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COVID Vaccine Update as Johnson & Johnson Trial Suffers Setback, Sanofi Aims for Mid-2021 Rollout

There are currently nearly 200 potential COVID-19 vaccine candidates in development, including 42 under clinical evaluation and 151 under pre-clinical evaluation, according to a report by the World Health Organization published on October 2.



a person wearing a costume: A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi's laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.


© Joel Saget/AFP via Getty Images
A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi’s laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.

On Monday, U.S.-based Johnson & Johnson announced a pause on all of its COVID-19 vaccine candidate clinical trials due to an “unexplained illness” in one of its study participants.

French pharmaceutical company Sanofi is hoping to have its vaccine candidate rolled out by mid-next year, according to Olivier Bogillot, its chief executive officer.

“We are in a very concrete environment at the regulatory level. We ourselves have signed a charter with various laboratories so as not to compromise on the safety of the vaccine. If the vaccine is effective and it is safe, yes, the next year, in mid-year, the French will be able to be vaccinated,” Bogillot said Tuesday.

Last week, U.S. Secretary of Health and Human Services Alex Azar said: “Pending FDA [Food and Drug Administration] authorizations, we believe we may have up to 100 million doses by the end of the year—enough to cover especially vulnerable populations—and we project having enough for every American who wants a vaccine by March to April 2021.”

The First Phase 3 Clinical Trial Of A Coronavirus Vaccine In The US Has Begun

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Here we take a closer look at some of the latest COVID-19 vaccine developments.

France

Last month, Sanofi and U.K.-based GlaxoSmithKline (GSK) announced they has begun a clinical trial of their COVID-19 vaccine candidate, aiming to reach a phase-three trial by December.

“The companies initiated a Phase 1/2 study on September 3 with a total of 440 subjects being enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year,” Sanofi confirmed in a statement last month.

“If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant respectively with the target of producing up to one billion doses in total per year, globally.”

U.S.

Johnson & Johnson

Johnson & Johnson, whose vaccine candidate JNJ-78436735 is being developed by Belgium’s Janssen Pharmaceutical Companies, announced: “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.

“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.

“Adverse events—illnesses, accidents, etc.—even those that are

The Wanted’s Tom Parker aims to raise awareness following diagnosis

Tom Parker has been diagnosed with an inoperable brain tumour, pictured in May 2013. (Getty Images)
Tom Parker has been diagnosed with an inoperable brain tumour, pictured in May 2013. (Getty Images)

The Wanted’s Tom Parker has been diagnosed with an inoperable brain tumour.

The boy band singer, 32, said he was “still in shock” after being told six weeks ago that he had a type of tumour called a stage 4 glioblastoma

He received the diagnosis shortly before he is due to become a dad for the second time.

“There’s no easy way to say this but I’ve sadly been diagnosed with a Brain Tumour and I’m already undergoing treatment,” he wrote on Instagram, alongside a picture of himself and his wife, Kelsey Hardwick and their 16-month-old daughter, Aurelia.

Parker went on to say he hopes to remain positive, despite being told the cancer diagnosis is terminal.

“We are all absolutely devastated but we are gonna fight this all the way,” his post continues. “We don’t want your sadness, we just want love and positivity and together we will raise awareness of this terrible disease and look for all available treatment options.

“It’s gonna be a tough battle but with everyone’s love and support we are going to beat this.”

Read more: Brain cancer patient, 32, given six weeks to live ‘still fighting’ two years later

In an interview with OK! magazine, Parker revealed he suffered a seizure in July and was put on a waiting list for an MRI scan.

Six weeks later he had another, more serious seizure during a family trip to Norwich and was rushed to hospital.

After three days of tests, he was given the diagnosis that he was suffering from grade four glioblastoma.

What are the symptoms of a brain tumour?

The symptoms of a brain tumour will depend upon which part of the brain is affected, according to Brain Tumour Research.

The most common symptoms are caused by an increase in pressure in the skull caused by the growth of a tumour in the brain.

Other common symptoms, which may initially come and go, can include one or more of the following:

  • Headaches

  • Eye and vision-related problems (such as squinting and double-vision)

  • Continuing nausea, vomiting 

  • Extreme or sudden drowsiness

  • Tinnitus (ringing in the ears) or hearing loss 

  • Unexplained twitches of the face or limbs

  • Seizures (fits or faints)

  • Appearing to be lost in a deep daydream for a short while

  • Confusion

  • Loss of balance

  • Numbness or weakness in the arms or legs, especially if progressive and leading to paralysis

  • Numbness or weakness in a part of the face, so that the muscles drop slightly

  • Numbness or weakness on one side of the body, resulting in stumbling or lack of co-ordination

  • Changes in personality or behaviour

  • Impaired memory or mental ability, which may be very subtle to begin with

  • Changes in senses, including smell

  • Problems with speech, writing or drawing

  • Loss of concentration or difficulty in concentrating

  • Changes in sleep patterns

Read more: Sarah Harding is undergoing treatment for breast cancer

“Depending on which part of the

COVID-19 Complications: Registry Aims to Track Virus Impact on Heart | U.S. News Hospital Heroes

The intensive care unit remained fully operational, primarily to treat patients with the new virus, as well as those who needed emergent care. But that meant clinicians like Dr. James de Lemos, cardiologist, didn’t have much to do, since many of the non-COVID-19 procedures he performed, like echocardiograms and surgeries to put in heart stents, were postponed or canceled.

De Lemos and many of his colleagues were frustrated; they wanted to help fight the COVID-19 pandemic, but felt sidelined. “We sort of felt powerless, working a lot from home during this terrible public health challenge,” de Lemos says.

Determined to take on the COVID crisis in some way, de Lemos, his colleagues and the cardiovascular fellows they work with brainstormed a way to join the battle: They launched a registry to collect comprehensive data on COVID-19 patients in the Dallas area. The registry also includes detailed information on how the virus attacks the heart of some patients.

UT Southwestern is a teaching hospital. De Lemos is a professor of medicine in the hospital’s cardiology division. He’s also a former director of the hospital’s cardiovascular fellowship program, and remains involved in the initiative.

The purpose of the registry is to help clinicians determine which therapies are most effective in treating COVID-19, based on the collected data. In November, de Lemos and his colleagues are scheduled to present some of their findings at a virtual meeting of the American Heart Association. The research is on race and ethnic differences in COVID-19 presentation and the impact of obesity in the severity of the illness. The findings of the studies are embargoed until then.

Within a few weeks of launching the local effort, de Lemos and his colleague, Dr. Sandeep Das, pitched the AHA on the idea of expanding the registry, taking it nationwide. The AHA quickly agreed. To date, de Lemos and his colleagues have collected data on about 15,000 COVID-19 patients from more than 100 hospitals in 35 states.

Texas is one of the states that’s been hit the hardest by the pandemic. As of Oct. 1, it had recorded more than 700,000 novel coronavirus cases, second only to California.

A registry is an observational study that tracks patients with a particular condition and collects detailed information about who they are – their age, gender, race and ethnic background – and how they respond to different treatments. De Lemos and his colleagues collect these data points – which have been de-identified so patients can remain anonymous – from participating hospitals. Patients do not have to opt in to participate in the research, and are not asked to.

Creating a registry is particularly important when clinicians are seeking to develop therapies to treat a new illness, like COVID-19, de Lemos says. Researchers use detailed hospital records to learn how patients responded to different treatments.

In the early days of the pandemic, it was widely believed that COVID-19 was a disease of the lungs; the vast majority of

Trump, moving to show strength, aims for Monday release

BETHESDA, Md. (AP) — President Donald Trump was hoping for a Monday discharge from the military hospital where he is being treated for COVID-19, a day after he briefly ventured out while contagious to salute cheering supporters by motorcade in a move that disregarded precautions meant to contain the deadly virus that has killed more than 209,000 Americans.

White House officials said Trump was anxious to be released after three nights at Walter Reed National Military Medical Center, where doctors revealed on Sunday that his blood oxygen level dropped suddenly twice in recent days and that they gave him a steroid typically only recommended for the very sick. Still, the doctors said Trump’s health is improving and volunteered that he could be discharged as early as Monday to continue the remainder of his treatment at the White House.

“This is an important day as the president continues to improve and is ready to get back to a normal work schedule,” White House chief of staff Mark Meadows told Fox News on Monday. He said the determination on whether Trump would leave the hospital won’t be made until later in the day after the president is evaluated by his medical team, but that Trump was “optimistic” he could be released Monday.

Less than one month until Election Day, Trump was eager to project strength despite his illness. The still-infectious president surprised supporters who had gathered outside the hospital, driving by in a black SUV with the windows rolled up. Secret Service agents inside the vehicle could be seen in masks and other protective gear.

The move capped a weekend of contradictions that fueled confusion about Trump’s health, which has imperiled the leadership of the U.S. government and upended the final stages of the presidential campaign. While Trump’s physician offered a rosy prognosis on his condition, his briefings lacked basic information, including the findings of lung scans, or were quickly muddled by more serious assessments of the president’s health by other officials.


In a short video released by the White House on Sunday, Trump insisted he understood the gravity of the moment. But his actions moments later, by leaving the hospital and sitting inside the SUV with others, suggested otherwise.

“This is insanity,” Dr. James P. Phillips, an attending physician at Walter Reed who is a critic of Trump and his handling of the pandemic. “Every single person in the vehicle during that completely unnecessary presidential ‘drive-by’ just now has to be quarantined for 14 days. They might get sick. They may die.”

White House spokesman Judd Deere said Trump’s trip outside the hospital “was cleared by the medical team as safe to do.” He added that precautions were taken, including using personal protective equipment, to protect Trump as well as White House officials and Secret Service agents.

Joe Biden’s campaign, meanwhile, said the Democratic presidential nominee again tested negative for coronavirus Sunday. The results come five days after Biden spent more than 90 minutes on the debate stage with Trump. Biden,