Health
F.D.A. Allows Second Coronavirus Boosters for Everyone 50 and Older
WASHINGTON — Federal regulators licensed second booster pictures of the Pfizer-BioNTech and Moderna coronavirus vaccines on Tuesday for everybody 50 and older, describing the transfer as an effort to bolster waning immunity in opposition to extreme illness in case the virus sweeps the nation once more within the coming months.
The Meals and Drug Administration mentioned folks within the age group may get the extra shot a minimum of 4 months after their first booster. The company additionally licensed a second booster for folks 12 and older with sure immune deficiencies.
The choice implies that tens of thousands and thousands of People at the moment are eligible for what could be their fourth shot. And despite the fact that the general public could also be tiring of repeated doses, the transfer is almost definitely an interim one: Federal well being officers say it’s fairly potential that People of all ages may have one other shot within the fall to organize for any winter surge. The hope is that by then, scientists may have reconfigured the prevailing vaccines to work higher and last more in opposition to the variants which have emerged since November.
Federal well being officers initially thought-about limiting second boosters to these a minimum of 60 or 65 years previous. However at a information briefing, Dr. Peter Marks, who oversees the F.D.A.’s vaccine division, mentioned a decrease age restrict made extra sense as a result of so many People over 50 have power medical situations that put them in danger.
Whereas a single booster dose continues to guard most People from hospitalization and demise because of Covid-19, he mentioned, these 50 or older who acquired their first booster greater than 4 months in the past “ought to significantly take into account getting one other.”
The Facilities for Illness Management and Prevention was a bit extra circumspect. Within the fall, when the primary spherical of boosters was licensed, the company cited a transparent profit from an added shot.
On Tuesday, in distinction, the C.D.C. up to date its vaccine steering to notice that second boosters have been now allowed. Dr. Rochelle P. Walensky, the company’s director, mentioned the choice of one other dose was “particularly necessary for these 65 and older and people 50 and older with underlying medical situations that improve their danger for extreme illness from Covid-19 as they’re the almost definitely to learn from receiving an extra booster dose right now.” About one-third of individuals aged 50 to 65 have important medical situations, officers mentioned.
The F.D.A. made the choice with very restricted information, largely from Israel. Consultants mentioned there was pretty strong information displaying a necessity for stronger safety now that variants have reduce into the vaccines’ efficiency. There may be considerably much less information on whether or not a second booster will present that safety, and for the way lengthy. Regulators mentioned one other dose posed no new security issues.
The concept that simply six months after federal regulators licensed the primary spherical of boosters, one other booster is already essential may add to public fatigue with Covid vaccines. The proof now means that the federal government’s determination final fall to authorize a primary booster — the topic of a lot scientific debate on the time — saved lives over the winter. Whereas the Omicron variant surged, those that have been boosted have been 21 instances much less prone to die from Covid and 7 instances much less prone to be hospitalized than those that have been unvaccinated, in response to the C.D.C.
However at this level, “every further dose is providing marginal worth,” mentioned Dr. Eric Rubin, an infectious illnesses knowledgeable on the Harvard T.H. Chan Faculty of Public Well being. At an occasion hosted by Columbia College this week, Dr. Kate O’Brien, the director of the vaccines division on the World Well being Group, mentioned, “We’re in a comparatively weak place on the type of coverage entrance round precisely what the info are which can be compelling choices about fourth doses.”
The strongest information in help of a second booster got here from a newly launched Israeli research that has not but been peer reviewed. Throughout a 40-day interval this 12 months, the researchers studied Covid demise charges amongst greater than half one million adults 60 to 100 years previous who had obtained a minimum of one booster.
Among the many 234,868 who had just one booster, 232 folks died of Covid. Among the many 328,597 individuals who acquired a second booster, 92 died of Covid. The mortality fee “was considerably decrease amongst those that had obtained an extra booster,” the researchers mentioned.
Federal officers additionally studied statistical fashions that prompt that if the virus surged once more in late spring or summer season, a second booster may save 1000’s of lives and stop tens of 1000’s of hospitalizations.
The C.D.C. singled out Johnson & Johnson recipients for particular remedy. The company has already really useful Moderna’s and Pfizer’s vaccines over Johnson & Johnson’s for security causes.
On Tuesday, it mentioned adults who acquired an preliminary dose plus a booster of Johnson & Johnson’s vaccine a minimum of 4 months in the past — a gaggle that would embrace greater than 1.4 million folks — have been eligible for a second booster with one of many mRNA vaccines. The company cited new information that confirmed Johnson & Johnson’s vaccine was much less efficient than the opposite two.
Each Pfizer and Moderna have argued for a second booster. Pfizer and BioNTech have mentioned information collected in the course of the Omicron wave confirmed that the efficiency of their preliminary booster wanes inside three to 6 months in opposition to each symptomatic an infection and extreme illness. Knowledge from Israel suggests a second booster restores safety, however researchers haven’t tracked the recipients of these boosters for lengthy.
Dr. Paul Burton, Moderna’s chief medical officer, advised CNN on Monday that the virus’s mutations had weakened the vaccines’ protect. “The one method that we’re going to get to a interval of stability and finally to an endemic illness is to maintain folks protected, hold their antibody ranges up, and I’m afraid meaning common boosting,” he mentioned.
Each Pfizer and Moderna have an apparent monetary incentive to advertise extra pictures: They’re projecting tens of billions of {dollars} in Covid vaccine gross sales this 12 months alone.
Neither the F.D.A. nor the C.D.C. convened its outdoors committee of consultants to debate the brand new coverage, sparking criticism. Dr. Rubin, an F.D.A. panel member, referred to as that call cheap however mentioned it was essential for the company to make public any information it relied upon for others to scrutinize. The company’s determination memo is predicted to be posted on-line quickly.
Like different consultants, Dr. Rubin mentioned what is basically wanted now’s a vaccine that works higher than the prevailing ones in opposition to the brand new variants. Many research at the moment are underway to seek out it, however the earliest outcomes are usually not anticipated till later this spring.
“It’s not really clear but what the optimum booster needs to be,” Dr. Marks mentioned.
The F.D.A. panel is scheduled to satisfy on April 6 to debate what the nation’s booster technique needs to be transferring ahead. Federal well being officers have prompt that pictures within the fall could possibly be wanted, simply as they’re for the flu. “Sooner or later,” Dr. Marks mentioned, “we’re going to have to appreciate that this can be a virus that’s going to be with us and that we’ve got to come back to grips with coping with it frequently.”
One other main determination looms, probably subsequent month, when the F.D.A. could rule on whether or not to authorize a vaccine for the nation’s youngest kids — the one group nonetheless ineligible for pictures. Moderna plans to submit information within the coming weeks from what it has described as a profitable medical trial of a two-dose routine for kids beneath 6. Pfizer and BioNTech have mentioned they count on outcomes from their three-dose trial subsequent month for kids beneath 5.
Dr. Marks mentioned on Tuesday that the F.D.A. would search enter from its advisory committee earlier than making choices on pictures for the youngest kids.
For lots of the roughly 3 p.c of People with immune deficiencies, Tuesday’s determination authorizes what would primarily be a fifth dose. These 12 and older can get Pfizer’s shot, whereas these adults can decide between Pfizer’s and Moderna’s.
How a lot public demand there’s for an additional booster is unclear. With the pandemic in a lull, the nation’s enthusiasm for pictures has been flagging. New reported infections have been falling because the third week in January, when the Omicron wave peaked.
In keeping with C.D.C. estimates on Tuesday, an much more contagious subvariant of Omicron, generally known as BA.2, is now dominant amongst new U.S. circumstances. The subvariant has led to a surge of latest circumstances in Europe. However some consultants assume the US could escape the brunt of its influence, partly as a result of the Omicron variant contaminated so many People.
Cheryl Shell, a 71-year-old retiree within the city of Spring Arbor in southern Michigan, mentioned she was not ready round to seek out out. She acquired her first booster in November, she mentioned, and she or he is keen to get a second as a result of she is anxious about waning efficiency. “I’ve acquired to go for any safety I can get,” she mentioned.
Kate Bedingfield, the White Home communications director, mentioned the brand new authorization “is an effective factor and it’s a simple factor.” She mentioned the federal government had loads of provide to supply second boosters to these now eligible.
However she reiterated some extent the White Home has made repeatedly in latest weeks: If booster pictures are really useful for the overall inhabitants, she mentioned, Congress must present more cash to pay for them.
Noah Weiland and Adeel Hassan contributed reporting.
A Costco-brand cold and flu medicine has been pulled from shelves by the thousands.
A total of 8,640 boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night packs were recalled by the Food & Drug Administration (FDA) last week.
This is following the FDA’s proposal to ban the use of oral phenylephrine as an over-the-counter nasal decongestant in early November.
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After “extensive review,” the FDA concluded that the active ingredient in the product (oral phenylephrine) is “not effective” as a nasal decongestant.
Nearly 9,000 boxes of Kirkland Severe Cold & Flu Plus Congestion Day and Night were recalled for quality control issues. (iStock)
Dr. Marc Siegel, Fox News senior medical analyst, said he agrees with the recent pushback against the ingredient.
“This chemical is shown to be ineffective against cold and flu in its oral form, except at a dose that has some heart toxicity and can lead to palpitations, arrhythmia and high blood pressure.”
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The FDA stated that the Kirkland recall was related to quality control issues, noting in the official recall that the “released product should have been rejected.”
This was a Class II recall, which the FDA describes as a “situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Recalled boxes of Kirkland Severe Cold & Flu Plus Congestion had lot numbers P139953 or P139815 with an August 2026 expiration date. (eBay)
Katy Dubinsky, a New York pharmacist and founder and CEO of Vitalize, confirmed with Fox News Digital that the recall most likely occurred due to deviations from CGMP (Current Good Manufacturing Practice).
“[That means] the product failed to meet required quality control standards and should have been rejected before release,” she said.
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“To guarantee all products meet strict safety and quality guidelines, the FDA made a Class II recall, which suggests low consumer risk and typically addresses issues unlikely to cause serious harm.”
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Manufacturing inconsistencies and labeling errors can cause “many” CGMP deviations, according to the pharmacist, as well as other procedural issues rather than ingredient problems.
“Acetaminophen, dextromethorphan, guaifenesin and phenylephrine – the listed active ingredients – are widely used as well as considered safe when taken as directed,” she said.
Pharmacist Katy Dubinsky told consumers to stop using recalled lots of this product. (iStock)
Dubinsky instructed consumers to stop using the recalled lots and consult with a health care professional if concerns or symptoms arise after taking the product.
“However, there is no need for panic,” she said. “Recalls like this are important to keep products safe and help people trust the over-the-counter medications they rely on.”
Recalled boxes of the Kirkland Cold & Flu product had lot numbers P139953 or P139815 with an August 2026 expiration date.
Fox News Digital reached out to the FDA and Costco for comment.
Bird flu (H5N1) continues to spark warnings around the country.
On Friday, the Centers for Disease Control and Prevention (CDC) confirmed the country’s first severe case of bird flu in a human.
The patient, who lives in southwestern Louisiana, is currently hospitalized, according to a release from the Louisiana Department of Health (LDH).
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The infected person is known to have been exposed to sick and dead birds that are “suspected to have been infected,” the same source stated.
The LDH is working with the CDC on genomic testing of the virus infecting the hospitalized patient. Fox News Digital reached out to the department for comment.
The Centers for Disease Control and Prevention on Friday confirmed the country’s first severe case of bird flu in a human. (iStock)
There have been a total of 61 human cases throughout the country since April.
No human-to-human transmission has been reported, leading the CDC to maintain its stance that risk to the public is low.
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Despite the low risk, California Gov. Gavin Newsom on Wednesday declared a state of emergency due to the bird flu.
The declaration follows an outbreak of the virus among dairy cows in Southern California farms, according to the news release on the governor’s website.
“This proclamation is a targeted action to ensure government agencies have the resources and flexibility they need to respond quickly to this outbreak,” Newsom said in a statement.
California Gov. Gavin Newsom on Wednesday declared a state of emergency due to the bird flu. (Mario Tama)
“Building on California’s testing and monitoring system — the largest in the nation — we are committed to further protecting public health, supporting our agricultural industry, and ensuring that Californians have access to accurate, up-to-date information,” he continued.
“While the risk to the public remains low, we will continue to take all necessary steps to prevent the spread of this virus.”
Doctors discuss bird flu risk
Sam Scarpino, PhD, director of AI and life sciences at Northeastern University in Boston, said the “tragic case” in Louisiana is evidence of the “widespread nature” of H5N1 in the U.S.
“It also reinforces the very serious situation we are facing,” he told Fox News Digital.
“We need to take more decisive action to control the spread of H5N1 in animal populations.”
“We need to take more decisive action to control the spread of H5N1 in animal populations. Until then, we will continue to see human spillover cases, and some of them will unfortunately be severe.”
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, pointed out that this severe case represents just one instance of the infection and is not necessarily cause for alarm.
No human-to-human transmission has been reported, leading the CDC to maintain its stance that risk to the public is low. (iStock)
“We’d have to know more about the patient’s particular medical details,” he told Fox News Digital. “We can’t conclude [from one case] that it’s becoming more severe in humans.”
Previous iterations of bird flu have had a 50% death rate in humans, Siegel noted, but the 61 human cases in the U.S. this year have been “very mild.”
“That is actually a good sign, that the virus is mutating away from severity, as traditionally H5N1 makes humans very sick,” he told Fox News Digital.
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The most critical thing to watch, according to the doctor, is whether bird flu will begin to spread from human to human.
“That’s the key thing we’re concerned about — that it doesn’t get into the upper respiratory tract among humans,” Siegel said.
“Bird flu is a group of influenza viruses that primarily circulate among bird populations,” an expert told Fox News Digital. “However, influenza viruses are also known to jump species, and bird flu has done this a few times in history.” (Uli Deck/picture alliance via Getty Images)
“It hasn’t up until now, and that’s because it would take some mutations — at least one. We’re tracking that, but probably not closely enough.”
The vast majority of recent human cases have stemmed from direct contact with animals, he said — “but it’s now spread into the cattle population and into milk, which worries a lot of people, including me.”
Rebecca C. Christofferson, PhD, associate professor in the Department of Pathobiological Sciences at Louisiana State University, commented to Fox News Digital about the potential for a pandemic.
“Nobody wants another pandemic.”
“Bird flu is a group of influenza viruses that primarily circulate among bird populations,” she told Fox News Digital.
“However, influenza viruses are also known to jump species, and bird flu has done this a few times in history.”
A researcher wears a protective suit while collecting samples of wildlife where the H5N1 bird flu virus was detected in Chilean Antarctic territory in Antarctica. (Reuters/Instituto Antartico Chileno)
“The more the virus gets into mammals and then the more it passes from mammal to mammal, the greater the concern that it will adapt to mammals and spread more easily among them and then spill over into humans,” Christofferson added.
“Nobody wants another pandemic.”
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The good news, Cristofferson said, is that it’s easy to protect yourself from catching bird flu.
“If you have to handle birds or suspected ill animals (or be around ill people), wearing gloves and masks and washing your hands will protect you as it does with other respiratory viruses,” she said.
For those who are feeling “stuck” or overwhelmed while striving for work-life balance, some experts recommend adopting a “pendulum lifestyle.”
Coined by Dr. Jeffrey Karp, Ph.D, a professor of biomedical engineering at Brigham & Women’s Hospital Harvard Medical School in Boston, the pendulum lifestyle is defined as a “concept that acknowledges life’s natural ebb and flow, and empowers you to thrive amidst the swings.”
“Rarely are we in balance … it’s just unrealistic and an anxiety-inducing expectation,” the doctor told Fox News Digital in an interview.
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Seeing the world as a pendulum fosters a more compassionate mindset and alleviates the pressure to be perfect, Karp said.
For those who are feeling “stuck” or overwhelmed while striving for work-life balance, some experts recommend adopting a “pendulum lifestyle.” (iStock)
With this approach, people can take small steps to “swing the pendulum,” enabling them to feel more emotionally, mentally and physically “balanced” during the day, according to the expert.
This could also empower individuals who feel “stuck” when facing daily challenges, he said.
“Looking at nature, there are so many cycles, so many things that are kind of going back and forth, like night and day …. changes of seasons, and the waxing and waning of the moon,” noted Karp.
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The pendulum lifestyle involves daily “self-check-ins” where the person gauges their physical, emotional and mental energy levels, Karp said. They can then take immediate steps to move their levels in a positive direction toward the ideal balance.
“If we can visualize everything on a pendulum, we can think, ‘What’s the one step I could take today to bring the pendulum a little closer to where I want it to be?’” he said.
With this approach, people can take small steps to “swing the pendulum,” enabling them to feel more emotionally, mentally and physically “balanced” during the day. (iStock)
For example, a person who has low physical energy could visualize a pendulum with the lowest energy on one side and the highest energy on the other.
He would then do a “self-check” to identify where his energy level lies on the pendulum and what small steps could move it closer to the ideal balance point, Karp said.
“True well-being doesn’t lie in perfection or consistency, but in our ability to navigate the ebb and flow of life.”
That might mean taking a 10-minute walk, doing some jumping jacks or performing a few stretches to move the pendulum to a higher energy level position.
“This empowers the person and reminds them they are not stuck,” Karp said.
Taking a 10-minute walk, doing some jumping jacks or performing a few stretches can move the pendulum to a higher energy level position, the expert said. (iStock)
On the flip side, if it’s late at night and a person needs to wind down, she might engage in a calming exercise like meditation or listening to relaxing music as a way to swing the pendulum to a level more conducive to sleeping, the expert advised.
The pendulum lifestyle can also serve as a mood-booster, Kelp said. When someone is feeling down, watching a funny movie or practicing gratitude can help shift the pendulum.
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The approach could also help launch forward momentum if someone feels “stuck” in life, the expert said.
“When you start to realize that you’re not limited to being at that spot on the pendulum, but can take a step forward and be intentional, it’s just so empowering,” he said.
The daily check-in process could help individuals identify when they are feeling in less than tip-top shape and find ways to swing in a better direction, one expert said. (iStock)
Dr. Molly Sherb, an assistant professor of psychiatry at the Icahn School of Medicine at Mount Sinai and a licensed psychologist at Mount Sinai in New York City, commented on Karp’s concept of a pendulum lifestyle.
“When you start to realize that you’re not limited to being at that spot on the pendulum, but can take a step forward and be intentional, it’s just so empowering.”
She agreed that the daily check-in process could help individuals identify when they are feeling in less than tip-top shape and find ways to swing in a better direction.
“That might include getting better sleep or eating a healthier breakfast … to help you wake up with a better bandwidth tomorrow,” Sherb said.
Progress, not perfection
Dr. Christopher Fisher, a psychologist at Zucker Hillside Hospital Northwell Health in Queens, New York, said the pendulum lifestyle could help those who feel pressured to achieve a perfect work-life balance.
“The pendulum of life’s experiences – whether emotional, cognitive or physical – is one of the truest expressions of what it means to be human,” he told Fox News Digital.
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“True well-being doesn’t lie in perfection or consistency, but in our ability to navigate the ebb and flow of life,” he told Fox News Digital.
Sherb agreed that the essence of the pendulum lifestyle is that it’s not always possible to strike that 50-50 equal balance.
Adopt a constructive viewpoint and ask yourself what positive changes or routines can help you achieve a more optimal level on the pendulum path, one expert advised. (iStock)
“It’s about constantly tuning into yourself … and seeing which parts of your life might need you more at certain times,” she said.
“It’s not a one-size-fits-all approach, but a more tailored approach based on what you need and what people in your life need from you.”
4 steps to implementing the pendulum lifestyle
Karp shared some specific strategies for adopting the pendulum approach.
1. Perform a head-to-toe check-in each morning
Ask yourself how you are feeling emotionally, physically and mentally. What parts do not feel at a 100% level?
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2. Make any necessary adjustments
Based on your self-check-in, consider changing your routine to accommodate your energy level or take simple steps to help move the pendulum in a positive direction, Karp suggested.
3. Be compassionate and curious
If you feel off-balance, Karp said to recognize that as part of the natural pendulum swing and to embrace it with self-compassion rather than shame and criticism.
“It’s about constantly tuning into yourself … and seeing which parts of your life might need you more at certain times.”
Adopt a constructive viewpoint and ask yourself what positive changes or routines can help you achieve a more optimal level on the pendulum path, he advised.
4. Understand your pendulum swings
It could be helpful to ask yourself specific questions, such as the following.
“What factors helped contribute to a state of feeling balanced?”
“What factors contributed to feeling off-balance?”
“What small changes can I make today to foster a sense of better balance?”
“How did I respond to feeling imbalanced and was it effective?”
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Above all, Karp said, it’s important to remember that finding balance is a “lifelong journey.”
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