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Big gap between Pfizer, Moderna vaccines seen for preventing COVID hospitalizations

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Amid persistent considerations that the safety provided by COVID-19 vaccines could also be waning, a report launched Friday by the Facilities for Illness Management and Prevention finds that America’s workhorse shot is considerably much less efficient at stopping extreme instances of illness over the long run than many consultants had realized.

Information collected from 18 states between March and August counsel the Pfizer-BioNTech vaccine reduces the chance of being hospitalized with COVID-19 by 91% within the first 4 months after receiving the second dose. Past 120 days, nevertheless, that vaccine efficacy drops to 77%.

In the meantime, Moderna’s vaccine was 93% efficient at decreasing the short-term danger of COVID-19 hospitalization and remained 92% efficient after 120 days.

General, 54% of absolutely vaccinated Individuals have been immunized with the Pfizer shot.

The stunning findings got here as a Meals and Drug Administration advisory panel advisable in opposition to providing booster doses of the Pfizer vaccine to all Individuals ages 16 and older. In a hanging rebuke, 16 of 18 consultants informed the company it had not mustered sufficient information to make a 3rd shot the norm.

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In prolonged briefings to the panel, representatives from Pfizer pointed to medical trial outcomes involving 306 largely wholesome members to argue {that a} booster “restores” the 95% vaccine effectiveness fee seen earlier within the pandemic.

Firm officers additionally touted proof from Israel, which rolled out boosters after seeing an increase in hospitalizations amongst individuals who had been absolutely vaccinated. These hospitalizations dropped dramatically after third doses got, Israeli scientists have mentioned.

However panel members made clear that regardless of Pfizer’s aggressive stance, it had not gathered sufficient proof {that a} third shot was secure for younger folks and for these at lesser danger of changing into severely ailing with COVID-19.

“We’d like age-specific information” on the protection and protecting advantages of an extra booster, mentioned Dr. Ofer Levy, a panel member who directs the Precision Vaccines program at Boston Kids’s Hospital.

FDA clearance for booster photographs for everybody 16 and older could be seen as one thing “near a mandate,” mentioned Dr. Eric Rubin, a panel member and infectious-disease knowledgeable on the Harvard T.H. Chan College of Public Well being. Rubin fearful that such a transfer might redefine what it takes to be thought of absolutely vaccinated in opposition to COVID-19.

“None of us are there but,” he mentioned.

However others apparently are. Dr. Anthony Fauci, President Biden’s high advisor on vaccines, has come out strongly in favor of booster photographs, saying earlier than Friday’s vote {that a} failure to endorse the photographs “could be a mistake.”

And in mid-August, Biden himself mentioned his administration would start making booster photographs obtainable the week of Sept. 20 to these vaccinated for at the least eight months.

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Biden cautioned on the time that his plan was contingent on FDA approval. However his announcement stoked considerations of political meddling in a matter that required the unhindered analysis of scientists.

“This could display to the general public that the members of this committee are unbiased of the FDA,” Dr. Archana Chatterjee, dean of the Chicago Medical College, mentioned after the vote. “In actual fact, we do convey our voices to the desk once we are requested to serve on this committee.”

The panel unanimously agreed {that a} third shot of the vaccine now offered beneath the model title Comirnaty needs to be provided to pick teams: people 65 and older, folks susceptible to growing extreme illness, and people, together with healthcare employees, whose occupations put them at excessive danger of an infection.

Dr. Peter Marks, who leads the FDA’s analysis of medication and vaccines, informed panel members that the company might give its blessing to booster photographs with an emergency use authorization — a regulatory step that falls in need of the total approval Pfizer had sought.

The corporate issued no assertion Friday in response to the panel’s vote.

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Researchers in the USA have been warning for months that the immunity afforded by COVID-19 vaccines may be waning. The CDC reported that in late July, near three-quarters of the 469 folks swept up in a Massachusetts outbreak had been absolutely vaccinated. And the company has launched a number of research geared toward detecting adjustments in vaccine effectiveness in healthcare employees and others who had been vaccinated early.

However nearly all of these infections gave the impression to be delicate. And well being officers desirous to induce vaccine skeptics to step up for his or her shot — together with Fauci and Dr. Rochelle Walensky, director of the Facilities for Illness Management and Prevention — have repeatedly praised the vaccines for conserving most absolutely vaccinated folks out of hospitals.

The brand new report on waning vaccine efficacy challenges that expectation.

Vials of Pfizer-BioNTech COVID-19 sit on a tray at a mass vaccination clinic in Ontario, Calif.

(Irfan Khan / Los Angeles Occasions)

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Researchers from across the nation discovered hanging variations between two mRNA vaccines lengthy considered interchangeable.

When the Moderna vaccine obtained emergency use authorization in December, the corporate reported that 30 folks in its medical trial developed extreme instances of COVID-19, together with 9 who required hospitalization. All 30 sufferers had been within the placebo group, leading to a vaccine efficacy in opposition to extreme illness of 100%.

Ten folks in Pfizer’s preliminary medical trial developed extreme instances of COVID-19. 9 of them had been within the placebo group, together with seven who had been hospitalized, leading to a vaccine efficacy in opposition to extreme illness of 88.9%.

As soon as the Moderna and Pfizer vaccines had been rolled out to the general public, their data of stopping COVID-19 hospitalizations within the first 4 months had been neck and neck — 93% and 91% efficient, respectively. However the diploma of safety diverged after that.

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After they centered particularly on the interval 120 days past the second dose, the research authors discovered that the Moderna vaccine remained 92% efficient at stopping COVID-19 hospitalizations. However the equal determine for the Pfizer vaccine was 77%.

The outcomes had been printed within the CDC’s Morbidity and Mortality Weekly Report.

Each the Pfizer and Moderna vaccines are based mostly on mRNA know-how, which delivers non permanent directions to the physique’s muscle cells that assist it study to acknowledge the spike protein, a key a part of the coronavirus’ construction. However “they’re truly not essentially interchangeable,” mentioned Dr. Timothy Brewer, a professor of drugs and epidemiology at UCLA.

Every vaccine is formulated and administered otherwise, Brewer mentioned, and people variations might have an effect on the power and period of the 2 vaccines’ safety.

Moderna’s shot comprises 100 micrograms of vaccine, greater than thrice the 30 micrograms within the Pfizer shot. And Pfizer’s two doses are given three weeks aside, whereas Moderna’s two-shot routine is run with a four-week hole.

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Brewer additionally pointed to proof that the Moderna vaccine appeared to elicit greater ranges of a key antibody than the Pfizer vaccine.

“We all know from different research the neutralizing antibody ranges will decay over time, so beginning at a better stage will imply that you’ve farther to go earlier than you decay to a degree the place efficacy drops off,” he mentioned.

Dr. Robert Murphy, who directs Northwestern College’s Institute for International Well being, mentioned the Pfizer vaccine’s diminished safety in opposition to extreme illness might bolster the case for boosters for all who received the vaccine, not simply the precise teams recognized by the FDA advisory panel.

“Primarily based on the information I’ve seen, individuals who obtained the Pfizer vaccine would profit from a booster dose right now,” he mentioned. “I don’t see why we now have to attend till the youthful folks get sick and grow to be hospitalized.”

However Dr. Arnold Monto, who chairs the FDA advisory panel, applauded the company’s willingness to withhold a full-throated name for boosters till a stronger case may be made. And he recommended that as extra proof accumulates, boosters for all may nonetheless get the nod.

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“That’s the great thing about the emergency use authorization,” mentioned Monto, an epidemiologist at College of Michigan. “It may be modified based mostly on altering information.”

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Live poultry markets may be source of bird flu virus in San Francisco wastewater

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Live poultry markets may be source of bird flu virus in San Francisco wastewater

Federal officials suspect that live bird markets in San Francisco may be the source of bird flu virus in area wastewater samples.

Days after health monitors reported the discovery of suspected avian flu viral particles in wastewater treatment plants, federal officials announced that they were looking at poultry markets near the treatment facilities.

Last month, San Francisco Public Health Department officials reported that state investigators had detected H5N1 — the avian flu subtype making its way through U.S. cattle, domestic poultry and wild birds — in two chickens at a live market in May. They also noted they had discovered the virus in city wastewater samples collected during that period.

Two new “hits” of the virus were recorded from wastewater samples collected June 18 and June 26 by WastewaterSCAN, an infectious-disease monitoring network run by researchers at Stanford, Emory University and Verily, Alphabet Inc.’s life sciences organization.

Nirav Shah, principal deputy director of the U.S. Centers for Disease Control and Prevention, said that although the source of the virus in those samples has not been determined, live poultry markets were a potential culprit.

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Hits of the virus were also discovered in wastewater samples from the Bay Area cities of Palo Alto and Richmond. It is unclear if those cities host live bird markets, stores where customers can take a live bird home or have it processed on-site for food.

Steve Lyle, a spokesman for the state’s Department of Food and Agriculture, said live bird markets undergo regular testing for avian influenza.

He said that aside from the May 9 detection in San Francisco, there have been no “other positives in Live Bird Markets throughout the state during this present outbreak of highly-pathogenic avian flu.”

San Francisco’s health department referred all questions to the state.

Even if the state or city had missed a few infected birds, John Korslund, a retired U.S. Department of Agriculture veterinarian epidemiologist, seemed incredulous that a few birds could cause a positive hit in the city’s wastewater.

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“Unless you’ve got huge amounts of infected birds — in which case you ought to have some dead birds, too — it’d take a lot of bird poop” to become detectable in a city’s wastewater system, he said.

“But the question still remains: Has anyone done sequencing?” he said. “It makes me want to tear my hair out.”

He said genetic sequencing would help health officials determine the origin of viral particles — whether they came from dairy milk, or from wild birds. Some epidemiologists have voiced concerns about the spread of H5N1 among dairy cows, because the animals could act as a vessel in which bird and human viruses could interact.

However, Alexandria Boehm, professor of civil and environmental engineering at Stanford University and principal investigator and program director for WastewaterSCAN, said her organization is not yet “able to reliably sequence H5 influenza in wastewater. We are working on it, but the methods are not good enough for prime time yet.”

A review of businesses around San Francisco’s southeast wastewater treatment facility indicates a dairy processing plant as well as a warehouse store for a “member-supported community of people that feed raw or cooked fresh food diets to their pets.”

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Be grateful for what you have. It may help you live longer

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Be grateful for what you have. It may help you live longer

Death may be inevitable, but that hasn’t stopped health researchers from looking for ways to put it off as long as possible. Their newest candidate is something that’s free, painless, doesn’t taste bad and won’t force you to break a sweat: Gratitude.

A new study of nearly 50,000 older women found that the stronger their feelings of gratitude, the lower their chances of dying over the next three years.

The results are sure to be appreciated by those who are naturally inclined toward giving thanks. Those who aren’t may be grateful to learn that with practice, they might be able to enhance their feelings of gratitude and reap the longevity benefits as well.

“It’s an exciting study,” said Joel Wong, a professor of counseling psychology at the University of Indiana who researches gratitude interventions and practices and wasn’t involved in the new work.

Mounting evidence has linked gratitude with a host of benefits for mental and physical health. People who score higher on measures of gratitude have been found to have better biomarkers for cardiovascular function, immune system inflammation and cholesterol. They are more likely to take their medications, get regular exercise, have healthy sleep habits and follow a balanced diet.

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Gratitude is also associated with a lower risk of depression, better social support and having a greater purpose in life, all of which are linked with longevity.

However, this is the first time researchers have directly linked gratitude to a lower risk of earlier death, Wong and others said.

“It’s not surprising, but it’s always good to see empirical research supporting the idea that gratitude is not only good for your mental health but also for living a longer life,” Wong said.

Study leader Ying Chen, an empirical research scientist with the Human Flourishing Program at Harvard University, said she was amazed by the dearth of studies on gratitude and mortality. So she and her colleagues turned to data from the Nurses Health Study, which has been tracking the health and habits of thousands of American women since 1976.

In 2016, those efforts included a test to measure the nurses’ feelings of gratitude. The women were asked to use a seven-point scale to indicate the degree to which they agreed or disagreed with six statements, including “I have so much in life to be thankful for” and “If I had to list everything I felt grateful for, it would be a very long list.”

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A total of 49,275 women responded, and the researchers divided them into three roughly equal groups based on their gratitude scores. Compared with the women with the lowest scores, those with the highest scores tended to be younger, more likely to have a spouse or partner, more involved in social and religious groups, and in generally better health, among other differences.

The average age of nurses who answered the gratitude questions was 79, and by the end of 2019, 4,068 of them had died. After accounting for a variety of factors such as the median household income in their census tract, their retirement status, and their involvement in a religious community, Chen and her colleagues found that the nurses with the most gratitude were 29% less likely to have died than the nurses with the least gratitude.

Then they dug deeper by controlling for a range of health issues, including a history of heart disease, stroke, cancer and diabetes. The risk of death for the most grateful women was still 27% lower than for their least grateful counterparts.

When the researchers considered the effects of smoking, drinking, exercise, body mass index and diet quality, the risk of death for the nurses with the most gratitude remained lower, by 21%.

Finally, Chen and her colleagues added in measures of cognitive function, mental health and psychological well-being. Even after accounting for those variables, the mortality risk was 9% lower for nurses with the highest gratitude scores.

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The findings were published Wednesday in JAMA Psychiatry.

Although the study shows a clear link between gratitude and longevity, it doesn’t prove that one caused the other. While it’s plausible that gratitude helps people live longer, it’s also possible that being in good health inspires people to feel grateful, or that both are influenced by a third factor that wasn’t accounted for in the study data.

Sonja Lyubomirsky, an experimental social psychologist at UC Riverside who studies gratitude and was not involved in the study, said she suspects all three things are at work.

Another limitation is that all of the study participants were older women, and 97% of them were white. Whether the findings would extend to a more diverse population is unknown, Wong said, “but drawing on theory and research, I don’t see a reason why it wouldn’t.”

There can be downsides to gratitude, the Harvard team noted: If it’s tied to feelings of indebtedness, it can undermine one’s sense of autonomy or accentuate a hierarchical relationship. Lyubomirsky added that it can make people feel like they’re a burden to others, which is particularly dangerous for someone with depression who is feeling suicidal.

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But in most cases, gratitude is an emotion worth cultivating, Lyubomirsky said. Clinical trials have shown that gratitude can be enhanced through simple interventions, such as keeping a gratitude journal or writing a thank-you letter and delivering it by hand.

“Gratitude is a skill that you can build,” she said.

And like diet and exercise, it appears to be a modifiable risk factor for better health.

Lyubomirsky has found that teenagers who were randomly assigned to compose letters of gratitude to their parents, teachers or coaches took it upon themselves to eat more fruits and vegetables and cut back on junk food and fast food — a behavior not shared by classmates in a control group. Perhaps after reflecting on the time, money and other resources invested in them, the teens were inspired to protect that investment, she said.

More research will be needed to see whether interventions like these can extend people’s lives, but Chen is optimistic.

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“As the evidence accumulates, we’ll have a better understanding of how to effectively enhance gratitude and whether it can meaningfully improve people’s long-term health and well-being,” she said.

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Drug can amplify naloxone's effect and reduce opioid withdrawals, study shows

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Drug can amplify naloxone's effect and reduce opioid withdrawals, study shows

Naloxone has long been hailed as a life-saving drug in the face of the opioid epidemic. But its capacity to save someone from an overdose can be limited by the potency of the opioid — a person revived by naloxone can still overdose once it wears off.

Stanford researchers have found a companion drug that can enhance naloxone’s effect — and reduce withdrawal symptoms. Their research on mice, led by Stanford University postdoctoral scholar Evan O’Brien, was published today in Nature.

Typically, overdose deaths occur when opioids bind to the part of the brain that controls breathing, slowing it to a stop. Naloxone reverses overdoses by kicking opioids off pain receptors and allowing normal breathing to resume.

However, it is only able to occupy pain receptors for 30 to 90 minutes. For more potent opioids, such as fentanyl, that may not be long enough.

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To determine how the naloxone companion drug, which researchers are calling compound 368, might boost naloxone’s effectiveness, researchers conducted an experiment on pain tolerance in mice, said Jay McLaughlin, a professor of pharmacology at the University of Florida. How quickly would mice pull their tails out of hot water, depending on which combination of opioids and treatments they were given?

Mice that were injected with only morphine did not respond to the hot water — given their dulled pain receptors. Mice given morphine and naloxone pulled their tails out within seconds. No surprises yet.

When the dosage of naloxone was reduced and compound 368 was added, the compound was found to amplify naloxone’s effects, as if a regular dose was used. When used on its own, the compound had no effect, indicating that it is only helpful in increasing the potency of naloxone.

What researchers did not expect, however, was that the compound reduced withdrawal symptoms.

McLaughlin said withdrawal is one reason that people who have become physically dependent on opioids may avoid naloxone.

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“Opioid withdrawal will not kill you, but I have talked to a number of people who have gone through it, and they have all said the same thing: … ‘I wished I was dead,’” McLaughlin said. “It has a massive range of nasty, horrible effects.”

The idea that the compound could amplify naloxone’s effect at a lower dosage, while limiting withdrawal symptoms, indicates that it may be a “new therapeutic approach” to overdose response, McLaughlin said.

The research team said their next step is to tweak the compound and dosage so that the effects of naloxone last long enough to reverse overdoses of more potent drugs.

Though the compound is not yet ready for human trials, the researchers chose to release their findings in the hope that their peers can double check and improve upon their work, said Susruta Majumdar, another senior author and a professor of anesthesiology at the Washington University School of Medicine in St. Louis.

“We may not be able to get that drug into the clinic, but somebody else may,” Majumdar said. He added: “Let them win the race.”

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