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Europe eyes loophole for early distribution of unlicensed coronavirus vaccine

Concerns are mounting that the Trump administration may push for the distribution of an unapproved c..



Concerns are mounting that the Trump administration may push for the distribution of an unapproved coronavirus vaccine. Quietly, Europe is also reluctantly preparing to be ready to do the same.

If another option isnt available, national medicines regulators and the European Commission, together with the European Medicines Agency, want to be sure that everything is in place to distribute an unlicensed vaccine.

Ordinarily, a coronavirus vaccine would get a central recommendation for approval, or conditional approval, from the European Medicines Agency. But theres a legal loophole: Under a 2001 directive, member countries may temporarily authorize the distribution of an unauthorized medicinal product “in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation, any of which could cause harm.”

The coronavirus pandemic is one such situation — and the United Kingdom has already made clear it could use this loophole. In fact, Britain is working on strengthening its own legislation to enable certain conditions to be attached to the distribution of an unlicensed vaccine.

But the U.K. isnt alone in readying itself for this possibility. Several national European regulators have acknowledged to POLITICO that they can use the existing legislation to temporarily distribute a vaccine pre-approval, with some regulators saying this idea is already being discussed.

Under compassionate use, a patient with no other treatment options can access a drug still in development.

At the EU level, the Commission and the EMA are working on a model in collaboration with member countries that could provide national regulators with a “coordinated and harmonized scientific assessment,” similar to that of compassionate use schemes. Under compassionate use, a patient with no other treatment options can access a drug still in development.

If the model worked in the way that the compassionate use schemes do, the EMA would come up with a common set of conditions for using an unapproved vaccine, as well as for distribution and who should be given the vaccine. EU countries would then be able to use these guidelines to distribute the vaccine.

The Commission was unable to provide further information on the new model as it is still under development.

The backup plan

Of the 27 national medicines regulators contacted by POLITICO, 13 responded and two — Belgium and Croatia — admitted that theyre discussing distributing an unlicensed vaccine.

A spokesperson for Croatias Agency for Medicinal Products and Medical Devices (HALMED) said that “taking into account the interests of public health, we have, naturally, considered the possibility of distribution of an unlicensed vaccine.”

Meanwhile, Belgiums Federal Agency for Medicines and Health Products (FAMHP) said that “the possibility of considering the distribution of unlicensed vaccines as a back-up situation is under discussion.”

Several other national regulators said that they wouldnt need any additional changes to their legislation (as the U.K. is doing) to distribute a vaccine. Lithuania said the EU directive would be directly transmitted through its laws, and both Spain and Sweden said they dont expect a need for additional legislative changes.

In contrast, Hungary, Slovenia, Austria and Denmark said either that they had not considered distributing an unlicensed vaccine or that distribution of a vaccine in their countries would follow the EMAs central approval process.

Meanwhile, the drugmaker Moderna, whose vaccine is in phase 3 trial stage, has previously said that its in discussions with several European regulators on possible mechanisms for pre-approval access to the vaccine. And Belgium and Hungary said that they had offered scientific advice to pharmaceutical companies, but would not disclose the names. Belgiums FAMHP specified that the scientific advice applications have been received for coronavirus vaccines from both commercial and noncommercial sponsors.

For their part, pharmaceutical companies are at pains to reassure the public that they wont be driven by politics to rush out a vaccine. On September 8, the CEOs of nine major pharmaceutical companies at the forefront of developing these vaccines took the unusual step of pledging to “uphold the integrity of the scientific process” as they work toward regulatory approval.

Approving at warp speed?

But its clear that using an unlicensed vaccine isnt any regulators first choice.

“It is worth noting that the possible use of a vaccine before an authorization should not be seen as an encouragement for such use, rather as a proactive effort to ensure a coordinated EU approach to be prepared for a situation wheRead More – Source

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How does overeating affect the immune system?



Overeating is a common problem that affects millions of people worldwide. While it is widely understood that excessive eating leads to obesity and other health problems, many people are unaware of the impact that overeating has on the immune system. In this article, we will explore how overeating affects the immune system and what can be done to prevent or mitigate the damage.

The immune system is the body’s defense mechanism against harmful substances and infections. It is responsible for identifying and eliminating harmful pathogens and other invaders that may cause harm to the body. When the body is functioning normally, the immune system works efficiently to keep us healthy. However, when the body is subjected to chronic stress, such as from overeating, it can become weakened, making it less effective at protecting the body against illness and disease.

One of the ways in which overeating affects the immune system is by increasing inflammation. Inflammation is a natural response of the body to injury or infection, but when it becomes chronic, it can have a negative impact on the immune system. Chronic inflammation is associated with a range of health problems, including heart disease, diabetes, and certain types of cancer. When the body is constantly exposed to high levels of glucose and other harmful substances as a result of overeating, it can lead to chronic inflammation, which can weaken the immune system and increase the risk of illness.

Another way in which overeating affects the immune system is by altering the gut microbiome. The gut microbiome is the collection of microorganisms that live in the digestive tract and play a crucial role in maintaining good health. When the body is exposed to a high-fat diet, the balance of gut bacteria can become disrupted, leading to the overgrowth of harmful bacteria and the suppression of beneficial bacteria. This can result in decreased gut function and reduced immune function, making it more difficult for the body to protect itself against harmful pathogens.

In addition, overeating can also lead to obesity, which is a major risk factor for a range of health problems, including heart disease, diabetes, and certain types of cancer. Obesity is associated with a range of physiological changes, including insulin resistance and the release of cytokines, which are signaling molecules that play a crucial role in the immune response. When the body is constantly exposed to high levels of cytokines, it can lead to a state of chronic inflammation, which can weaken the immune system and increase the risk of illness.

Finally, overeating can also affect the immune system by causing oxidative stress. Oxidative stress occurs when the body is exposed to an excessive amount of free radicals, which are highly reactive molecules that can cause damage to cells and tissues. When the body is constantly exposed to high levels of glucose and other harmful substances as a result of overeating, it can lead to oxidative stress, which can weaken the immune system and increase the risk of illness.

In conclusion, overeating can have a profound impact on the immune system. By increasing inflammation, altering the gut microbiome, causing obesity, and inducing oxidative stress, overeating can weaken the body’s ability to protect itself against harmful pathogens and other invaders. To maintain a healthy immune system, it is important to eat a balanced diet, engage in regular exercise, and avoid overeating. By taking these simple steps, you can help protect your immune system and reduce your risk of illness and disease.

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Homelessness and mental illness are two intertwined issues that have a complex relationship. Homelessness can cause or worsen mental illness and, conversely, mental illness can contribute to homelessness. It is a vicious cycle that can be difficult to escape, and it is important to understand the ways in which these two issues are interconnected.

Homelessness can have a significant impact on a person’s mental health. Living on the streets can be a traumatic experience, with a constant fear of violence, theft, and disease. Homeless individuals often face stigma, discrimination, and a lack of privacy, which can lead to feelings of shame, hopelessness, and isolation. The stress and unpredictability of homelessness can trigger or exacerbate mental health problems, including depression, anxiety, and post-traumatic stress disorder (PTSD).

Mental illness, on the other hand, can also contribute to homelessness. Mental illness can make it difficult for individuals to maintain employment, manage their finances, and maintain stable housing. Individuals with mental illness may struggle with accessing treatment and support, and the stigma and discrimination associated with mental illness can also contribute to feelings of shame and isolation. These challenges can lead to a cycle of homelessness and mental illness, where each issue exacerbates the other.

There is a need for a coordinated and comprehensive approach to addressing homelessness and mental illness. This includes providing safe and stable housing, access to mental health treatment and support, and addressing the underlying social determinants of health that contribute to homelessness, such as poverty, lack of education and job opportunities.

Housing First, a program that prioritizes providing permanent housing to homeless individuals before addressing any other issues, has been shown to be effective in reducing homelessness and improving mental health outcomes. This approach recognizes that stable housing is a critical foundation for addressing other issues, including mental health.

In conclusion, homelessness and mental illness are complex and interrelated issues that require a comprehensive and coordinated approach to address. Providing stable housing and access to mental health treatment and support is critical for breaking the cycle of homelessness and mental illness and improving outcomes for individuals experiencing these issues. It is important to continue to address the root causes of homelessness, including poverty and lack of access to education and employment opportunities, to reduce the prevalence of homelessness and improve outcomes for those experiencing it.

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Improving Reception For Children With Cancer – Basque Family Support Association



The association “Tous avec Agosti” wants 2023 to rhyme with new dynamics. For nine years now, the structure has been working to welcome families of hospitalized children in Bayonne. Since 2018, 47 families have been able to find some respite in an apartment in Anglet.

Apartment in Anglet

Since she has benefited from an apartment in Anglet, the association “Tous avec Agosti” has enabled nearly 50 families of patients hospitalized at the Center Hospitalier de la Côte Basque to stay close to their loved ones. This represents 600 overnight stays, 47 families from 23 departments and even from Belgium and Spain. At the beginning of 2023, the structure has just had its prefectural approval renewed and sees things big.

“We have been working in our area for years,” notes Frédéric de Arroyave, the association’s president, but “in 2023, we will show ourselves much more, on the markets for example, but also in acts. The apartment we have in Anglet is a haven of peace for families going through terrible times, but for some it is difficult to access”. The apartment is located on the alleys of the Jardins d’Arcadie, near Biarritz – Pays Basque airport. We want to get closer to the Bayonne hospital.

The association “Tous avec Agosti” was born in 2015. Agosti, 10 years old, is suffering from cancer and taken care of at Bordeaux hospital for 6 months. His father, Frédéric de Arroyave, living in Ahetze, has the possibility of integrating a parents’ house and can stay with his child. Such a structure did not exist in Bayonne, so he launched the project and the association which lives today thanks to donations from contributors and the dozen (very) active volunteers. Each year, approximately 4,000 children are hospitalized in Bayonne.

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