Cardiologist says COVID-19 vaccinations ‘must stop’ due to the risk of adverse eventsscientists and doctors push back – Cardiovascular Business

Cardiologist says COVID-19 vaccinations ‘must stop’ due to the risk of adverse eventsscientists and doctors push back – Cardiovascular Business

Second doses of monkeypox vaccine available in B.C. this week  Hope Standard – Hope Standard

Second doses of monkeypox vaccine available in B.C. this week Hope Standard – Hope Standard

October 5, 2022

Second doses of the monkeypox vaccine will be available to British Columbians starting this week.

The Provincial Health Services Authority says those who received their first dose at least 28 days ago are eligible to make appointments for their second, as part of a two-dose series approved by Health Canada.

More than 19,000 doses of Imvamune have been administered to those most at risk of contracting the virus in B.C.

The health authority says eligible people who have not yet received a first dose are encouraged to do so, but those who have had a monkeypox infection do not need a vaccine.

It says more appointments will be added in the coming weeks as capacity for delivering the vaccine grows.

Monkeypox spreads when people have close, physical contact with an infected persons lesions, their clothing or bedsheets, and symptoms can include rash, swollen lymph nodes and fever.

The Public Health Agency of Canada says a total of 1,400 cases of the virus have been confirmed in Canada, including 162 in British Columbia.

RELATED: B.C. releases details of monkeypox vaccine availability as outbreak spreads globally

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The Daily Explains: Navigating COVID-19, monkeypox and the flu this season – Daily Northwestern

The Daily Explains: Navigating COVID-19, monkeypox and the flu this season – Daily Northwestern

October 5, 2022

Wintertime may look bleak in Chicago, but your health and wellness dont have to be. The public health landscape can often seem daunting, but The Daily is here to break down the three prevalent viruses to watch out for this season.

How an outbreak becomes an epidemic

Outbreaks can lead to epidemics or pandemics if case numbers rise quickly within a short period of time. These pandemics differ from seasonal variations in that people have little to no immunity given the novelty of the viruses.

On the other hand, the seasonal flu leads to an expected rise in cases that peaks between December and February. Scientists develop a new influenza vaccine yearly to target virus mutations and waning immunity over time, though previous infection and vaccination offer some immunity.

Though coronaviruses have also been around for a while, the COVID-19 pandemic originated from the SARS-CoV-2 strain. With mutations affecting the infectivity and severity of the disease, vaccine modifications have followed. Similarly to the seasonal flu, infections and booster doses strengthen immunity against COVID-19.

How each virus spreads

The key difference between the recent monkeypox outbreak, the seasonal flu and the COVID-19 pandemic is the rate at which transmission occurs.

Monkeypox primarily spreads through close, skin-to-skin contact, which can include direct contact to monkeypox rash or fluids from an infected person. The virus is therefore not as easily transmissible as COVID-19 and the flu, which primarily spread through respiratory droplets. Though the majority of monkeypox cases have been reported among men who have sex with other men, anyone who has close contact with an infected person can contract the virus.

COVID-19 and the flu spread in similar ways, but the smaller particle sizes of SARS-CoV-2 allow these respiratory droplets to stay in the air longer, increasing the rate of infection. This difference has made COVID-19 spread more rapidly than the flu.

COVID-19 also has a longer incubation period than the flu: someone who contracts the flu will typically experience symptoms within one to two days of exposure, while an individual with COVID-19 may not experience symptoms until within two days to two weeks. With this delay between symptom onset and viral exposure, people are more likely to spread SARS-CoV-2 before they quarantine or isolate.

Monkeypox has an even wider incubation period, ranging from five to 21 days.

Symptoms to watch out for

COVID-19 and the seasonal flu have many overlapping symptoms, including fever, fatigue, headache and nausea. However, unlike the flu, COVID-19 may also present with loss of taste or smell as well as shortness of breath.

Though monkeypox symptoms also include fever, headache and exhaustion, the more distinctive symptoms include rash and swollen lymph nodes. Symptoms typically persist for two to four weeks.

Prevention and possible treatment

Vaccines are currently available for all three viruses to increase immunity in case of exposure.

For COVID-19, vaccination eligibility differs by age. The Centers for Disease Control and Prevention recommend first receiving a two- or three-dose primary vaccination series of Pfizer, Moderna or Novavax, or the one-dose Johnson & Johnson vaccine.

Those 12 years or older should then receive a bivalent booster dose authorized Sept. 1 at least two months after their last COVID-19 vaccination. This updated dose provides protection against the original COVID-19 virus as well as the more infectious omicron BA.4 and BA.5 variants that comprise the majority of current infections.

Individuals between the ages of five and 11 are not yet eligible for the bivalent booster dose and should instead get the original monovalent booster dose at least five months after their last COVID-19 vaccination if they received the Pfizer primary-series vaccination.

The CDC has approved two vaccines for monkeypox, though vaccination is only recommended for those exposed to monkeypox or at high risk of exposure. Eligible individuals can either receive the two-dose Jynneos vaccination series or the single-dose ACAM2000 vaccine. Northwestern Medicine Student Health Service provides a list of local monkeypox vaccine providers on its website.

In terms of influenza vaccination, the CDC recommends individuals obtain the single-dose flu vaccine by the end of October. NU students can make a flu vaccine appointment at the Evanston campus, and all individuals can seek vaccination at nearby pharmacies like CVS and Walgreens.

In terms of treatment, a health care professional can prescribe antiviral medications for the influenza virus. For COVID-19 and monkeypox, professionals can prescribe antiviral medications to eligible, high-risk populations.

University policies and guidelines

NU currently does not have vaccination requirements for the flu or monkeypox but encourages vaccination against these viruses for eligible individuals. All community members are required to have at least primary-series vaccination unless granted an exemption.

Individuals who suspect they have monkeypox should contact the health service for assessment and treatment. Students who test positive are required to self-isolate until fully healed in order to prevent transmission of the virus including using separate bathrooms, towels, clothing and linens from others. If living on campus, individuals must seek temporary off-campus housing for the duration of the isolation period, though the University has a limited number of isolation spaces available.

If students test positive for COVID-19, they will also be required to isolate for a minimum of five days. Students living on campus must complete their isolation period at 1835 Hinman Ave. NU recently updated its isolation housing policies for Fall Quarter.

While the University doesnt have isolation requirements for the flu, the CDC recommends isolation protocols similar to those outlined for COVID-19. Infected individuals should self-isolate until at least 24 hours after the absence of fever without fever-reducing medications.

Email: [emailprotected]

Twitter: @amittal27

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Monkeypox studies suggest ways to reduce viral spread – University of Toronto

Monkeypox studies suggest ways to reduce viral spread – University of Toronto

October 5, 2022

Less than three months since it launched, themonkeypox rapid research responseled by the University of TorontosEmerging and Pandemic Infections Consortium(EPIC) and three partner hospitals is generating results that could help curb transmission of the virus.

When monkeypox first arrived in Canada, we quickly learned about the stockpile of smallpox vaccine [which also protects against monkeypox], saidJesse Knight, a PhD student in U of TsInstitute of Medical Science in the Temerty Faculty of Medicine. Given that the vaccine supply was quite limited early on, it was important to use it quickly and efficiently to help reduce cases.

Knight is the first author on a new modellingstudythat looks at how to optimize the initial rollout of vaccine to prevent the most infections. The study,which hasnot yet been peer-reviewed,suggests that the greatest number of infections could be prevented by prioritizing vaccines to bigger cities with larger networks of communities at risk, the highest epidemic potential and largest number of initial cases.

Knight notes these results do not mean that areas outside of big cities should not receive vaccines, but rather they provide guidance on how to maximize immediate impact early in an epidemic of an extremely limited supply until more doses become available. Indeed, while Ontarios vaccination efforts initially centred on Toronto, they soon expanded to areas outside the city.

Darrell Tan and Sharmistha Mishra

The preliminaryfindings were co-authored by Knights academic supervisorSharmistha Mishraand collaboratorDarrell Tan, both clinician-researchers atSt. Michaels Hospital, Unity Health Toronto, and associate professors in U of Ts Temerty Faculty of Medicine.

Mishra and Tan are also co-leads of EPICs monkeypox rapid research response. EPIC is one of several U of T institutional strategic initiatives.

For their study, the researchers built a mathematical model that simulated the potential transmission of monkeypox virus in the context of sexual networks of gay, bisexual, and other men who have sex with men. The model reflects two interconnected sexual networks that can be thought of as communities within two cities one larger network like in Toronto and a smaller network in a medium-sized Ontario city and simulated the roll-out of 5,000 vaccine doses starting two months after the first case of monkeypox.

The team tested scenarios in which they changed the relative population size in each network (i.e., city), the interconnectedness between the two sexual networks (sex among individuals between cities), epidemic potential of the virus in each cityand the distribution of initial imported cases across cities.

A citys epidemic potential reflects how likely a person carrying the virus is to pass it on to othersby taking into account the density and configuration of the sexual network, access to prevention and careand the underlying social and structural contexts that shape sexual networks and shape access.

Early insights from these analyses helped inform vaccine prioritization by health units across Ontario, which to date has centred on community-based organizations, service providers, health unitsand public health teams at every level working together to mobilize access and deliver vaccines to gay, bisexual and other men who have sex with men who may be most at risk of infection, said Mishra.

From the start, Mishra said, community leadership has been at the forefront of the response, including the science with modeling questions, inputs, interpretationand application shaped by communities and the public health actors working to serve communities.

Knight hopes that this work will also have an impact on how vaccines are deployed globally.

Given our increasingly connected world, our findings really highlight the importance of global vaccine equity in responding to outbreaks, and also in preventing them in the first place," he said.

Vaccines can help break chains of transmission when deployed strategically, but another opportunity to stop transmission is in the environment where people infected with the virus may shed it onto surfaces and objects.

We knew very little about fomite [surface] transmission of monkeypox prior to this outbreak, saidChristopher Kandel, an infectious disease physician atMichael Garron Hospital, Toronto East Health Network, and assistant professor in the Temerty Faculty of Medicinesdepartment of medicine.

To study the risk of environmental transmission of monkeypox, Kandel andSharon Sukhdeo, aninfectious diseasesresident at U of T, teamed up with EPIC faculty membersAllison McGeer, who is atMount Sinai Hospital and is a professor in the Temerty Faculty of Medicine and at the Institute of Health Policy, Management and Evaluation (IHPME) in the Dalla Lana School of Public Health,Adrienne Chan, who is atSunnybrook Health Sciences Centre and is an associate professor in the Temerty Faculty of Medicine and the Dalla Lana School of Public Health,andMatthew Muller, who is atSt. Michaels Hospital and is an associate professor in the Temerty Faculty of Medicine and at IHPME.

For the first part of their study, the team swabbed a mixture of high- and low-touch surfaces in hospital exam rooms where patients with monkeypox had received care. They tested the same surfaces again after the rooms had been cleaned.

Their preliminary results showed detectable levels of monkeypox DNA on many high-touch and a few low-touch surfaces. Encouragingly, the researchers could not detect the virus on the majority of surfaces after cleaning. Where they did detect the virus after cleaning, levels were significantly reduced.

Kandel notes that while they were able to detect monkeypox DNA, their methods cant determine whether the detected virus was infectious.

As a next step, the researchers will expand their study to look at environmental transmission within households. They will ask people who are self-isolating with monkeypox to swab objects and surfaces in their home at different timepoints, which will provide insight into how long an infected person sheds the virus and whether common at-home cleaning products can effectively disinfect contaminated surfaces.

There are so many questions that need to be answered, said Kandel. With these studies, well have a much better understanding of monkeypox transmission, including how infectious people are and how long isolation should last to best protect others.


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Monkeypox studies suggest ways to reduce viral spread - University of Toronto
Should we be concerned about monkeypox at ACL? – KUT

Should we be concerned about monkeypox at ACL? – KUT

October 5, 2022

Austin City Limits Music Festival kicks off this weekend, and people are excited to dance, drink and watch their favorite artists perform. But with many attendees traveling from out of town and possible skin-to-skin contact in the crowds, some might be wondering if the festival will worsen the spread of monkeypox.

As of Sept. 30, Travis County has had 186 confirmed cases. Texas has reported the fourth highest number of monkeypox cases in the U.S. since the outbreak began earlier this year. Nationally, though, cases have been on the decline since late August.

Dr. Michael Stefanowiczs, associate director of sexual health programs at CommUnityCare Health Centers and a UT Dell Medical School assistant professor, said health care professionals havent seen any outbreaks of monkeypox associated with large public gatherings, but he can understand why people may feel anxious.

Large gatherings, or superspreader events, worsened and prolonged the COVID-19 pandemic. However, Stefanowiczs said, in the U.S., monkeypox is mostly spreading through sexual contact.

For ACL and other large-scale events, it is not no-risk, but it is categorically low-risk, Stefanowiczs said.

Stefanowiczs said ACL attendees are more likely to contract COVID-19 at this years festival than monkeypox. And the good news is more than 82% of people in Travis County have received at least one coronavirus vaccine.

We have the tools that we need to mitigate and reduce risk, and those tools include knowledge, he said.

Monkeypox is spread through close contact with an infected person, or by touching clothing or linens that were in contact with the infected persons rash or body fluids, according to Austin Public Health. Symptoms include high fever, swollen lymph nodes, muscle aches, headaches, chills and a pimple or blister-like rash.

APH recommends limiting skin-to-skin contact with strangers and avoiding direct contact with monkeypox rashes and scabs and body fluids from a person with monkeypox.

Stefanowiczs urges people to be proactive if they experience any symptoms and to isolate at home as soon as possible to reduce the risk of transmitting the virus.

The sooner you isolate, the lower the risk of exposing others, he said. And thats true whether your symptoms are concerning monkeypox, COVID-19 or the flu.

Stefanowiczs said these are all vaccine-preventable illnesses and encourages all those who are eligible to get their COVID-19 vaccines and boosters as well as the monkeypox JYNNEOS vaccine.

COVID-19 vaccines and boosters are available at local doctor's offices, pharmacies and clinics. You can find a vaccine provider near you at Vaccines.gov.

Monkeypox vaccines are available to those who are at high risk of developing infection. You can check your eligibility for a vaccine and schedule an appointment here.


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Evaluation of COVID-19 vaccine effectiveness in a changing landscape of COVID-19 epidemiology and vaccination – World Health Organization

Evaluation of COVID-19 vaccine effectiveness in a changing landscape of COVID-19 epidemiology and vaccination – World Health Organization

October 5, 2022

Overview

In March 2021 the World Health Organization (WHO) made interim guidance available on best practices for undertaking vaccine effectiveness (VE) evaluations in Evaluation of COVID-19 vaccine effectiveness: interim guidance, followed in July 2021 by an addendum addressing VE evaluations in the context of new variants of concern (VOC). That guidance still generally applies to carrying out VE evaluations. Nonetheless, in the past year, several factors have arisen that indicate the need for a second addendum to the interim guidance, including lessons learned from the many VE evaluations already conducted to date, waning of protection, Omicron emergence, and the increasing proportion of the population with hybrid immunity. This addendum addresses some of the methodological aspects of VE evaluations that have been learned during the past year, as well as those that have become relevant in the current epidemiological setting of the COVID-19 pandemic. For some of the COVID-19 vaccine methodology issues there are still insufficient data to make a recommendation, in which case different options for approaching VE evaluations are presented.

Questions should be directed to[emailprotected].


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Evaluation of COVID-19 vaccine effectiveness in a changing landscape of COVID-19 epidemiology and vaccination - World Health Organization
WashU COVID-19 nasal vaccine technology licensed to Ocugen  Washington University School of Medicine in St. Louis – Washington University School of…

WashU COVID-19 nasal vaccine technology licensed to Ocugen Washington University School of Medicine in St. Louis – Washington University School of…

October 5, 2022

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Aim is for commercialization in U.S., Europe, Japan

Washington University in St. Louis has licensed the rights to develop, manufacture and commercialize its proprietary COVID-19 nasal vaccine in the United States, Europe and Japan to Ocugen Inc., a U.S.-based biotechnology company.

A nasal vaccine for COVID-19 based on technology developed at Washington University in St. Louis is on the path to becoming available in the U.S., Europe and Japan. The university has licensed the rights to develop, manufacture and commercialize its proprietary COVID-19 vaccine in the United States, Europe and Japan to Ocugen Inc., a U.S.-based biotechnology company focused on developing and commercializing novel gene and cell therapies and vaccines.

A nasal vaccine is thought to provide greater protection against the virus than current injectable vaccines, which help prevent severe illness and death but do little to prevent infections, especially as highly contagious newer variants continue to spread. The advantage of the nasal vaccine is that it delivers a boost to immunity in the nose and upper respiratory tract, right where the virus enters the body, thereby potentially preventing infections altogether.

Ocugen intends to work closely with U.S. government agencies tasked with pandemic preparedness and response to initiate clinical trials and manufacture the intranasal vaccine. The company also is interested in the potential for the nasal vaccine to be a universal booster, regardless of a persons previous COVID-19 vaccination history.

Despite the many challenges of a global pandemic, our accomplished, dedicated faculty have continued to push the boundaries of discovery, said Dedric Carter, PhD, Washington Universitys vice chancellor for innovation and chief commercialization officer. The licensing of the nasal vaccine technology highlights the culture of innovation were developing at Washington University. All of our facultys extraordinary efforts in research innovation are with the goal of translating insights from the laboratory into improvements in the health and lives of people in our communities and across the globe.

The Washington University nasal vaccine technology was previously licensed to Bharat Biotech International Limited in 2020 for development in India and limited parts of the world. This September, health authorities in India approved the vaccine for emergency use in that country, making it the worlds first intranasal vaccine for COVID-19 to be approved.

The investigational nasal vaccine was co-developed by Washington University scientists David T. Curiel, MD, PhD, the Distinguished Professor of Radiation Oncology, and Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine, of molecular microbiology and of pathology & immunology, with members of their laboratories. They started collaborating in early 2020, as the virus that causes COVID-19 first began its wildfire-like spread across the globe.

Curiel had long worked on using harmless, deactivated cold viruses called adenoviruses to deliver gene therapies for cancer and other diseases. Diamond, an expert in viruses and infectious diseases, was already studying the virus that causes COVID-19 in his laboratory, having obtained a sample from the National Institutes of Health (NIH) in the first weeks of the pandemic. Curiel and Diamond teamed up to create and test their adenovirus-based nasal vaccine for COVID-19.

In recent months we have seen COVID-19 continue to spread despite high levels of vaccination the U.S., Europe and Japan have achieved, Diamond said. Because the vaccine can be delivered directly into the nose, it is specifically designed to block infection at the portal of virus entry, and we believe it may help prevent transmission as well as provide protection against new COVID-19 variants.

Their early studies at Washington University showed that nasal delivery of this vaccine creates a strong immune response throughout the body, especially in the nose and respiratory tract. In animal studies, the nasal vaccine entirely prevented infection from taking hold in the nose and lungs suggesting that vaccinated individuals would be able to fend off the virus before it could multiply and cause an infection.

Another advantage to a nasal vaccine is that it doesnt require a needle, Curiel said. Many people who are hesitant to receive an injection are willing to inhale a vaccine. This vaccine also could be used to boost immunity in people who were previously vaccinated with any of the other vaccines. I think it could be very helpful in the ongoing effort to reduce SARS-CoV-2 infection and transmission here in the U.S. and worldwide.

Added Shankar Musunuri, PhD, chairman, CEO and co-founder of Ocugen: Washington Universitys COVID-19 nasal vaccine technology has been shown to induce strong mucosal immunity with potential to reduce SARS-CoV-2 infection, transmission and the emergence of new variants. As the effort to end the pandemic focuses on effective booster options, Ocugen is excited about the potential for this vaccine to be a universal booster, regardless of previous COVID-19 vaccination history. We look forward to working with U.S., European and Japanese regulators to expedite development.

About Washington University School of Medicine

WashU Medicine is a global leader in academic medicine, including biomedical research, patient care and educational programs with 2,700 faculty. Its National Institutes of Health (NIH) research funding portfolio is the fourth largest among U.S. medical schools, has grown 54% in the last five years, and, together with institutional investment, WashU Medicine commits well over $1 billion annually to basic and clinical research innovation and training. Its faculty practice is consistently within the top five in the country, with more than 1,790 faculty physicians practicing at over 60 locations and who are also the medical staffs of Barnes-Jewish and St. Louis Childrens hospitals of BJC HealthCare. WashU Medicine has a storied history in MD/PhD training, recently dedicated $100 million to scholarships and curriculum renewal for its medical students, and is home to top-notch training programs in every medical subspecialty as well as physical therapy, occupational therapy, and audiology and communications sciences.


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South Africa’s vaccine regulator reaches new WHO level to ensure safety, quality and effectiveness – World Health Organization

South Africa’s vaccine regulator reaches new WHO level to ensure safety, quality and effectiveness – World Health Organization

October 5, 2022

WHO has ranked South Africas vaccine regulatory system at a functional level of maturity, according to WHOs global classification system for national medical products regulatory authorities. This recognises that South Africa has a stable,well-functioning and integrated regulatory system to ensure the quality, safety, and effectiveness of vaccines manufactured, imported or distributed in the country.

WHO confirmed the countrys attainment of maturity level three (ML3)the third of four levels in the WHOs classification. Maturity level four (ML4) is the highest.

This achievement affirms South Africas trailblazing endeavour in health research. Beyond its technical aspects, this milestone carries real implications for peoples health. We cannot talk about better health care without quality medicalsupplies, said Dr Matshidiso Moeti, WHO Regional Director for Africa. This is an important new step not only for South Africa, but for the region towards self-sufficiency in vaccines and medicines.

This rapid progress on vaccines regulation is a significant milestone for South Africa, the Southern African region and the continent. It is an important win for vaccine equity, as the country is a major manufacturer of medical products and thisregulatory milestone will help maximise the impact of the mRNA vaccine technology hub. said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

We commend the tireless efforts of all those involved in ensuring the integrity and rigour of the health products registration processes. This achievement is testament to the role the regulator has played in ensuring that vaccines that are safe,efficacious and of a high quality are available in South Africa. SAHPRA will continue to be an agile and responsive African health products regulator, whilst working towards the aim of being a globally recognised as an enabler of access to safe, effectiveand quality health products said Dr Boitumelo Semete-Makokotlela, South African Health Products Regulatory Authority (SAHPRA) Chief Executive Officer.

In 2019, SAHPRA participated in WHO-supported self-benchmarking of its regulatory system and functions. Between July and August 2021, SAHPRA further refined and enhanced this self-benchmarking with WHO assistance.

In November 2021, WHO completed its benchmarking of SAHPRA, with a team of 19 international experts from 10 countries, which concluded that SAHPRA was required to address several gaps with regards to vaccines regulation. Recommendations were providedin the form of an Institutional Development Plan (IDP) for SAHPRA.

Between November 2021 and August 2022, SAHPRA made major progress in several areas including: staffing, quality management, establishing a framework for renewal of marketing authorization of medical products, and regulatory presence at ports of entry.

In September 2022, a subsequent WHO formal benchmarking mission concluded that SAHPRA had achieved ML3 for vaccines regulation.

SAHPRA is the fourth National Regulatory Authority (NRA) to become a ML3 regulatory authority for vaccines in the WHO African Region alongside Tanzania, Ghana and Nigeria. It is the fifth to achieve this status in the African continent, following Egyptwhich achieved ML3 for vaccines earlier in 2022. This move to ML3 will significantly contribute to WHO work to build capacity in low- and middle-income countries to produce mRNA vaccines through a centre of excellence and training (the mRNA vaccine technology hub) located in Cape Town, South Africa.

Results of the global benchmarking evaluation are presented as maturity levels on a scale of 1 to 4. Achieving Maturity Level 1 means some elements of a regulatory system exist. Maturity Level 2 indicates an evolving national regulatory system that partiallyperforms essential regulatory functions. More information is available here.


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South Africa's vaccine regulator reaches new WHO level to ensure safety, quality and effectiveness - World Health Organization
Learning lessons from the pilots: overcoming knowledge gaps around the malaria vaccine schedule in support of vaccine uptake – World Health…

Learning lessons from the pilots: overcoming knowledge gaps around the malaria vaccine schedule in support of vaccine uptake – World Health…

October 5, 2022

A primary objective of the MVIP pilot programme was to assess the feasibility of administering the recommended 4 doses of the RTS,S malaria vaccine to young children in routine use in African settings. When pilot introductions started in Ghana, Kenya and Malawi in 2019 there had never been a childhood vaccine for malaria, and its administration would require caregivers to bring their children to vaccination clinics for extra vaccine visits, with one near 2 years of age, later than for other childhood vaccines.

More than 3 years after the launch of the malaria vaccine in pilot implementations, evidence and experience gained in the pilots have confirmed that the vaccine is safe, life-saving and feasible to deliver. The pilots also provided the opportunity to learn how to overcome challenges administering the 4-dose vaccination schedule to achieve good uptake and community acceptance.

Across the 3 countries, challenges around the dosing schedule were similar, as were some of the interventions put in place to tackle them. In this article, Expanded Programme on Immunization (EPI) officers from each of the countries share their reflections.

The 3 countries shared similarities when it came to identifying missed opportunities for vaccination and tackling misunderstandings among health workers about the vaccination schedule. Across the board, visits to health facilities by EPI officers to witness vaccination in action and provide on-site training to health workers known as supportive supervisionidentified challenges and ways to rectify them.

Early on, we noted poor uptake of the vaccine in some facilities. When we went deeper through supportive supervision, and we went through scenarios with health workers of what they do if a child comes at a certain age [outside of the formal vaccination schedule], we uncovered a lot of misunderstood information, so we had to come in and intervene, said Mr Thomas Mavuto, Ministry of Health (MoH), Malawi.

Across the countries, health workers experienced challenges handling children who did not show up for vaccination on the expected schedule: 5, 6, 7 and 22 months in Malawi; and 6, 7, 9 and 24 months in Ghana and Kenya. In the first few months of introduction, health workers were often unsure whether to vaccinate children coming late for their 1st dose, or for subsequent doses.

There were missed opportunities for vaccination. In some areas, when a child came and was age 7 months, health workers would not give the vaccine, said Dr Kwame Amponsa-Achiano, MoH Ghana.

One reason for the confusion was that countries initially adopted schedules that emphasized specific ages for each dose. In trainings, health workers were instructed to vaccinate children who fit specified age brackets. One reason for emphasizing specific ages for vaccination was concern about available vaccine supply in the initial months: the fear was that if all children under age 1 were eligible for the 1st dose there would not be enough vaccine to meet demand. As this was the first real-world vaccine implementation, countries were unsure how much to deviate from the recommended schedule. The result was that health workers were less confident handling scenarios that called for flexibility. In response, the countries reviewed and revised communications and training materials for health workers to clarify guidance (see number 4 below).

Shortly after becoming aware of some misunderstanding on the schedule, countries went back to the drawing board to ensure that information products, job aids and health messages for caregivers were as clear as possible.

In Kenya, at the launch of pilot introduction, the recommended schedule for dose 1 was age 6 months. When decisions were made to relax the eligibility and offer the 1st dose to children up to 1 year of age, it took some time for health workers to become familiar with the change and implement it.

When we first trained health workers, we told them the schedule was 6, 7, 9 and 24 months. But during implementation, after noticing missed opportunities for vaccination, we expanded the eligibility for the first dose from 6 months to before the child celebrates their 1st birthday. The change introduced some problems, said Dr Rose Jalang'o, MoH Kenya.

In Kenya, the team decided to modify vaccination stickers to further reduce confusion. While child health book stickers to document receipt of doses initially were labelled 6, 7, 9 and 24 months, the team changed those to read dose 1, 2, 3 or 4, so there wasnt any confusion if a child presented late for vaccination.

Ghana and Malawi developed short educational videos for health workers that outlined the dosing schedule and how to handle scenarios that might arise when children came late. In Ghana, this included a virtual, interactive quiz distributed on messaging platforms that presented multiple situations and real-time feedback on the correct way to respond. These remote tools were particularly useful in the Covid-19 context when trainings and visits to communities were limited or put on hold.

We came up with messages that are tailored for health workers, particularly those responsible for screening children for vaccination. The caregiver might bring the child to the clinic, but the health worker might not offer that service to a child if the vaccinator cannot determine if the child should receive the vaccine, said Mr Mavuto.

Countries also noted the importance of collaboration between the EPI and national malaria control programmes to ensure that health messages, leaflets and posters include facts on malaria and how to prevent it as well as the benefits of the new malaria vaccine.

The two programmes can leverage each others strengths during community engagements, communication efforts and media events. The malaria control team can use the existing EPI infrastructure as much as possible, said Dr Jalango.

A key challenge across the 3 countries is uptake of the 4th dose, which is scheduled near age 2 years and several months after children would have finished other childhood vaccinations.

In Malawi the last vaccination visithad been the 2nd dose of the measles-rubella vaccine, which comes when the child is 15 months old. Caregivers were used to the last visit at that age, but now they had to come again when the child is almost 2 years old, said Mr Mavuto.

Today, WHOs March 2022 position paper on the malaria vaccine recommends flexibility for country immunization programmes to determine the malaria vaccine schedule in ways that optimize delivery, for example, to align the 4th dose with other vaccines given in the 2nd year of life.

Following the WHO recommendation, and based on the countrys experience, Ghana recently decided to re-set its schedule for the 4th dose of malaria vaccine to age 18 months to coincide with the countrys schedule for dose 2 of the measles-rubella vaccine.

Based on our experience, I believe the first 3 doses wont be a challenge, but for the 4th dose, given that all 3 pilot countries are struggling somewhat on uptake of the final dose, other countries may be able to learn from our experience. If they can start 4th dose administration from 18 months, or at an age at which most countries have other vaccines, I think that its better, said Dr Kwame.

Kenya is considering a similar change to its vaccination schedule. Malawi has decided to retain its schedule of 22 months for dose 4. Additionally, to promote increased uptake of all doses, Malawi has increased training to health workers to inform them that they should offer the vaccine to any child who presents for vaccination from 5 months of age and should maintain a minimum of 4 weeks between vaccine doses; furthermore, the MoH plans to take opportunities to inform caregivers about the vaccine and its schedule, including via community-based radio. Looking forward, all of the pilot countries are considering ways to build on additional malaria vaccine visits to increase uptake of other child health services.

We are working to make parents aware that apart from malaria vaccination, they should come to the facility for normal growth monitoring and other services like vitamin A. We need to communicate that as a package, added Dr Mavuto.

A key takeaway from this discussion with experts in the malaria vaccine programme was that countries should tailor the recommended vaccination schedule and information, education and communication efforts to their context.

Scheduling decisions should be based on getting the maximum impact. There are always pros and cons, and every schedule will have some limitations, or some challenges, so its about making the decision based on what works best for your country, said Dr Kwame.

Countries should consider using the same traditional communication channels they use for other vaccines. They know how they do their own communications, how to communicate with communities, and that will help them tackle potential challenges, said Mr Mavuto.

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Thank you to Dr Kwame Amponsa-Achiano, Ghana Ministry of Health, Dr Rose Jalang'o, Kenya Ministry of Health, and Mr Thomas Mavuto, Malawi Ministry of Health for your contributions.


Read the original post: Learning lessons from the pilots: overcoming knowledge gaps around the malaria vaccine schedule in support of vaccine uptake - World Health...
Vaccines against the flu and COVID-19: What you need to know – Harvard Health

Vaccines against the flu and COVID-19: What you need to know – Harvard Health

October 5, 2022

Autumns arrival heralds cool temperatures, warm sweaters, and anticipation of the upcoming holiday season. But its also when infectious respiratory viruses start to spread more readily. Thats why October is the ideal time to shore up your immunity against two common, potentially life-threatening viruses: influenza (flu) and SARS CoV2, the virus that causes COVID-19.

With all the attention on COVID over the past two years, the focus on flu has waned somewhat. Last years flu season was very mild in fact, the peak number of positive cases was the lowest in at least the 25 years prior to the COVID-19 pandemic. But dont count on a repeat this winter.

"The general consensus is that this years flu season could be worse than average, for a couple of reasons," says infectious disease specialist Dr. John J. Ross, assistant professor of medicine at Harvard Medical School.

First, Australia had a particularly severe flu season this year, with three times the normal amount of cases. Australia is in the southern hemisphere and their winter flu season peaks in August, often predicting what happens in the United States and elsewhere in the northern hemisphere, he notes. Second, the masking and social distancing that many people followed to prevent COVID also prevented the flu. "But the era of widespread masking has ended, so were expecting more viral transmission this season," says Dr. Ross.

COVID cases and hospitalizations have dropped dramatically since earlier this year. On average, about 340 people died each day from the virus in August and September, compared to about 3,400 per day in early February 2022. "We expect that COVID rates will rise again over the winter, although not at the same magnitude as last winter," Dr. Ross says. Theres clear evidence that Omicron currently the most widely circulating COVID variant spreads more easily than earlier strains, but its less likely to kill you, he adds.

All adults should get an annual flu vaccine, with the rare exception of people whove had a life-threatening reaction to the shot in the past. The vaccine is especially important for those with a higher risk for serious complications from the flu. This includes

If youre over 65, the CDC recommends getting one of the vaccines that produces higher levels of antibodies that help protect you against the flu: the Fluzone High-Dose Quadrivalent, Flublock Quadrivalent recombinant, or the Fluad Quadrivalent adjuvanted vaccines. The first two contain higher amounts of antigens, the proteins that trigger the bodys antibody response. The third contains an adjuvant, which is an additive that enhances immune response. People who fall into the other high-risk categories mentioned above might also want to seek out one of these vaccines, says Dr. Ross. But get the standard flu vaccine if none of the other options are readily available.

The CDC is urging all adults to also stay up to date with COVID vaccines, including the new bivalent mRNA booster. The bivalent shots target both the original COVID strain and the two most recent Omicron subvariants (BA.4 and BA.5), which are more contagious than earlier strains. You should wait at least two months after your previous booster or primary vaccine series to get the new booster. Booster recommendations may differ for people who have a weakened immune system. See the CDC website for more detail on COVID vaccines and boosters.

"The real-world effectiveness of these boosters is a big question mark, but I certainly recommend one to anyone whos due for a booster, especially if youre older," says Dr. Ross. Certain data from the earlier rounds of boosters suggests that anything you can do to expand your immune systems repertoire of response to Omicron will likely protect you against severe disease and hospitalization from COVID, he adds. For example, a recent study among nursing home residents shows 26% fewer COVID infections, a 60% reduction in hospitalizations, and a 90% reduction in deaths for those who had received two booster shots at appropriate intervals compared with only one booster shot.

Theres no downside to getting the booster at the same time you get your annual flu shot, although those who experienced unpleasant side effects from a COVID vaccine in the past might want to get their flu shot on a different day. But for many people, getting both shots over and done with is a smart strategy.

Simple measures such as washing your hands often, using hand sanitizer when you cant wash your hands, and avoiding touching your eyes, nose, and mouth can help you stay healthy. Also, be sure to eat well, stay active, and get a good nights sleep.

The CDC has additional advice for protecting yourself against COVID-19, such as moving indoor activities outdoors, improving ventilation of indoor air, and taking precautions like wearing masks and distancing when in crowded places, or when COVID cases are high in your community.


More here: Vaccines against the flu and COVID-19: What you need to know - Harvard Health
Japan invests to ensure pandemic vaccines can be made in 100 days – Gavi, the Vaccine Alliance

Japan invests to ensure pandemic vaccines can be made in 100 days – Gavi, the Vaccine Alliance

October 5, 2022

COVID-19 was the first global outbreak for which a brand new vaccine was developed in just one year. This was lightning fast compared to previous vaccine development efforts, but in 2021, countries like the UK and US came up with a radically more ambitious goal of producing vaccines, diagnostic tests and treatments for scaling up within 100 days of a pandemic threat being identified.

Now, Japan has announced it will invest US$ 2 billion in achieving the same goal through its Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA), due to formally launch next month.

The intensified spread of COVID-19 through the emergence of highly contagious variants such as Omicron was a factor in the creation of the centre. In late 2021, Prime Minister Fumio Kishida said he wanted to fundamentally reinforce crisis management.

Early in the pandemic, Gavi and partners set up the COVAX facility to ensure equitable access to COVID-19 vaccines and a market for manufacturers supplying them. For organisations like Gavi, Japans investment is welcome, paving the way for future collaborations with Japan in the case of future pandemics.

In March this year, the global health community came together at The Global Pandemic Preparedness Summit, led by the UK government and the Coalition for Epidemic Preparedness Innovations (CEPI), to turn the moonshot goal of a 100-day vaccine into a reality.

Compressing the vaccine development timeline to just 100 days will mean as much preparation as possible. This means anticipating future threats a universal vaccine against coronaviruses is high on the list as three coronaviruses (MERS-CoV, SARS and COVID-19) have caused global outbreaks already.

Another goal to speed up vaccine development will be to build a library of vaccine candidates against other threats. The ability to leapfrog from work done on MERS vaccines, for instance, meant that COVID-19 vaccine development could be sped up.

Developing a vaccine in 100 days will need to be followed by rapid scale-up, and there will also need to be investment in manufacturing innovations that can support scale-up, especially in low-income settings.

Japanese researchers speaking to Nature said that the country appreciates the value of developing research capacity and early, preparatory investment in vaccines so that when an emergency does arise, the country is ready to respond. Although the country did invest in COVID-19 vaccine development, nearly three years after the pandemic started the most advanced vaccine candidates are still in clinical trials and not approved for use.

Of the $2 billion, $1.2 billion will go to vaccine research and development projects, and $400 million to support start-ups in drug development. The final $400 million will create a virtual network of centres of excellence for basic research in vaccine science as well as testing vaccine candidates in early-stage trials.

The centre will invest in vaccine research for eight pathogens, including coronaviruses, monkeypox, dengue virus and Zika virus. The vaccines being developed include a range of delivery technologies, such as mRNA technology (that was used for some COVID-19 vaccines), viral vectors and recombinant proteins. The idea is to find seeds for future vaccines, Dr Yoshihiro Kawaoka, a virologist at the University of Tokyo told Nature.


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Japan invests to ensure pandemic vaccines can be made in 100 days - Gavi, the Vaccine Alliance