Indiana’s top doctors frustrated about the state’s COVID-19 vaccination rate – 953mnc.com

The states top doctors are frustrated because nearly half of the population who can get the vaccine have not done it. Now hospitals are having to put off some surgeries and procedures to take care of people who need hospitalization because of COVID-19.

Forty-eight percent of our eligible population remains unvaccinated, said Chief Medical Officer Dr. Lindsay Weaver, in an update from the state Dept. of Health, Friday. That statistic allows the virus to continue to thrive and puts those who cannot yet be vaccinated at greatest risk.

But, Weaver said there has been some improvement in the last week.

We have noticed an increase in Hoosiers scheduling their vaccine, she said. Weaver noted a ten percent increase in appointments.

Both Weaver and state Health Commissioner Dr. Kris Box said the state is having some trouble keeping up with the demand for testing. Box said that only ten percent of schools across the state reported being able to offer tests for students. The Dept. of Health is working to remedy that capacity issue.

Almost all of the new coronavirus activity is attributed to the Delta surge.

Weaver also said that guidance points to you getting a third dose of the vaccine, either Pfizer or Moderna, if you meet the following criteria: people undergoing treatment for cancer; recipients of solid organ or stem cell transplants; people with advanced or untreated HIV; and people who are taking certain medications that suppress the immune system.

Weaver also said you can expect information in the fall about a booster shot for anyone who has gotten the vaccine.

Both said the majority of people who have been hospitalized or who have died from COVID were not vaccinated.

Box said you are still going to be seeing large numbers of people testing positive for coronavirus for a while. She called this the darkest part of the pandemic.

Unfortunately we have many more weeks of this high level of activity before we can expect this Delta surge to start declining.

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Indiana's top doctors frustrated about the state's COVID-19 vaccination rate - 953mnc.com

OpRegen: tackling the leading cause of blindness with cell replacement – Clinical Trials Arena

Clinical Trials Arena speaks to Lineage Cell Therapeutics CEO Brian Culley about the firms lead candidate OpRegen for dry AMD and the unexpected cases of retinal restoration in an ongoing Phase I/IIa trial.

Age-related macular degeneration (AMD) is one of the worlds leading causes of blindness in people over the age of 50. There are two types of the disease wet AMD and dry AMD.

The less common wet AMD is well understood as being caused by leaky blood vessels and has numerous effective treatments available. Dry AMD causes layers of the macula (including the photoreceptors and the retinal pigment epithelium) to get progressively thinner and function less and less well. This is called atrophy.

Advanced cases of dry AMD are known as geographic atrophy (GA) because large sections of the retina stop functioning.

There are around two million people in the US suffering with this severe form of the condition, and there are currently no treatments available, representing a huge unmet need. Historically, dry AMD has been viewed as an inevitably progressive disease.

California-headquartered Lineage Cell Therapeutics is taking a very different approach to the disease compared to traditional pharmaceutical approaches, which often involve targeting inflammation with small molecules and antibodies and treating patients either orally or locally in the eye.

With its lead candidate OpRegen, which is in an ongoing Phase I/IIa open-label clinical study, Lineage is manufacturing brand new retina cells and taking a transplant approach to the condition.

Its been very exciting what we have seen in the clinic so far, the companys CEO Brian Culley tells Clinical Trials Arena.

The one-time therapy consists of allogeneic retinal pigment epithelium (RPE) cells and is administered subretinally in patients with dry AMD and GA. The patient is locally anaesthetised and the procedure only takes about 30 minutes.

The firm uses pluripotent stem cells as a starting material to manufacture the therapy. Just as flour can become bread or a cookie, [pluripotent] stem cells have within them the capability or the capacity to become any of the 200 cell types in your body, says Culley.

We instruct the cells to become a specific and exclusive type of cell and then we transplant those into the body. In the case of dry AMD we manufacture enormous numbers of retina cells and only retina cells, and then we transplant those cells to treat disease of the eye.

The manufacture of cells requires exquisite control over your process as you are manufacturing a dynamic living entity at scale, Culley says. If you cannot manufacture at large scale, you will never have an economically affordable solution.

The allogeneic rather than autologous nature of Lineages manufactured retinal cells provides advantages in scale, he argues.

There are approaches that people take even in dry AMD where they take cells from a persons eye, and they manipulate them and then they replace them, but here youre talking about personalised medicine, which sounds great until you consider the cost.

Weve invested significantly in our manufacturing skills and created a huge number of patents from our manufacturing techniques. We are already at the point where, in a three-litre bioreactor, we can manufacture the equivalent of 2500 clinical courses so many thousands of treatments can come from basically a milk jug and scaling up is straightforward because we grow the cells on little microcarriers. We grow the cells in three-dimensional space and that allows us to increase the volume because the cell doesnt really know the difference between growing in a tiny thimble or growing in a swimming pool.

Cell therapy brings with it the complexity of dealing with a whole cell rather than just a single molecule, but that complexity is also the key to this approach.

By the time retina cells are dying off, there are so many things going wrong in the eye that we dont think that a single molecule is going to have enough horsepower to be able to drive a clinical outcome, Culley says. So we think you have to replace the entire cell.

The ongoing Phase I/IIa clinical trial evaluating OpRegen enrolled 24 people. Twelve of the participants treated with the therapy had very advanced AMD and were legally blind.

Culley says this cohort was used to assess the treatments safety and not much was seen in terms of efficacy but some encouraging anatomical changes were observed.

In the eye, the vision cycles metabolic activity leads to a waste material called drusen, which is cleared by healthy retina cells. In some of these patients, a reduction in drusen was observed.

The next group of 12 patients disease was far less advanced and they had far better baseline vision than the first; some even still had their drivers licenses. At their earlier stage of disease, they had more retinal tissue with potential to be rescuable. When the trial moved into the group of patients with better starting vision, Culley and his team started to see very exciting effects in terms of visual acuity and anatomical changes.

We were really happy to see that in that group of individuals, weve had better results, Culley says. We have seen an increase in vision, so people are seeing more letters on an eye chart, compared to their untreated eye. The majority of untreated eyes have gotten worse, which is what you would expect over time. In the treated eye it is reversed; weve actually seen people gain vision.

No patients in the trial, which started treating patients with OpRegen five years ago, have rejected the cells, meaning all have stably integrated them. Most exciting of all are three cases of retinal restoration, which Culley says is really unprecedented stuff due to the progressive nature of the disease.

This is a new phenomenon, says Culley. Human beings cannot regenerate retinal tissue; when you lose retina cells, theyre gone forever. And thats what this disease is all about losing retina cells.

Over a year ago, while looking at images of a patients eyes after OpRegen treatment, doctors noticed retina cells growing back around the spot of GA.

We were absolutely blown away, Culley says. We actually sat on this initial finding for quite some time, because even though it was incredible, and exciting and maybe even predictable in some ways youre transplanting cells and if theyre taken up, survive and are functional why wouldnt this happen but nobody thought it was possible.

The question the firm focused on while analysing the data and sending it out to third-party independent retinal imaging experts was simple why did this patient experience retinal tissue regeneration while no one else did?

We think the answer was that patient got a very complete delivery of our cells all across that atrophic area, explains Culley.

Lineage repeated the procedure and got similarly extensive coverage across another two patients, and they also exhibited retinal restoration. So we now have three cases that have exhibited retinal restoration. Now its not a one-time thing we have some understanding, we could reproduce it, its quite clear.

One of the trial participants atrophy originally got smaller but now has grown back to the size it was three years ago meaning that essentially her AMD had been halted.

In the three years since I had the operation, the eye that was operated on has not deteriorated which I reckon is almost miraculous, said the patient, Sonia Cohen. Its really amazing. I cant imagine what my life would have been like if I had continued to deteriorate.

Culley says that with OpRegens clinical research thus far, his team has learned that being more aggressive with where they place the cells leads to better outcomes.

Now we know that so we can repeat that. I think over time, it will get better and better, and Id be really delighted if we get up to the point where it becomes like LASIK surgery, which is close to 100% success rate.

Later this year, Lineage is planning to discuss the design of its next trial with the US Food and Drug Administration. For now, the three cases of retinal restoration or reversal of AMD have provided a vital proof of concept.

We want to go as quickly as possible into the next study, and having the backing of this reversal is very exciting because, from a statistical perspective, we probably dont need 2,000 patients were talking about hundreds of patients.

On the future of cell therapy, Culley says it is a field that is quickly maturing. It used to be like the wild west but now companies like ours are doing these rigorous clinical trials to find out ways to control it and dry AMD is a really cool place to start, he says. But, there are 199 other cell types that we could investigate so there is a long-term medical story here that is really about ushering in a new branch of medicine manufacturing cells, transplanting them that Im really excited to be part of.

Dry AMD is not the firms only focus; it has also embarked on clinical trials for VAC2, an allogeneic dendritic cell therapy currently enrolling a Phase I trial for the treatment of non-small cell lung cancer and has treated 25 people with spinal cord injuries with its candidate OPC1 in a Phase I/II trial, which Culley says has been very emotional.

I know if I live long enough my retina cells are going to die off; if I smoke four packs of cigarettes [a day] I will get lung cancer, but nobody expects to get a spinal cord injury. All of these young people who fall off mountain bikes or get in car crashes and their lives are turned upside down. Their ability to just get some hand control to be able to move their wheelchair thats mobility and independence so if we can help regain mobility, thats freedom so I think the spinal cord program is really powerful.

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OpRegen: tackling the leading cause of blindness with cell replacement - Clinical Trials Arena

Should You Get a COVID Booster Shot? Our Doctor Explains – Articles and Videos, COVID-19, Featured, Health Topics – Hackensack Meridian Health

August 24, 2021

COVID-19 booster shots are now being offered.

The U.S. Food & Drug Administration (FDA) has authorized the use of an additional dose of mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna) for those who are moderately to severely immunocompromised, and health officials intend to make them available to the general public starting the week of September 20, pending FDA and CDC review. Plans for additional doses of the Johnson & Johnson (J&J) shot are forthcoming, once more data is collected and analyzed.

We connected with Hackensack Meridian Healths chief physician executive, Daniel Varga, M.D., to talk through why we need booster shots now and what you should know.

An immunocompromised person has a weakened immune system. Your immune system is a combination of your cells, organs and proteins that work in tandem to protect your body from unwelcome intruders like viruses, bacteria, parasites and toxins.

If your immune system is compromised, it can impact your ability to fight off infections and disease, including COVID-19.

The COVID-19 vaccines utilize our immune system to fight off the virus the vaccine provides your body with the instructions on how to recognize and destroy COVID-19 to prevent it from multiplying. For immunodeficient patients, you may not have as strong of a response to the vaccine as someone without deficiencies, thus the need for a boost.

For the general public, it is currently unknown how long immune protection lasts from the vaccines. Developed antibodies may decrease over time, weakening your protection against COVID and emerging variants; a booster shot will help reinvigorate that protection.

Its important to note, data collected has shown that protection against infection may decrease over time, however the vaccine remains very effective in preventing hospitalizations and death. As time passes, you may be more susceptible to catching COVID-19, but if youre vaccinated your symptoms are expected to be less severe.

This is not the first vaccine that requires a booster for example, every year there is a new flu vaccine, and its recommended to get a tetanus, diphtheria and pertussis (Tdap) booster every 10 years.

No. The COVID-19 vaccine is effective and advisable. The vaccine is proven to protect people from getting severly ill, being hospitalized or dying from COVID.

For the immunocompromised, a COVID-19 booster will increase your immunity if your immune system did not respond as strongly to the first or second dose. For the general public, a booster would help you stay protected as your immunity wanes over time.

The FDA has authorized a third dose of the COVID-19 vaccine to certain immunocompromised populations, specifically people who have:

As of right now, only those who are immunocompromised are able to get a booster shot of the COVID-19 vaccine.

The FDA and CDCs recommendation for the immunocompromised is that the booster be given at least 28 days after the second dose of the Pfizer or Moderna vaccine. There is no current recommendation for those who received the J&J vaccine.

Pending approval from the FDA and CDC, booster shots are slated to become available to the general public (to those who are 18 and older) the week of September 20. It is advised that all who received the Pfizer or Moderna vaccines should receive a booster eight months after they receive their second shot.

The duration of a vaccines effectiveness depends on the vaccine and an individuals immune response. Researchers are continually monitoring the immunity in those who have received the COVID-19 vaccines.

All three companies, Pfizer, Moderna and J&J are investigating the use of boosters.

For those eligible, the CDC recommends that if you received the Pfizer or Moderna vaccine, that you should receive a booster of the same vaccine. You should not receive more than three doses. If the mRNA vaccine given in the first two doses is unknown or unavailable, you can receive either brand.

For the immunocompromised who received the J&J vaccine, the CDC notes there is not enough data at this time to determine if a third dose would improve your immune response.

The material provided through HealthU is intended to be used as general information only and should not replace the advice of your physician. Always consult your physician for individual care.

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Should You Get a COVID Booster Shot? Our Doctor Explains - Articles and Videos, COVID-19, Featured, Health Topics - Hackensack Meridian Health

I blamed stress for my three-month period but it turned out to be much more sinister… – The Sun

A WOMAN blamed stress for her three-month long period until doctors found out the true cause was devastating.

Bansri Dhokia, 30, from Ealing, West London, is now urging others to see their GP as soon as they are unwell.

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She thought at worst, her odd periods, fatigue and breathlessness would be down to anaemia or low thyroid function that could be treated with medication.

But the truth was far worse, and Bansri was diagnosed with a blood cancer.

Bansri was taken into hospital that night where she stayed for 12 weeks having intense treatment to save her life.

Speaking of her symptoms, which started in May 2020, Bansri said: I blamed it on being overworked.

With blood cancer, the symptoms are often quite vague and hard to diagnose.

I really noticed the fatigue first. I could sleep for 12 hours a night and still feel exhausted.

Then I started to get breathless all the time. There were activities like climbing stairs or walking down the road that I used to find easy but was suddenly finding more difficult.

Bansris heavy period, which had been ongoing for three months, was particularly unusual for her.

She made repeated trips to the doctor to find out what was wrong but kept being pushed back.

I just knew something wasn't right and repeatedly asked for blood tests, Banrsri said.

The first four blood tests between May and July came back clear and by the time she had a fifth on 21 July, she was starting to get fed up.

Busy with work, Bansri almost missed the appointment but luckily, her husband Amrit Sagoo encouraged her to go.

She said: I went for the blood test in the afternoon and that evening, I was brushing my teeth when I got a call to say the ambulance was coming to collect me.

They explained I needed to go to hospital right away. I thought it was just for a night and packed an overnight bag.

"I didnt know what was wrong and that I would end up staying in hospital for 12 weeks.

Tests at the Royal London hospital revealed Bansri had acute lymphoblastic leukaemia (ALL), a rare cancer affecting just 790 people in the UK each year, mostly children and young people.

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A problem in the bone marrow leads to insufficient important blood cells, causing symptoms of unusual bleeding, tiredness and muscle aches.

Almost seven in 10 will survive ALL for five years or longer after diagnosis, and four in ten in those aged 25 to 64.

Bansri said: I didn't know much about leukaemia. I was really scared for my life. I had no idea what the prognosis was. I just cried and I kept questioning why this was happening to me."

With lockdown restrictions still in place, Bansri had to tell her friends and family about her diagnosis over Zoom.

She said: It was the hardest thing I have ever had to do. I asked my sister to gather my family in the living room. We are very close and I could not look at her because I just couldn't deal with seeing the sadness in her face."

Bansri started chemotherapy straight away, because ALL is very aggressive and develops quickly.

She said: "It was so upsetting seeing pieces of my hair fall out on my pillow. I was growing it as we were planning to have Hindu and Sikh religious wedding ceremonies in 2020, after our civil wedding the year before.

"One day I just asked the nurse to shave my head, and in that moment, I felt really empowered."

But one of the hardest parts of the treatment - which she now needs therapy to recover from - is that she couldnt have visitors for the first eight weeks due to Covid.

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Bansri then needed a stem cell transplant to improve the chances that she would go into remission.

During the procedure, the patient has stem cells of a donor, sometimes a complete stranger, injected into their blood. The cells find their way to the bone marrow, helping it to start making normal cells again.

Most people who are white Europeans find a match from a related or unrelated donor on a large registry, but 400 UK patients don't find a suitable donor each year.

Bansri said: I knew immediately that being from an Indian background, there was a very low chance that I would find a match.

According to charities, donors are more likely to be white, and people from minority ethnic backgrounds are more likely to have rarer tissue types, making it harder to find patients from these backgrounds a matching donor.

That was quite scary because I knew how important it was to have a donor to save my life, Bansri said.

Luckily one of Bansris two siblings was a match, and the transplant took place in February 2021.

Bansri said: My recovery is going well so far but a stem cell transplant comes with many side effects, which are lifelong.

I have a long road to go but I take it day by day. Each month I get through is a success."

Bansri is vulnerable to infections because the transplant made her immune system weaker, and so she and her husband are still having to shield.

Bansri is urging people to join the stem cell donor register, particularly those in Asian communities.

REGISTERING to be a blood stem cell donor is easy.

Even if you can't donate to your relative, you might be ableto become a donor for someone else. You can do this by contacting one of the UK registers.

There are different donor registersin the UK.These work with each otherand with international registersto match donors with people who need stem cells.

You can sign up with:

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She said: People often have a misconception that, when you join the donor registry, you're giving something up, for example, in a kidney transplant, you do give up your kidney, and it's a longer recovery time.

My sibling was in hospital for a few hours on the day and didn't have any side effects afterwards.

In my community, cancer is a bit of a taboo subject and people dont speak about it so I think there is a lack of awareness of the importance of signing up to be on the register.

Bansri is also taking part in the Leukaemia Cares Spot Leukaemia campaign, which urges the general public to understand and recognise the signs.

She said: I want to see more Asian people talking about it because its not the fault of the person - its just bad luck.

If youre experiencing any of the symptoms, contact your GP and ask for a blood test. Early diagnosis saves lives.

The NHS says most of the symptoms of ALL are caused by a lack of healthy blood cells. They include:

In some cases, the affected cells can spread from your bloodstream into your central nervous system. This can cause neurological symptoms (related to the brain and nervous system), including:

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I blamed stress for my three-month period but it turned out to be much more sinister... - The Sun

New fault lines emerge in Car-T therapy – Vantage

For Car-T therapy to become anything other than a niche hospital procedure it has to move into early treatment lines. Novartiss Kymriah seems unlikely to secure such an accolade, however, having today failed to beat autologous stem cell transplantation in a second-line lymphoma study.

For the Swiss group this is especially galling as Kymriahs two big competitors, Bristol Myers Squibbs Breyanzi and Gileads Yescarta, have just succeeded in similar trials. Still, it will be important to bear in mind trial design differences, though one take is that important fault lines are emerging between CD19-directed Car-T therapies.

On a cross-study basis this was already becoming apparent in these treatments approved salvage uses in second-line or later lymphoma, where for instance Yescarta and Breyanzi boast overall remission rates above 70% while Kymriahs is 50%, according to US prescribing information.

Second line

Now the battle lines move to second-line lymphoma, an important setting where patients have relapsed after or are refractory to front-line Rituxan plus chemo.

Belinda, the trial Novartis today said had failed, compared giving these patients Kymriah head to head against the standard of care of chemo followed, in responders, by autologous transplant. Novartis said Belindas primary endpoint, event-free survival (EFS), failed to show a benefit for Kymriah.

An important point is that Belinda allowed the option of platinum-based immunochemotherapy before dosing Kymriah or the standard of care, a fact that might have rendered any subsequent benefit statistically insignificant.

Bristols corresponding Transform and Gileads Zuma-7 studies had similar designs and also tested EFS as primary endpoint, though they did not have the immunochemotherapy option. On June 10 Bristol said Breyanzi had beaten chemo plus transplant in terms of EFS, as well as in terms of complete response rates.

Two weeks later Yescarta scored in Zuma-7, with Gilead quantifying the EFS benefit versus chemo and transplant as a 60% reduction in event risk (p<0.0001). There was also a benefit in overall remission rate; overall survival was insufficiently maturefor Transform and Zuma-7 alike.

Note: *all 2nd line after Rituxan + chemo, compared against standard of care/autologous transplant in responders; **included the option of platinum immunochemotherapy before Kymriah or SoC. BCL=B-cell lymphoma; DLBCL=diffuse large B-cell lymphoma. Source: company statements.

Next it will be time to pick apart the data, with a clear focus falling on the possible effect of Belinda's addition of platinum immunochemotherapy.

In terms of disease criteria, Zuma-7 enrolled only diffuse large B-cell lymphoma patients, while Transform and Belinda both specified aggressive B-cell lymphoma but allowed subjects with grade 3B follicular lymphoma, a less aggressive type.

The precise balance of baseline characteristics will be scrutinised to see whether the studies offer an apples-to-apples comparison. A similar thing goes for subsequent therapy. How many patients in each studys control cohorts went on to receive Car-T, and did this influence outcomes? How durable are responses and what will the gold standard of median overall survival tell us once it is reached?

Some answers should be forthcoming when full data from these recent interim analyses are presented, perhaps at Decembers Ash meeting. In the meantime doctors and analysts alike will digest the emerging data suggesting that Kymriah, the first Car-T therapy to make it to market, might not be the best.

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New fault lines emerge in Car-T therapy - Vantage