Video Credit: Reuters - Politics - Duration: 01:34s - Published
J&J files for U.S. COVID-19 vaccine authorization
Johnson & Johnson said on Thursday it has asked U.S. health regulators to authorize its single-dose COVID-19 vaccine for emergency use, and it will apply to European authorities in coming weeks.
Johnson & Johnson asked U.S. regulators to greenlight its COVID-19 vaccine for emergency use on Thursday, and says it will apply to European authorities in the coming weeks.
The company's application to the U.S. Food and Drug Administration follows its report last week which said its vaccine had a 66% success rate of preventing moderate and severe disease in its global trial.
That's less than the currently authorized Pfizer-BioNTech and Moderna shots, which were 95% effective in global trials.
But studies on those shots were carried out before the highly contagious new variants of the virus appeared to have emerged.
J&J's vaccine is single-dose and could help boost supplies and simplify the U.S. vaccination campaign, as concerns emerge over the potential of lower vaccine efficacy against those variants.
Unlike the two other vaccines, J&J's also doesn't need to be shipped frozen.
The U.S. has agreed to pay $1 billion for 100 million doses, which J&J said it expected to supply in the first half of the year.
The company aims to deliver 1 billion doses this year with production in the United States, Europe, South Africa and India.
The FDA said Thursday evening it's scheduled a meeting on Feb.
26 to discuss the company's request for emergency use authorization.
Both Pfizer and Moderna's vaccines were authorized just a day after those meetings.
Experts' Tips on Taking, Supplements as Sleep-Aids.
'Time' recently spoke with experts regarding
over-the-counter sleep aids and whether they
can really help someone with insomnia.
'Time' recently spoke with experts regarding
over-the-counter sleep aids and whether they
can really help someone with insomnia.
Melatonin has become a popular
supplement in recent years for being
a safe and effective sleep aid.
According to a 2023 study by the American Academy of Sleep
Medicine (AASM), nearly two-thirds of people in the
United States have tried using melatonin to help them sleep. .
It’s not something that is generally
harmful or toxic, which is probably
why people are tempted to take
more when a little bit doesn’t work, Dr. Milena Pavlova, neurologist at Brigham and Women’s
Faulkner Hospital and an associate professor of
neurology at Harvard Medical School, via 'Time'.
'Time' points out that supplements, such as
melatonin, are not regulated by the
U.S. Food and Drug Administration.
Similar to melatonin, over-the-counter antihistamines
like Benadryl have become a popular sleep-aid due to
containing doxylamine, which causes drowsiness.
However, doxylamine also comes
with a number of side effects,
including a potential hangover the next day.
The big problem with antihistamines
is they can make people extremely
groggy and really impair cognitive
function the next day, Dr. Indira Gurubhagavatula, professor of medicine
in the division of sleep medicine at the
University of Pennsylvania, via 'Time'.
While antihistamines can induce
drowsiness, they don't normally
result in quality, restorative sleep.
Experts suggest eliminating things that prevent healthy sleep, like alcohol and caffeine, while also incorporating physical activity into your daily routine.
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA to Outlaw Soda Ingredient , Already Banned Around the World.
Brominated Vegetable Oil (BVO) has been used as an emulsifier in various products
since the 1930s, ScienceAlert reports. .
Countries such as India, Japan and nations within
the European Union have banned BVO for years.
California also outlawed it in 2022.
Studies have indicated that BVO builds up in fat tissue when consumed and prevents iodine from properly functioning within the thyroid. .
BVO has also been linked with heart and behavioral problems, ScienceAlert reports. .
Recent toxicology studies prompted
the Food and Drug Administration (FDA)
to propose banning BVO in November.
The proposed action is an example of how
the agency monitors emerging evidence
and, as needed, conducts scientific research
to investigate safety related questions, , James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
... and takes regulatory action when the
science does not support the continued
safe use of additives in foods, James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
Over the years many beverage makers
reformulated their products to replace
BVO with an alternative ingredient, and
today, few beverages in the US contain BVO, James Jones, FDA deputy commissioner
for human foods, via ScienceAlert.
The FDA's BVO reclassification will still need to
go through a review process before completion.
James Jones, FDA deputy commissioner
for human foods, said that regulations
for authorizing other food additives are
currently being reviewed by the agency...
... in order to automatically block
the approval of ingredients known to
cause cancer in animals or humans
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Warns These , Cinnamon Brands , Could Contain Lead.
NPR reports that the Food and Drug Administration
has issued an advisory that several brands
of cinnamon could potentially contain lead.
The six brands impacted by the advisory are: , La Fiesta, Marcum, MK, Swad,
Supreme Tradition and El Chilar. .
These brands are commonly on sale at
discount stores and were found to contain
between 2.03 and 3.4 parts per million of lead.
The FDA said that while no illnesses have been
linked to the products, it has recommended
a voluntary recall of the cinnamon brands.
It is important to note that the lead
levels found in the ground cinnamon
products listed above are significantly
lower than lead levels in cinnamon in
the recalled apple sauce pouches
removed from the market this past fall, FDA statement, via NPR.
The FDA added that the impacted products , "could be unsafe for prolonged use.".
NPR reports that long-term lead exposure
in children can lead to slower development,
brain and nervous system damage,
as well as behavioral and learning problems.
According to the CDC, while adults
can experience similar impacts, higher
amounts of exposure are necessary.
The FDA said that "historically, lead chromate has
been illegally added to certain spices" to increase
their weight and enhance their color, "which
increases the monetary value of the adulterated spices." .
FDA's leading hypothesis
remains that this was likely
an act of economically
motivated adulteration, FDA statement, via NPR
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Approves Marketing , That Cites Yogurt's Ability , to Reduce Diabetes Risk.
NBC reports that the Food and Drug Administration
has decided that food makers can advertise
that regularly consuming yogurt could
reduce the risk of Type 2 diabetes.
NBC reports that the Food and Drug Administration
has decided that food makers can advertise
that regularly consuming yogurt could
reduce the risk of Type 2 diabetes.
The decision comes following a 2018 petition from
Danone North America, which owns major yogurt
brands Dannon, Activia, Wallaby Organic and Silk. .
The decision comes following a 2018 petition from
Danone North America, which owns major yogurt
brands Dannon, Activia, Wallaby Organic and Silk. .
The petition sought to have the FDA allow the
company to market yogurt's ability to reduce
the risk of Type 2 diabetes without objection.
On March 1, the FDA confirmed that
it would not oppose the marketing
campaign, while including some caveats. .
Those caveats include that the marketing must
note that evidence is limited to eating two cups,
equal to three servings, of yogurt per week. .
NBC reports that Danone's petition is
part of a standard process which the
FDA calls "qualified health claims.".
While these claims do not require the FDA's
approval, companies often petition the
agency to define the specific language
necessary to avoid making false claims.
The petition reportedly cited yogurt's nutrient
profile of proteins, vitamins and low sodium.
The petition also cited studies which have supported
the link between regularly consuming yogurt and
reduced risk of diabetes and related conditions.
The petition also noted that
the evidence supports the health
effects of yogurt as a food rather
than related to any single nutrient
or compound and thus is
independent of fat or sugar content. , FDA announcement, via NBC
Credit: Wibbitz Top Stories Duration: 01:31Published
Expert Advice About Daily , Caffeine Consumption.
NBC reports that while research has shown the
positive long-term health effects of coffee,
high caffeine consumption also comes with risks. .
Studies have found that those include
increased risk of dementia and stroke, in addition to
a higher risk of death from cardiovascular disease. .
According to experts, people with
pre-existing health conditions may experience
more of coffee's negative side effects. .
The Food and Drug Administration suggests
people limit daily caffeine intake to 400 milligrams,
equal to about four or five 8-ounce cups.
According to the FDA, people are unlikely to
experience serious side effects unless they consume
1,200 milligrams, or approximately 12 cups daily.
Tricia Psota, a dietitian with Nutrition on Demand, warns
that even 400 milligrams of caffeine can be associated with
side effects like jitteriness, anxiety and difficulty sleeping.
According to Psota, some people have a lower
tolerance for caffeine and are more likely
to experience negative side effects.
According to Jessica Sylvester, a dietition at the
Florida Nutrition Group, with everyone's tolerance varying, there are warning signs that you've had too much caffeine. .
Within those milligram or cup of coffee
recommendations, if you start feeling
overly tired and the caffeine is not
helping, then you’ve got to stop, Jessica Sylvester, Dietition at the Florida Nutrition Group, via NBC.
If your heart starts beating
incredibly fast, you’ve got to stop.
It’s different for each person, Jessica Sylvester, Dietition at the Florida Nutrition Group, via NBC
Credit: Wibbitz Top Stories Duration: 01:31Published
Study Warns Deadly , Ocean Upswells Increasing , Due to Climate Crisis.
'The Guardian' reports that a new study highlights how
the climate-disrupted ocean has pushed a number of aquatic
species to flee increasing temperatures in the tropics.
The forced migration has increasingly resulted in
sharks, rays and other species dying amid intense
upswells of cold water from the depths of the ocean.
In 2021, extreme cold upswelling off of
South Africa's coast caused a mass die-off of over
260 marine organisms from 81 different species.
A recent study found that these
upswellings are increasing in
both frequency and intensity. .
Scientists were able to study the 2021
mass die-off in precise detail, due to one of
the victims being a satellite-tagged bull shark.
The bull shark died in waters 10 degrees
Celsius below the temperature
tropical species are accustomed to.
Despite the shark's attempts to avoid the
cold swell, it could not escape the impacted
area before succumbing to hypothermia.
'The Guardian' reports that the team found
that the frequency of these cold upswelling
events has been increasing since 1981.
Other species killed in similar events
include whale sharks, bigeye trevallies, convict
surgeonfish and the common blacktip shark. .
Other species killed in similar events
include whale sharks, bigeye trevallies, convict
surgeonfish and the common blacktip shark. .
Other species killed in similar events
include whale sharks, bigeye trevallies, convict
surgeonfish and the common blacktip shark. .
Other species killed in similar events
include whale sharks, bigeye trevallies, convict
surgeonfish and the common blacktip shark. .
The team's findings were published
on April 15 in 'Nature Climate Change.'
Credit: Wibbitz Top Stories Duration: 01:31Published
Edinburgh's revenge mission to South Africa ends in defeat as the Sharks dump the Scots out of the European Challenge Cup at the quarter-final stage. BBC Sport
Edinburgh's revenge mission to South Africa ends in defeat as the Sharks dump the Scots out of the European Challenge Cup at the quarter-final stage. BBC Sport
With the FDA granting Johnson & Johnson's one-shot COVID-19 vaccine emergency use authorization, health officials in Pittsburgh believe it's going to be crucial in the fight against the pandemic...
Credit: KDKA CBS 2 Pittsburgh Duration: 02:44Published
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