Pfizer Inc plans to ask U.S. regulators to authorize a booster dose of its COVID-19 vaccine within the next month, the drugmaker's top scientist said on Thursday, based on evidence of greater risk of reinfection six months after inoculation and the spread of the highly contagious Delta variant.
Pfizer said on Thursday that it will ask U.S. regulators to authorize a third booster shot of its COVID-19 vaccine within the next month, based on evidence of greater risk of reinfection six months after inoculation and the fast-spreading Delta variant.
Pfizer's chief scientific officer, Mikael Dolsten, said a recently reported dip in the vaccine's effectiveness in Israel was mostly due to infections in people who had been vaccinated in January or February.
Pfizer did not release the full set of Israeli data on Thursday, but said it would be published soon.
But Pfizer stressed that data from Israel and Britain suggests that even with waning antibody levels, the vaccine remains around 95% effective against severe disease.
Dolsten said that early data from the company's own studies shows that a third booster dose generates antibody levels that are five to 10-fold higher than after the second dose, suggesting that a third dose will offer promising protection.
He said that multiple countries in Europe and elsewhere have already approached Pfizer to discuss booster doses, and that some may begin administering them before a potential U.S. authorization.
Meanwhile, U.S. regulators said late on Thursday that Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time, writing quote:"We are prepared for booster doses if and when the science demonstrates that they are needed."
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
The defence secretary pledged support for Israel as long as it 'behaves responsibly' ' and 'within international law'. Grant Shapps blamed Iran for all the problems in the region and reiterated Israel's right to defend itself. Report by Gluszczykm. Like us on Facebook at http://www.facebook.com/itn and follow us on Twitter at http://twitter.com/itn
Hezbollah launched a missile and drone attack on a military facility in northern Israel on April 17, injuring 14 Israeli soldiers. This retaliation followed Israeli airstrikes that killed Hezbollah members in southern Lebanon. Israel responded with airstrikes in Lebanon, continuing the months-long conflict. The fighting has caused significant casualties on both sides.
#hezbollahisrael #hezbollahisraelwar #hezbollahisraellive #hezbollahisraelborder #hezbollahisraelnews #Israel #Lebanon #US #Worldnews #Oneindia #Oneindianews
~ED.103~GR.123~
FDA Grants , Priority Review to, Pfizer's COVID-19 Vaccine.
On July 16, the U.S. Food and Drug Administration (FDA) announced that the Pfizer/BioNTech COVID-19 vaccine has been granted priority review..
Credit: Wibbitz Top Stories Duration: 00:52Published
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