Vaccine | Jotup

Religion and COVID-19: methodists and Church of England followers more likely to have been vaccinated than Muslims and Pentecostals

Retrieved on:

Giovedì, Aprile 25, 2024

Trust, COVID-19, Muslims, Religion, Public, Vaccination, Research, NHS, Methodism, Vaccine

While some religious groups were keen to be vaccinated against COVID-19, others were much more hesitant.

Key Points:

While some religious groups were keen to be vaccinated against COVID-19, others were much more hesitant.
During the height of the pandemic, getting vaccinated against COVID-19 quickly became the social norm.
Having experienced pandemic life, most people were keen to get a full series of vaccinations as soon as they were made available.
Members of the Methodist and Church of England denominations are more likely to have been vaccinated, while Pentecostal, evangelical and Muslim respondents have received far fewer vaccinations.

R21 anti-malaria vaccine is a game changer: scientist who helped design it reflects on 30 years of research, and what it promises

Retrieved on:

Giovedì, Aprile 25, 2024

Until three years ago nobody had developed a vaccine against any parasitic disease. Now there are two against malaria: the RTS,S and the R21 vaccines. Adrian Hill, director of the Jenner Institute at the University of Oxford and chief investigator for the R21 vaccine, tells Nadine Dreyer why he thinks this is a great era for malaria control.What makes malaria such a difficult disease to beat?Our hominoid predecessors were being infected by malaria parasites tens of millions of years ago, so these parasites had a lot of practice at clever tricks to escape immune systems long before we came along.

Key Points:

Until three years ago nobody had developed a vaccine against any parasitic disease. Now there are two against malaria: the RTS,S and the R21 vaccines. Adrian Hill, director of the Jenner Institute at the University of Oxford and chief investigator for the R21 vaccine, tells Nadine Dreyer why he thinks this is a great era for malaria control.

What makes malaria such a difficult disease to beat?

Our hominoid predecessors were being infected by malaria parasites tens of millions of years ago, so these parasites had a lot of practice at clever tricks to escape immune systems long before we came along.
Additionally, the malaria parasite goes through four life cycle stages.
Medical researchers have been trying to make malaria vaccines for over 100 years.

How does the R21/Matrix-M vaccine work?

An antigen is any substance that causes the body to make an immune response against that substance.
We targeted the sporozoites, which is the form that the mosquito inoculates into your skin.
Read more:
Two new malaria vaccines are being rolled out across Africa: how they work and what they promise

A child dies every minute from malaria in Africa. Why are children more susceptible than adults?

The age you’re most likely to die of malaria in Africa is when you are one year old.
For the first six months you are protected largely by your mother’s immunity and the antibodies she transfers during pregnancy.
Without malaria, children would be healthier in general — the disease makes you susceptible to other infections.

What about the pace of vaccine rollouts?

We’ve been disappointed that it’s taken more than six months to roll out the R21 vaccine since it was approved in October last year.
Compare that to a COVID-19 vaccine from Oxford and AstraZeneca that was approved on New Year’s Eve 2020 and rolled out in several countries the very next week.

How big a role will vaccines have in the fight to eradicate malaria?

Nobody is quite sure how many of the older tools such as insecticides and bed nets we need to carry on with.
Anti-malaria medication only lasts for days and parasites are building up resistance against these drugs as well.
There are about 40 million children born every year in malaria areas in Africa who would benefit from a vaccine.
The Serum Institute of India, our manufacturing and commercial partner, can produce hundreds of millions of doses each year.

Adrian Hill receives funding from government and charitable funders of malaria vaccine development. He has received funding awarded to the University of Oxford from the Serum Institute of India to support clinical trials of the R21/Matrix-M vaccine. He may benefit for a share of any royalty stream to Oxford University from the vaccine.

Chemical pollutants can change your skin bacteria and increase your eczema risk − new research explores how

Retrieved on:

Martedì, Aprile 23, 2024

Also known as atopic dermatitis, this chronic skin disease affects about 1 in 5 children in the industrialized world.

Key Points:

Also known as atopic dermatitis, this chronic skin disease affects about 1 in 5 children in the industrialized world.
Some studies have found rates of eczema in developing nations to be over thirtyfold lower compared with industrialized nations.
Scientists know that factors such as diets rich in processed foods as well as exposure to specific detergents and chemicals increase the risk of developing eczema.
Living near factories, major roadways or wildfires increase the risk of developing eczema.

There’s something in the air

Then we looked at databases from the U.S. Environmental Protection Agency to see which chemicals were most common in those areas.
Diisocyanates were first manufactured in the U.S. around 1970 for the production of spandex, nonlatex foam, paint and polyurethane.
The manufacture of xylene also increased around that time, alongside an increase in the production of polyester and other materials.

After 1975, when all new cars became outfitted with a new technology that converted exhaust gas to less toxic chemicals, isocyanate and xylene both became components of automobile exhaust.
How directly exposing mice to these toxins compares to the typical levels of exposure in people is still unclear.

Skin microbiome and pollution

Every person is coated with millions of microorganisms that live on the skin, collectively referred to as the skin microbiome.
You’ve probably seen moisturizers and other skin products containing ceramides, a group of lipids that play an important role in protecting the skin.

To see which toxins could prevent production of the beneficial lipids that prevent eczema, my team and I used skin bacteria as canaries in the coal mine.
Lysine helps protect the bacteria from the harms of the toxins but doesn’t provide the health benefits of ceramides.
Bacteria that help keep skin healthy could live on any fabric, but, just as with air pollution, the amount of beneficial lipids they made dropped to less than half the levels made when grown on fabrics like cotton.

Addressing pollution’s effects on skin

Detectors capable of sensing low levels of isocyanate or xylene could help track pollutants and predict eczema flare-ups across a community.
Better detectors can also help researchers identify air filtration systems that can scrub these chemicals from the environment.
In the meantime, improving your microbial balance may require avoiding products that limit the growth of healthy skin bacteria.
I believe that it may one day allow us to get back to a time when these diseases were uncommon.

Ian Myles receives funding from the Department of Intramural Research at the National Institute of Allergy and Infectious Diseases. He is the author of, and receives royalties for, the book GATTACA Has Fallen: How population genetics failed the populace. Although he is the co-discoverer of Roseomonas mucosa RSM2015 for eczema, he has donated the patent to the public and has no current conflict of interest for its sales.

Two new malaria vaccines are being rolled out across Africa: how they work and what they promise

Retrieved on:

Martedì, Aprile 23, 2024

Malaria incidents are on the rise. There were 249 million cases of this parasitic disease in 2022, five million more than in 2021. Africa suffers more than any other region from malaria, with 94% of cases and 95% of deaths worldwide. This year two revolutionary malaria vaccines are being rolled out across the continent. Nadine Dreyer asks Jaishree Raman if 2024 will be the year the continent takes a significant leap towards beating the disease.The RTS,S malaria vaccineThe long-awaited vaccine was described as a breakthrough for science, child health and malaria control.

Key Points:

Malaria incidents are on the rise. There were 249 million cases of this parasitic disease in 2022, five million more than in 2021. Africa suffers more than any other region from malaria, with 94% of cases and 95% of deaths worldwide. This year two revolutionary malaria vaccines are being rolled out across the continent. Nadine Dreyer asks Jaishree Raman if 2024 will be the year the continent takes a significant leap towards beating the disease.

The RTS,S malaria vaccine

The long-awaited vaccine was described as a breakthrough for science, child health and malaria control.
It is being aimed at children under the age of 5, who make up about 80% of all malaria deaths in Africa.
Among children aged 5 and 17 months who received 4 doses of RTS,S, the vaccine prevented about 30% of them from developing severe malaria.
Since 2019 more than 2 million children in Ghana, Kenya and Malawi have been vaccinated with the RTS,S malaria vaccine.

R21/Matrix M

The R21 vaccine is a significant improvement on the RTS,S vaccine, with 75% efficacy over a year.
The R21/Matrix M vaccine is very cost-effective, projected to retail at $2-$4 a dose, comparable in price to other childhood vaccines used in Africa.
These very encouraging findings prompted several malaria-endemic African countries, including Ghana and Nigeria, to approve use of the R21/Matrix M vaccine well before the World Health Organization.
The WHO finally approved and prequalified R21/Matrix M for use in the last quarter of 2023.

No silver bullet

While the fight against malaria has been significantly bolstered by the availability of these vaccines, they are not the silver bullets that are going to get us to an Africa free of malaria.
This will be the year that many vulnerable young African children will have access to not one, but two malaria vaccines.

Jaishree Raman receives funding from the Global Fund, the Gates Foundation, the South Africa Research Trust, the South African Medical Research Council, the National Research Foundation, and the National Institute for Communicable Diseases. She is affiliated with the Wits Research Institute for Malaria, University of Witwatersrand, and the Institute for Sustainable Malaria Control, the University of Pretoria.

How to get vaccines to remote areas? In Sierra Leone they’re delivered by foot, boat or motorbike

Retrieved on:

Giovedì, Aprile 18, 2024

In Sierra Leone almost 59% of the population live in remote, rural areas.

Key Points:

In Sierra Leone almost 59% of the population live in remote, rural areas.
Roads may be non-existent or in bad condition, making it very difficult for rural dwellers to access healthcare.

Why are vaccination rates low in Sierra Leone?

In stark contrast, only 15% of people had been vaccinated in low-income countries.
The hardships Sierra Leoneans face are typical of the obstacles people in low-income countries have to overcome to access healthcare.
In the early days of the COVID-19 vaccination campaign in Sierra Leone, it took the average Sierra Leonean living in a rural community three-and-a-half hours each way to the nearest vaccination centre.

How did this vaccine drive tackle the problem?

The primary aim of this intervention was to take vaccine doses and nurses to administer vaccines to remote, rural communities, preceded by seeking permission and community mobilisation.
At the time, only 6% to 9% of the adults who took part in the programme were already immunised.
The leaders were asked for their cooperation in encouraging eligible community members to take the COVID-19 vaccine.
Finally, vaccine doses and healthcare workers arrived at the villages to administer the doses.

Looking forward

This approach proved 76% more cost-effective than other vaccination campaigns.
Transport accounted for a large share of the costs, so the cost-effectiveness of last mile delivery can be increased by offering a “bundle” of health products.
Other estimates put the death toll for the same period at 14.83 million, which is 2.74 times higher.
Developing cost-effective strategies to make vaccines easily accessible to everyone, everywhere, is the most promising solution to prevent future pandemics.

Niccolò Francesco Meriggi receives funding from Weiss Asset Management, UKRI and the International Growth Centre.

Cancer Medicines Forum: February 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, 26 February 2024

Retrieved on:

Giovedì, Aprile 18, 2024

Location, Cancer, EMA, CMF, Vaccine

Date

Key Points:

Date
- Monday, 26 February 2024
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
The Cancer Medicines Forum (CMF) aims to explore how EMA can contribute towards addressing remaining uncertainties about the use of cancer medicines in clinical practice.
The forum brings together representatives of academic organisations from EMA’s Healthcare Professionals Working Party and the European medicines regulatory network.
The results of discussions will support the prioritisation of actions to fight cancer in EMA's Regulatory Science Strategy to 2025 and Academia Collaboration Matrix Action Plan.
The meetings of the forum are by invitation only.

EMA/FVE info session on restrictions for the use of certain antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 May 2024, 15:00 (CEST) to 23 May 2024, 16:00 (CEST)

Retrieved on:

Giovedì, Aprile 18, 2024

Location, Public, Regulation, EMA, Human, Risk, AMR, Science, Veterinarian, Agency, WHO, Animal, Cisco Webex, Vaccine

During this session, participants will have the opportunity to engage with experts who contributed to the development of the available guidance.

Key Points:

During this session, participants will have the opportunity to engage with experts who contributed to the development of the available guidance.
Registration
Please register for the webinar using the below online form:
EMA/FVE info session on restrictions for the use of certain antimicrobials in animals
Please note this event will be recorded and published on the EMA website.
By registering for this event, you are consenting to EMA to process your personal data in accordance with Regulation (EU) 2018/1725.
EMA's data protection notice below explains how personal data is processed by the Agency and via the tool Webex:

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Retrieved on:

Giovedì, Aprile 18, 2024

Steps, Union, Patient, CTD, Syndrome, CCI, Local, Disclosure, Toxicity, Process validation, MAH, Clinical trial, IP, RMP, Pharmacovigilance, Cell, Legislation, Annex, Trial of the century, Escherichia coli, Safety, Pediatrics, INTRODUCTION, Documentation, Prevalence, Vital signs, Tablet, Design, Transparency, Conclusion, Pip, Analysis, European Parliament, INN, Record, Quality, Generic, Biology, CMO, Genotoxicity, Composition, CTIS, Uncontrolled, Health care, European Medicines Agency, Prejudice, Committee, Policy, HCP, Animal, Characterization, Cell bank, Fertility, IRB, CMOS, Risk management, Private law, European Pharmacopoeia, Telephone, Research, Good, Data Protection Directive, Ampere-hour, IEC, QP, Human, Personal data, Labelling, Bibliography, Figure, MAA, R4, Institutional review board, Elucidation, Marketing, M4, ChromeOS, Contract research organization, Mental, Impairment, Toxicokinetics, NCA, Independent, Metabolite, Drug, Risk, Metabolism, GMO, Organ, EMA, Common Technical Document, General Data Protection Regulation, Confidentiality, PPD, PI, Language, DRUG, Privacy, Result, Claimed, Medication, Comparison, Ethics, Drive, PD, Narrative, EEA, Developmental toxicity, Saccharomyces cerevisiae, Pharmacopoeia, PIP, MCB, HMA, Physical chemistry, Midol, Particle size, Council, GCP, European Economic Area, Draft, Fermentation, Overview, Justification, Control, Dicarboxylic acid, Pharmacology, WCB, Expert, Immunogenicity, Data, Study, Publication, European, ICH, Element, Analytical procedures (finance auditing), Name, Common, Guideline, Exceptional circumstances, ID, Liver, Chin Na, Toxicology, Protein primary structure, Immunosuppressive drug, Vaccine

See websites for contact details

Key Points:

See websites for contact details
Heads of Medicines Agencies www.hma.eu
European Medicines Agency www.ema.europa.eu
11

Table of contents

12

Abbreviations .............................................................................................. 3

13

Definitions ................................................................................................... 4

14

1.
redaction, masking,
68

hiding) in such a manner that the recipient can no longer attribute the resulting information to a data

69

subject and make it identifiable.
81
Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

82

manufacturer provides upstream manufacturing services under contract on behalf of third-party

83

pharmaceutical companies.
94
Protected Personal Data (PPD): shall mean any personal data which should be protected from

95

disclosure.
?Finalised? shall mean that the marketing
102

authorisation (MA) has been granted or refused or that the MAA has been withdrawn.
The application of the general principles laid down in this guidance is without prejudice to
106

national rules on transparency.
The guidance should be read in conjunction with the relevant applicable
107

legislation and case law on transparency and data protection.
117
This guidance document is intended to apply to information/documents on medicinal products for

118

human use, for which the procedure has been finalised under the national, mutual recognition,

119

decentralised and centralised procedures.
Third
124

parties shall be informed or consulted as needed depending on respective national and European legal

125

frameworks.
140
In the following sections, the agreed principles on PD and CCI are presented, including guidance on

141

whether such information can be disclosed.
EMA/131365/2024
Page 5/50

142

Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

143

to the possible disclosure of the information/documents.
Principles on the protection of personal data (PD)
145

The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.
In
146

compliance with the applicable European/national legislation, PD should be anonymised in order to

147

avoid the disclosure of the document undermining the privacy and integrity of any individual.
EMA/NCA applies a risk-based approach to assess which PD elements are to be
152

removed from the information/documents in order to limit the risk of re-identification.
are included in the MAA dossier because they have a legally
164

defined role or responsibility and it is in the public interest to disclose this data.
168
Applicants are advised that non-essential information (e.g., personal address, personal phone number)

169

should not be included in the MAA dossier.
The
183

confidentiality of records that could identify subjects should be protected, respecting the privacy and

184

confidentiality rules in accordance with the applicable regulatory requirement(s).
185
The applicant remains responsible for compliance with the relevant legislation in cases where such data

186

is inadvertently included in the MAA dossier.
188
EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

189

from the information/documents in order to limit the risk of re-identification.
194
EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

195

from the information/documents in order to limit the risk of re-identification.
205
Any proposal to consider information as commercially confidential should be properly justified by the

206

owner of the information.
In this respect, any reference(s) to the risk of that interest being
209

undermined should be foreseeable and not purely hypothetical.
210
Information that is already in the public domain is not considered to be commercially confidential.
Information on the Quality and Manufacturing of medicines
226

A general principle regarding quality and manufacturing information is that detailed information could

227

be considered commercially confidential but general information should be disclosed.
234
In general, and if not in the public domain, the names of manufacturers or suppliers of the active

235

substance or the excipients are considered commercially confidential.
248
A general description of the type of test methods used and the appropriateness of the specification is

249

not commercially confidential.
General information on the fermentation and purification process
259

is not commercially confidential, although details including operating parameters and specific material

260

requirements are commercially confidential.
273
A general description of the type of test methods used and the appropriateness of the specification is

274

not commercially confidential.
In general, the data included in clinical trial study reports is considered to be data that can be
283

disclosed once PD has been anonymised.
338
In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information

332
333

339

(CCI) is included.
?
Direct contact details such as telephone

Therefore, please refer to the appropriate sub-

number, fax number, email, postal address,

modules hereafter for guidance.
?
Information that may reveal strategic
(contractual) agreements

?

Any quality information on the clinical batches

principal investigator

that might be included here (such as e.g.
?
Information that may reveal strategic
(contractual) agreements

principal investigator

Study Reports
5.3.3.3

as the evaluation of new formulation, innovative

number, fax number, email, postal

Paediatric Development Plan (PIP), etc.
This may include taking into
More Than One Study
5.3.5.4

Other Clinical Study Reports

5.3.6

Reports of Post-Marketing
Experience

5.3.7

Direct identifiers such as name,
signature, contact details, etc.

PFAS ‘forever chemicals’: Why EPA set federal drinking water limits for these health-harming contaminants

Retrieved on:

Mercoledì, Aprile 10, 2024

The U.S. Environmental Protection Agency now believes there is no safe level for two common PFAS – PFOA and PFOS – in drinking water, and it acknowledges that very low concentrations of other PFAS present human health risks.

Key Points:

The U.S. Environmental Protection Agency now believes there is no safe level for two common PFAS – PFOA and PFOS – in drinking water, and it acknowledges that very low concentrations of other PFAS present human health risks.
The agency issued the first legally enforceable national drinking water standards for five common types of PFAS chemicals, as well as PFAS mixtures, on April 10, 2024.

What exactly are PFAS?

This is a large group of human-made chemicals – currently estimated to be nearly 15,000 individual chemical compounds – that are used widely in consumer products and industry.
They can make products resistant to water, grease and stains and protect against fire.

The short answer is that PFAS are harmful to human health and the environment.
Some of the very same chemical properties that make PFAS attractive in products also mean these chemicals will persist in the environment for generations.
The U.S. Geological Survey estimates common types of PFAS are now in at least 45% of the country’s tap water.

What are the health risks from PFAS exposure?

Research consistently demonstrates that PFAS are associated with a variety of adverse health effects.
A review by a panel of experts looking at research on PFAS toxicity concluded with a high degree of certainty that PFAS contribute to thyroid disease, elevated cholesterol, liver damage, and kidney and testicular cancer.

Additionally, current research suggests that babies exposed prenatally are at higher risk of experiencing obesity, early-onset puberty and reduced fertility later in life.
Collectively, this is a formidable list of diseases and disorders.

Who’s regulating PFAS?

DuPont called it Teflon, which eventually became a household name for its use on nonstick pans.
Decades later, in 1998, Scotchgard maker 3M notified the Environmental Protection Agency that a PFAS chemical was showing up in human blood samples.
At the time, 3M said low levels of the manufactured chemical had been detected in people’s blood as early as the 1970s.
The Agency for Toxic Substances and Disease Registry has a toxicological profile for PFAS.

How can you reduce your PFAS exposure?

The best ways to protect yourself and your family from risks associated with PFAS are to educate yourself about potential sources of exposure.
Products labeled as water- or stain-resistant have a good chance of containing PFAS.
Strategies for monitoring and reporting PFAS contamination vary by location and PFAS source, so the absence of readily available information does not necessarily mean the region is free of PFAS problems.

Kathryn Crawford receives funding from National Institutes of Health and US Geological Survey.

EQS-News: CureVac Announces Promising Phase 2 Interim Data from Seasonal Influenza Vaccine Development Program in Collaboration with GSK

Retrieved on:

Mercoledì, Aprile 10, 2024

GSK, Ageing, CureVac, CVAC, Antigen, Messenger, Candidate, Safety, Vaccine

The multivalent candidate was selected from a comprehensive Phase 1 part, which tested vaccine candidates with up to eight separate mRNA constructs per candidate.

Key Points:

The multivalent candidate was selected from a comprehensive Phase 1 part, which tested vaccine candidates with up to eight separate mRNA constructs per candidate.
Targeted optimizations to further improve immune responses against influenza B strains will be tested in an additional Phase 2 study.
“The Phase 2 interim data show that CureVac’s highly effective and flexible mRNA technology platform puts us on the right track to advance our joint seasonal influenza vaccine program,” said Dr. Myriam Mendila, Chief Development Officer of CureVac.
For older adults, immune responses were compared to a high dose seasonal flu vaccine.