4,400 Modern Doses of Vaccine Not Kept Cool

4,400 Modern Doses of Vaccine Not Kept Cool Enough Might be Unusable. Maine health officials noticed that during transport, several Moderna vaccine shipments were not kept sufficiently cool. According to the CDC, Moderna’s vaccine vials must stay at freezing temperatures between -25°C and -15°C. Whether the doses of the vaccine would have to be tossed away or even be used is uncertain. The vaccine was shipped from the manufacturer’s processing plant in Massachusetts to 50 locations throughout the state, health officials said. Processes are to guarantee that the doses are held cool, the U.S. Centers for Disease Control and Prevention reports.

Resource
4,400 Moderna Vaccine Doses Not Kept Cold Enough May Be Unusable. https://www.npr.org/2021/01/19/958539556/4-400-moderna-vaccine-doses-not-kept-cold-enough-may-be-unusable

One week after obtaining a federal green light from Pfizer and BioNTech’s COVID-19 vaccine

On Friday, only one week after obtaining a federal green light from Pfizer and BioNTech’s COVID-19 vaccine, the Food and Drug Administration officially approved a second emergency vaccine—this one produced by Moderna. The vaccine produced by Moderna, whose headquarters in Cambridge, Mass., has been given an immediate usage permit by federal regulators. The vaccine produced by Moderna, whose headquarters in Cambridge, Mass., has been given an immediate usage permit by federal regulators. FDA Authorizes Moderna COVID-19 Vaccine For Emergency Use: Coronavirus Changes Food and Drug Administration greenlights the U.S. biomedical firm’s emergency vaccine. The step bolsters a massive inoculation campaign already underway.With last week’s Pfizer vaccine permit, health and defense authorities have undertaken a vast campaign to deliver millions of doses throughout the world. Amid the flurry accompanying the rollout of the Pfizer vaccine, Moderna’s alternative made steady headway in its drive toward a permission.

Reference
Moderna’s COVID-19 Vaccine Becomes 2nd To Earn FDA Authorization.https://www.npr.org/sections/coronavirus-live-updates/2020/12/18/947948227/modernas-covid-19-vaccine-becomes-2nd-to-earn-fda-authorization?refresh=true

Pfizer will only be able to deliver 2.9 million doses in the first few days

It is expected that Pfizer will only be able to deliver 2.9 million doses in the first few days and only up to 6.4 million doses by 19 December, according to Operation Warp Speed, the government’s vaccine effort.

“As part of the discussion on who should qualify for phase 1b access to the vaccine, ACIP has so far discussed individuals with high-risk medical conditions such as cancer, chronic kidney disease, chronic obstructive pulmonary disease (COPD), immunocompromised organ transplant status, obesity, severe heart disease, sickle cell disease, and type 2 diabetes,” said the Muscular Dystrophy Association.

For example, last month, the head of the Hawaii Healthcare Association told CNN that not a single hospital in Hawaii had a freezer that could remain cold enough to store Pfizer’s coronavirus vaccine and that the state may not have enough access to dry ice to make proper use of the company’s distribution boxes.

They resolve quickly, but CDC and other officials are worried that they might scare some people away from getting a second dose of vaccine and are preparing educational materials to let people know the symptoms are a sign that the vaccine is working to reactivate the body’s immune response and is harmless.

Vaccine counselors have already broken down priority groups into subgroups, and only the first people to receive vaccines have been identified.

Operation Warp Speed Chief Counselor Moncef Slaoui has projected that Pfizer and Moderna can make and deliver between 60 million and 70 million vaccines in January and hopes that two other vaccine makers, AstraZeneca, and Johnson & Johnson, will join the vaccine mix in the coming months.

Moderna and Pfizer each claim that they can take up to a billion doses by the end of 2021, but Moderna say that it could be half that—a product that has never been sold before—and Pfizer has already severely adjusted its timeline for delivery of vaccines after unspecified manufacturing problems.

Slaoui said that up to 15% of Pfizer and Moderna vaccine participants had quite noticeable side effects,” including nausea, body aches, headaches, and chills.

Pfizer’s vaccine had its first scare in the US with a health worker in Juneau, Alaska, suffering from an allergic reaction.

“Around one in every million people who get a vaccine can have a severe allergic reaction to the vaccine,” Dr.

And what about the essential workers? ACIP’s expert bodies, including Johns Hopkins University and the National Academies of Science, Engineering, and Medicine, suggest it will be prudent to vaccinate those who work in food processing, emergency responders, and service workers before the general public.

The US Food and Drug Administration granted emergency use authorization for Pfizer and BioNTech’s vaccine on Friday, and it is widely expected that EUA will give a similar vaccine to Moderna next week.

Reference

Trump says he is ‘not scheduled’ to take Covid-19 vaccine …. https://www.rt.com/usa/509567-trump-white-house-vaccine-later/

Public health authorities and drug manufacturers need to be open regarding the side effects of coronavirus vaccine

Public health authorities and drug manufacturers need to be open regarding the side effects of coronavirus vaccines, doctors say. Doctors met with CDC advisers as states plan to administer doses as early as next month. Both Pfizer and Moderna vaccines need two doses at different intervals. Participants in the trials registered high fever, body aches, extreme headaches, day-long fatigue after the shots. “We need to make patients aware that this will not be a walk in the park,” says Dr. Sandra Fryhofer. Nurse practitioners recommend that drug manufacturers should use terms such as “response” instead of “adverse reaction” to explain side effects. “If this proves to work, people are going to toughen up,” says the nurse practitioner.

“These are immune responses,” says Stinchfield, a former member of the committee who voted. “If you feel something after vaccination, expect to feel that” Pfizer and its partner BioNTech applied for an emergency license for their coronavirus vac.

Reference

Doctors say CDC should warn people the side effects from Covid vaccine shots won’t be ‘a walk in the park’. https://www.cnbc.com/2020/11/23/covid-vaccine-cdc-should-warn-people-the-side-effects-from-shots-wont-be-walk-in-the-park-.html

Interleukin-1 has been involved as a mediator of chronic pericarditis

Interleukin-1 has been involved as a mediator of chronic pericarditis. A phase 3 trial of rilonacept was performed in patients with acute symptoms and systemic inflammation. During the run-in period, the median time for pain resolution or near-resolution was 5 days, and the median time for normalization of CRP was 7 days. Injection site reactions and upper respiratory tract infections were the most common adverse events. Among patients with chronic periecarditis, treatment resulted in rapid resolution and a slightly lower risk of recurrence than placebo. The most common side effects were injection site reactions and upper respiratory tract infections.

Reference

Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis. https://www.nejm.org/doi/full/10.1056/NEJMoa2027892

Regeneron Pharmaceuticals has paused critically ill COVID-19 patients’ enrollment

Regeneron Pharmaceuticals has paused critically ill COVID-19 patients’ enrollment with its trial studying the antibody cocktail treatment, which was fond of President Trump earlier this month. The choice is because of potential safety concerns.
The drugmaker on Friday said it was suspending the enrollment of hospitalized #COVID-19 patients requiring high-flow oxygen or mechanical ventilation after an unbiased monitoring committee observed “a potential safety signal and an unfavorable risk/benefit profile at the moment.”

The enrollment of individuals in this category should be on hold, pending the collection and evaluation of additional data.

Trials continue to test the antibody cocktail in hospitalized patients necessitating little if any extra oxygen. Other trials involving mild or moderately ill patients also can move ahead.

The drug has revealed encouraging outcomes. Regeneron on Wednesday said early data confirmed the therapy lowered COVID-19 related medical visits by 57 percent.

Regeneron earlier this month asked the foodstuff and Drug Administration for emergency approval and said it could make doses accessible to the American people free of charge. The drugmaker said it might have sufficient doses for 300,000 people when looking at the coming months.

Reference

Regeneron stops enrolling critically ill COVID-19 patients …. https://news.immitate.com/2020/10/30/regeneron-stops-enrolling-critically-ill-covid-19-patients-for-antibody-drug-trial-thehill-the-hill/.

It is a mystery that increased dementia risk linked to drugs commonly used to treat intestinal, respiratory and mood disorders

Anticholinergic drugs are utilized to produce a panoply of factors—for depression and psychosis, bladder and gastrointestinal conditions, allergies and symptoms of Parkinson’s disease.


Yet, within the study published Monday in Journal of the American Medical Association’s Internal Medicine, patients over age 55 who used strong anticholinergic medication daily for more than four years had a 50 percent increased danger of developing dementia.

“This research provides further evidence that doctor should be cautious when prescribing particular drugs that have anticholinergic properties,” Tom Dening, perhaps one of the authors and head of one’s Center for Dementia for the University of Nottingham, said within a press release. “However, it’s important that individuals taking medications along these lines just not only stop them unexpectedly as this can be a great deal more harmful. If patients have concerns, they would have to discuss them along with their doctor to think about what you should know about the treatment they are actually receiving.”

Researchers assessed medical data on nearly 59,000 people with dementia, which they collected between January 2004 and January 2016. Of given records they analyzed, the average age of patients was 82 and about 63 percent of them were women.

Approximately 57 percent considering the patients in the study received a prescription for a minimum of at least one strong anticholinergic drug, one to 11 years before being diagnosed with dementia. Though the link found between the drugs and creating of dementia appears strong, the scientists noted that their findings are associations and do not demonstrate that drugs cause dementia.

Doctors prescribe anticholinergic drugs as a treatment for conditions like chronic obstructive pulmonary disease, bladder conditions, allergies, gastrointestinal disorders and warning signs of Parkinson’s disease.

The investigation was mighty at some limitations—for example, some patients will possibly not have obtained their drugs as directed, so anticholinergic exposure levels could have been misclassified.
“Further research is essential to make sure that regardless of the association between these drugs and the chance of dementia is causal. These drugs are prescribed for a range of medical conditions and all of the concerns patients might have to stop them appearing should be discussed using their doctors,” Professor Martin Rossor, NIHR National Director of Dementia Research, said.

These health conditions may be as acute as seizures or psychosis, so weighing the pros and cons of taking clonazepam along with a physician is critical professionals say.

Did you know that your bathroom cabinet contains drugs that might increase your likelihood of dementia by 50%?

Long-term use of some common prescription medications may be regarding the heightened danger of dementia.

Photo by freestocks.org on Pexels.com

Researchers found a statistically significant association between dementia and contact with anticholinergic drugs, especially antidepressants, antipsychotic drugs, anti-Parkinson drugs, anti-epilepsy drugs, and bladder antimuscarinics, which are applied to treat urinary incontinence, as stated by the observational study published in the peer-reviewed journal JAMA Internal Medicine.

Anticholinergic drugs work by blocking a neurotransmitter called acetylcholine within the general health.

The scientists analyzed data from 2004 to 2016 from 284,343 patients in England aged 55 and increase. They found “nearly a 50% increased odds of dementia” associated with absorption of a little over 1,095 daily doses of anticholinergics over a decade, “equivalent to three years’ daily using of one single strong anticholinergic medication along at the minimum effective dose recommended for older people.”

Reference

Your Bathroom Cabinet Contains Drugs That Could Increase Your Risk Of Dementia By 50%. Meera Jagannathan – https://www.marketwatch.com/story/these-drugs-in-your-bathroom-cabinet-could-increase-your-risk-of-dementia-by-50-2019-06-27

It is amazing how drugs make headway against lung, breast, and prostate cancers

Newer drugs are substantially improving and enhancing the chances of survival for some individuals with hard-to-treat forms of lung, breast, and prostate cancer, doctors, reported at the world’s largest cancer conference.

Photo by Pixabay on Pexels.com

Immunotherapy drugs such as Keytruda have transformed the various treating types of cancerous tumors, but they’re still relatively new and don’t help most patients. The most extensive study yet of Keytruda in patients with advanced lung cancer discovered that 23 percent of those who got the drug as an element of their initial therapy survived at least five years, whereas 16 percent of those who tried other treatments first did. The risk of this rises with age, but about 48,000 cases each in the U.S. are in women under age 50 years. About 70 percent are “hormone-positive, HER2-negative” — that is, cancer’s growth is fueled by estrogen or progesterone and not by the gene that the drug Herceptin targets.

In research of 672 women with such cancers that had spread or been very advanced, adding the Novartis drug Kisqali to the usual hormone blockers as initial therapy helped more than hormone treatment alone.

After 3½ years, 70 percent of females on Kisqali were alive, compared to 46 percent for the remainder. Side effects were more typical with Kisqali.

This is the very first time any treatment has boosted survival beyond what hormone blockers do for such patients.

The choices keep expanding for men with prostate cancer that has spread beyond the gland. Standard therapy is drugs that block the male hormone testosterone, which helps these cancers grow, plus chemotherapy or even a newer drug called Zytiga.

Now, two other drugs have proved to extend survival whenever used like chemo or Zytiga in guys who were getting natural hormone therapy and still being helped by it.

One study tested Xtandi, sold by Pfizer and Astellas Pharma Inc., in 1,125 guys, half of whom also were chemo that is getting. After three years, 80 % of those offered Xtandi plus standard treatments were alive, contrasted to 72 percent of men given the other treatments alone. The other research involved 1,052 guys who got hormone treatment with or minus the Janssen drug Erleada. After two years, success was 82 percent among those on Erleada and 74 percent those types of who wasn’t.

Men now have a range of four drugs that provide comparable benefits, with no studies yet have compared them against one another, said Dr. Ethan Basch, a prostate specialist at the University of North Carolina’s Lineberger Comprehensive Cancer Center who may have no financial ties to any drugmakers.

However, chemo can cause numbness and tingling in the tactile arms and feet and may even maybe not be suitable for men with diabetes who already are at higher risk because of this problem. Zytiga must be studied having a steroid; Xtandi and Erleada can cause fainting and falling.

Chemo has more side effects, but it costs much less and requires only four to six intravenous treatments. One other three medications are pills that cost more than $10,000 a month and tend to be taken indefinitely.

Reference
Drugs make headway against lung, breast, prostate cancers …. https://www.everyday-scoop.com/drugs-make-headway-against-lung-breast-prostate-cancers-the-associated-press/

Science is moving forward in China, surgeons are treating addiction with brain implants

Deep brain stimulation (DBS), an experimental technology that involves implanting a pacemaker-like device in a patient’s brain to send electrical impulses, is a hotly debated subject in the field of medicine. It’s an inherently risky procedure and the exact effects on the human brain aren’t yet fully understood.

But some practitioners believe it could be a way to alleviate the symptoms of depression or even help treat Alzheimer’s – and now they suspect it could help with drug addiction as well.

In a world’s first, according to the Associated Press, a patient in Shanghai’s Ruijin Hospital had a DBS device implanted in his brain to treat his addiction to methamphetamine.Other studies in China have yielded mixed results trying to treat opioid addictions using DBS, according to the AP. In the United States, at least two studies that tried to treat alcoholism with DBS were dropped for not being able to justify the risks.

The idea of using DBS to treat drug addiction has raised concerns in medical communities across the globe – and not just concerning the inherent risks of a brain hemorrhage, seizures, infections, or personality changes.

Some researchers argue that the precise relationship between the technique and drug addiction are not yet known and require further study. Animal studies have shown some signs of its effectiveness, but remain inconclusive.The idea of using DBS to treat drug addiction has raised concerns in medical communities across the globe – and not just concerning the inherent risks of a brain hemorrhage, seizures, infections, or personality changes.

Some researchers argue that the precise relationship between the technique and drug addiction are not yet known and require further study. Animal studies have shown some signs of its effectiveness, but remain inconclusive.