Connect with us


Inside Oxfords vaccine saga: From wild hype to sobering reality

In April, Sarah Gilbert, the British scientist leading Oxfords COVID-19 vaccine effort, said she was..



In April, Sarah Gilbert, the British scientist leading Oxfords COVID-19 vaccine effort, said she was 80 percent confident her team would be able to produce a successful vaccine by September.

It was a remarkable statement — conspicuously confident — especially given the timing: Oxfords vaccine had yet to be tested in a single human, and the results from a preliminary trial involving monkeys hadnt yet been published.

With pandemic death rates in the U.S. and Britain ratcheting upward, Gilberts forecast soothed panicky citizens who had been told that it typically takes years to develop a successful vaccine. The New York Times wrote that Oxford had leapt ahead of the competition and was “sprinting fastest” to the finish line. Within weeks, Oxford had partnered with British pharmaceutical giant AstraZeneca and the two were inking deals around the world to manufacture and distribute hundreds of millions of doses. The vaccine became one of the worlds best hopes: By late August, with Phase III trials to determine safety and efficacy ongoing, the world had ordered more of the Oxford candidate than any other, at least 2.94 billion doses.

Now, Gilberts and the worlds hopes are coming back down to earth, with the news that AstraZeneca paused Phase III trials after one participant in Britain showed symptoms consistent with transverse myelitis, a rare neurological disease caused by inflammation of the spinal cord. Obstacles like this one are not unexpected in vaccine development, say experts. The fact that AstraZeneca is pausing trials to investigate, they point out, is a good thing — a signal that that system is working as it should, that drug companies are taking safety seriously, that there are some scientific norms that politics hasnt trampled.

But the interruption is also a reminder that no amount of hype — from the endless media headlines, from politicians on Twitter, from the vaccine scientists themselves — is going to save the world from the deadliest pathogen in a century. This weeks news is a cautionary note for those who think a magic bullet might be around the corner — or who think that it might be worth slashing safety protocols to get one.

In fact, the Oxford/AstraZeneca groups self-assurance raised some eyebrows right from the start.

“I felt this way about a number of the companies,” says Paul Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia and co-creator of a rotavirus vaccine. “They would do small Phase I trials, basically dose-ranging trials, and then talk about how they could make tens of millions of doses.”

“How about a little humility?” he thought.

Gilberts prediction reflected more “pride than reality,” says Michael Kinch, director of the Centers for Research Innovation in Biotechnology and Drug Discovery at Washington University in St. Louis. “The reality is that developing a vaccine … is generally quite challenging. Oftentimes, you dont see the big problems coming.”

This week, that reality arrived for the Oxford vaccine. An independent committee must now determine whether the illness is directly linked to the vaccine or not — both possible outcomes. If the two are related, that will likely be the end of this vaccine. If not, the trial will likely resume after several weeks.

The hitch is also a reminder that a lot of COVID-19 science is uncharted territory. “We dont have much experience with these types of vaccines,” says Tom Frieden, former director of the Centers for Disease Control. Adenovirus vectored vaccines, like Oxfords, are relatively new, and mRNA vaccines — like those developed by Moderna and Pfizer — have never been used before in humans. The Trump administration is reportedly making plans to distribute the Moderna and Pfizer candidates, which are still in Phase III trials, in the U.S. by early November.

Kinch is worried that many countries are placing big bets on these newer vaccine technologies, while shunning old, established ones like inactivated virus vaccines, which China is pursuing. Thats one more reason to take safety with COVID-19 vaccines very, very seriously.

“Well designed and executed studies are so crucial,” he wrote in an email. “Autoimmune sensitives can be rare … and often take time (weeks or months) to develop.” Which means rushing a trial can be deadly. “A one in a thousand [reaction] sounds rare except when you scale those numbers up to 350 million Americans, or seven billion humans worldwide, the outcomes can be disastrous.”


Oxford was at the front of the pack from day one.

A few years ago, Gilbert, a top scientist at the universitys Jenner Institute, created a MERS vaccine by inserting genetic material of the MERS surface spike protein into a weakened chimpanzee adenovirus (a common cold virus). Once in the body, the adenovirus infects cells and unloads the gene, hopefully generating an immune response. The vaccine started trials in December in Saudi Arabia, where MERS is still a concern.

A month later, in January, when Gilbert heard about a mysterious, deadly pathogen raging through Wuhan, she was ready: Her team simply inserted genetic material from the spike protein of the SARS-CoV-2 virus inside the chimp adenovirus instead, theorizing that would confer immunity to the new virus.

“The MERS study was absolutely critical,” one of Gilberts vaccine colleagues told Bloomberg. “We could say, OK, we can start tomorrow.”

In the first test of the vaccine, scientists inoculated six monkeys before exposing them to a large dose of SARS-CoV-2. Adrian Hill, Gilberts colleague who leads the Jenner Institute, called the results “fantastic” — none of the vaccinated monkeys showed signs of sickness after being exposed. In April, around the time the monkey results came in, the Jenner team began planning to mass produce their vaccine. “The aim is to have at least a million doses by about September,” Hill said at the time, describing that number as a “fairly modest target.” The Trump administrations Operation Warp Speed announced a billion-dollar investment in May.

The results of a combined Phase I/II trial in July reported no serious safety issues and showed that the vaccine produced neutralizing antibodies in those tested — an outcome that was deemed “encouraging” and “promising.” “This is very positive news. A huge well done to our brilliant, world-leading scientists & researchers at @UniofOxford,” tweeted British Prime Minister Boris Johnson before adding “there are no guarantees.”

But the vaccine had its skeptics, too. Nasal swabs showed the monkeys from the first test still had the virus in their nose, meaning they might still be able to spread the virus to others, and their neutralizing antibody count was quite low. In a Forbes article, former Harvard Medical School professor and prominent cancer and HIV researcher William Haseltine argued the Jenner Institute didnt have the data to support their claim that their vaccine protected the monkeys. “Time will tell if [proceeding to human trials] is the best approach,” he wrote. “I wouldnt bet on it.” The Phase I/II trial, meanwhile, reported levels of neutralizing antibodies comparable to those seen in recovered COVID-19 patients, but lower than those generated by other vaccine candidates. And the scientists administering the trial only tested 35 participants for antibodies out of 543 who had received the vaccine.

It was too early, scientists cautioned, to know whether this vaccine, or any other, was effective or safe. Incremental and early trial data might bump up stock prices, or even land a government contract, but it cant predict the future.

The final determination would only come at the end of large Phase III trials, which AstraZeneca began in the U.S. in late August. (The company began smaller Phase II/III trial in Britain, Brazil and South African in July.) Today, there are nine other vaccines currently in the Phase III stage — with no definitive results yet. “Lets be clear: No one knows anything” about the specifics of the vaccine timeline right now, says Zeke Emanuel, former Obama adviser and chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania. “Were all bullshitting.”

That doesnt mean that governments shouldnt be dealing for doses or investing in vaccine projects — that is no doubt why the COVID-19 vaccine process is unfolding historically fast. But scientists have worried that all the vaccine hype could push politicians to cut off the normal scientific process too soon. While Anthony Fauci and other top U.S. government health officials insist the U.S. will not rush science, President Donald Trump continues to agitate scientists with his rosy vaccine predictions, now a keystone of his election campaign, that the U.S. will have a vaccine ready by Election Day; just last month the Financial Times reported the Trump administration was considering fast-tracking approval of the Oxford vaccine if results from a 10,000-person late-stage clinical trial looked promising, rather than waiting until the 30,000-person Phase III U.S. trial was complete. (AstraZenenca said it had not discussed this with the Trump administration.)

But the news of AstraZenecas pause seems to have relaxed scientists a bit, confirming that drug companies are proceeding with caution and not neglecting safety even as theyre under pressure from governments to produce. It even soothed some early skeptics of the Oxford teams bravado.

“This is a hopeful sign that the organizatiRead More – Source

Continue Reading


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.

Continue Reading




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.

Continue Reading


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.

This article is originally published on

Continue Reading


Copyright © 2020 ,