Pfizer’s COVID Booster Shot for 5 to 11 Year Olds Authorized by FDA
Video Credit: Wibbitz Top Stories - Duration: 01:30s - Published
Pfizer’s COVID Booster Shot for 5 to 11 Year Olds Authorized by FDA
Pfizer’s COVID Booster Shot , for 5 to 11 Year Olds, Authorized by FDA.
NBC News reports on May 17, the Food
and Drug Administration (FDA)...
… announced it had authorized Pfizer-BioNTech's coronavirus
booster dose for 5 to 11 year olds.
The FDA says eligible recipients of a booster dose could receive the extra shot starting five months after their initial two-dose series.
Per NBC News, Pfizer's booster shot for
5 to 11 year olds is 10 micrograms ... .
... a third of the dosage given
to citizens 12 and older.
FDA To Pull Juul E-Cigarettes , off US Market.
Fox News and other outlets report that the Food and Drug Administration (FDA) is gearing up to order Juul Labs Inc.
to remove its e-cigarettes from store shelves in America.
Fox News and other outlets report that the Food and Drug Administration (FDA) is gearing up to order Juul Labs Inc.
to remove its e-cigarettes from store shelves in America.
The announcement is expected to come
as data presented by Juul has been
under review for nearly two years. .
The announcement is expected to come
as data presented by Juul has been
under review for nearly two years. .
Fox News reports that four years ago,
the vaping company came under fire for
its fruity flavors and marketing direction.
Fox News reports that four years ago,
the vaping company came under fire for
its fruity flavors and marketing direction.
Fox News reports that four years ago,
the vaping company came under fire for
its fruity flavors and marketing direction.
Critics say underage vaping surged as a result.
Juul has since cut back on its marketing,
and in 2019, the company stopped selling
fruity, sweet cartridge flavors. .
Still, sales have dramatically declined
for the e-cigarette manufacturer. .
The sale of all fruity e-cigarette flavors
has since been banned by the FDA.
Juul's impending departure would pave the way for
Reynolds American Inc. and NJOY Holidings Inc. to corner the tobacco-flavored segment of the e-cigarette market.
Juul's impending departure would pave the way for
Reynolds American Inc. and NJOY Holidings Inc. to corner the tobacco-flavored segment of the e-cigarette market.
Juul's impending departure would pave the way for
Reynolds American Inc. and NJOY Holidings Inc. to corner the tobacco-flavored segment of the e-cigarette market.
Fox News reports Juul will be able to file an appeal through the FDA, take the matter to court or file a new application with revised products. .
Fox News reports Juul will be able to file an appeal through the FDA, take the matter to court or file a new application with revised products.
Credit: Wibbitz Top Stories Duration: 01:30Published
Juul e-cigarettes will soon be off the shelves, at least according to a report, that states the FDA is planning to ban the product from being sold in the U.S... TMZ.com
FDA Panel , Endorses
COVID Vaccines, for Children Under 5.
On June 15, an advisory panel to the United States
Food and Drug Administration voted to recommend
two COVID-19 vaccines for kids ages 5 and under.
Yahoo reports that both Pfizer/BioNTech
and Moderna were under review by the panel. .
The unanimous FDA panel vote
is the first step in what is predicted
to be a quick authorization process.
According to Yahoo, data from trials shows
that both vaccines continue to protect against severe disease, hospitalization and death.
According to Yahoo, data from trials shows
that both vaccines continue to protect against severe disease, hospitalization and death.
Yahoo reports that parents now
have two options for how
to vaccinate their children.
Pfizer's vaccine for kids is delivered in three,
three-microgram doses, while Moderna's vaccine
is delivered in two shots of a 25-microgram dose.
Our robust clinical study shows that
three doses can provide protection for
the circulating Omicron variant and
offers promise for protection against
potential future waves of COVID-19, Dr. Bill Gruber, Pfizer's Vaccine Clinical Research
and Development head, via Yahoo.
Our robust clinical study shows that
three doses can provide protection for
the circulating Omicron variant and
offers promise for protection against
potential future waves of COVID-19, Dr. Bill Gruber, Pfizer's Vaccine Clinical Research
and Development head, via Yahoo.
The committee’s support today
is imperative to providing a critical tool
for pediatricians, parents, and caregivers
who eagerly await an option
for children under five, Dr. Bill Gruber, Pfizer's Vaccine Clinical Research and Development head, via Yahoo.
Both companies are now awaiting approval from
the FDA and the CDC which will hold an advisory
committee meeting on the topic over the weekend.
Credit: Wibbitz Top Stories Duration: 01:30Published
Pfizer's COVID Vaccine
for Kids Under 5 , Moves Closer to FDA Approval .
Pfizer announced on June 1 that its application to the Food and Drug Administration (FDA) for the vaccine was complete.
Pfizer announced on June 1 that its application to the Food and Drug Administration (FDA) for the vaccine was complete.
The three-dose vaccine is for children between the ages of six months and five years.
Pfizer released a statement detailing the application.
Pfizer and BioNTech completed a rolling application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA)... , Pfizer Statement, via ABC News.
... of the 3-µg [microgram] dose of the Pfizer-BioNTech COVID-19 Vaccine.., Pfizer Statement, via ABC News.
... for children 6 months through
4 years of age (also referred to as
6 months to under 5 years of age) on June 1, 2022, Pfizer Statement, via ABC News.
Pfizer reported an 80 percent effectiveness rate in children in May.
The FDA also released a statement on June 1, confirming that the agency had accepted the Pfizer application.
We recognize parents are anxious to have their young children vaccinated against COVID-19... , FDA Statement, via ABC News.
... and while the FDA cannot predict how long its evaluation of the data and information
will take, , FDA Statement, via ABC News.
... we will review any EUA request we receive as quickly as possible using a science-based approach, FDA Statement, via ABC News.
According to a poll conducted by the
Kaiser Family Foundation in April of this year.
... just 18 percent of parents intend to have their children vaccinated once the vaccine is approved.
27 percent of parents stated that they will "definitely not" vaccinate their children against COVID
Credit: Wibbitz Top Stories Duration: 01:31Published
FDA Warns Viral Avocado Hack , Could Make You Sick.
Fox News reports a recent
viral kitchen hack intended
to keep avocados fresh for
increased periods of time
could make you sick.
The hack involves storing
ripe avocados in jars of water.
The method has gained traction
on social media platforms.
After garnering millions of views, the
Food and Drug Administration (FDA) has determined the hack to be unsafe.
The FDA does
not recommend
this practice. , FDA spokesperson, via Fox News .
The main concern is with the possibility that any residual human pathogens... , FDA spokesperson, via Fox News .
... for example, Listeria monocytogenes, Salmonella spp., etc. – that may be residing on the avocado surface... , FDA spokesperson, via Fox News .
... may potentially multiply during the storage when submerged in water, FDA spokesperson, via Fox News .
In a 2016 study, FDA researchers
found dangerous bacteria can
accumulate on avocado skins, often causing cross-contamination.
Rather than submerging avocados in water, the FDA recommends storing them in a cool and dry environment
Credit: Wibbitz Top Stories Duration: 01:30Published
Pfizer’s 3-Dose Vaccine , 80% Effective Against Omicron, Infection for Youngest Children.
ABC News reports new data shows
Pfizer's 3-dose vaccine is 80% effective against omicron infections in children
five years old and younger.
In all age groups, Pfizer's coronavirus
vaccine has been less effective against
mild breakthrough infections.
but has been shown to offer high protection against severe disease and death.
Experts say Pfizer's announcement offers reassurance to parents who wish to protect their children against coronavirus.
We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of
the dose strength for adults ... , statement from Albert Bourla, chairman CEO Pfizer, via ABC News.
... was well tolerated
and produced a strong immune response. , statement from Albert Bourla, chairman CEO Pfizer, via ABC News.
After two years without a vaccine for young children, many pediatricians and parents intend to vaccinate as soon as possible.
However, recent polls have shown over 50% of parents feel they need more information before their children receive a COVID-19 shot.
Parents should also be
aware that this preliminary
data will be supplemented by additional data in June ... , Dr. Alok Patel, pediatric hospitalist Stanford Children's Health, via ABC News.
... which will then be
thoroughly reviewed by
both the FDA and the CDC. , Dr. Alok Patel, pediatric hospitalist Stanford Children's Health, via ABC News
Credit: Wibbitz Top Stories Duration: 01:30Published
CDC Signs Off on COVID Vaccine Boosters , for Kids Ages 5–11.
CNN reports that on May 19, the CDC's
Advisory Committee on Immunization Practices (ACIP)... .
... voted in support of recommending an additional Pfizer shot for 5- to 11-year-olds who've received their first two doses.
The vote was 11-1 with 1 abstention.
CNN reports that the FDA authorized
the booster dose earlier this week.
Children within this age group are advised to wait at least five months after receiving their two-dose regimen before getting a booster shot.
CNN reports a fourth dose is recommended for children who are immunocompromised. .
According to Pfizer, a trial of 4,500 children ages 5-11 showed Omicron-fighting antibodies were 36 times stronger upon receiving a booster.
The company also says
no new safety issues were detected.
On May 16, the American Academy of Pediatrics reported that COVID cases in U.S. children rose 76%
the previous week compared to two weeks prior.
CDC Director Dr. Rochelle Walensky gave opening remarks before the ACIP's vote.
The sadness I feel for
lives lost, the families
devastated and the
communities changed
is steep. We have the
tools we need to protect
these people from severe
disease and prevent any
more tragic deaths, Dr. Rochelle Walensky, via opening remarks
before the ACIP's vote, via CNN
Credit: Wibbitz Top Stories Duration: 01:31Published
CDC Warns of COVID 'Rebound' , After Taking Paxlovid.
Paxlovid can be prescribed for those who may have a high risk of being hospitalized with COVID. .
But CDC Director Dr. Rochelle Walensky recently revealed that those who take it can have "rebound" symptoms.
If you take Paxlovid, you might get symptoms again, Dr. Rochelle Walensky, CDC Director,
via CBS News.
We haven't yet seen anybody who has returned with symptoms needing to go to the hospital. , Dr. Rochelle Walensky, CDC Director,
via CBS News.
So, generally, a milder course, Dr. Rochelle Walensky, CDC Director,
via CBS News.
Dr. Walensky maintains that the drug is useful in
preventing COVID illness that requires hospitalization.
Data from the CDC shows that Paxlovid prevents death and hospitalization for unvaccinated COVID patients by up to 90 percent.
Health officials are unsure as to the cause of COVID rebound in patients who have taken Paxlovid.
One health official described their experience with contracting COVID, taking the drug and getting sick again.
I was totally shocked. I did not expect that. , Dr. David Ho, Infectious Disease Expert,
via CBS News.
And that's because I had tested negative six consecutive days, including two PCR, Dr. David Ho, Infectious Disease Expert,
via CBS News.
In order to prevent infecting others,
Dr. Walensky says that those who experience COVID rebound should take standard virus precautions.
They should test. They should put their mask back on. , Dr. Rochelle Walensky, CDC Director,
via CBS News.
And if their test is positive,
restart the isolation protocol, Dr. Rochelle Walensky, CDC Director,
via CBS News
Credit: Wibbitz Top Stories Duration: 01:31Published
CDC Says One-Third of Americans , Should Be Wearing Masks.
CNN reports that the U.S. Centers for Disease Control and Prevention (CDC) is urging local officials to encourage their constituents to mask up.
Currently, over 32% of Americans live
in regions experiencing medium to high
COVID-19 community levels.
Per CDC data, 9% of Americans live in areas with high COVID-19 community levels.
23% of citizens are currently living
in areas with a medium amount of
coronavirus transmission.
We urge local leaders to
encourage the use of prevention strategies like masking in public indoor settings and increasing
access to testing and to treatment. , Dr. Rochelle Walensky, CDC Director, via CNN.
In areas where community levels are high, everyone should be using prevention measures and wearing a mask in public indoor settings. , Dr. Rochelle Walensky, CDC Director, via CNN.
As of May 18, nearly 4.25% of counties in the
United States have soaring COVID-19 community levels. .
As we’re currently seeing
a steady rise of cases in parts of the country... , Dr. Rochelle Walensky, CDC Director, via CNN.
... we encourage everyone
to use the menu of tools we have today to prevent further infection and severe disease, , Dr. Rochelle Walensky, CDC Director, via CNN.
... including wearing a mask, getting tested, accessing treatments early if infected and getting vaccinated or boosted, Dr. Rochelle Walensky, CDC Director, via CNN
Credit: Wibbitz Top Stories Duration: 01:30Published
Increase in US COVID Rates , Prompts Health Officials
to Urge Mask-Wearing, in Some Areas.
Federal health officials presented an assessment from the White House on May 18.
Speaking were Dr. Ashish Jha, the
White House COVID response coordinator, .
and Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention (CDC).
We urge local leaders to encourage the use of prevention strategies like masking in public indoor settings.., Dr. Rochelle P. Walensky, CDC Director,
via 'The New York Times'.
... and increasing access to testing and treatment
for individuals, Dr. Rochelle P. Walensky, CDC Director,
via 'The New York Times'.
The COVID briefing was the first to be conducted from the White House in six weeks.
According to federal data, hospital admissions related to COVID have increased by 20 percent over the past week.
The Northeastern U.S. has experienced the most dramatic increase in cases.
Dr. Jha urged Congress to approve additional COVID aid to address the rising cases and a potential wave in the fall.
Experts weighed in, stating that now is a good time
to reimplement prevention measures.
We’re seeing rising cases and hospitalizations and testing positivity rates; now is not the time to end these flexibilities that allow great access to care, Ashley Thompson, American Hospital Association, via 'The New York Times'.
We are not out of the woods yet, Ashley Thompson, American Hospital
Association, via 'The New York Times'.
We could be entering a period where we have an increased number of cases but a substantially decreased severity of illness, Dr. Michael T. Osterholm, University of Minnesota,
via 'The New York Times'.
... so that we see fewer hospitalizations and many
fewer deaths, Dr. Michael T. Osterholm, University of Minnesota,
via 'The New York Times'
Credit: Wibbitz Top Stories Duration: 01:30Published
Pfizer's First Quarter , Profits Blast Past, 2022 Forecast.
ABC reports that Pfizer's COVID-19 vaccine and treatment
sales helped propel the pharmaceuticals company
beyond Wall Street's first quarter expectations. .
Pfizer's coronavirus vaccine
Comirnaty raked in over $13 billion
in sales for the first quarter. .
Pfizer's coronavirus vaccine
Comirnaty raked in over $13 billion
in sales for the first quarter. .
The vaccine has remained
Pfizer's top selling product
for almost the last year. .
The drugmaker's pill treatment
Paxloid reportedly added an additional
$1.5 billion to the company's sales. .
ABC reports that Pfizer's, profits grew 61% , in the first quarter. .
On May 3, the company posted
a net income of $7.86 billion and first
quarter adjusted earnings of $1.62 per share. .
The results easily exceeded
the $1.49 increase predicted
by industry analysts. .
Compared to the same time last year,
the company's revenue skyrocketed 77% , to reach $25.66 billion. .
According to ABC, the drugmaker
expects the company's total revenue in 2022
to reach between $98 billion and $102 billion. .
Pfizer's COVID vaccine launched late
in 2020 and quickly became the company's
top selling product by the second quarter of 2021.
In December of 2021,
Pfizer's stock reached an
all-time high of $61.71 per share.
Credit: Wibbitz Top Stories Duration: 01:31Published
Anthony Fauci, Tests Positive
for COVID.
The National Institute of Allergy and Infectious Diseases (NIAID) released a statement on
Dr. Fauci's positive COVID test on June 15.
He is currently experiencing
mild symptoms, NIAID, via statement.
The statement specified that Fauci "is fully vaccinated and has been boosted twice.".
Dr. Fauci's diagnosis was confirmed by a rapid antigen test. He is being treated with Paxlovid.
Dr. Fauci is the Chief Medical Advisor
to President Joe Biden.
He has not recently been in contact
with the president.
He has not recently been in close contact with President Biden or other senior government officials, NIAID, via statement.
The NIAID statement also specified how he will approach the coming days.
Dr. Fauci will follow the COVID-19 guidelines of the Centers for Disease Control and Prevention and medical advice from his physician and return to the NIH when he tests negative, NIAID, via statement.
Fauci has consistently urged caution when faced with social encounters.
Each of us, in our own personal way, has to make an assessment of what risk you’re willing to accept about getting infected, Anthony Fauci, via CNN.
He recently declined attendance at the White House Correspondents' Dinner.
In general, the risk is low, but I made a personal assessment. I’m 81 years old, and if I get infected, I have a much higher risk, Anthony Fauci, via CNN.
Recently, Dr. Fauci revealed that he has not had a day off since the beginning of the pandemic
Credit: Wibbitz Top Stories Duration: 01:30Published
US To End , COVID Testing
Requirement , for Air Travelers.
CNN reports that on June 10, the Biden administration will announce that the CDC will lift the restriction
for air travelers entering the country.
The change will reportedly go into
effect at midnight on June 12.
CNN reports that the travel industry had lobbied against the requirement for months.
claiming the protocol wasn't necessary anymore "based on the science and data.".
It has been in place
since January 2021.
But since new COVID variants are
continuously arising, the CDC will re-examine the decision to end testing in 90 days.
Roger Dow, U.S. Travel Association President, commended the decision.
Prior to the pandemic, travel was one of our nation's largest industry exports. , Roger Dow, U.S. Travel Association President, via CNN.
The lifting of this requirement will enable the industry to lead the way toward a broader U.S. economic and jobs recovery, Roger Dow, U.S. Travel Association President, via CNN
Credit: Wibbitz Top Stories Duration: 01:30Published
Moderna Says New Booster , Shows 'Superior' Omicron Response.
NPR reports Moderna claims its most recent vaccine candidate has shown a "superior neutralizing
antibody response" when compared to its first vaccine.
It is "bivalent," engineered to
target two different antigens.
Per NPR, Moderna intends to make its
newest booster available in fall 2022.
We are submitting our
preliminary data and analysis to regulators with the hope that the Omicron-containing bivalent booster will be available in the late summer. , Stéphane Bancel, Moderna CEO, via statement.
Due to a higher antibody response, Moderna believes its newest vaccine will offer protection that is "more durable over time" against Omicron.
Due to a higher antibody response, Moderna believes its newest vaccine will offer protection that is "more durable over time" against Omicron.
Moderna officials think their new vaccine could potentially offer protection for one year.
As new variants continuously arise, Moderna officials
hope the new bivalent vaccine can counter the
more contagious strains taking hold in the United States.
As new variants continuously arise, Moderna officials
hope the new bivalent vaccine can counter the
more contagious strains taking hold in the United States.
According to the Centers for Disease
Control and Prevention (CDC), two new
subvariants of Omicron, BA.4 and BA.5,
are spreading quickly across the country.
Experts say another wave of coronavirus
is bound to occur next winter as cold weather drives citizens back indoors
Credit: Wibbitz Top Stories Duration: 01:30Published
CDC Ramps Up Monkeypox Alert , to Level 2 .
The Center for Disease Control and Prevention (CDC) raised the level of alert concerning monkeypox on June 6.
Known global cases of the virus have exceeded 1,000 across 29 countries.
An alert level of three, the highest level, would recommend against travel that is non-essential.
The agency is encouraging the public to “practice enhanced precautions” to curb the spread of the virus.
New guidance issued from the CDC recommends that individuals avoid close contact with other infected people and infected animals.
According to reporting on the new guidance, those with visible skin legions could be more infectious. .
According to the World Health Organization, the virus has been circulating undetected for “weeks, months or possibly a couple of years.”.
Experts say that the ease of international travel is likely a significant reason as to why the virus has spread.
Diseases that were locally spread are now able to make their way across countries and continents much more easily, Professor Eyal Leshem, Sheba Medical Center,
via CNBC.
Meanwhile, interaction between humans and animals has
also amplified. , Professor Eyal Leshem, Sheba Medical Center,
via CNBC.
Experts also say that climate change has likely played a role in the speed at which the virus has spread.
Climate change has forced some animals into closer contact with humans, you will see more of these types of diseases, Professor Eyal Leshem, Sheba Medical Center,
via CNBC.
Monkeypox infections are considered rare and the threat to the general public remains low.
Symptoms of the virus include headache, fever, swelling, back-pain, and muscle ache
Credit: Wibbitz Top Stories Duration: 01:30Published
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