Category: Vaccine

News Release

Tuesday, September 27, 2022

Large NIH-funded study included participants in North America and Europe.

A large international study has confirmed the findings of a previous U.S. study that linked COVID-19 vaccination with an average increase in menstrual cycle length of less than one day. The increase was not associated with any change in the number of days of menses (days of bleeding). Funded by the National Institutes of Health, the new study included data from nearly 20,000 people from Canada, the United Kingdom, the United States, Europe and other parts of the world who received any of nine different vaccines. For most study participants, the increase resolved in the cycle following vaccination.

The studys principal investigator was Alison Edelman, M.D., M.P.H., of Oregon Health & Science University in Portland. It appears in the BMJ Medicine.

These findings provide additional information for counseling women on what to expect after vaccination, said Diana Bianchi, M.D., director of NIHs Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Changes following vaccination appear to be small, within the normal range of variation, and temporary.

NICHD and NIHs Office of Research on Womens Health funded the study, which was part of $1.67 million awarded to five institutions to explore potential links between COVID-19 vaccination and menstrual changes.

A change in cycle length of less than eight days is considered within the normal range of variation. Although small menstrual changes may not be meaningful to health care professionals and researchers, the study authors wrote, perceived changes in a bodily function linked to fertility may be alarming to those experiencing it and could contribute to vaccine hesitancy.

Researchers analyzed de-identified data from the fertility tracking app, Natural Cycles. Users of the app provided it information on their temperature and their menstrual cycles. They also had the option to consent to the use of their de-identified data for research. Worldwide rollout of COVID-19 vaccines allowed the study authors to expand on their original study of people in the United States. The study included data from participants throughout the world, but most were from the United Kingdom (32%), the United States and Canada (29%) and Europe (34%). In addition to the messenger RNA COVID-19 vaccines (Pfizer-BioNTech and Moderna), participants received COVID-19 vaccines made from engineered viruses (AstraZeneca, Covishield, Janssen/Johnson & Johnson and Sputnik), and inactivated viruses (Covaxin, Sinopharm, and Sinovac).

A total of 19,622 individuals participated. Of these, 14,936 were vaccinated and 4,686 were not. The researchers analyzed data on at least three consecutive cycles before vaccination and at least one cycle after. Data from at least four consecutive cycles were analyzed over a similar time interval for unvaccinated participants.

On average, vaccinated people experienced an increase of less than one day in each cycle in which they were vaccinated: a .71 day increase after the first dose and a .56 day increase after the second dose. Participants who received both doses in a single cycle had a 3.91 day increase in cycle length. After vaccination, cycle length had increased by only .02 days for individuals who received one dose per cycle, and .85 days for individuals who received two doses in one cycle, compared to participants who were not vaccinated. Changes in cycle length did not differ according to the type of vaccine received.

Of the total, 1,342 participants experienced a change in cycle length of eight or more days, comprising 6.2% of vaccinated individuals and 5.0% of unvaccinated individuals. Women who were younger and who had longer cycle length before vaccination were more likely to experience the increase.

The authors called for future studies on other aspects of vaccination-linked changes to menstrual cycles, such as unexpected vaginal bleeding and menstrual flow and pain. They also called for studies to determine the physical reasons why such changes might occur.

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit https://www.nichd.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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Study confirms link between COVID-19 vaccination and temporary increase in menstrual cycle length - National Institutes of Health (.gov)

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How a generally well-accepted measles vaccine mandate may lead to inequities and decreased vaccine uptake: a preregistered survey study in Germany -...

Responding to questions from Members of Parliament about safeguards to prevent overdosing or underdosing of COVID-19 vaccines, Dr Puthucheary said all providers under the National Vaccination Programme are licensed and regulated by the MOH.

Additional regulations stipulating eligibility criteria, dilution and administration of the recommended dosage for each vaccine have been issued specifically for COVID-19 vaccination.

Vaccination providers are expected to assess their staff competencies in COVID-19 vaccination administration, he added.

Dr Puthucheary said that in the event of any vaccine administration errors and medical emergencies following vaccination, vaccination providers are required to report to MOH no later than three hours after the incident.

Providers also need to inform patients immediately when a vaccination error has occurred, and monitor their health with daily calls for the next seven days to ensure their well-being.

In the event of an error, MOH will investigate and if there are any systemic issues, it will work with providers to review and improve their work processes, Dr Puthucheary added.

He said MOH was currently investigating ProHealth Medical Group about the incident and will take appropriate enforcement actions if there are any regulatory breaches.

"The vast majority of the clinics and vaccine providers do a great job of ensuring that the patients are cared for safely, the vaccines are provided safely with the correct dosage," said Dr Puthucheary.

"We have to identify, first of all, whether this is an issue with individual member personnel, whether it's something about the processes at the site or whether it is something systemic about the overall vaccination process.

"All our data, so far, suggests that the last is not likely, and the vast majority of our doses have been delivered quite safely. Nevertheless MOH continues to review all of this."

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130 people have received incorrect doses of COVID-19 vaccines: MOH - CNA

NEWS RELEASESIMCOE MUSKOKA DISTRICT HEALTH UNIT************************The Simcoe Muskoka District Health Unit is continuing to offer one-day pop-up COVID-19 vaccination clinics at locations throughout Simcoe Muskoka, with upcoming clinics taking place from Oct 3 to Oct. 11. Walk-ins forindividuals aged 5 years and older will be available, including the bivalent booster dose for people 18 years of age and older,as capacity allowsas follows:

Wednesday, Oct. 5

Thursday, Oct. 6

Friday, Oct. 7

Tuesday, Oct. 11

GO-VAXX busand mobile clinics continue to operate on an appointment only basis. Appointments for the GO-VAXX clinics may also be booked up to four days prior to the clinic through theCOVID-19 vaccination portalor by calling the Provincial Vaccine Contact Centre at1-833-943-3900.

The health unit continues to offer COVID-19 vaccinations on an appointment only basis to individuals aged six months and older at theGeorgian Mall, 509 Bayfield St. (upper level) in Barrie:

Appointments are also available at the health unit office immunization clinic locations in Midland, Orillia, Cookstown, Collingwood, Huntsville and Gravenhurst and can be booked through theCOVID-19 vaccination portalor by calling the Provincial Vaccine Contact Centre at1-833-943-3900.

In addition, the RVH COVID-19 Immunization Clinic at 29 Sperling Dr. in Barrie continues to offer bookedappointmentsand walk-ins from 10 a.m. to 6 p.m. on Tuesdays and Thursdays. Appointments may also be booked with theCouchiching Ontario Health Team Clinic located in the Orillia Soldier's Memorial Hospital Kiwanis Building - West Entrance 170 Colborne St., W.

Individuals six months of age and older may also receive the vaccine at somelocal pharmaciesor booked appointments through some primary care providers, and Family Health Teams who are offering the vaccine as part of their regular clinical practice. Pop-up and GO-VAXX mobile clinics will continue to be scheduled throughout Simcoe and Muskoka.

Individuals are recommended to receive the bivalent booster six months after their last dose of COVID-19 vaccine or COVID-19 infection, however people who want to receive their booster earlier can do so at a minimum of three months. As we approach the fall respiratory season,high-risk populationsare recommended to receive their bivalent booster as soon as they are eligible (i.e. the minimum three-month interval) to protect themselves as people spend more time indoors.

Staying up to date with all COVID-19 vaccine doses you are currently eligible for remains the best defense against infection, severe illness, long term COVID-19 symptoms, hospitalization and death.

For more information about COVID-19 vaccination, dose eligibility and booking an appointment, please visitwww.smdhu.org/GetVaccinated.

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Health unit hosts pop-up vaccine clinics throughout the week - BradfordToday

A doctor who spread false rumours about vaccines causing stillbirths at a Vancouver-area hospital and made other misleading claims about COVID-19 while standing in front of effigies portrayingB.C. politiciansbeing hanged will face a disciplinary hearing with his regulatory college.

The College of Physicians and Surgeons of B.C. posted a notice onThursday announcing that a citation has been issued alleging misconduct by family physician Dr. Daniel Nagase.

Nagase, who has resigned his licence to practise in B.C., is accused of violating professional standards by "making public addresses regarding the COVID-19 pandemic and related issues that included his making misleading, incorrect, or inflammatory statements about vaccinations, treatmentsand measures for COVID-19," the public notice says.

That includes falsely stating, in public, that the vaccines are dangerous, publicly suggesting that the anti-parasitic drug ivermectin is a safe and effective treatment for the virus, and "making at least some of these public statements while appearing in front of effigies of political figures who were [hanged] from nooses."

The latterincident was caught on camera on Dec. 9, 2021, when Nagase spoke outside the B.C. Legislature while dummies labelled as Premier John Horgan, Health Minister Adrian Dix and Public Safety Minister Mike Farnworth were raised behind him, with ropes tied around their necks.

During that speech, he falsely claimed that COVID-19 vaccines are "the most dangerous injection in the history of vaccination."

Dr. Charles Hoffe of Lytton, B.C., also spoke at the event, and is set to face his own disciplinary hearing with the college.

Just a couple of weeks before that speech, Nagase was filmed participating in an anti-vaccine protest outside the North Vancouver RCMP detachment.

He was shown repeating disinformation suggesting there were more than a dozen stillbirths in 24 hours at Lions Gate Hospital among mothers who hadreceived the COVID-19 vaccine.

That lie spread so widely that hospital operator Vancouver Coastal Health was forced to issue a statement making it clear that there was no truth to the rumours.

The health authority also clarified that Nagase has no connection to Lions Gate, and no hospital privileges anywhere in the region.

Nagase's claims about COVID-19 previously attracted attention in Alberta, where he has spent recent years working in rural hospitals.

Last fall, Alberta Health Services issued a warning about Nagase's public claims of using ivermectin to cure COVID-19 in elderly patients, stating that neither the veterinary nor human versions of the drug have been proven safe or effective treatments for the virus.

Nagase's medical licence has been cancelled in Alberta for non-renewal and non-payment of fees, and there's a notice next to his name in the College of Physicians of Alberta registry saying he's forbidden from writing mask or vaccine exemption letters, prescribing ivermectin or from treating any COVID-19 patients.

Nagase is the third doctor that the B.C. college has publicly acknowledged investigating for spreading misinformation about COVID-19 and vaccines. Though disciplinary hearings have been announced for both Nagase and Hoffe,dates have yet to be scheduled for those proceedings.

Dr. Stephen Malthouse of Denman Island remains under investigation, but the college announced in March that it was suspending his licence to protect the public while that process is underway.

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Doctor who gave anti-vaccine speech in front of effigies of officials being hanged faces discipline hearing - CBC.ca

Funding of $11.1 million for two UBC projects that will improve pathogen response and boost the impact of B.C. biotechnology on the global stage

VANCOUVER, BC, Oct. 3, 2022 /CNW/ - Pacific Economic Development Canada

British Columbians continue to feel the effects of the COVID-19 pandemic, whether at home, at work, or in their community. Throughout the pandemic, science has provided the greatest defense, particularly through mRNA vaccines. These vaccines trigger the body's immune response to help protect against infection and severe illness.

Today, the Honourable Harjit S. Sajjan, Minister for International Development and Minister responsible for the Pacific Economic Development Agency of Canada (PacifiCan), announced over $11.1 million in funding through PacifiCan for the University of British Columbia (UBC) to undertake two new projects to enhance the delivery and efficacy of mRNA vaccines.

The first of these two complementary projects is receiving $3.5 million in PacifiCan support. It aims to optimize how mRNA vaccines are administered on a cellular level, improving uptake into the body. This will reduce potential side-effects of mRNA vaccines, improve their efficacy and allow for a smaller vaccine dosage. Research conducted through this project will help to streamline the production of existing mRNA vaccines and inform the development of future medicines across the globe.

The second project, with $7.6 million in PacifiCan support, aims to identify and address new COVID-19 variants before they can spread. Through studying existing variants at the molecular level, researchers will use Artificial Intelligence (AI) to predict and develop mRNA vaccine treatments for potential future pathogens. This project will enable a nimble, home-grown response to emerging COVID-19 variants, helping to protect Canadians, and further solidify B.C. as a leader in the biotechnology sector.

Investing in the health and safety of all Canadians is a key priority for the Government of Canada. In British Columbia, PacifiCan is committed to advancing the research and commercialization of life-saving biotechnology, supporting the regional economy, and building pandemic resilience across the globe.

Quotes

"PacifiCan is committed to supporting British Columbia's life sciences sector andthese projects at the University of British Columbia reflect that commitment.Establishing a home-grown pipeline for mRNA vaccine researchwillnot only save lives, but create jobs for British Columbians and position Canada as a global leader in biotechnology innovation."

- The Honourable Harjit S. Sajjan, Minister of International Development and Minister responsible for the Pacific Economic Development Agency of Canada

"With cutting-edge research led by some of the brightest minds globally, UBC continues to excel in biotechnology and life sciences research and innovation. With the generous support of the Government of Canada through PacifiCan announced today, our researchers will be able to help development treatments for new COVID-19 variants and improve the efficacy of mRNA vaccines and other therapeutics for a wide range of diseases."

- Santa J. Ono, President and Vice-Chancellor, University of British Columbia

"UBC has long been a major driver of the B.C. biotech sector, but those connections and their outputs really gained international attention during the pandemic. AbCellera, Acuitas, and Precision Nanosystems, among many others, are now major players in the treatment and prevention of diseases. This funding builds off many years of collaboration between UBC and local biotech companies and will enable us to continue developing and refining vaccines, drugs, and biologics."

- Dr. Leonard Foster, Professor, Department of Biochemistry and Molecular Biology, University of British Columbia

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Follow PacifiCanonTwitterandLinkedInToll-Free Number:1-888-338-9378TTY (telecommunications device for the hearing impaired):1-877-303-3388

Backgrounder: Government of Canada announces funding for advancements in mRNA vaccine technology at the University of British Columbia

Today, the Honourable Harjit S. Sajjan, Minister of International Development and Minister responsible for the Pacific Economic Development Agency of Canada (PacifiCan), announced an investment of over $11.1 million through the Regional Innovation Ecosystem program for two projects at the University of British Columbia (UBC).

These projects will focus on advancing the delivery and efficacy of mRNA vaccine technology. The two project teams will work in tandem, meeting regularly and coordinating research to maximize the value and effectiveness of both projects.

Improve the delivery technology behind mRNA vaccines and other nanomedicines$3,500,000

The University of British Columbia will acquire key equipment and enhance lab resources to improve vaccine delivery technology. In partnership with leading B.C. biotechnology companies, UBC aims to accelerate the development of vaccine delivery techniques for commercial application on a global scale.

Through analyzing how mRNA vaccines interact with cells and create defenses against pathogens, researchers will work to optimize the administration of those vaccines. Key objectives in this research project include minimizing any potential side effects, reducing the necessary vaccine dosage, and optimizing the potency of mRNA vaccines, among others.

This work will advance the development of future mRNA vaccines and other medicines. Expected economic benefits of this project include the creation of 70 new jobs, the training of 80 new highly qualified biotechnology professionals, and revenue growth of at least $90 million for the B.C. biotechnology sector.

Grow B.C. biotech by advancing in-vitro and in-situ antiviral therapy for SARS-CoV2 variants$7,680,000

This project will see UBC acquire key equipment and enhance lab operations to advance antiviral therapy for COVID-19 variants. This will involve identifying, testing and developing responses to existing COVID-19 variants and establishing a vaccine development framework in B.C.

Working closely with B.C. biotechnology companies, UBC will study the COVID-19 Delta variant at a molecular level and use AI predictive models to create mRNA vaccine treatments for potential future variants. Through this process, UBC and its partners will develop a pipeline for rapid anti-viral drug development, enabling a local response to new and emerging COVID-19 variants for worldwide commercial application.

Overall, this will allow B.C. to provide international leadership in vaccine research and raise the visibility of B.C. biotech within the global community. Expected economic benefits of this project include creating at least 170 jobs at UBC and industry partners, training 75 highly qualified personnel and growing revenue by at least $70 million for the B.C. biotechnology sector.

SOURCE Pacific Economic Development Canada

For further information: Contacts: Haley Hodgson, Press Secretary, Office of the Minister of Economic Development, [emailprotected]; Amanda Costa, Senior Communications Advisor, Pacific Economic Development Canada, [emailprotected]

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Government of Canada announces funding for advancements in mRNA vaccine technology at the University of British Columbia - Canada NewsWire

Imagine trying to medicate a bug.

That was the task taken on by a group of researchers at MassBiologics of UMass Chan Medical School (UMass Chan) in Massachusetts: They developed a way to get an antibody into ticks to neutralize the bacterium that causes Lyme disease, the most common vector-born disease in the United States.

But no, the researchers did not give shots to ticks. They injected the antibody into humans so that people can transmit the antibody to ticks that bite them.

We are trying to deliver a medicine to a tick so that it doesnt pass on the infection to the patient, says Mark S. Klempner, MD, a professor of medicine at UMass Chan. The patient provides the vehicle to deliver the antibody to the infected tick.

Targeting ticks to prevent Lyme rather than fighting off an infection after it begins is the fundamental strategy behind three projects that aim to create the only medication to prevent the disease in people. The disease sets off a series of escalating symptoms, starting with a red rash, fatigue, fever, headache, and a mild stiff neck, and sometimes escalating if left untreated to serious complications to joints (arthritis), the heart, and the nervous system.

The current projects come two decades after the first human Lyme vaccine, LYMErix, was pulled from the market because of factors that researchers believe their new products will overcome. Heres where the projects stand:

If any of these products are eventually approved by the Food and Drug Administration (FDA), it would put humans nearly on par with dogs; they can get four Lyme vaccines made just for them. The lack of a human version has little to do with the science of making one. Klempner knows that well, as he worked on one of two Lyme vaccines that showed strong clinical trial results in the 1990s.

It was not very difficult to develop, Klempner recalls of the vaccine, Imulym, made by Pasteur Merieux Connaught but never brought to market. In terms of difficulty from a biological and medical standpoint, it was relatively straightforward.

The new efforts build on the basic strategy of those vaccines.

Creatures that spread diseases through bites such as mosquitos that transmit malaria and raccoons that transmit rabies usually deliver the virus, bacteria, or parasite instantly. But when a black-legged tick latches onto someone, it takes at least 36 hours to pass along the Lyme-causing bacterium, Borrelia burgdorferi, says Gary Wormser, MD, chief of the Division of Infectious Diseases at New York Medical College. That lag, he notes, provides time for antibodies to get into the ticks gut and prevent transmission of the bacterium before it sets off an infection in the human.

Whats more, the bacterium has virtually no machinery to survive mutation, Klempner says, so that researchers can identify and stick with antibodies that eradicate the bacterium rather than having to keep up with mutated versions. (Rapid viral mutation is a main reason that scientists have yet to develop a vaccine against HIV.)

LYMErix, manufactured by what was then SmithKline Beecham, induced patients to produce antibodies that a tick would absorb from its victims blood and that neutralized Borrelia burgdorferi. Studies showed the vaccine to be about 75% effective in blocking the disease. The FDA approved it in 1998.

It wasnt a perfect vaccine, but it was good, says Eugene Shapiro, MD, professor of epidemiology and investigative medicine at Yale School of Medicine in Connecticut.

As a marketable product, however, LYMErix faced compounding drawbacks. Sam Telford, ScD, professor of vector-borne infections and public health at Tufts University in Massachusetts, who helped run the vaccines clinical trials, notes that Lyme was far less prevalent then and was more restricted to a few geographic regions, thus limiting the market for a vaccine. (The Ixodes ticks that can carry Lyme disease, commonly known as deer ticks, have been most common in the northeast, Mid-Atlantic and north-central states, but their reach has been expanding.)

That, along with Lyme being seen as easily treatable if you catch it at the early stages, led the Centers for Disease Control and Prevention (CDC) to issue a lukewarm recommendation for the vaccine as rarely necessary and prompted many doctors to shrug it off, Telford recalls. Potential consumers felt lukewarm as well, for reasons that included the inconvenience of the three-dose regimen of injections over 12 months, uncertainty over how long the protection would last, and the absence of approval for use on anyone under 15 because LYMErix was not tested in children.

The final blow, Telford says, was claims by some recipients that the vaccine induced a form of arthritis. Although an FDA analysis of side effects among vaccinated people found no evidence to support the allegation, LYMErix sales fell under the weight of the negative publicity and a class action suit. The manufacturer (renamed GlaxoSmithKline) withdrew the vaccine in 2002.

That experience chilled research into prophylactic treatments against Lyme, Klempner says, even though biologically, its an easy target.

Over the past 20 years, cases of Lyme disease have multiplied and spread , with experts citing climate change (which can make cold areas more hospitable to the ticks lifecycle) and the increasing encroachment of human development adjacent to forested animal habitats.

Lyme disease is all over the place in much of the U.S., Telford says.

Nailing down its prevalence is tricky. The CDC says it gets about 30,000 reported cases from doctors each year, but notes that this number does not reflect all diagnosed cases. An analysis based on private insurance claims , conducted by CDC researchers, estimated that each year 476,000 people in the U.S. are diagnosed and treated for the disease. (Some people are treated based on symptoms without confirmation of having Lyme.) A recent report from the nonprofit FAIR Health, which studies health care costs and coverage, found that from 2007 to 2021 Lyme diagnoses rose 357% in rural regions and 65% in urban areas.

The growth of cases and public awareness have encouraged researchers that a market exists for prophylactics against Lyme. The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens, Pfizer and Valneva said in a news release last month about their vaccine project.

Here is a summary of the three most advanced development projects:

Pfizer and Valneva: Their vaccine, VLA15, induces the patient to create antibodies that block a protein, OspA, on the surface of the Borrelia burgdorferi bacterium. Blocking OspA inhibits the bacteriums ability to leave the tick and infect humans, the companies state.

The vaccine requires three doses. With a phase 2 trial showing promising results in producing immune responses, the companies have started a phase 3 trial to enroll approximately 6,000 participants, ages 5 years and up, at 50 sites where Lyme is prominent. Because the vaccine produces antibodies to combat strains of the virus in Europe as well as the United States, there are test sites in the U.S., Finland, Germany, the Netherlands, Poland, and Sweden.

Shapiro notes that this vaccine does not include an epitope the part of a molecule to which an antibody attaches itself that was implicated in the arthritis claims against LYMErix.

The companies say they hope to have the vaccine licensed in 2025.

MassBiologics: Rather than prompt a patient to produce antibodies, the Lyme Pre Exposure Prophylaxis (Lyme PrEP) delivers a monoclonal antibody a lab-made protein that binds to the surface of the bacteria against the common U.S. strain of Lyme. Like VLA15, this medication targets the OspA protein.

Lyme PrEP conveys immunity almost immediately, Klempner says, as opposed to the weeks it might take a person to develop antibodies on their own after several shots. The person is immune within hours or days, he says.

In addition, Klempner notes, one antibody is less likely to trigger adverse effects in a patient than a medication that involves numerous antibodies, and the shot would be given once a year, at the start of tick season.

With a phase 1 trial showing no significant adverse effects, Klempner,former executive vice chancellor at MassBiologics, hopes a phase 2-3 clinical trial to test effectiveness can start in spring 2023.

Yale SOM: Yale University researchers designed a vaccine that recognizes a ticks saliva and sparks a skin reaction that makes it hard for ticks to hang on and feed. Created with mRNA technology which helps to accelerate the production of vaccines, such as those against COVID-19 this medicine quickly produces redness at the site of a tick bite, alerting victims to the bite and increasing the chances that they can remove the tick before it delivers the Lyme-causing bacterium.

If you can remove the tick that was on for less than 36 hours, youre not going to get Lyme, Wormser says.

Trials on guinea pigs showed that when ticks were removed after redness appeared, none of the immunized animals developed Lyme disease. In addition, the ticks fed poorly and detached sooner than normal, Yale reports.

These advances provide hope for a Lyme disease vaccine within several years. Yet researchers offer caution. They warn that people vaccinated against Lyme will have to take precautions against other diseases that ticks transmit, like by wearing long-sleeved clothing in wooded areas and inspecting themselves for ticks after forest forays.

Its not like you can go out and say, Im vaccinated, I dont have to worry about tick bites, Telford says. There is no such thing as a good tick bite.

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Lyme disease is on the rise. Why is there still no vaccine? - AAMC

The nonprofit Partnership for Public Service hosted its annual Samuel J. Heyman Service to America Medals (the Sammies) on Tuesday evening, during which a trio from the Centers for Disease Control and Prevention won the COVID-19 response award for their work starting in mid-2020 designing and implementing a plan to distribute COVID-19 vaccines across the country and to inform the public about them before the vaccines were even available.

Thanks to the efforts of the CDCs task forcewhich at its peak had more than 700 full-time members and, overall, benefited from the work of more than 1,500 peoplemore than 570 million COVID-19 vaccine doses have been administered in the United States, said the Partnership. This occurred with regular public communication and new levels of data-sharing among local, state and federal levels about safety issues, and strategies to reach new populations approved for vaccination.

Dr. David Fitter, an epidemiologist at the CDC who co-led the vaccine distribution task force, told Government Executive at the event that we get to represent thousands of people who worked on this together.

CDCs Dr. Amanda Cohn said the ceremony and seeing all the winners makes you really proud to work for the federal government. Here are some of the other recent headlines you might have missed.

The Justice Department announced on Tuesday federal criminal charges against 47 defendants for their alleged part in a $250 million fraud scheme exploiting a federally funded program meant to feed underserved kids in Minnesota during the pandemic. These indictments, alleging the largest pandemic relief fraud scheme charged to date, underscore the Department of Justices sustained commitment to combating pandemic fraud and holding accountable those who perpetrate it, said Attorney General Merrick Garland, in a statement. In partnership with agencies across government, the Justice Department will continue to bring to justice those who have exploited the pandemic for personal gain and stolen from American taxpayers.

On Wednesday, the Justice inspector general office released a report on how the departments criminal division and Executive Office for U.S. Attorneys managed and coordinated pandemic-related allegations and referrals. While [both] have provided guidance, training, and policies to their prosecutors, they can better leverage the limited resources available to address fraud by enhancing the tracking, management, and notification of fraud referrals and initiated cases, said the report. We also identified successful prosecutorial practices employed by various USAOs, which, once shared by EOUSA across the districts, could further improve the Department of Justices response to pandemic-related fraud.

Following testing failures early in the pandemic, the Food and Drug Administration has an opportunity to better plan for and respond to current and future public health emergencies, the Health and Human Services Department watchdog said in a report published this week. One recommendation is prior to the next emergency, FDA should work with key stakeholders in the lab community to determine how to communicate during and in advance of a public health emergency, said the report. Another is FDA should develop technical guidance and educational material [for test developers] to ease some of its workload during any current and future emergency response and to ensure that these resources are available to developers as early in an emergency as possible. The FDA agreed with all six recommendations from the IG.

The Pandemic Response Accountability Committee issued a risk advisory this week warning of potential identity theft of minors and elderly individuals in the Housing and Urban Developments housing assistance programs to apply for the Small Business Administrations COVID relief programs. The PRACs Pandemic Analytics Center of Excellence identified possible identity or other fraud in one or more of these SBA programs involving 945 minors (under 18 years old) and 231 elderly individuals (80 years and older), said the advisory. While we understand that the information may not involve fraud or identity fraud in all instances, we are offering to provide the supporting data directly to SBA because it strongly indicates that further SBA management review is warranted.

Help us understand the situation better. Are you a federal employee, contractor or military member with information, concerns, etc. about how your agency is handling the coronavirus? Email us at newstips@govexec.com.

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Coronavirus Roundup: A CDC Team Is Honored for Its Vaccine Distribution Work - GovExec.com

In May 2022, the United States confirmed the first monkeypox case in Massachusetts. As of Sept. 24, there have been 24,846 confirmed cases in all 50 states, including the District of Columbia and Puerto Rico, according to the Centers for Disease Control and Prevention website.

Monkeypox virus is a part of the same family as the variola virus, the virus that causes smallpox. Individuals who are infected may experience a milder version of smallpox symptoms, according to the CDC.

The most common symptoms are rashes that initially may look like pimples or blisters, and can appear on various parts of the body such as the face, inside the mouth, hands, feet and genitals, the CDC said.The lesions are often described as painful until the healing phase. The illness normally lasts 2-4 weeks. The virus is rarely fatal.

Monkeypox can be spread to anyone through close contact with a person that is infected. The virus can be transmitted through intimate physical contact such as sex, kissing, hugging or direct contact with infectious rashes, scabs or fluids.

Jeff Hogan, an animal health researcher at the University of Georgias Department of Infectious Diseases, said once a person is infected with monkeypox, the virus begins to slowly replicate to where it spreads systemically in the body. This means that after the rashes appear on the skin, the virus will spread through the circulatory system, which deals with pumping blood through the body, and to the internal organs such as the spleen and liver.

When it comes to creating the vaccine for monkeypox, the process in which the virus is repeatedly grown causes it to be diluted and not as harmful as it originally was, Hogan said. Later on, the weakened live virus is injected into a person as the vaccine.

Once an individual has been vaccinated, the virus will replicate in the body, Hogan said. With the presence of the virus in the body, white blood cells respond against the virus by creating antibodies.

The immune system would recognize that vaccine as something foreign, generating the antibodies response, said Jarrod Mousa, a UGA assistant professor in the Department of Infectious Diseases. The antibodies would then create a long lasting protection against monkeypox and smallpox.

With the shortage of vaccine availability, the vaccines are given with a decrease in the dosage.

Overall, the decrease in dosage may be beneficial to the individual getting vaccinated as it also decreases the number of adverse effects, Hogan said, but the person needs to have enough of the virus particles in order for the antibodies to be created.

The decrease in dosage has led to the monkeypox vaccine being administered two different ways: subcutaneously, where the vaccine is inserted in a layer of fat between the skin and muscle, and intradermally, where the vaccine is injected into the top layer of the skin, according to the CDC.

Rama Amara, a professor at Emory Universitys vaccine center and department of microbiology and immunology, said injecting the vaccine into the skin and giving a lower dose of it could produce an immune response. There are different kinds of cells in the skin that trigger the white blood cells to make antibodies.

In comparison to the COVID-19 virus, the monkeypox vaccine is a live virus while the COVID-19 dealt with an mRNA vaccine, Mousa said. The COVID-19 vaccine uses messenger RNA as its genetic material but the vaccines are only the instructions for making a part of the virus, meaning that the live virus is not injected.

According to Mousa, with monkeypox, once the individual is vaccinated, the DNA of the live virus gives instructions to the cells on how to make more of it. The virus has proteins on its surface and contains DNA on the inside to store its genetic material.

For individuals who are planning to get vaccinated, it is important to look at risk factors, Amara said. We need to think about people with HIV [and who had a] transplant; these are more vulnerable people. So we need to see if we are going to see an increased infection among these people, Amara said.

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Everything to know about the Monkeypox vaccine | Health - Red and Black

U.S. health officials say 4.4 million Americans have rolled up their sleeves for theupdated COVID-19 booster shot.The Centers for Disease Control and Prevention posted the count Thursday as public health experts bemoaned President Joe Bidens recent remark that the pandemic is over.

The White House said more than 5 million people received the new boosters by its own estimate that accounts for reporting lags in states.

Health experts said it is too early to predict whether demand would match up with the 171 million doses of the new boosters the U.S. ordered for the fall.

No one would go looking at our flu shot uptake at this point and be like, Oh, what a disaster, said Dr. David Dowdy, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health. If we start to see a large uptick in cases, I think were going to see a lot of people getting the (new COVID) vaccine.

A temporary shortage of Moderna vaccine caused some pharmacies to cancel appointments while encouraging people to reschedule for a Pfizer vaccine. The issue was expected to resolve as government regulators wrapped up an inspection and cleared batches of vaccine doses for distribution.

I do expect this to pick up in the weeks ahead, said White House COVID-19 coordinator Dr. Ashish Jha. Weve been thinking and talking about this as an annual vaccine like the flu vaccine. Flu vaccine season picks up in late September and early October. Were just getting our education campaign going. So we expect to see, despite the fact that this was a strong start, we actually expect this to ramp up stronger.

Some Americans who plan to get the shot, designed to target the most common omicron strains, said they are waiting because they either had COVID-19 recently or another booster. They are following public health advice to wait several months to get the full benefit of their existing virus-fighting antibodies.

Others are scheduling shots closer to holiday gatherings and winter months when respiratory viruses spread more easily.

Retired hospital chaplain Jeanie Murphy, 69, of Shawnee, Kansas, plans to get the new booster in a couple of weeks after she has some minor knee surgery. Interest is high among her neighbors from what she sees on the Nextdoor app.

Theres quite a bit of discussion happening among people who are ready to make appointments, Murphy said. I found that encouraging. For every one naysayer there will be 10 or 12 people who jump in and say, Youre crazy. You just need to go get the shot.

Biden later acknowledged criticism of his remark about the pandemic being over and clarified the pandemic is not where it was. The initial comment didnt bother Murphy. She believes the disease has entered a steady state when well get COVID shots in the fall the same as we do flu shots.

Experts hope shes right, but are waiting to see what levels of infection winter brings. The summer ebb in case numbers, hospitalizations and deaths may be followed by another surge, Dowdy said.

Dr. Anthony Fauci, asked Thursday by a panel of biodefense experts what still keeps him up at night, noted that half of vaccinated Americans never got an initial booster dose.

We have a vulnerability in our population that will continue to have us in a mode of potential disruption of our social order, Fauci said. I think that we have to do better as a nation.

Some Americans who got the new shots said they are excited about the idea of targeting the vaccine to the variants circulating now.

Give me all the science you can, said Jeff Westling, 30, an attorney in Washington, D.C., who got the new booster and a flu shot on Tuesday, one in each arm. He participates in the combat sport jujitsu, so wants to protect himself from infections that may come with close contact. I have no issue trusting folks whose job it is to look at the evidence.

Meanwhile, Bidens pronouncement in a 60 Minutes interview broadcast Sunday echoed through social media.

We still have a problem with COVID. Were still doing a lot of work on it. But the pandemic is over, Biden said while walking through the Detroit auto show. If you notice, no ones wearing masks. Everybody seems to be in pretty good shape. And so I think its changing.

By Wednesday on Facebook, when a Kansas health department posted where residents could find the new booster shots, the first commenter remarked snidely:

But Biden says the pandemic is over.

The presidents statement, despite his attempts to clarify it, adds to public confusion, said Josh Michaud, associate director of global health policy with the Kaiser Family Foundation in Washington.

People arent sure when is the right time to get boosted. Am I eligible? People are often confused about what the right choice is for them, even where to search for that information, Michaud said.

Any time you have mixed messages, its detrimental to the public health effort, Michaud said. Having the mixed messages from the presidents remarks, makes that job that much harder.

University of South Florida epidemiologist Jason Salemi said hes worried the presidents pronouncement has taken on a life of its own and may stall prevention efforts.

That soundbite is there for a while now, and its going to spread like wildfire. And its going to give the impression that Oh, theres nothing more we need to do, Salemi said.

If were happy with 400 or 500 people dying every single day from COVID, theres a problem with that, Salemi said. We can absolutely do better because most of those deaths, if not all of them, are absolutely preventable with the tools that we have.

New York City photographer Vivienne Gucwa, 44, got the new booster Monday. Shes had COVID twice, once before vaccines were available and again in May. She was vaccinated with two Moderna shots, but never got the original boosters.

When I saw the new booster was able to tackle omicron variant I thought, Im doing that, Gucwa said.

I dont want to deal with omicron again. I was kind of thrilled to see the boosters were updated.

___

AP Medical Writer Lauran Neergaard and AP White House Correspondent Zeke Miller contributed. ___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

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The U.S. ordered 171 million updated COVID booster shots but only 4.4 million went into arms as Biden says the pandemic is over - Fortune