By Sola Ogundipe
Over 3.9 million girls aged between 9 and 14 years in Nigeria have been vaccinated with the Human Papilloma Virus, HPV, vaccine against cervical cancer since the rollout of the vaccination exercise by the Federal government in October.
The Federal government recently introduced the HPV vaccine into its routine immunisation system, aiming to reach 7.7 million girls in the targeted age group with a single dose of the vaccine.
Disclosing this during a virtual discourse themed Cervical Cancer and HPV vaccination: Matters Arising , the Ag. Director of Disease Control and Immunisation, National Primary Healthcare Development Agency, NPHCDA, Dr. Garba Rufai, said no serious adverse events had been recorded among those vaccinated.
Rufai, who represented the Executive Director/ CEO of the NPHCDA, Dr Muyi Aina, in his presentation entitled, The Role of the NPHCDA in Mitigating the Challenges and Bottlenecks around Vaccines and Mass Vaccination Programmes in Nigeria, said the vaccines were being well received despite concerns raised in certain quarters.
We have been able to start in 12 states and the Federal Capital Territory, FCT and we still have three states that we are yet to commence. In some of these states, they are almost running out of vaccines, because they are being accepted in huge numbers.
From these 12 states, we have almost vaccinated four million young girls, we are around 3.9 million plus and by the end of today (Friday), we might be crossing the four million mark. By the time Kano state starts, we would close out close to five million.
In all of these numbers, we have not seen one serious Adverse Event Following Immunisation, AEFI, not one. It is remarkable being able to put about four million needles into people and none of the side effects, not even the early ones that we normally see have not happened.
Rufai who said there were initial gaps in information communication about the vaccine, however, affirmed that the government was up to the task of ensuring that the exercise was successful.
Introducing a vaccine is a process, there are activities lined up. We are building capacity and reminding ourselves about what vaccines are what they do and their possible adverse side effects, so vaccine safety monitoring by the NPHCDA and NAFDAC is ongoing.
It is a country introduction, and there is a monitoring and surveillance system in place not just for the HPV but for polio, measles, and the pentavalent vaccines, he stated.
A Consultant Obstetrician and Gynecologist at the College of Medicine, University of Lagos, Prof Rose Anorlu, said that the purpose of the vaccination was to prevent and
In her presentation Cervical Cancer: The Right Communication for Prevention, she emphasised that cervical cancer screening has been shown to reduce the rate of the disease.
Anorlu, who heads the Oncology & Pathological Studies, at Lagos University Teaching Hospital, argued that cervical cancer is the fourth most prevalent cancer globally, even as she stressed that the HPV vaccine was the primary prevention for the disease.
Mathematical model shows that the vaccine can last up to 20 years without a booster dose. A single dose is equally as effective as two or three doses, but it is not yet known if the vaccine can give lifetime protection.
Awareness of a disease is key in the prevention. It is right to say cervical cancer screening than screening for cervical cancer. They do not mean the same thing. Cervical cancer screening is to detect the pre-cancer of the cervix.
Screening is not for detection of invasive cervical cancer, it is for the detection of the pre-cancer of the
The Conservative Party of BC is calling on the New Democrat-led government to fire Dr. Bonnie Henry over a continued requirement that health-care workers in the province be vaccinated against COVID-19.
In the legislature this week, Abbotsford Souths Bruce Banman one of only two Conservative MLAs accused the extreme leftist NDP government and its unelected bureaucrats of failing British Columbians with its mandate in the midst of a health-care crisis. He and party leader John Rustad, who represents Nechako Lakes, doubled down on their call on Thursday.
2:48 BC Greens remove deputy leader Dr. Sanjiv Gandhi for inappropriate tweet
British Columbia is one of very few jurisdictions in the world that refuses to hire back unvaccinated health-care workers, Banman posted on X.
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We need these people in the system. Weve got ERs that are shutting down, hospitals that are a mess I think it is incompetent not to hire these people back and put them to work.
The calls came just before the deputy leader of the BC Greens, Dr. Sanjiv Gandhi, stepped down for liking a post on X that compared Henry, the provincial health officer, to Josef Mengele, the infamous Nazi doctor who experimented on concentration camp victims during the Second World War. Gandhi has since said that the like was accidental.
In mid-September, an individual I follow on X (formerly Twitter) posted a letter and comments, including an impassioned critique of healthcare delivery in BC. Intending to like that post, I inadvertently liked the post of a third party whom I do not follow, quoting the original tweet, he posted to X on Thursday.
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I did not realizing my error until yesterday as the subject of considerable racism in my own life, I know that words do matter.
Gandhi apologized for the harm he caused.
2:05 Critics call for simpler vaccine rollout in B.C.
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While the Tories have opposed the vaccine mandate for health-care workers, the Greens have questioned Henrys decision to lift a number of public health restrictions and questioned transparency around the process.
Health Minister Adrian Dix is defending Henry, citing a tendency among the Conservatives and Green party to launch a personal attack against the doctor, which is unacceptable.
Ninety-nine per cent of health-care workers were vaccinated when we brought the order in, he said Thursday. Dr. Henry is an outstanding scientist, an outstanding leader. B.C. led Canada during the COVID-19 pandemic, led North America.
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While Bonnie Henry isnt responsible for all of that, she was a very important and courageous public health leader through all those times, and she was and I think she has my 100 per cent support and shell continue to.
2:05 Health-care professionals react to return of mandatory mask policy
The provinces Bill 36, passed in November last year, gave the health minister the authority to require vaccination against specified transmissible illnesses for health-care workers, and the boards of medical colleges to create bylaws to that effect.
The Health Professions and Occupations Act also ushered in sweeping changes to the oversight and regulation of health workers in the province, merging 15 health profession regulatory colleges into six and eliminating elected positions on college boards. It outlined discrimination as a form of professional misconduct, required anti-discrimination measures to be embedded in health-care delivery, separated investigations under the complains and adjudications process, and more.
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Effective Oct. 3, health-care workers in most settings were also required to wear face masks as a temporary public health measure during respiratory season.
2023 Global News, a division of Corus Entertainment Inc.
SALEM, Ore. -- Oregon Health Authority is insisting people protect themselves against mpox following an increase in cases of the virus in the state during the past three months.
Oregon Health Authority (OHA) says seventeen mpox cases were reported in about a 100-day span to OHA and local public health authorities between July 20 and October 31.
It is reminding people about the availability of a safe and effective vaccine against mpox, or poxvirus formerly called monkeypox.
OHA says Oregon's recent mpox cases are prompting state health officials to distribute a statewide advisory to healthcare providers this month recommending they consider mpox when evaluating patients with mpox symptoms regardless of the patient's reported risk, vaccination status or level of community transmission. The advisory also states that testing patients with rashes, lesions or symptoms compatible with mpox should be considered part of comprehensive sexual health care.
OHA says mpox spreads primarily through close, skin-to-skin contact, "Most often, it has spread through intimate or sexual contact and during contact with the lesions of an individual with mpox through a caregiving relationship, such as a parent caring for a child or an adult caretaker of another person."
Dr. Tim Menza is senior health adviser for OHAs mpox response who says Oregon recorded one to three mpox cases per month before mid-summer. He says while the recent case increase since July is lower than the 10-15 cases reported weekly at the height of the 2022 outbreak, these cases show mpox is spreading in Oregon, "We never declared the 2022 outbreak over because we were concerned about increases like the one we are seeing now, and it gives us an opportunity to remind folks in the community that vaccination against mpox remains a valuable tool for reducing the risk of mpox infection."
OHA says the JYNNEOS mpox vaccine is free and available to anyone in Oregon who wants to be vaccinated, regardless of insurance status. OHA says, "It is also highly effective: According to a study published in May in the Centers for Disease Control and Preventions (CDC)Morbidity and Mortality Weekly Report, the vaccine was found to be 75% effective for those receiving one dose and 86% effective for those who had two doses."
Mpox symptoms can start between a few days to three weeks after contact, which most commonly are flu-like symptoms of fever, chills, sweats, headache, muscle aches, swollen lymph nodes and fatigue. OHA says most people will develop a rash within a few days of the flu-like symptoms; some people only develop a rash, which may start on or near the penis, testicles, labia, vagina or anus. It may also be on other areas like the hands, feet, chest, face or mouth.
People who suspect they have mpox should contact their healthcare providers to let them know before going in to be seen. The provider may recommend testing for mpox. People who dont have a healthcare provider can call 2-1-1 for help finding a clinic or healthcare provider.
More information about mpox in Oregon is at OHAsmpox websiteor the CDCs mpox page,https://mpoxvaxmap.org/. Vaccination clinics can be searched by ZIP code with the mpox vaccine locator tool athttps://www.oregon.gov/oha/PH/Monkeypox/Pages/vaccine.aspx.
Monkeypox virus
What is monkeypox?
Monkeypox is a rare viral disease that primarily affects animals, including monkeys, rodents, and other mammals. However, it can also be transmitted to humans, causing a similar but less severe illness compared to smallpox. The disease was first identified in 1958 when outbreaks occurred in monkeys kept for research purposes.
The virus responsible for monkeypox belongs to the Orthopoxvirus genus, which also includes the variola virus that causes smallpox. Monkeypox is endemic in Central and West African countries, particularly in remote regions where people have close contact with infected animals.
How is monkeypox transmitted?
Monkeypox can be transmitted to humans through direct contact with infected animals, such as handling their blood, bodily fluids, or lesions. Additionally, human-to-human transmission can occur through respiratory droplets, contact with body fluids, or contaminated objects. The disease is not easily transmitted between humans, and sustained human-to-human transmission is rare.
What are the symptoms of monkeypox?
The symptoms of monkeypox in humans usually appear within 7 to 14 days after exposure to the virus. Initially, individuals may experience fever, headache, muscle aches, and fatigue. This is followed the development of a rash, which typically starts on the face and then spreads to other parts of the body. The rash progresses through different stages, including the formation of fluid-filled blisters that eventually crust over.
Is monkeypox a deadly disease?
Although monkeypox is generally a self-limiting disease, meaning it resolves on its own without specific treatment, severe cases can occur, particularly in individuals with weakened immune systems. In rare instances, monkeypox can be fatal, with a mortality rate of around 1-10%, depending on the strain of the virus.
How can monkeypox be prevented?
Preventing monkeypox primarily involves avoiding contact with infected animals and practicing good hygiene. This includes washing hands regularly with soap and water, avoiding close contact with sick individuals, and using personal protective equipment when handling animals or their specimens.
Is there a vaccine for monkeypox?
Currently, there is no specific antiviral treatment or vaccine available for monkeypox. However, smallpox vaccine has been shown to provide some protection against monkeypox. In case of an outbreak, public health measures such as isolation of infected individuals, contact tracing, and surveillance are implemented to control the spread of the disease.
In conclusion, monkeypox is a rare viral disease that can be transmitted from animals to humans. While it is generally less severe than smallpox, it can still cause significant illness. Preventive measures, such as avoiding contact with infected animals and practicing good hygiene, are crucial in reducing the risk of transmission.
November 11, 2023 1:51 AM
Global cases of tuberculosis continued to rise last year, as disruption to health services caused by the COVID-19 pandemic set back efforts to fight the disease, according to the latest annual report from the World Health Organization. Henry Ridgwell reports.
A patient receiving their flu vaccination
Public Health officials are urging those eligible to get their flu vaccine before the worst of the winter flu season begins.
To maximize their protection against flu, people need to get vaccinated a few weeks before the flu season starts usually it begins around early December.
Vaccination will help to protect them from getting seriously ill before Christmas and the New Year when flu cases are expected to peak.
Over half a million people have already been vaccinated for flu in Wales so far this year.
People who are eligible are urged to come forward for their winter vaccines as soon as possible.
Parents of 2 and 3 year olds are particularly encouraged to make an appointment with their GP to get their child vaccinated.
Young children can spread flu easily to more vulnerable members of their family and community.
They can also suffer unpleasant symptoms themselves and if they catch the flu it can lead to secondary infections such as bronchitis and pneumonia.
Most children have the vaccine as a quick and painless nasal spray, which is highly effective at protecting against the virus. Flu vaccines are very safe and simple to give to children.
There is still a concern that children who didnt encounter the flu virus between 2020-2022, when there was less social mixing, could be particularly vulnerable.
Those who are under 65 years old and in a clinical risk group (for example; those who are diabetic, have a heart problem, liver disease or respiratory problems) are also urged to come forward for their flu vaccine.
Flu and COVID-19 are both respiratory illnesses that thrive in winter. Getting vaccinated remains our best line of defence against serious disease.
The COVID-19 autumn booster programme is also live. Everyone over 65 years old are among those being offered a COVID-19 booster to reduce their chances of getting seriously ill with the virus. More information on how to get the vaccines is available from your local health board.
With added winter pressures on the NHS, it is more important than ever that those who are eligible for a free flu or COVID-19 vaccine get vaccinated to help prevent them becoming seriously unwell and protect the NHS this winter.
Vulnerable
Dr Christopher Johnson, Consultant Epidemiologist and Head of Public Health Wales Vaccine Preventable Disease Programme said: Flu can be serious. The very young, those with a health condition and the very old are particularly vulnerable. As the weather gets colder, viruses like flu are more easily spread. No-one wants to be ill over Christmas and New Year so it really is worth getting your vaccine.
Any side effects from the vaccinations are normally mild and dont last long. The chances of becoming seriously ill with flu or COVID-19 are greatly reduced by vaccination, as are the risks of spreading these viruses. Vaccination really is the best way to protect ourselves and others this winter from serious illness.
Vaccination is particularly important for those who are older, pregnant, or have a health condition and are more vulnerable to complications as a result of the infections.
It is also very important that frontline healthcare workers and those who work in care homes or providing care in peoples own homes get their vaccines to help reduce spread.
For more information about who is eligible and how to get the vaccines, please visit: Flu vaccine and COVID-19 Autumn Booster Public Health Wales (nhs.wales)
For the price of a cup of coffee a month you can help us create an independent, not-for-profit, national news service for the people of Wales, by the people of Wales.
Study design
We conducted a retrospective ecological study based on French national surveillance data (see Data sources), from December 28, 2020 (week 532020 start of the vaccination campaign) to March 6, 2022 (week 92022 end of Omicron BA.1 wave). The study population was the French population aged 50years and above, stratified into four age groups: 5059, 6069, 7079 and 80years old and above. We estimated the impact of the first and second doses of primary vaccination and the first booster, in terms of the number of averted hospitalizations (admissions to all types of hospitalization services), ICU admissions and deaths.
To compute the number of averted events, we used a method initially developed for tuberculosis [13], which was later applied to influenza [14, 15] and more recently to COVID-19 [6, 7]. Details are given in Additional file 1: Text S1. Basically, the number of averted events (({N}_{mathrm{averted}})) can be estimated from the number of observed events (({N}_{mathrm{observed}})), vaccine coverage ((VC)) and vaccine effectiveness ((VE)), as follows:
$${N}_{mathrm{averted}}= {N}_{mathrm{observed}} times frac{VCtimes VE}{1 - (VC times VE)}$$
(1)
where the term (VCtimes VE) represents the proportion of the population that is protected by vaccination. This method only accounts for the direct effects of vaccination on severe outcomes (not its indirect effects such as impact on transmission) and therefore provides a lower bound estimate of the true number of averted events. Besides, in a scenario without vaccination, it is probable that additional control measures would have been implemented, which we do not account for here (i.e. we estimate the impact of vaccination under the assumption that the same NPIs would have been implemented over the study period). These two points will be further addressed in the discussion.
This formula can be extended to account for the week of observation ((w)) and the number of doses received ((k), ranging from one to three (two doses and one booster)) [6, 15]:
$${{N}_{mathrm{averted}}}_{w}= {{N}_{mathrm{observed}}}_{w} times frac{sum_{k=1}^{3}{VC}_{w,k} times {VE}_{k}}{1 - (sum_{k=1}^{3}{VC}_{w,k} times {VE}_{k})}$$
(2)
where ({VC}_{k}) represents the vaccine coverage of exactly (k) doses (not at least (k) doses).
This formula assumes that VE is the same for all vaccinated individuals, regardless of the time elapsed since vaccination. However, VE is not constant over time: it quickly increases in the first weeks following vaccination due to the build-up of immunity and declines over time due to waning immunity [16,17,18,19]. In order to account for the evolution of VE according to the time elapsed since vaccination (left(Delta right)) in weeks, we modified the formula as follows:
$${{N}_{mathrm{averted}}}_{w}= {{N}_{mathrm{observed}}}_{w} times frac{sum_{k=1}^{3}sum_{Delta =0}^{w-1}{VP}_{w,k,Delta } times {VE}_{k, Delta }}{1 - (sum_{k=1}^{3}sum_{Delta =0}^{w-1}{{VP}_{w,k, Delta } times VE}_{k, Delta } )}$$
(3)
where ({VE}_{k, Delta }) is the vaccine effectiveness of the (k)th dose (Delta) weeks after vaccination, and ({VP}_{w,k,Delta }) represents the proportion of people who received their last dose (k)exactly (Delta) weeks before the week of observation (w). Of note, the sum of ({VP}_{w,k,Delta }) over all (Delta) corresponds to the vaccine coverage of exactly (k) doses on week (w) ((sum_{Delta =0}^{w-1}{VP}_{w,k,Delta }={VC}_{w,k})).
This formula was applied separately for each age group and each variant, in order to account for different VE according to age groups and variants. The total number of events directly averted by vaccination (number of hospitalizations, ICU admissions and deaths) was then obtained by summing the number of averted events over all weeks, age groups and variants. All analyses were conducted in R software version 4.1.2 (R Foundation, Vienna, Austria).
For the number of observed events, we relied on hospitalization and death data from the SI-VIC database, maintained by the ANS (Agence du Numrique en Sant) and sent daily to Sant publique France, the French national public health agency. This database provides real-time data on patients hospitalized for COVID-19 in French public and private hospitals, including their age, date of hospitalization, type of hospitalization services and outcome (discharged/deceased). All COVID-19 cases are either biologically confirmed or present with a computed tomographic image highly suggestive of SARS-CoV-2 infection. For hospitalizations, we included patients hospitalized in all types of services (general wards, ICU, long-term care and rehabilitation, emergency care) and excluded patients hospitalized for reasons not linked to a COVID-19 infection. For deaths, we included all patients deceased in the hospitals with a COVID-19 infection and added individuals deceased in nursing homes (resident homes for elderly) with a COVID-19 infection from the SurvESMS database. The SurvESMS database, administered by Sant publique France, was designed for the monitoring of COVID-19 cases and deaths among the residents of nursing homes; it allows the distinction between residents who died in nursing homes from those who died in hospitals (already accounted for in the SI-VIC database). In the absence of data on age, individuals were considered 80+years old; this assumption was based on 2019 data which showed that the mean age of people deceased in nursing homes was 89years old [20]. Deaths at home could not be accounted for. The time series of hospitalizations, ICU admissions and deaths according to each variant were reconstructed using the SI-DEP database, the national surveillance system describing SARS-CoV-2 RT-PCR and antigen test results arising from all private and public French laboratories (see details in Additional file 1: Text S2). The three databases (SI-VIC, SurvESMS and SI-DEP) are intended to be exhaustive.
Regarding vaccine coverage, we used the VAC-SI database, the national information system developed by the French Health Insurance to monitor the implementation of COVID-19 vaccination campaigns, since the start of vaccine distribution in December 2020, across the country. Individual data include the number of doses, the date of vaccination, the type of vaccine, and socio-demographic information such as age. All types of vaccine were considered (Pfizer/BioNTech BNT162b2, Moderna mRNA-1273, Oxford/AstraZeneca ChAdOx1-S and Johnson & Johnson Ad26.COV2.S). For each week of observation (w) and each age group, the number of vaccinated individuals according to the number of doses received before the week of observation (w) and to the week of vaccination (in order to compute the time elapsed since vaccination, (Delta)) were extracted. For each individual, on a given week of observation (w), only the last dose received before that week was taken into account, to avoid counting the same person twice: e.g. when an individual received a second dose on week (w), they were no longer counted among the first-dose individuals from week (w) onwards (they were only counted among the first-dose individuals up to week (w-1)). We excluded individuals for which the date of the first dose was posterior to the date of the second dose or the booster dose, or the date of the second dose was posterior to the date of the booster. For the denominator (number of individuals per age group in the French population), we used 2022 demographic data from the National Institute of Statistics and Economic Studies (INSEE).
With regards to the effectiveness of COVID-19 vaccines against COVID-19 variants, we extracted data from a recent VE study conducted by Sant publique France [12]. The study investigated VE of the two mRNA vaccines Pfizer/BioNTech BNT162b2 and Moderna mRNA-1273 against Alpha (unpublished data), Delta and Omicron BA.1 severe outcomes (general ward hospitalizations and ICU/deaths) among immunocompetents50years old French individuals, between January 11, 2021, and February 10, 2022. Analyses were performed according to 5079 and 80years old and above age groups, and the number of vaccine doses (one dose, two doses and the first booster dose). VE according to time since vaccination were also estimated. These estimates were smoothed to remove random fluctuations over time.
Note that VE against Omicron severe outcomes were sourced from multiple studies available in the literature: the aforementioned French study for VE of the first dose against ICU/deaths [12], a test-negative casecontrol study in England for VE against hospitalizations among people aged 65years and older (which we applied to our 50+population) [21], and a test-negative casecontrol study in Canada for VE of the second dose and booster against deaths among people aged 18years and older (which we applied to our 50+population) [16].
In these three studies, the date associated to an individual is the date of the test or the date of symptom onset. In order to account for the time between the test or symptom onset and the event of interest (hospitalization, ICU admission or death), we applied a lag of 1week to VE against hospitalization and ICU admission and a lag of two weeks to VE against death. Finally, a linear decay of VE was assumed to account for the waning of immunity at longer time horizons. The decay values were extracted from the literature and set to0.5 points/week for the second dose after 21weeks [22, 23] and0.4 points/week for the booster dose after 21weeks [24]. In the absence of data from the literature for the first dose, we applied a coefficient twice higher than for the second dose (1 point/week). This coefficient was applied from the 13th week after vaccination [25]. In order to estimate uncertainty around the number of averted events, we used the 95% confidence intervals of VE estimates published in the three aforementioned studies [12, 16, 21].
For Immediate Release: November 09, 2023
Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.
The most common symptoms of chikungunya include fever and joint pain. Other symptoms may include a rash, headache, and muscle pain. Some individuals may experience debilitating joint pain that persists for months or even years. Treatment includes rest, fluids, and over-the-counter medications for pain and fever.
Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Todays approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.
Ixchiq is administered as a single dose by injection into the muscle. It contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.
The safety of Ixchiq was evaluated in two clinical studies conducted in North America in which about 3,500 participants 18 years of age and older received a dose of the vaccine with one study including about 1,000 participants who received a placebo. The most commonly reported side effects by vaccine recipients were headache, fatigue, muscle pain, joint pain, fever, nausea and tenderness at the injection site.
In addition, although not commonly reported, severe chikungunya-like adverse reactions that prevented daily activity and/or required medical intervention occurred in 1.6% of Ixchiq recipients and none of the placebo recipients. Two recipients with severe chikungunya-like adverse reactions were hospitalized. In addition, some recipients had prolonged chikungunya-like adverse reactions that lasted for at least 30 days. The Prescribing Information includes a warning to inform that the vaccine may cause severe or prolonged chikungunya-like adverse reactions.
The FDA is requiring the company to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of Ixchiq.
Transmission of chikungunya virus to newborn babies from pregnant individuals with viremia (virus present in the blood) at delivery has been reported and can cause severe, potentially fatal chikungunya virus disease in newborns. In one study that evaluated whether the vaccine virus was present in the blood after vaccination, most individuals had vaccine virus detected in the blood within the first week following vaccination; the vaccine virus was not detected 14 days after vaccination. The Prescribing Information includes a warning to inform that it is not known if the vaccine virus can be transmitted from pregnant individuals to newborns, nor is it known if the vaccine virus can cause any adverse effects in the newborn. The warning also conveys that when considering administration to pregnant individuals, healthcare providers should take into consideration the individuals risk of exposure to chikungunya virus, gestational age and risks to the fetus or neonate from disease caused by chikungunya virus in the pregnant individual.
The effectiveness of Ixchiq is based on immune response data from a clinical study conducted in the United States in individuals 18 years of age and older. In this study, the immune response of 266 participants who received the vaccine was compared to the immune response of 96 participants who received placebo. The level of antibody evaluated in study participants was based on a level shown to be protective in non-human primates that had received blood from people who had been vaccinated. Almost all vaccine study participants achieved this antibody level.
Ixchiq was approved using the Accelerated Approval pathway. Accelerated approval allows the FDA to approve certain products for serious or life-threatening conditions based on evidence of a products effectiveness that is reasonably likely to predict clinical benefit. In the FDAs evaluation of Ixchiq for accelerated approval, evidence of effectiveness is based on immune response data in clinical trial participants. As a condition for approval for Ixchiq, the FDA is requiring confirmatory clinical studies to be conducted to verify clinical benefit.
Ixchiq was granted Fast Track and Breakthrough Therapy designations and the application was granted Priority Review. In addition, the FDA awarded the manufacturer of Ixchiq a tropical disease priority review voucher, under a provision included in the Food and Drug Administration Amendments Act of 2007. This provision aims to encourage the development of new drugs and biological products for the prevention and treatment of certain tropical diseases.
The FDA granted approval of Ixchiq to Valneva Austria GmbH.
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Boilerplate
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
Peak flu season hasnt struck yet. But the Centers for Disease Control and Prevention yesterday revealed signs pointing to a higher-than-normal incidence of a range of infectious illnesses, including influenza, this year.
Heres one reason why. CDC numbers released this week show national rates of certain required vaccinations (diphtheria, tetanus, and acellular pertussis (DTaP) and polio vaccines) for kindergartners hovering around 93 percent. These numbers, relatively flat over the past few years, have not rebounded to the pre-COVID level of 95 percent in 2019-20.
While 93 percent might sound high, some medical professionals are calling that rate worrisome.
Its going to impact attendance in schools and set up schools for preventable outbreaks that could impact not just students, but whole communities, said Lynn Nelson, president-elect of the National Association of School Nurses.
Heres a look at whats behind these trends, some immediate and potential implications, and tactics Nelson says can be effective at changing attitudes.
Nelson attributes the stubbornly flat vaccine rates to both vaccine hesitancy among parents and guardians, and challenges for families in accessing vaccinations.
Were dealing with a subset of parents who have really come to believe that vaccines in general are detrimental to their children, Nelson said.
She blames a general mistrust of the medical field and readily available misinformation, spread on social media sites and by word of mouth, for fueling this belief. It used to be that families with young children would trust their health-care providers, she said. Now, some people are generally distrustful of the medical field.
The repercussions of this distrust extend beyond the skeptics themselves. For instance, the presence of protesters at school vaccine clinicsusually families and other community members who are against vaccine mandatescan dissuade other nearby districts from hosting clinics of their own.
In some communities that are vaccine hesitant, districts will not even put on clinics, Nelson said.
Negative attitudes about vaccines can also sway public officials decisions around vaccine mandates. For instance, The city council in the District of Columbia voted this week to repeal a COVID-19 vaccine mandate for eligible public school students that was passed in 2021.
Testifying before thecouncil, Thomas Farley, senior deputy director of community health administration with the districts health department, said that parents resistance [to the vaccine] would make it very difficult to enforce a mandate for COVID-19, according to a local news report .
In addition to less than ideal vaccination rates, health officials report an increase across states in vaccine exemptions, which allow parents to opt out of having their children vaccinated. Up to 3 percent of children entering kindergarten in 2022-2023 received a vaccine exemption for medical, religious, and/or philosophical reasons. (Currently, 50 states allow medical exemptions, 44 offer religious exemptions, and 15 states permit philosophical/personal belief exemptions.)
Overall, the share of vaccine exemptions rose in 40 states and the District of Columbia. In 10 states, such exemptions exceeded 5 percentthe point where achievable vaccination coverage against a preventable disease is no longer applicable, according to health officials.
Also this week a high school in Carlisle, Pa.among the 15 states that allow exemptions for medical, religious, and philosophical reasonsconfirmed 10 cases of pertussis, or whooping cough, among its students. Two weeks ago, the Pennsylvania department of public health confirmed a similar outbreak in Cumberland County, Pa. Two standard childhood vaccinations protect against pertussis: DTaP and Tdap. Before the vaccines development, pertussis was a major cause of infant morbidity and mortality. But incidents of the illness dropped from between 150,000 and 250,000 cases per year to a low of 1,010 cases in 1976. Its back on the rise, in part because of waning adolescent and adult immunity, according to data from the National Institutes of Health .
Amid these challenges to vaccinations, Nelson acknowledged that school nurses, as trusted members of the community, can have a positive influence on families decision-making.
I do think those personal efforts to reach out to families, such as phone calls from a school nurse, can influence them much more effectively than broader campaigns, she said.
Some school communities struggling with a lack of access to health-care providers, especially in rural locales, have had success bringing vaccine clinics to schools. Generally, the school nurse will partner with a local health-care provider whos willing to travel and set up a clinic at school, usually on weekends or after school. Typically, state departments of public health will contract with private pharmacies and provide vaccines to students free of charge, Nelson explained.
Weve had really good results doing this, she said, referring to Washington State, where there is a large number of rural and remote school districts.
Theres one other thing that can change behavior, although its not one health professionals ever want to see: When an outbreak of a preventable infectious disease affects a community where vaccine hesitancy runs high.
Nelson said shes old enough to remember outbreaks of pertussis, whose spread has the most deleterious effects on infants, the elderly, and people who are immunocompromised.
These outbreaks generally serve as a catalyst for people to get vaccinated, she said. Sometimes, thats what it takes to get people to think differently about vaccinations.
An expert panel that advises the United Kingdom on vaccine policy has recommended using a meningitis B vaccine to try to bring down spiking rates of gonorrhea. If adopted, the U.K. would be the first country to use the meningitis B vaccine for this purpose.
The Joint Committee on Vaccination and Immunization released a report Friday saying that targeted use of a meningitis B vaccine GSKs Bexsero in people at high risk of contracting gonorrhea should reduce the incidence of an infection that is becoming increasingly difficult to treat.
Introducing a MenB vaccination program to prevent gonorrhea in England would be a world first and should significantly help to reduce levels of gonorrhea, which are currently at a record high, JCVI Chair Andrew Pollard said in a statement.
The committee recommended the meningitis B vaccine should be offered to gay, bisexual, and other men who have sex with men who are at high risk of contracting gonorrhea, either because they currently have it or have been previously diagnosed with it, or who report high-risk sexual behavior with multiple partners. Gonorrhea infection does not induce immunity; people who have been cured can be reinfected.
The decision to offer the vaccine to an individual should be based on a risk assessment by a sexual health clinical professional, the JCVI report said. The report notes there is no evidence on whether being vaccinated while infected would work, so it recommends holding off on vaccination until the infection has been cured.
It also suggested other individuals at similar risk should be offered the vaccine. Those include transgender women, gender-diverse people assigned male at birth, and other people, regardless of gender, who are at high risk, including those with a recent history of a bacterial STI, and sex workers.
Gonorrhea is the second most commonly diagnosed sexually transmitted infection in England, with around 80,000 diagnoses a year.
Neisseria gonorrhoeae, the bacteria responsible for the infection, has over the years developed resistance to virtually every antibiotic that has been used to treat it. The current recommended therapy, ceftriaxone, is the last licensed antibiotic that can reliably cure gonorrhea. But there have been increasing reports of ceftriaxone-resistant cases of the infection.
A vaccination program to impact gonorrhea cases would be a hugely welcome intervention to ensure we are better prepared to address this increasing threat, said Katy Sinka, head of the sexually transmitted infections program at the U.K. Health Security Agency. We saw a rapid rise last year with more cases than ever before and with gonorrhea becoming increasingly resistant to antibiotics, tackling this infection is a serious concern.
JCVI also recommended routine use of mpox vaccine among at-risk people, a step that its U.S. equivalent, the Advisory Committee on Immunization Practices, recommended last month. The U.K.s department of health and social care will now study both recommendations. It must approve them before the JCVI advice can be put into effect.
Bexsero protects against meningitis B, one of the serotypes of Neisseria meningitidis bacteria. It is closely related to Neisseria gonorrhoeae; the genetic sequences of the two are between 80% and 90% alike.
In theory, the similarity of the two bacteria suggests that the meningitis B vaccine could offer some protection against gonorrhea. And over the past decade or so, real-world evidence to support the idea has been piling up.
A range of studies that have been conducted in a number of countries have estimated that the vaccine is between about 33% and 42% effective at protecting against gonorrhea.
But to date all of the data supporting the use of the vaccine to protect against gonorrhea have been observational, meaning researchers have looked at gonorrhea rates in cohorts of people who received the vaccine for meningitis-control purposes. To get a clearer picture of whether and how well using it to protect against gonorrhea works, data from a randomized controlled trial that compares gonorrhea rates among vaccinated people to similar people who are unvaccinated will be needed.
Scientists funded by the National Institutes of Health are conducting just such a study, enrolling 2,200 adults in the U.S., Thailand, and sites in Africa. Jodie Dionne, an STI expert at the University of Alabama at Birmingham, is one of the trial site investigators and protocol co-chair. She told STAT that so far about 1,600 people have been enrolled. Its expected that the trial will reach full enrollment by mid-2024.
The trial will follow all participants for about 15 months after enrollment, so were not on the precipice of having data available very soon.
Asked about the JCVIs recommendation, Dionne noted that Bexsero has a good safety profile, which is reassuring in terms of what would be off-label use of the vaccine. But she thinks that making a decision like this without clinical trial data is early.
I think that waiting for the clinical trial data is preferable whenever you can, Dionne said. I think for the average person, they are reassured when I can tell them as their doctor, that this vaccine has been studied in a clinical trial and shown to be effective. As opposed to, Observational studies think maybe this will have an impact. Thats not quite as powerful.
If the vaccine is protective against gonorrhea, its not yet known for how long the protection will last, the JCVI report noted. It also said it will be important to impress upon people getting the vaccine that they are still at risk of becoming infected.
Although vaccination would be expected to reduce the chance of becoming infected with gonorrhea, it would not completely eliminate the possibility, it stated.
