Moderna to seek COVID vaccine authorization for teens
Video Credit: Reuters - Politics - Duration: 01:23s - Published
Moderna to seek COVID vaccine authorization for teens
Moderna's COVID-19 vaccine was found to be effective in adolescents aged 12-17 and showed no new or major safety problems in a clinical trial, the developer said on Tuesday, potentially setting the stage for a second vaccine for school-aged children to be authorized in July.
Vaccine-makers are racing to get approval for their COVID-19 shots in younger and younger people.
And on Tuesday, Moderna announced it would be the second firm to seek clearance to use their vaccine in school-age children in the U.S. A clinical trial showed Moderna’s shot was effective in adolescents aged 12-17, with no new or major safety problems. The Moderna vaccine – already authorized for adults aged 18 and up – will now go to the U.S. Food and Drug Administration, which could grant emergency use authorization as soon as July.
It took U.S. regulators about a month to review and approve the Pfizer/Biontech shot for ages 12-15.
Moderna's trial studied 3,732 adolescents aged 12 to 17.
Two thirds got the vaccine and one third got a placebo.
Two weeks after the second dose, researchers found no cases of COVID-19 in the vaccine group and four cases in the placebo group.
Children rarely develop COVID-19 symptoms. But they remain at risk of falling seriously ill and can still transmit the virus.
Widely vaccinating kids aged 12 and up could allow U.S. schools and summer camps to relax masking and social distancing measures suggested by the CDC.
Moderna is currently testing its vaccine in children as young as 6 months of age.
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
US Surgeon General , Declares Gun Violence in America , a ‘Public Health Crisis’.
U.S. Surgeon General Dr. Vivek Murthy
made the declaration in a new advisory released on June 25, CNN reports.
It is the first time that a surgeon general
has focused on gun violence's "profound consequences" in a national publication. .
Over the last decade or two,
this problem has been worsening and we
have now reached the point where gun violence is the leading cause of death among kids and teens – the leading cause of death. , Dr. Vivek Murthy, to CNN's John Berman.
That is something that we should
never take as the new normal.
There’s nothing normal about that, Dr. Vivek Murthy, to CNN's John Berman.
According to Murthy, the advisory is intended to take the polarizing issue of firearms "out of the realm of politics and put it into the realm of public health, which is where it belongs.".
According to Murthy, the advisory is intended to take the polarizing issue of firearms "out of the realm of politics and put it into the realm of public health, which is where it belongs.".
The advisory highlights measures that Murthy believes can have an impact on gun violence.
just as steps to address vehicle crashes and tobacco-related illnesses have in the past. .
just as steps to address vehicle crashes and tobacco-related illnesses have in the past. .
Historically, we have seen how the
release of Surgeon General reports on
public health issues such as the dangers
of smoking ignited a wave of policy,
legal, and public health initiatives.., Dr. Joseph V. Sakran, Brady board chair
and chief medical officer, via CNN.
... that saved countless American
lives and in this case led to
deprogramming our nation from
the tobacco industry’s lies. , Dr. Joseph V. Sakran, Brady board chair
and chief medical officer, via CNN.
We hope this report will have
the same resounding impact on
the gun violence epidemic, Dr. Joseph V. Sakran, Brady board chair
and chief medical officer, via CNN.
In 2022, over 48,000 people in America died from gun-related injuries, according to CDC data.
In the new advisory, Dr. Murthy said, "It is up to
us to take on this generational challenge with
the urgency and clarity the moment demands.".
The safety and well-being
of our children and future generations are at stake, Dr. Vivek Murthy, via advisory
Credit: Wibbitz Top Stories Duration: 01:31Published
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