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

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/

The latest Covid-19 vaccines from Pfizer and Moderna

The latest Covid-19 vaccines from Pfizer and Moderna tend to be exceptionally effective at avoiding severe illness. Scientists are worried that if vaccinated people are silent spreaders of the virus, they could keep it circulating in their populations, putting unvaccinated people in danger. In certain respiratory infections, like the current coronavirus, the nose is the primary access stage. Vaccines are inserted directly into the tissues to activate the immune system to generate antibodies. This seems to be ample security to discourage the individual from being vaccinated from being sick.


Next-generation coronavirus vaccines can trigger immunity in the nose and the rest of the respiratory tract. Mucosal vaccinations are safer than intramuscular procedures to keep respiratory viruses from arising. The lungs are far more open than the nose or mouth to circulating antibodies. Vaccine studies did not produce results about how many patients became afflicted with the infection but showed no effects. The amount of the virus that you replicate in the nose can be decreased if one gets sick, says the immunologist. An informed guide to the global epidemic can be found at com/Heroes.


Coronavirus vaccinations demonstrate robust safety from being ill. Life can return to normal only when civilization as a whole has an inadequate defense against coronavirus. For the time being, even vaccinated citizens would continue to use masks to prevent indoor crowds. The Pfizer and BioNTech vaccines are given as an injection through the arm, as most traditional vaccines. The injection will not be any different from that one had previously, and there are no significant side effects. Moderna and Pfizer vaccines utilize a genetic molecule to activate the immune response. The enzyme, known as mRNA, is ultimately killed by the body. The mRNA is wrapped in an oily bubble that can fuse into a cell, enabling the molecule to slide in. The cell uses mRNA to produce coronavirus proteins that may activate the immune system. The mRNA will only survive for at most a few days until it is lost.

Reference
Here’s Why Vaccinated People Still Need to Wear a Mask. https://www.nytimes.com/2020/12/08/health/covid-vaccine-mask.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

Fluvoxamine antidepressant avoids the deterioration of COVID-19 infections

In a clinical trial performed by the Washington University School of Medicine in St. Louis, fluvoxamine was associated with a placebo in 152 adult outpatients afflicted with coronavirus. They are hoping to start a more significant trial in the next few weeks.

After 15 days, none of the 80 subjects who got fluvoxamine were critically ill, although six patients who received the placebo did. Of the six, four were hospitalized for periods ranging from four to 21 days. All of them were on the ventilator for ten days.

Although the sample size was limited, the researchers say the findings are statistically significant and that fluvoxamine merits further study as a COVID-19 therapy. They are hoping to start a more significant trial in the next few weeks.

“Patients who take fluvoxamine did not experience severe respiratory issues or need hospitalization for complications with lung function,” said Eric J. Lenze, MD, of the Washington University School of Medicine. “Most of the investigational therapies for COVID-19 have been focused on very ill patients, but it is often necessary to identify treatments that keep patients from being sick enough to need extra oxygen or to have to go to the hospital. Our analysis shows that fluvoxamine can help fill that niche.”

Reference

Antidepressant may prevent severe COVID-19, U.Va. research finds. https://wtop.com/virginia/2020/11/antidepressant-may-prevent-severe-covid-19-u-va-research-finds/

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.

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.

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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/

Alert! Generic Drugs may not be as effective as you think

While the price of prescription medication soars, individuals are increasingly taking generic drugs: low-cost solutions to brand-name medications. Frequently medical health insurance plans require patients to change to generics as an easy way of controlling costs. Though, almost all of the generic medications being sold into the U.S. are produced offshore, mainly in India and China. The U.S. Food and Drug Administration claims, so it holds foreign plants into the same criteria as U.S. drug manufacturers. The FDA frequently declares its offshore inspections weeks in advance, which allows plants where generic drugs have produced the opportunity to fabricate data and outcomes.

Generic drugs sometimes head to the market in the U.S. without the right vetting. The FDA is overloaded and under-resourced with its efforts so that the safety of offshore drug manufacturing.

Consumers have to research who manufactures their generics and appear up any conditions that regulators have discovered out about them. However, some consumers could find they are not allowed by their health plan to change to alternatives, because of cost.

Behaviors concerning antibiotic use may possibly forecast cardiovascular problem

person holding white medication tablet

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A brand new research that examined the medical information of a large number of women of all ages discovered that long term antibiotics use is linked to high risk from encountering a cardiovascular occurrence.

Women of all ages may want to consider restricting their usage of antibiotics to avoid cardiovascular problems.

Researchers for Tulane University in Brand-new Orleans, LA, Harvard Standpoint School and Harvard Testosterone levels. H. Chan School from Public Health in Boston, MUM, and Fudan University during Shanghai, China looked at how antibiotic use is associated with can certainly probability of encountering cardiovascular complications.

Researchers were serious about the connection concerning antibiotics and cardiovascular overall health because, researchers explain, medication is capable of having a significant effect on the stomach microbiota, which, in turn, could affect several other facets of overall health.

“Antibiotic use is one of the most crucial aspect in modifying the healthy balance concerning bacteria inside the stomach, ” affirms research co-author Prof. Lu Qi.

” Prior research have demonstrated a link between changes in the micro-biotic natural environment in the stomach and swelling and so thinning of the blood vessels, cardiovascular accident, and cardiovascular disease, ” the researcher contributes.

The research – that results that appear in that European Heart Journal supports evaluates details the researchers gathered from a cohort concerning 36, 429 women of all ages enrolled in the Nurses’ Well being Study.

Antibiotics can be harmful