FDA Postpones Meeting With Expert Advisers on Pfizer’s Vaccine for Young Kids
Video Credit: Wibbitz Top Stories - Duration: 01:30s - Published
FDA Postpones Meeting With Expert Advisers on Pfizer’s Vaccine for Young Kids
FDA Postpones Meeting , With Expert Advisers , on Pfizer's Vaccine for Young Kids.
FDA Postpones Meeting , With Expert Advisers , on Pfizer's Vaccine for Young Kids.
NPR reports that the FDA has postponed
a meeting of expert advisers about the use of the
Pfizer-BioNTechCOVID-19 vaccine for young children.
NPR reports that the FDA has postponed
a meeting of expert advisers about the use of the
Pfizer-BioNTech COVID-19 vaccine for young children.
Pfizer reportedly told the Food and Drug Administration
(FDA) that new data regarding the vaccine's use in
children from 6 months to 4 years of age has emerged.
.
Pfizer reportedly told the Food and Drug Administration
(FDA) that new data regarding the vaccine's use in
children from 6 months to 4 years of age has emerged.
.
According to the FDA, the agency postponed
the meeting to evaluate the additional data.
.
We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization, Food and Drug Administration statement, via NPR.
Pfizer and BioNTech were applying
for authorization of the first two shots, while
data was still being collected on a third dose.
.
Pfizer and BioNTech were applying
for authorization of the first two shots, while
data was still being collected on a third dose.
.
NPR reports that the companies have now
changed course, a decision that will delay access
to a COVID vaccine for the youngest children.
.
Given that the study is advancing
at a rapid pace, the companies will wait for
the three-dose data as Pfizer and BioNTech
continue to believe it may provide a higher
level of protection in this age group, Pfizer-BioNTech statement, via NPR.
The companies expect
to have three-dose protection
data available in early April, Pfizer-BioNTech statement, via NPR.
On February 11, Peter Marks, director
of the FDA's Center for Biologics
Evaluation and Research, said that, "it makes sense to wait to evaluate
a third dose before taking action." .
On February 11, Peter Marks, director
of the FDA's Center for Biologics
Evaluation and Research, said that, "it makes sense to wait to evaluate
a third dose before taking action." .
We realize the need for a vaccine
for COVID-19 — even with the drop
in cases.
We will do our part to
move ahead as fast as we can, Peter Marks, Director of the FDA's Center for
Biologics Evaluation and Research, via NPR
FDA Reviewing Data on MDMA , for Potential Approval of , Groundbreaking PTSD Treatment.
'The Independent' reports that federal health advisers are
considering a first-ever approval of MDMA, a psychedelic
drug, to treat post traumatic stress disorder (PTSD).
'The Independent' reports that federal health advisers are
considering a first-ever approval of MDMA, a psychedelic
drug, to treat post traumatic stress disorder (PTSD).
The news comes after decades of
psychedelic advocates urging regulators
to give the drug medical acceptance. .
On June 4, the Food and Drug Administration
(FDA) called on a group of outside experts
to review the latest MDMA research. .
The research suggests that when the drug is paired with talk therapy, it can help alleviate PTSD. .
However, regulators at the FDA have questioned the
reliability of the data, as well as the potential safety risks,
which include possible heart problems and addiction.
FDA approval could open the door for federal
approval to be granted as soon as this summer. .
Approval would make MDMA, often referred to as
ecstasy or molly, the first illegal psychedelic
to receive approval for mainstream medicine. .
'The Independent' reports that a number of
psychedelics are expected to receive FDA
reviews in the coming years amid interest in their
potential to treat depression, anxiety and addiction.
'The Independent' reports that a number of
psychedelics are expected to receive FDA
reviews in the coming years amid interest in their
potential to treat depression, anxiety and addiction.
It’s clear that MDMA-assisted
therapy would be a welcome
addition to the currently
available options, Dr. Kelley O'Donnell, a New York University psychiatrist who
helped conduct the MDMA studies, via 'The Independent'.
I’ve seen firsthand
how this treatment can
be lifesaving for some, Dr. Kelley O'Donnell, a New York University psychiatrist who
helped conduct the MDMA studies, via 'The Independent'
Credit: Wibbitz Top Stories Duration: 01:30Published
Cucumbers Are Recalled , in 14 States.
Fresh Start Produce Sales in Florida is
recalling cucumbers over possible salmonella contamination, 'Newsweek' reports.
The 14 states affected by the recall include Alabama, Florida, Georgia, Illinois, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and West Virginia.
Only large, whole cucumbers
are included in the recall.
Mini and English cucumbers
are considered safe to eat.
The Pennsylvania Department of Agriculture first informed Fresh Start that its product tested positive for salmonella.
The FDA is conducting whole genome
sequencing to determine if this sample
is related to an ongoing salmonella
outbreak investigation, Via recall notice.
Fresh Start believes it recalled the product before it could make it into consumers' hands.
Although these cucumbers are
unlikely [to be found] in the
marketplace, anyone with the
recalled product should not
consume it and should destroy
and discard it or return it to the
place of purchase for a refund, Fresh Start Produce Sales, via statement.
Consumers should check with their
retailer or place of purchase to
determine whether the recalled
cucumbers were sold where they shop, Fresh Start Produce Sales, via statement
Credit: Wibbitz Top Stories Duration: 01:31Published
Hims and Hers , to Offer Weight Loss Injections.
GLP-1 medications like Ozempic and Wegovy have become increasingly popular.
However, the market has faced some supply constraints recently because of that popularity.
On May 20, Hims & Hers Health announced that it will be providing access to compounded GLP-1 weight loss injections, CNBC reports. .
Company shares jumped over 30%
following the announcement.
Compounded versions of medications are created
by certain manufacturers who meet FDA requirements when there are medication shortages.
However, the products are not tested
for safety and efficacy by the FDA.
The new offering of compounded GLP-1 medications can be accessed by getting a prescription from a health care provider on the Hims & Hers site.
Branded GLP-1 injections will be made available
once the supply becomes more consistent.
The price for compounded injections will
start at $199 per month, CNBC reports. .
Prior to announcing its GLP-1 offerings,
Hims & Hers revealed in an earnings report...
... that it anticipates its weight loss
program to garner over $100 million
worth of revenue by December 2025.
Hims & Hers CEO Andrew Dudum said that he is "confident" that a steady supply of the compounded injections will be available for customers.
We have a certain degree of
exclusivity with that facility that
will guarantee our consumers
consistent volume and supply, Hims & Hers CEO Andrew Dudum, via statement
Credit: Wibbitz Top Stories Duration: 01:31Published
Experts Question Claim , That Yogurt Can Help , Prevent Type 2 Diabetes.
Associated Press reports that the United States Food
and Drug Association's recently allowed yogurt
producers to claim it reduces the risk of Type 2 diabetes. .
However, at the time, the agency acknowledged
that the claim is based on limited evidence.
In 2018, Danone North America, the U.S. side
of the French firm, sought FDA clearance
for making the "qualified health claim.".
Qualified health claims lack full scientific support
but are allowed as long as manufacturers include
a disclaimer to avoid misleading the public.
Similar qualified health claims have been
allowed for dietary supplements since
2000 and for food products since 2002. .
In March of 2024,
the FDA granted
Danone's request. .
According to the FDA, there is some evidence
that eating at least 2 cups of yogurt a week
could reduce the risk of developing Type 2
diabetes, which impacts about 36 million Americans.
Critics of the FDA's decision have countered
that the claim is not based on randomized
control trials which could prove or disprove
yogurt's purported health benefits.
Critics of the FDA's decision have countered
that the claim is not based on randomized
control trials which could prove or disprove
yogurt's purported health benefits.
The Center for Science in the Public
Interest, an advocacy group, cautions
that no single food can reduce the risk of
developing a disease linked to overall diet.
AP reports that experts have expressed
concerns that the label change could encourage
people to eat yogurt high in sugar, which could
increase the risk of developing diabetes
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Testing Reveals , Bird Flu Virus , in 1 in 5 Milk Samples.
'Time' reports that the Food and Drug Administration
(FDA) has warned that traces of bird flu have been found
in nearly one-fifth of commercial milk samples tested. .
In a statement released on the agency's website,
the FDA said that traces of the virus do not
necessarily indicate a risk to consumers. .
According to the FDA, more tests are needed
to confirm if intact pathogens that remain
infectious are present in the samples.
Those tests would determine , "whether there is any risk of illness
associated with consuming the product.".
'Time' reports that the results of the study
come as a stark warning of how quickly the
virus is spreading among dairy cows in the U.S.
The virus has already killed millions of birds globally,
raising both health and food security concerns,
as well as spooking global markets.
The virus has already killed millions of birds globally,
raising both health and food security concerns,
as well as spooking global markets.
So far, the Department of Agriculture has already
confirmed 33 infected herds across eight states,
including Texas, Michigan and Ohio.
So far, the Department of Agriculture has already
confirmed 33 infected herds across eight states,
including Texas, Michigan and Ohio.
In an effort to understand the extent of the outbreak
and potentially contain it, the USDA has implemented
mandatory testing of cows moving across state borders.
Authorities have stressed that the current
risk to humans remains low, with only one
identified human case in the U.S. this year. .
To date, the retail milk studies
have shown no results that would
change our assessment that the
commercial milk supply is safe. , FDA statement, via 'Time'
Credit: Wibbitz Top Stories Duration: 01:31Published
In a scathing attack, Rahul Gandhi criticised Prime Minister Modi for his recent statement claiming, "I am not biological; God has sent me." Gandhi slammed Modi, questioning the nature of a leader who, amidst the COVID crisis, made such remarks while people suffered. The statement underscores the ongoing political tension between the two leaders.
#RahulGandhi #RahulvsModi #LSPolls2024 #RahulGandhiMocksPMModi #Elections2024 #AAP #INDIA #BJP #PMModi #COVIDJibe #ModiClaims #DivineOrigin #NotBiological #GodSentMe #IndiaPolitics #COVIDResponse #ModiCriticism #RahulVsModi #PoliticalControversy #COVIDIndia #LeadershipDebate #IndianDemocracy
~PR.152~ED.102~HT.318~GR.121~
The next EU Commission will have to cope with a legacy of debt accummulated out of necessity by its predecessor in response to the Covid crisis and the Ukraine War. Instruments are in place to both control debt and invest in the future, but challenging times lie ahead.
Credit: euronews (in English) Duration: 00:56Published
The current EU Parliament and Commission had just begun the work of their five-year agenda when it was derailed by Covid-19 and then the Ukraine war. As the institutions' mandate enters a final phase, Real Economy gets the views of key players in Brussels on one of the EU's most difficult chapters.
Credit: euronews (in English) Duration: 08:00Published
Northern Ireland First Minister Michelle O'Neill has apologised for the hurt that was caused by her attendance at the funeral of republican Bobby Storey during the Covid-19 pandemic. "I know that my actions also angered the families and for that I'm truly sorry,” she told the Covid-19 Inquiry. Report by Jonesia. Like us on Facebook at http://www.facebook.com/itn and follow us on Twitter at http://twitter.com/itn
With an unprecedented breaththrough the Greens were among the surprise winners of the last European elections. Their ambitious climate agenda won over many voters. But Covid-19, the war in Ukraine, inflation and soaring energy costs have all taken heavy toll on the movement's popularity
Credit: euronews (in English) Duration: 20:00Published
Some Early Tesla Bulls , Are Ditching the Stock.
Reuters reports that Tesla's shares
are down about 30% this year.
Since 2021, shares have fallen
over 50%, causing the company to
lose $600 billion in market value. .
Q1 results fell short of analysts' expectations.
As a result, many of Tesla's
institutional shareholders are saying
goodbye to the stock, Reuters reports. .
Gabelli Funds sold all of
its 65,900 shares in Q1. .
It started to feel like the
fundamentals were becoming
detached from reality. , John Belton, a portfolio manager at Gabelli Funds, via NPR .
We think the stock works best when
there are auto company fundamentals
that justify the stock price, John Belton, a portfolio manager at Gabelli Funds, via NPR .
Ross Gerber of Gerber Kawasaki Wealth
& Investment Management has sold
about 200,000 Tesla shares this year. .
I think the story is over,
is the best way to say it, Ross Gerber of Gerber Kawasaki Wealth
& Investment Management, via NPR.
Over the last year and a half, Elon’s
personal quests based on the way that
he sees the world have superseded the
interests of Tesla and its shareholders, Ross Gerber of Gerber Kawasaki Wealth
& Investment Management, via NPR.
However, not all of Wall Street
has given up on the stock.
Five mutual funds tracked by Morningstar
increased their Tesla shares last quarter,
and 19 analysts have given Tesla a "buy" or "strong buy" rating, Reuters reports.
Credit: Wibbitz Top Stories Duration: 01:30Published
Claudia Sheinbaum Is Elected , As Mexico’s First Female President.
The former Mexico City mayor was elected as the country's first female president on June 2.
She's estimated to win the
election with "between 58% to
over 60% of the votes," NPR reports. .
Xóchitl Gálvez is projected to
get about 28% of the vote.
while Jorge Álvarez Máynez will likely
receive about 10% of the vote.
Outgoing President Andrés Manuel López Obrador took to X to congratulate Sheinbaum.
Today is a day of glory because
the people of Mexico freely and
democratically decided that Claudia
Sheinbaum becomes the first
female president in 200 years of
independent life of our Republic. , Andrés Manuel López Obrador, via X.
Congratulations to all of us who
have the joy of living in these stellar
times of pride and transformation, Andrés Manuel López Obrador, via X.
Sheinbaum is considered by many to be López Obrador’s political protege, promising to uphold policies and programs he instated while in office.
Sheinbaum is considered by many to be López Obrador’s political protege, promising to uphold policies and programs he instated while in office.
Many voters consider the transition to be "perfect" since Sheinbaum has López Obrador’s support.
I don’t have a lot of life left to live,
but I will support him to the death, 77-year-old Ignacio Morales, via NPR.
Others weren't so supportive. .
He’s a dictator,
and Sheinbaum is his puppet, Almarosa Anaya, via NPR
Credit: Wibbitz Top Stories Duration: 01:30Published
American Airlines Is Sued for Discrimination , After Removing Black Men From Flight.
Three Black men filed a lawsuit against
the airline on May 29, NPR reports.
The men allege that they and five
other Black men were subjected to
"blatant and egregious racial discrimination"...
... when they were removed from
a flight in January "without any valid
reason, based solely on their race.".
The eight men reportedly did not know one another and weren't seated by each other on the flight. .
The lawsuit claims that an American Airlines representative singled out each of the men, asking them to leave the plane and book another flight.
In fact, once they reached the jet bridge,
they saw that several other Black men were
also being removed from the plane. In fact,
it appeared to Plaintiffs that American had
ordered all of the Black male passengers
on Flight 832 off the plane, Via lawsuit.
Later, the men discovered that they had been removed from the plane because a passenger complained about body odor, although none of them were approached about body odor. .
When the men told another American
Airlines staff member that they were being
racially targeted, the employee said she
"did not disagree," the lawsuit claims.
Ultimately, the passengers re-boarded the flight because there were no other flights available to their destination that evening.
Plaintiffs then had to re-board the plane
and endure the stares of the largely
white passengers who viewed them
as the cause of the substantial delay. , Via lawsuit.
They suffered during the entire
flight home, and the entire incident
was traumatic, upsetting, scary,
humiliating and degrading, Via lawsuit.
American Airlines is "currently
investigating the matter, as the claims do
not reflect" the company's "core values."
Credit: Wibbitz Top Stories Duration: 01:31Published
Struggling With Everyday Decisions? , Here's How to Be More Decisive.
Have you ever found yourself scrolling through streaming services, overwhelmed by the thousands of options,
so you continue scrolling for what seems like forever?.
NPR reports that indecisiveness is a trait that has gained momentum among citizens of the United States since the onset of the COVID-19 pandemic.
NPR reports that indecisiveness is a trait that has gained momentum among citizens of the United States since the onset of the COVID-19 pandemic.
Per the American Psychological Association's yearly
'Stress in America' Survey, almost one-third of American adults say they often have trouble making everyday decisions.
Per the American Psychological Association's yearly
'Stress in America' Survey, almost one-third of American adults say they often have trouble making everyday decisions.
Here's how to be less indecisive:.
Nothing is Perfect.
Have you been frozen by the sheer amount of options on a restaurant menu? Are you afraid of making the "wrong" choice?.
Have you been frozen by the sheer amount of options on a restaurant menu? Are you afraid of making the "wrong" choice?.
Experts say there is often no perfect choice, and the idea that one may exist could prevent you from choosing at all. Trust yourself.
Limit Your Options .
Experts say, if possible, give
yourself less room to choose.
For instance, while at the grocery
store, avoid "analysis paralysis" by preparing a list and sticking to it.
For instance, while at the grocery
store, avoid "analysis paralysis" by preparing a list and sticking to it.
Self-Trust.
Second opinions can be invaluable,
though experts say you must
learn to trust yourself.
There are situations
where I want to sit
with the discomfort
of making the
decision myself, , Monica Johnson, licensed psychologist, via NPR.
... and then [I] kind of look at what is the outcome of the decision, so that I can build up trust in my ability to
know what's right for me... , Monica Johnson, licensed psychologist, via NPR.
... and then [I] kind of look at what is the outcome of the decision, so that I can build up trust in my ability to
know what's right for me... , Monica Johnson, licensed psychologist, via NPR
Credit: Wibbitz Top Stories Duration: 01:31Published
Why You Should , Set Healthy Boundaries .
Do you feel pressured to say yes to yet another work request? Maybe you've been burnt out by
too many social gatherings?.
It could be time to set some healthy boundaries.
A boundary is something that keeps you safe and comfortable in your relationships. , Nedra Glover Tawwab, therapist, author of 'Set Boundaries, Find Peace,' via NPR.
Signs You Need
to Set Boundaries.
If you feel forced into things you don't want to do, you're compromising on your boundaries.
Experts say ignoring to set boundaries often leads to frustration and resentment.
Increased anxiety prior to interacting with certain people or anticipating declining a request may also be a sign it's time to fortify your boundaries.
Those [feelings] are indicators that perhaps there is space for boundaries in this situation. , Nedra Glover Tawwab, therapist, author of 'Set Boundaries, Find Peace,' via NPR.
Practice Setting Boundaries.
Boundary-setting takes dedication and practice. Here are a few ways to refine your boundary-setting skills.
Ask yourself what you're willing to tolerate. When something doesn't feel right, set a boundary and communicate it clearly.
If you feel overextended, say so. Don't expect others to know what you can or can't handle.
If you don't have the energy to honor a request, be honest and politely decline.
Remember, boundaries start with you. Understanding your own capacity could lead to a life of healthier relationships
Credit: Wibbitz Top Stories Duration: 01:30Published
Dr. Anthony Fauci speaks with CNN’s Wolf Blitzer and gives his reaction to the FDA’s announcement that it had postponed a scheduled meeting to go over data from Pfizer and BioNTech’s vaccine..
Doctors question unusual COVID vaccine authorization for kids, as Pfizer says the FDA asked them to submit for the authorization despite lack of efficacy data 🤔
Doctors question unusual COVID vaccine authorization for kids, as Pfizer says the FDA asked them to submit for the authorization despite lack of efficacy data 🤔
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