Health
Pfizer and BioNTech Seek Authorization of a Second Booster Shot for Older Americans
WASHINGTON — Pfizer and BioNTech mentioned on Tuesday that that they had sought emergency authorization for a second booster shot of their coronavirus vaccine for adults 65 and older.
The businesses’ request to the Meals and Drug Administration was based mostly closely on information from Israel, the place such pictures are approved for a considerably broader group. Their transfer may additional inflame a tortuous debate amongst scientists over when and the way the vaccines’ safety ought to be bolstered, and for whom.
Pfizer’s chief govt, Dr. Albert Bourla, mentioned repeatedly over the previous week that he believed a further dose could be essential to counteract waning safety after the third dose, now approved for all People 12 and older. “The safety that you’re getting from the third, it’s adequate, truly fairly good for hospitalizations and deaths,” he advised CBS’s “Face the Nation” on Sunday. “It’s not that good towards infections.”
Earlier requests final fall for a booster shot set off a fierce public debate. Some public well being specialists vigorously opposed them for the overall inhabitants final fall, solely to alter their minds after the Omicron variant proved extra agile at evading the vaccines’ protect. Scientists have continued to conflict over how lengthy the vaccines’ safety actually lasts and the way a lot profit added pictures provide.
In an interview with Enterprise Insider on Monday, Dr. Stephen Hoge, the president of Moderna, whose vaccine is the second most generally utilized in the USA, sounded a extra cautious word than Dr. Bourla.
“For many who are immune-compromised, those that are older adults, over the age of fifty or a minimum of 65, we wish to strongly advocate and encourage” a fourth shot, he mentioned. However he didn’t say how quickly he thought it could be wanted. Like plenty of different specialists, he prompt that most individuals would want an annual shot to guard them towards the coronavirus, identical to the flu.
Of their justification, Pfizer and BioNTech cited partly two current research from Israel, each printed on preprint servers with out peer assessment. One examine, accomplished at the side of Israel’s Ministry of Well being, reviewed the well being data of 1.1 million individuals and concluded that they had been much less prone to turn into contaminated with the virus or to develop extreme sickness after a fourth dose of Pfizer’s vaccine.
However since Israel solely lately started its second booster program, researchers couldn’t decide whether or not the added safety was short-lived. Israel started providing fourth doses to well being care staff in late December, then rapidly broadened eligibility to these 60 and older and different weak teams.
The second examine, of Israeli well being care staff, confirmed that whereas fourth pictures of both Pfizer’s or Moderna’s vaccine boosted antibody ranges, it was not very efficient at stopping infections. Researchers mentioned these findings underscored the urgency of growing vaccines that focus on no matter variant is circulating.
The Nationwide Institutes of Well being in the USA and varied vaccine producers have been learning how the vaccines may very well be up to date.
Some senior administration officers say a fourth shot for all older People might make sense now, however that the overall inhabitants ought to in all probability wait till the autumn. The F.D.A. is anticipated to convene a gathering of its knowledgeable advisory committee subsequent month to debate the problem of fourth pictures. Developments on Pfizer’s request had been reported earlier by The Washington Submit.
Requested final month whether or not everybody would want yet one more injection, Dr. Peter Marks, the F.D.A.’s prime vaccine regulator, mentioned, “Barring any surprises from new variants, possibly the perfect factor is to consider our booster technique at the side of the influenza vaccine subsequent fall, and get as many individuals as attainable boosted then.” Dr. Anthony S. Fauci, the chief medical adviser to the White Home, has prompt that any suggestion earlier than then would almost definitely be geared toward these most in danger, presumably based mostly on underlying circumstances in addition to age.
So far, about two thirds of People 5 and older have been totally vaccinated with two pictures of a vaccine. Solely about half of these eligible for booster pictures have acquired them, however the proportion rises to two-thirds for these 65 and older, in accordance with the Facilities for Illness Management and Prevention.
In a name with reporters on Tuesday, senior administration officers mentioned that the administration was operating quick on funds for vaccines. Assuming that regulators authorize a fourth shot to individuals 65 and older, the administration has sufficient provide to handle that, officers mentioned. However they mentioned it couldn’t broaden that effort to everybody with out extra funding from Congress.
The C.D.C. has beneficial that many People with immune deficiencies get three pictures as a part of their preliminary sequence, adopted by a fourth shot as a booster.
A examine launched by the company final month confirmed waning safety after a booster shot of both Moderna’s or Pfizer-BioNTech’s vaccine. Whereas they didn’t break down circumstances by age, underlying circumstances or the presence of immune deficiencies, researchers mentioned the findings illustrated the attainable significance of a fourth shot.
The examine analyzed hospitalizations and visits to emergency rooms and pressing care clinics in 10 states by individuals who acquired booster pictures of both Moderna’s or Pfizer-BioNTech’s vaccine. It confirmed the extent of safety towards hospitalization fell from 91 p.c within the two months after a 3rd shot to 78 p.c after 4 to 5 months. Effectiveness towards visits to emergency rooms or pressing care clinics declined from 87 p.c to 66 p.c.
Kaiser Permanente Southern California prompt that the effectiveness of a booster dose towards each symptomatic and extreme illness wanes in three to 6 months, whereas a fourth dose restores antibody ranges to the height degree triggered by a 3rd dose.
However different current research have prompt that three doses of a Covid vaccine — and even simply two — are sufficient to guard most individuals from critical sickness and dying for a protracted time frame. Whereas antibody ranges fall off, different components of the immune system can bear in mind and destroy the virus over many months if not years, in accordance with a minimum of 4 research printed in top-tier journals in current weeks.
“We’re beginning to see now diminishing returns on the variety of further doses,” E. John Wherry, the director of the Institute for Immunology on the College of Pennsylvania, mentioned in an interview final month.
Health
Scientists May Be Able to Make Grapefruits Compatible With Medications They Currently Interfere With
You may be among the millions of people who have seen a surprisingly specific warning like this on the labels of drugs you take:
Avoid eating grapefruit or drinking grapefruit juice while using this medication.
Such warnings are issued for dozens of substances, including docetaxel, a cancer drug; erythromycin, an antibiotic; and some statins, the cholesterol-lowering drugs prescribed to more than a third of American adults over 40.
The problem is a set of molecules, furanocoumarins. High levels of furanocoumarins interfere with human liver enzymes, among other processes. In their presence, medications can build up to unhealthy levels in the body. And grapefruits and some related citrus fruits are full of them.
But there is no such warning for other kinds of citrus, such as mandarins and other oranges. Citrus researchers at the Volcani Center in Israel reported Wednesday in the journal The New Phytologist that, by crossing mandarins and grapefruit, they’ve uncovered genes that produce furanocoumarins in some citrus fruits. It’s a finding that opens the possibility of creating grapefruit that doesn’t require a warning label.
Scientists had worked out the compounds’ structures and pieced together a basic flowchart of how they are made years ago, said Yoram Eyal, a professor at the Volcani Center. But the precise identities of enzymes catalyzing the process — the proteins that snip off a branch here, or add a piece there — remained mysterious. He and his colleagues knew that one way to identify them was to breed citrus high in furanocoumarins with those without. If the offspring of such a cross had varying levels of the substances, it should be possible, by digging into their genetics, to pinpoint the genes for the proteins.
“We were afraid to approach it, because it’s very time-consuming and it takes many years,” he said, noting how involved it can be to grow new trees from seeds and assess their genetics. “But finally, we decided we have to dive in.”
When they examined the offspring of a mandarin and a grapefruit, the researchers saw something remarkable. Fifty percent of the young plants had high levels of furanocourmains, and 50 percent had none. That particular signature meant something very specific, in terms of how the ability to make these substances is inherited.
“We saw there was only one gene that could have controlled it,” said Livnat Goldenberg, a Volcani Center researcher who is the lead author of the new study.
The researchers soon identified the gene controlling the production of furanocoumarins in leaves and fruit, which produces an enzyme called 2-oxoglutarate-dependent dioxygenase, or 2OGD for short. Mandarins, it turns out, have a mutated form of this gene that keeps the enzyme from functioning properly. This version cropped up in all the mandarin and orange varieties the researchers checked, explaining why they do not cause the same problems as grapefruit in people taking prescription medications. In these plants, furanocoumarin production is paused.
With gene editing technology, it should be possible to alter the gene in grapefruit as well, Dr. Eyal suggests. The team at the Volcani Center is now exploring that project.
Looking at how widespread this mutated version is in mandarins and some other citrus, the scientists speculate that some gene nearby on the genome must play an important role in a highly prized trait. A long-ago citrus breeder, selecting for some unknown quality, must have unwittingly spread this furanocoumarin-busting version of the gene to an ancestor of modern varieties of mandarins and oranges.
All these years later, that person’s work is coming to light, under the gaze of geneticists, who may, someday, put grapefruit back on the menu.
Cases of tularemia, also known as “rabbit fever,” are on the rise in the U.S., according to a new report from the Centers for Disease Control and Prevention (CDC).
Caused by the bacteria Francisella tularensis, the disease commonly infects rabbits, hares and rodents. However, it is zoonotic, which means it can spread from animals to humans.
The bacteria is a “tier-1 select agent,” a classification given to agents and toxins that “present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effects to the economy, critical infrastructure or public confidence, and pose a severe threat to public health and safety,” per the CDC.
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Although tularemia is relatively rare, with only 2,462 diagnoses between 2011 and 2022, cases have risen 56% compared to the prior decade (2001 to 2010), as reported in the CDC’s Morbidity and Mortality Weekly Report.
Cases of tularemia, also known as “rabbit fever,” are on the rise in the U.S., according to a new report from the CDC. (iStock)
“Increased reporting of probable cases might be associated with an actual increase in human infection, improved tularemia detection or both,” the report states.
Millions of new cases of diabetes and heart disease every year are caused by sugary drinks, according to newly published research.
Tufts University in Boston led the study, which found that about 2.2 million new diagnoses of type 2 diabetes and 1.2 million new cases of cardiovascular disease were attributed to sugar-sweetened sodas and juices each year, according to a press release.
The findings were published in the journal Nature Medicine this week.
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The highest rates were found in Colombia, where 48% of new diabetes cases were linked to sugary drinks, and in Mexico, where nearly a third of cases were attributed to them.
Meanwhile, in Latin America, more than 24% of new diabetes cases were linked to sugary beverages, and 21% in sub-Saharan Africa, the study found.
About 2.2 million new cases of type 2 diabetes and 1.2 million new cases of cardiovascular disease occur each year worldwide due to consuming sugar-sweetened soda and juices, according to the findings of a new study. (iStock)
In South Africa, 27.6% of new diabetes cases and 14.6% of cardiovascular disease cases were attributed to sugary drinks.
Sugary drinks are rapidly digested, causing a spike in blood sugar levels with little nutritional value.
Sugary drinks cause blood sugar to spike because they are “rapidly digested,” the research team said.
When consumed on a long-term basis, these types of beverages, in addition to increasing the risk of type 2 diabetes and heart disease, can also lead to weight gain and insulin resistance, the researchers added.
Men are more likely than women to suffer the consequences of sugary drink consumption, as are younger adults compared to their older counterparts, a new study asserts. (iStock)
Professor Dariush Mozaffarian, the study’s senior author, said in a university press release, “Sugar-sweetened beverages are heavily marketed and sold in low- and middle-income nations.”
He added, “Not only are these communities consuming harmful products, but they are also often less well-equipped to deal with the long-term health consequences.”
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Certain groups are more likely to experience negative health effects from sugary drinks, including men and younger adults, the researchers noted, as news agency SWNS also noted.
New Jersey-based registered dietitian Erin Palinski-Wade, who was not involved in the research, said the findings were to be expected, as diets rich in added sugars are more likely to increase the risk of chronic health conditions, including type 2 diabetes.
When consumed on a long-term basis, these types of beverages can also lead to weight gain and insulin resistance, experts say. (iStock)
“Sugar-sweetened beverages are a major cause of added sugar in the diet and easy to overconsume, as they provide little fullness,” she told Fox News Digital.
“The high calorie content and lack of satisfaction due to little protein, fat or fiber in these drinks can lead to excess calorie consumption, which can lead to weight gain — especially gains in visceral fat (belly fat), which has been found to increase the risk of type 2 diabetes,” she went on.
“Sugar-sweetened beverages are easy to overconsume, as they provide little fullness.”
Palinski-Wade pointed out that there were some limitations to the new research.
“This was an observational study, not a causation study, and shows only an association between diets containing sugar-sweetened beverages and diabetes,” she noted.
“It does not prove that those drinks alone trigger an onset of type 2 diabetes.”
What needs to change?
To remedy the issue, the study authors called for a “multi-pronged approach,” including public health campaigns, regulations on advertising and taxes on sugar-sweetened beverages, the release stated.
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“We need urgent, evidence-based interventions to curb consumption of sugar-sweetened beverages globally, before even more lives are shortened by their effects on diabetes and heart disease,” first author Laura Lara-Castor, now at the University of Washington, said in the release.
Approximately 65% of adults in the U.S. consume sugar-sweetened beverages daily. (iStock)
Mexico implemented a sugary drinks tax in 2014, which has shown to be effective in reducing consumption, the researchers stated.
“Much more needs to be done, especially in countries in Latin America and Africa, where consumption is high and the health consequences severe,” wrote Mozaffarian.
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“As a species, we need to address sugar-sweetened beverage consumption.”
Many different factors are involved in insulin resistance and type 2 diabetes, Palinski-Wade noted.
“As a species, we need to address sugar-sweetened beverage consumption.”
“However, reducing your intake of sugar-sweetened beverages can go a long way toward improving overall blood sugar regulation and future health.”
The new research was supported by the Gates Foundation, the American Heart Association and Mexico’s National Council for Science and Technology.
Fox News Digital reached out to the researchers for further comment.
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