people, are readily available at most pharmacies in the U.S.

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Sep 30, 2023 • 8:45 am CDT

Texas Announces Influenza Awareness Day

Walgreens Flu Index map September 23, 2023

The Texas Department of State Health Services (DSHS) recently confirmed October 1, 2023, is Influenza Awareness Day, and everyone should prepare themselves to combat this respiratory virus.

DSHS says each flu season in Texas has its own characteristics.

According to the latest Walgreens Flu Index, Texas is ranked #4 in overall flu cases, with Beaumont-Port Arthur and Corpus Christi in the top ten cities.

“Seasonal influenza presents a real public health threat to Texans, and immunization remains our best defense against serious flu illness,” said DSHS Commissioner Jennifer Shuford, MD, in a September 29, 2023 press release.

“Other actions can also help protect you and people close to you, like covering coughs and sneezes, washing your hands often, and staying home from work or school when you are sick.”

DSHS recommends Texans six months of age and older get the flu shot by the end of October, as immunization can make flu symptoms less severe and reduce flu-related deaths and hospitalizations.

The Centers for Disease Control and Prevention recently confirmed about 10,000 people die each year from influenza.

Influenza viruses are spread mainly by tiny droplets when people with flu talk, sneeze, or cough.

You can also contact your doctor, local health department, or pharmacy to learn where to get a flu shot, says DSHS.

Most Texas pharmacies enable online appointment scheduling and offer a selection of influenza vaccines.

For more information about influenza and how to protect against flu illness, visit dshs.texas.gov/influenza-flu.

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Sep 29, 2023 • 9:10 am CDT

750 Million People Inoculated with Newest Polio Vaccine

by Pexels

To better address the evolving risk of type 2 circulating vaccine-derived poliovirus (cVDPV2), the Global Polio Eradication Initiative (GPEI) and partners have deployed the novel oral polio vaccine type 2 (nOPV2) to millions of people.

The nOPV2 vaccine has shown to be more genetically stable than older polio vaccines and less likely to be associated with the emergence of cVDPV2 in low immunity settings.

This means that nOPV2 has the potential to be a significant tool to help stop polio outbreaks, says the GPEI.

There have been over 30 countries reporting polio/poliovirus outbreaks in 2023.

The U.S. CDC's Advisory Committee on Immunization Practices presentation on October 19, 2022, confirmed that nOPV2 is more genetically stable and less likely to be associated with the emergence of cVDPV2 and can provide mucosal immunity to limit the virus's spreading among Inactivated polio vaccine (IPV)-vaccinated people.

According to the GPEI on September 27, 2023, nOPV2 has been deployed under the WHO's Emergency Use Listing procedure.

Approximately 750 million doses of nOPV2 have been administered across 35 countries. An additional 15 countries have met the requirements for nOPV2 use in the event of a poliovirus outbreak.

As of September 29, 2023, the United States has not approved the nOPV2 vaccine.

The CDC currently recommends that all children get vaccinated to protect against polio or poliomyelitis as part of the childhood vaccines.

The IPV is the only polio vaccine that has been given in the United States since 2000.

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Sep 29, 2023 • 4:11 am CDT

U.K. Orders 100 Million Vaccines for the Next Influenza Pandemic

by Albrecht Fietz

The U.K. Health Security Agency (UKHSA) recently announced signing an advance purchase agreement with CSL Seqirus, who will be on standby to produce over 100 million influenza pandemic vaccines if or when they are needed.

UKHSA and its predecessor organizations have had similar agreements, but this is the first time the manufacturing process will be based entirely in the U.K., giving better security of access if global demand ever outweighs supply.

These vaccines will be produced at CSL Seqirus's existing manufacturing plant in Liverpool if a pandemic is declared by the World Health Organization (WHO).

Pandemic influenza is not the same as seasonal influenza or avian influenza.

Seasonal influenza circulates every year and is passed between people. Avian influenza, meanwhile, cannot be passed from human to human.

Although influenza pandemics are highly unpredictable in duration and severity, historical events show they can occur anytime.

Four influenza pandemics have occurred over the past 100 years, arising in 1918, 1957, 1968, and 2009.

The 1918 pandemic was responsible for over 50 million deaths worldwide, reports the UKHSA.

Professor Dame Jenny Harries, Chief Executive of UKHSA, commented in a press release on September 26, 2023, "We have seen from past pandemic events that access to effective vaccines is vital to help save lives and minimize disruption to our lives and livelihoods."

"This agreement represents a major step forward in our preparedness against future influenza pandemics."

CSL Seqirus is a global leader in pandemic influenza preparedness and annual flu shot production.

On July 17, 2023, CSL Seqirus announced it is positioned to supply over 55 million doses of QUADRIVALENT influenza vaccines (FLUCELVAX®, FLUAD®, AFLURIA®) to U.S. healthcare providers for the 2023-2024 flu season.

And has produced Audenz™, a monovalent, adjuvanted, cell-based inactivated subunit vaccine designed to protect people from disease caused by the influenza A virus H5N1 subtype in the event of avian influenza (bird flu) pandemics.

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Sep 28, 2023 • 1:02 pm CDT

New Hampshire Mosquito and Tick Bites Cause Rare, Potentially Deadly Diseases

U.S. CDC Yellow Book 2024 - Mosquitoes, Ticks & Other Arthropods

The New Hampshire Department of Health and Human Services, Division of Public Health Services (DPHS) recently announced that the risk for both mosquito- and tick-transmitted infections remains high and urged everyone to prevent bites.

This is essential advice since no preventive vaccines or anti-virus medications target Jamestown Canyon Virus (JCV) or Powassan Virus (POWV) diseases.

During the summer of 2023, fourteen batches of mosquitos around the state tested positive for JCV.

On September 25, 2023, DPHS confirmed a human JCV infection in an adult from Hillsborough County.

New Hampshire has reported a total of 13 human cases of JCV since 2018.

People infected with JCV can develop more serious central nervous system diseases, including meningitis or encephalitis.

About half of patients reported with JCV disease are hospitalized.

The good news is deaths associated with JCV infection are rare, according to the U.S. CDC.

Other infections transmitted by mosquitos in New Hampshire include Eastern Equine Encephalitis and West Nile Virus, which also present with symptoms similar to JCV.

The CDC has reported four states have confirmed JVC cases this year.

In addition, DPHS reported two cases of POWV in September, one in an adult in Rockingham County and another in a child from Carroll County.

New Hampshire has identified 8 cases of POWV since 2013, when the disease was first detected in humans.

During 2023, nine states have reported POWV cases.

Approximately half of the people who survive severe disease have long-term health problems such as recurring headaches, loss of muscle mass and strength, and memory problems.

And about 10% of people with severe POWV disease die.

“Mosquitoes will be with us until the first hard frost, and ticks remain active as long as there is no snow cover and temperatures remain above freezing,” commented Ryan Tannian, Chief of the DPHS Bureau of Infectious Disease Control, in a press release.

“Preventing the bites that cause illnesses transmitted by mosquitoes and ticks is a key factor in reducing the risk for illness.”

For national data on JCV and POWV, visit https://www.cdc.gov/jamestown-canyon/statistics/current-season-data.html and https://www.cdc.gov/powassan/statistics-data/current-season-data.html.

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Sep 28, 2023 • 9:42 am CDT

COVID-19 Pandemic Could Be Ending

WHO COVID-19 dashboard as of September 28, 2023

According to recent World Health Organization (WHO) data, COVID-19 cases and related deaths continue to decrease.

As of September 18, 2023, the WHO's data dashboard indicates a global 54.93% decrease in weekly COVID-19 cases and 33.85% decrease in deaths.

These positive trends have been reported since January 2023.

The WHO stated on September 12, 2023, that some regions and countries continue to see increases in cases and deaths; in others, they are declining.

While the emergency phase of the COVID-19 pandemic is over, countries should continue to work towards vaccinating at least 70% of their populations, prioritizing 100% of health workers and the most vulnerable groups, says the WHO (Edition 159).

As of September 19, 2023, a total of 13,505,089,801 COVID-19 vaccine doses have been administered during the pandemic, according to the WHO.

Since 2020, about 50 different COVID-19 vaccines have been deployed during the pandemic. With the recent U.S. FDA and CDC approvals, updated COVID-19 vaccines are now available in the United States.

According to numerous media reports, these innovative vaccines have faced availability constraints.

This was not the experience most U.S. residents witnessed during the early days of the pandemic, thanks in part to General Gus Perna, the four-star general of logistics who was the Chief Operations Officer of Operation Warp Speed.

As General Perna explained in this recent video, knowing your purpose is a key to success for most business, health, and life challenges.

Note: This article was updated on October 1, 2023, to include reference link.

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Sep 27, 2023 • 5:44 pm CDT

$433 Million Funds self-amplifying mRNA COVID-19 Vaccine Candidate

Gritstone bio Inc.

Gritstone bio, Inc. today announced that it was awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study evaluating Gritstone's self-amplifying mRNA (samRNA) CORAL vaccine candidate containing Spike plus other viral targets to protect against COVID-19.

Gritstone's approach seeks to generate a therapeutic immune response by leveraging insights into the immune system's ability to recognize and destroy diseased cells by targeting select antigens.

The agreement, valued at up to $433 million, was awarded as part of 'Project NextGen,' an initiative by the U.S. Department of Health and Human Services (HHS).

Under the HHS contract, Gritstone will conduct a 10,000-participant, randomized Phase 2b double-blinded study in the United States in collaboration with the COVID-19 Prevention Network.

Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio, commented in a press release on September 27, 2023, "First-generation COVID-19 vaccines provided great utility during the height of the pandemic but are limited in breadth and durability of clinical protection."

"CORAL was designed to address these limitations by inducing durable neutralizing antibody and T cell-based immunity against current and future SARS-CoV-2 (betacoronavirus) variants."

"We are excited about this opportunity to work alongside BARDA and look forward to initiating the Phase 2b study (CORAL-BARDA) in the first quarter of 2024."

An introduction video is posted at this Gritstone About Us link.

This project has been funded with Federal funds from the Department of HHS, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00062.

In August 2023, HHS awarded more than $1.4 billion for Project NextGen through the Administration for Strategic Preparedness and Response.

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Sep 27, 2023 • 4:36 pm CDT

Colorado Confirms Another Fatal Plague Case

Colorado plague map 2021

Recent testing has confirmed a case of plague associated with the death of an Archuleta County resident.

The Colorado Department of Public Health and Environment and San Juan Basin Public Health (SJBPH) announced on September 25, 2023, that they are investigating this plague case.

Most human cases are acquired directly from fleas, and pets with plague can transmit the illness to humans. Over 80% of United States plague cases have been the bubonic form, according to the Centers for Disease Control and Prevention (CDC).

Plague (Yersinia pestis) is caused by bacteria that can be transmitted to humans by the bites of infected fleas or by direct contact with infected animals. Symptoms include the sudden onset of high fever and/or swollen lymph nodes, according to SJBPH.

Tiffany Switzer, Interim Executive Director of SJBPH, commented in a press release, "Plague is frequently detected in rock squirrels, prairie dogs, wood rats, and other species of ground squirrels and chipmunks."

The Colorado previously reported a plague case in Montezuma County in June 2023.

The risk to the general public is low, says SJBPH.

Most human cases in the U.S. are reported in two regions: Northern New Mexico, northern Arizona, and southern Colorado; and California, southern Oregon, and far western Nevada.

SJBPH stresses the importance of controlling wildlife and fleas around homes.

Furthermore, see a healthcare provider if you become ill with a high fever and/or swollen lymph nodes, as plague is a treatable illness.

And contact a veterinarian if your pet becomes ill with a high fever and/or an abscess (open sore) or swollen lymph nodes.

Plague was first introduced into the United States in 1900 by rat–infested steamships that had sailed from affected areas.

The last urban plague epidemic in the United States occurred in Los Angeles from 1924 through 1925.

New plague vaccine candidates are developing but are not expected to be commercially available immediately.

However, researchers from Tel Aviv University and the Israel Institute for Biological Research's mRNA-based, lipid nanoparticle vaccine were effective against a lethal bacteria.

Published on March 8, 2023, a mice study demonstrated that all vaccinated animals were fully protected against the bacteria that causes the plague.

To learn more about the symptoms, treatments, and other information for plague, visit https://sjbpublichealth.org/183/Communicable-Disease. Information is also available from the Colorado Department of Public Health and Environment at https://cdphe.colorado.gov/animal-related- diseases/plague.

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