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-BioNTech COVID-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
Supreme Court Upholds , FDA Regulation on Popular , Abortion Drug Mifepristone.
On June 13, the Supreme Court ruled against a group of
doctors who challenged the Food and Drug Administration's
(FDA) regulations on the abortion pill mifepristone.
CBS reports that the case once again highlighted
abortion access following the conservative
majority decision to overturn Roe v. Wade in 2022.
The court ruled unanimously that the group of
anti-abortion rights doctors and medical associations
lacked the legal right to challenge the FDA. .
However, the court also did not address
whether the FDA's decision to relax the
rules for mifepristone's use were lawful. .
The latest ruling was authored
by Justice Brett Kavanaugh. .
Under Article III of the Constitution,
a plaintiff's desire to make a drug
less available for others does
not establish standing to sue. , Justice Brett Kavanaugh writing for the court, via CBS.
Nor do the plaintiffs' other
standing theories suffice.
Therefore, the plaintiffs lack
standing to challenge FDA's actions, Justice Brett Kavanaugh writing for the court, via CBS.
CBS reports that the ruling does not impact other
challenges to the FDA's standing on mifepristone,
while preserving access to the popular abortion medication.
In 2016 and 2021, the FDA took steps to widen access
to mifepristone, which has been taken by over
5 million patients since first being approved in 2000.
Those steps included allowing the drug to be taken up to 10
weeks into a pregnancy, reducing the number of in-person
doctor visits and permitting it to be sold through the mail.
Credit: Wibbitz Top Stories Duration: 01:30Published
Microdose Chocolate , May Cause Seizures, FDA Warns.
The FDA says that several people in
four states have gotten sick after eating Diamond Shruumz chocolate bars.
Severe symptoms experienced by the victims include "seizures, central nervous system depression, agitation, abnormal heart rates, hyper/hypotension, nausea and vomiting," CBS News reports. .
The chocolate, which is sold across the country, landed six of the eight victims in the hospital. .
The company's website says that the chocolate
is manufactured with a "primo proprietary blend
of nootropic and functional mushrooms.".
In 2022, the FDA called nootropics "a term widely used to market unapproved products as 'smart drugs' and 'cognitive enhancers.'".
On June 7, the FDA warned parents to
keep their kids away from the chocolate
which is marketed as candy. .
Parents and caregivers should consider
discussing the information in this
advisory with their children and take
extra care to avoid this product being
consumed by younger people. , FDA, via statement.
Half of the victims were in
Arizona, CBS News reports. .
While these products claim to
contain only natural ingredients
and no scheduled drugs, there is
clearly something toxic occurring, Steve Dudley, director of the Arizona Poison and
Drug Information Center, via news release.
We've seen the same phenomenon
of people eating the chocolate bar
then seizing, losing consciousness,
and having to be intubated, Steve Dudley, director of the Arizona Poison and
Drug Information Center, via news release
Credit: Wibbitz Top Stories Duration: 01:30Published
FDA Reverses Ban , on Juul E-Cigarettes.
On June 6, the Food and Drug Administration
announced that it has reversed its ban on Juul
e-cigarettes while the agency reviews new information.
On June 6, the Food and Drug Administration
announced that it has reversed its ban on Juul
e-cigarettes while the agency reviews new information.
NBC reports that the FDA first ordered Juul to take its
product off the market in 2022, however the e-cigarettes
have remained on shelves pending the company's appeal.
NBC reports that the FDA first ordered Juul to take its
product off the market in 2022, however the e-cigarettes
have remained on shelves pending the company's appeal.
In that time, Juul has maintained
its position as the second-most
popular e-cigarette in the U.S.
The FDA noted that reversing the ban
temporarily was not an indication that the
company's product would be ultimately cleared. .
The FDA noted that reversing the ban
temporarily was not an indication that the
company's product would be ultimately cleared. .
Sales of alternative nicotine
products, like e-cigarettes, have
continued to grow in the past decade. .
In 2023, the Centers for Disease Control and
Prevention reported that e-cigarette use had
grown by almost 50% between 2020 and 2022. .
In 2023, the Centers for Disease Control and
Prevention reported that e-cigarette use had
grown by almost 50% between 2020 and 2022. .
Juul released a statement
following the FDA reversal, .
... saying the company looks forward to "re-engaging
with the agency on a science- and evidence-based
process to pursue a marketing authorization.".
We remain confident in the quality
and substance of our applications
and believe that a full review of
the science and evidence will
demonstrate that our products
meet the statutory standard
of being appropriate for
the protection of public health, Juul statement, via NBC.
We remain confident in the quality
and substance of our applications
and believe that a full review of
the science and evidence will
demonstrate that our products
meet the statutory standard
of being appropriate for
the protection of public health, Juul statement, via NBC.
'The Wall Street Journal' reports that Juul has argued
that the 2022 ban significantly disrupted the company's
finances, resulting in an investor bailout.
Currently, the FDA has only granted approval for 23
e-cigarette products, manufactured by only three
companies, to be marketed and sold to consumers
Credit: Wibbitz Top Stories Duration: 01:31Published
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
Supreme Court Rules That , Some Jan. 6 Defendants, Were Improperly Charged.
NPR reports that the United States Supreme Court voted to limit which defendants accused of taking part in the Jan. 6 Capitol riot can be charged by federal prosecutors.
The decision also casts doubt on two out of
the four felony counts in former President
Donald Trump's election subversion indictment.
According to conservative Chief Justice John Roberts,
the court ruled that the U.S. government must prove , “that the defendant impaired the availability or integrity
for use in an official proceeding of records, documents,
objects, or other things used in an official proceeding.”.
NPR reports that prosecutors relied
on a key criminal statute to prosecute
over 350 participants of the Capitol riot.
The statute makes it a crime to alter or
destroy official documents, or to otherwise
obstruct or impede official proceedings.
Roberts wrote that the statute was
not meant to broaden the meaning of
the law to make it a catchall provision. .
The decision will impact other cases related
to Jan. 6, many of which will have to be
resentenced, retried or defendants will be released. .
NYU law professor Ryan Goodman authored
a study that found only 346 of the 1,417 people
charged in connection with the Capitol riot
were charged under the obstruction statute.
The study also found that 71 people are still
awaiting trial on the obstruction charge, but over
half of them are also charged with another felony.
NPR points out that if found guilty of other felony charges,
the sentencing judge is still allowed to use the charge of
obstruction to determine the length of their sentence.
Credit: Wibbitz Top Stories Duration: 01:31Published
Supreme Court Rules , Against SEC's Authority, to Impose Fines.
NPR reports that the United States Supreme Court
recently voted 6-3 against the Securities and
Exchange Commission's policy on fraudulent conduct. .
NPR reports that the United States Supreme Court
recently voted 6-3 against the Securities and
Exchange Commission's policy on fraudulent conduct. .
Chief Justice John Roberts, writing for the court's
conservative majority, said the current rules deprive accused
transgressors of their constitutional right to a jury trial. .
Chief Justice John Roberts, writing for the court's
conservative majority, said the current rules deprive accused
transgressors of their constitutional right to a jury trial. .
The SEC relies on administrative
law judges (ALJ) to make legal conclusions
in cases brought before the agency.
The Supreme Court's decision has the potential
to send ripples through dozens of agencies,
from labor rights to energy regulation.
The Court did exclude from its decision those
agencies dealing with federal benefits, while some
conservative justices wanted the ruling to go further.
The three liberal justices
in dissent blasted the
decision by the majority. .
The case was brought by a former conservative
radio host and hedge fund manager, George Jarkesy,
following an SEC fraud investigation.
The case was brought by a former conservative
radio host and hedge fund manager, George Jarkesy,
following an SEC fraud investigation.
An in-house evidentiary hearing fined Jarkesy $300,000,
ordered him to pay back almost $700,000 in ill-gotten
profits and barred him from the securities industry.
Jarkesy argued that he was entitled to a jury trial
held in a federal court and that Congress lacked
the power to delegate such authority to the SEC.
NPR reports that Jarkesy's case was supported
by a number of conservative and business groups, and individuals such as Elon Musk.
NPR reports that Jarkesy's case was supported
by a number of conservative and business groups, and individuals such as Elon Musk
Credit: Wibbitz Top Stories Duration: 01:31Published
Amazon Reaches $2 Trillion , in Stock Market Value.
On June 26, Amazon became the 5th American company to join the $2 trillion club, NPR reports. .
Amazon shares ended the day up nearly 4%, giving the company a $2.01 trillion stock market valuation. .
Within the past year,
Amazon's stock has gained 52%.
Part of that gain can be attributed
to investors' enthusiasm about the
company's AI endeavors, NPR reports. .
A big part of the valuation boost has
been cloud and AI. Amazon is going to
be a major player in the AI revolution, Dan Ives, Wedbush tech analyst, via NPR.
Amazon currently has a chatbot called Q, which businesses that use AWS have access to. .
Amazon currently has a chatbot called Q, which businesses that use AWS have access to. .
Amazon CEO Andy Jassy recently said that
AI has rejuvenated the growth of AWS.
The cloud computing unit is reportedly on pace to bring in $100 billion in annual revenue.
Amazon recently invested in Anthropic, a California
AI company, "to develop so-called foundation models
that underpin generative AI systems," NPR reports. .
Amazon also makes its own AI chips.
The other four U.S. companies that
belong to the $2 trillion club are
Google, Microsoft, Apple and Nvidia. .
The other four U.S. companies that
belong to the $2 trillion club are
Google, Microsoft, Apple and Nvidia. .
The other four U.S. companies that
belong to the $2 trillion club are
Google, Microsoft, Apple and Nvidia. .
The other four U.S. companies that
belong to the $2 trillion club are
Google, Microsoft, Apple and Nvidia.
Credit: Wibbitz Top Stories Duration: 01:30Published
Border Arrests Fall Over 40% , Since Biden Suspended Asylum Processing.
The Homeland Security Department made the announcement on June 26, NPR reports. .
Average daily arrests that the
Border Patrol has made over a week-long period have dropped below 2,400.
That is a decrease of over 40% from before the president's proclamation went into effect on June 5.
That is a decrease of over 40% from before the president's proclamation went into effect on June 5.
However, arrests need to drop to the
1,500 mark before asylum processing can resume.
Still, the current data marks the lowest number
of arrests since Jan. 17, 2021, NPR reports. .
Last week, President Biden touted a 25% decrease
in border arrests since the order took effect, .
which means they've
dropped a lot more since then.
Homeland Security Secretary Alejandro Mayorkas has called the executive order a "tremendous success.".
We indeed have seen a tremendous
success early on, and I should emphasize
that it is early on in our implementation
of the president’s proclamation and
our accompanying regulation, Alejandro Mayorkas, to CNN.
Mayorkas will address border enforcement
efforts in Tuscon, Arizona, on June 26.
The area has served as "the busiest corridor for illegal crossings" recently, NPR reports.
Credit: Wibbitz Top Stories Duration: 01:31Published
Upcoming Presidential Debate , Between Biden and Trump, Breaks With Tradition.
Upcoming Presidential Debate , Between Biden and Trump, Breaks With Tradition.
On June 27, President Joe Biden and former
President Donald Trump will meet in the
first presidential debate of 2024 in Atlanta.
On June 27, President Joe Biden and former
President Donald Trump will meet in the
first presidential debate of 2024 in Atlanta.
NPR reports that the debate marks the beginning of
a new phase in the presidential election, with less
than five months until Election Day on November 5.
According to the latest NPR/PBS News/Marist polls,
Biden and Trump are nearly tied following a month-long
trend of national surveys with the same results.
According to the latest NPR/PBS News/Marist polls,
Biden and Trump are nearly tied following a month-long
trend of national surveys with the same results.
Breaking with campaign tradition, the debate comes
months earlier than usual, following a set of rules
agreed to by candidates and without a live audience.
The event is scheduled to start at 9 p.m. ET
and is expected to run for 90 minutes.
CNN's Jake Tapper and Dana Bash will
moderate the event, which will take
place at the network's Atlanta studio.
CNN's Jake Tapper and Dana Bash will
moderate the event, which will take
place at the network's Atlanta studio.
The presidential debate will also be available
on CNN and the Max streaming platform. .
The presidential debate will also be available
on CNN and the Max streaming platform. .
NPR reports that presidential debates
have traditionally occurred in front of a live
audience and are coordinated by the bipartisan
Commission on Presidential Debates (CPD).
However, both Biden and Trump have said they
will not participate in the CPD's planned debates,
pushing for earlier face offs ahead of the election.
However, both Biden and Trump have said they
will not participate in the CPD's planned debates,
pushing for earlier face offs ahead of the election.
The second debate is scheduled
for September and will be
hosted by ABC News
Credit: Wibbitz Top Stories Duration: 01:31Published
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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