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Pfizer asks FDA to authorize third dose for children 5 to 11 years old

Dr. Sandra Hughes prepares to administer a first dose of the Pfizer-BioNTech coronavirus vaccine (COVID-19) to Elise Langevina, 6, in Storrs, Connecticut, U.S., November 3, 2021. Pfizer on Tuesday asked the Food and Drug Administration to authorize a third dose of its Covid vaccine for children ages 5- to 11-years-old. The application comes after Pfizer released clinical trial data earlier this month showing that blood samples from 30 kids in the age group had a 36-fold increase in antibody levels against the omicron variant compared to two doses of the vaccine. This is breaking news. Please check back for updates.

cnbc.com

After COVID-19, mRNA vaccines could treat flu, HIV and even cancer

Unlike previously used viral vector vaccines, mRNA vaccines don’t introduce live or dead virus into the body as a means of triggering antibody production. “mRNA vaccine technology for treating diseases isn’t going anywhere. “It’s a totally different ball game.”Research into mRNA technology for vaccines goes back decades, though the efforts improved within the last 10 years. “Every pharma company now is investing billions of dollars into developing these mRNA vaccines into the anti-cancer medicine,” Walter said. While no mRNA vaccine for cancer has gained approval from the U.S. Food and Drug Administration, there’s hope that the success of COVID-19 vaccines will help accelerate clinical research.

mlive.com

Pfizer and BioNTech to ask FDA to authorize COVID-19 booster for kids as young as 5

Citing a "robust response" of antibodies against Omicron in their vaccine trials, the companies said they were planning to submit a request "in the coming days."

cbsnews.com

Germany may have to junk 3 million COVID shots by late June

Germany’s health ministry says the country may have to discard 3 million doses of expired COVID-19 vaccine by the end of June.

Stocks making the biggest moves premarket: BioNTech, Five Below, Lululemon and others

These are the stocks posting the largest moves before the bell.

cnbc.com

The Biden administration plans to give Americans 50 years and up an option to get a second booster shot: report

Pharmaceutical executives have expressed conflicting stances on whether additional shots past the initial booster are necessary.

news.yahoo.com

FDA advisory committee to discuss future of Covid boosters

An FDA advisory committee will discuss Covid-19 boosters for the coming months, and what factors would make it necessary to update the shots to target specific variants.

cnbc.com

Pfizer asks FDA to OK fourth dose of COVID vaccine for seniors

Pfizer's CEO told "Face the Nation" on Sunday that he believed another booster shot was now "necessary."

cbsnews.com

Pfizer Covid vaccine was just 12% effective against omicron in kids 5 to 11, study finds

NY health officials found that the effectiveness of Pfizer's vaccine against Covid plummeted from 68% to 12% for children ages 5 to 11 as the omicron surged.

cnbc.com
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COVID may increase risk of developing heart issues

A new study found that COVID-19 can increase the risk for developing 20 cardiac problems, including stroke and heart attack. Dr. Tara Narula reports.

news.yahoo.com

CDC says waiting longer between Pfizer, Moderna doses may reduce rare myocarditis risk for younger men

The CDC said males ages 12- to 39-years-old should consider waiting 8 weeks between the first and second doses of Pfizer and Moderna's vaccines.

cnbc.com

Covid: England to offer Covid jab to five to 11-year-olds and Hong Kong's surge

Five things you need to know about the coronavirus pandemic this Wednesday evening.

bbc.co.uk

Babies are protected from hospitalization for Covid if their moms get vaccinated, study suggests

The CDC found infants were 61% less likely to be hospitalized with Covid if their mothers received Pfizer or Moderna's vaccine while pregnant.

cnbc.com

Moderna, Pfizer stocks fall as omicron Covid wave subsides in U.S.

Moderna dropped more than 12%, the biggest decline in the S&P 500 as of Monday afternoon.

cnbc.com

Vaccine Makers Must Help the World Prepare for the Next Pandemic

Moderna, Pfizer and BioNTech should be lending expertise to a South African effort to create new mRNA shots.

washingtonpost.com

The FDA postpones a highly anticipated meeting on the Pfizer vaccine for young kids

"We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," FDA officials said in a statement.

npr.org

The FDA postpones a highly anticipated meeting on the Pfizer vaccine for young kids

"We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," FDA officials said in a statement.

npr.org

The FDA postpones a highly anticipated meeting on the Pfizer vaccine for young kids

"We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," FDA officials said in a statement.

npr.org
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Pfizer delays its application to the FDA to expand its Covid vaccine to kids under 5

The FDA said it's postponing a meeting Tuesday that was scheduled to look at the kids' data. Pfizer and BioNTech asked the FDA last week to expand the authorization for their vaccine to most kids under 5. The FDA had asked the companies to start submitting data for authorization of the first two-doses of the three-dose vaccine for children six months through 4-years-old. Pfizer and BioNTech expect kids under 5 will ultimately need three doses for the highest level of protection against the omicron Covid variant and future strains of the virus. The companies said data on the third dose will be finished and submitted to the FDA in the coming months.

cnbc.com

The CDC still needs to approve young kids' Covid shots, but it's telling health agencies to expect delivery by Feb. 21

State and local health officials can start preordering the first doses on Feb. 7 and will start receiving vaccine shipments on Presidents' Day.

cnbc.com

Pfizer Asks FDA To Authorize COVID-19 Vaccine For Children Under 5

Pfizer and BioNTech are requesting emergency use authorization for their two-dose Covid-19 vaccine for children age 6 months up to 5 years.

detroit.cbslocal.com

When can babies and kids under age 5 get their shots? Here's the timeline

The first big hurdle was crossed when Pfizer shared its clinical trial data with the FDA. Now there are five more steps get through before this vulnerable population can finally be vaccinated.

npr.org

Stocks making the biggest moves in the premarket: AT&T, AMC Entertainment, UPS and more

The stocks making the biggest moves in premarket trading include AT&T, AMC Entertainment, UPS, and more.

cnbc.com

Pfizer and BioNTech begin testing an omicron-specific COVID-19 vaccine

Though people who are vaccinated and boosted appear to be better protected against omicron, the highly contagious variant has still led to breakthrough cases and a surge in infections worldwide.

npr.org

Pfizer Opens Study Of Omicron-Specific COVID-19 Vaccine

The drugmaker and partner BioNTech will begin clinical trials on a new vaccine developed to protect against the more contagious variant.

newsy.com

Pfizer Opens Study Of Omicron-Specific COVID-19 Vaccine

The drugmaker and partner BioNTech will begin clinical trials on a new vaccine developed to protect against the more contagious variant.

www1.newsy.com

Pfizer and BioNTech launch clinical study of Covid vaccine targeting omicron

Pfizer CEO Albert Bourla has said the company will have the omicron vaccine ready by March.

cnbc.com
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Fauci says FDA could authorize Pfizer's Covid vaccine for kids under 5 in the next month

Fauci said younger children will likely need three doses, because two shots did not induce an adequate immune response in children 2- to 4-years-old.

cnbc.com

View: COVID booster shot eligibility

Here is the CDC’s most recent update to COVID-19 booster shot eligibility -- as of Dec. 28, 2021.

Covid vaccine programs could end with third dose for most people, Israeli doctor predicts

Professor Eyal Leshem is an infectious disease expert at Sheba Medical Center in Israel, where fourth vaccine doses are being rolled out as Covid cases soar.

cnbc.com

CDC panel recommends Pfizer boosters for 12- to 15-year-olds amid omicron surge

The recommendation comes amid an increase in pediatric hospitalizations.

cnbc.com

Stocks making the biggest moves premarket: Beyond Meat, Pfizer, Nikola and others

These are the stocks posting the largest moves before the bell.

cnbc.com

The CDC now recommends Pfizer boosters after 5 months, not 6

The move to shorten the Pfizer booster interval comes as the U.S. shatters daily case records. The recommended interval for those who received Moderna or Johnson & Johnson vaccines has not changed.

npr.org

FDA authorizes a Pfizer booster shot for children ages 12 to 15

The agency also shortened the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose, down to five months from six.

npr.org

FDA expands Pfizer booster eligibility to kids ages 12 to 15

New Covid infections have hit a pandemic high in the U.S. as the highly contagious omicron variant has supplanted delta as the dominant strain.

cnbc.com

Reports: FDA prepares to authorize Pfizer booster shot for kids 12 to 15

The Food and Drug Administration (FDA) plans to expand eligibility for Pfizer-BioNTech COVID-19 booster shots to children ages 12 to 15 in the coming days, NBC News reports.

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News headlines of 2021: How much do you remember? Take this quiz to find out.

We might not be able to claim that 2021 was *the* wildest year in recent history (2020 will likely get that credit for quite some time), but it might be a close second.

Israel begins trial of fourth coronavirus vaccine dose ahead of planned national campaign

The trial at Sheba Medical Center in central Israel involves 150 medical workers in what's believed to be the world's first trial of fourth Pfizer doses.

washingtonpost.com

Israel testing fourth Pfizer COVID vaccine shot

The clinical trial involves 150 volunteers from the staff of a hospital near Tel Aviv who are at least four months removed from their third vaccine shot and have signs of waning antibodies.

cbsnews.com

In Greece, taxis help with race to deliver booster shots

Public health authorities in Greece have stepped up a campaign to deliver booster shots to seniors and people with mobility difficulties at home, with some agencies using taxi companies to take healthcare workers to where the vaccinations are needed.

Military gives German hospital an edge in fighting COVID

As hospitals across Europe brace themselves for a surge in coronavirus cases because of the new omicron variant, Westerstede Clinical Center is cautiously hopeful it can weather the storm

washingtonpost.com

Pfizer Announces Vaccine Provides Insufficient Protection for Young Children

Pfizer and BioNTech will modify a clinical trial for their coronavirus vaccine in young children after a two-dose regimen did not produce a sufficient immune response.

news.yahoo.com

Pfizer executives say Covid could become endemic by 2024

Endemic means the coronavirus will not disappear, but rather will become a constant presence such as the flu.

cnbc.com

As Brazil agency approves COVID vaccine for kids, Bolsonaro wants to publish regulators' names for public "judgements"

Health agency bosses reported death threats before approving the Pfizer vaccine for young children. Bolsonaro says public should make "their own judgements" on the decisionmakers.

cbsnews.com

CDC reports heart inflammation cases among young kids who got Pfizer COVID-19 shot

The U.S. Centers for Disease Control and Prevention said on Thursday it had received reports of eight cases of myocarditis, a type of heart inflammation, in children aged 5-11 years who received Pfizer and BioNTech's COVID-19 vaccine.

news.yahoo.com
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Major South African study concludes omicron variant more resistant to vaccines but causes less severe version of covid

The study by South Africa's largest insurer involves 211,000 cases and is the most comprehensive to date.

washingtonpost.com

Stocks making the biggest moves in the premarket: Harley-Davidson, Arena Pharmaceuticals, Peloton and more

The stocks making the biggest moves in premarket trading include Harley-Davidson, Arena Pharmaceuticals, Peloton, and more.

cnbc.com

Israel extends travel restrictions for a further 10 days

The Israeli Prime Minister and Health Minister are extending Israel’s tough travel restrictions including its entry ban on all foreign nationals for a further ten days, in a bid to stop further cases of the omicron variant of coronavirus entering the country

washingtonpost.com

FDA expands eligibility for Pfizer Covid booster shots to 16- and 17-year-olds

The Food and Drug Administration on Thursday expanded eligibility for Pfizer and BioNTech's booster shot to people who are 16 and 17 years old. The FDA's emergency authorization comes after initial data from South African scientists and Pfizer indicate the omicron variant of the virus that causes Covid-19 significantly reduces protection provided by the initial two-dose vaccine series. However, Pfizer's initial lab data indicated a booster shot provides significant protection against omicron, with virus fighting ability comparable to the 95% protection that the two-dose series showed against the original strain of the virus. The Centers for Disease Control and Prevention still needs to authorize boosters for 16- and 17-year-olds before the shots are administered. The CDC cleared booster shots for all adults 18 and over last month.

cnbc.com

FDA greenlights Pfizer booster shots for Americans as young as 16

Less than a third of Americans 16 to 17 years old will initially be eligible to receive the additional dose.

cbsnews.com

US expands Pfizer COVID boosters, opens extra dose to age 16

The U.S. is expanding COVID-19 boosters, opening a third dose of Pfizer's vaccine to people as young as age 16.

Large studies shows huge benefit of COVID-19 booster shots

In a large study, the risk of a breakthrough infection was 10 times lower for people who got a COVID-19 booster shot than for people who hadn't.

latimes.com

Pfizer Says COVID Booster Offers Protection Against Omicron

A booster dose of the Pfizer-BioNTech COVID-19 vaccine appears to provide strong protection against the Omicron variant, the companies announced.

newsy.com

Stocks making the biggest moves premarket: Pfizer, BioNTech, Weber and others

These are the stocks posting the largest moves before the bell.

cnbc.com
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Pfizer says COVID booster offers protection against omicron

Pfizer says a booster dose of its COVID-19 vaccine appears to offer important protection against the new omicron variant.

Pfizer-BioNTech say booster dose provides high level of protection against omicron variant in initial lab study

Three doses of Pfizer and BioNTech's vaccine provide a high level of protection against the omicron variant of the virus that causes Covid-19, the companies announced on Wednesday. A booster shot of the vaccine increases antibody protection 25-fold compared with the initial two-dose series, according to a preliminary lab study. A third shot produces antibody levels comparable to those induced by the two-dose initial series against the original strain, which are associated with a high level of protection. The companies said two-doses of the vaccine showed a significant reduction in the ability of antibodies to target and neutralize omicron, though they may still protect against severe disease. Pfizer and BioNTech expect to have a vaccine that specifically targets omicron available by March 2022.

cnbc.com

Omicron significantly reduces Covid antibody protection in small study of Pfizer vaccine recipients

The preprint study has not yet been peer reviewed and it tested 14 plasma samples from 12 vaccinated people, 6 of whom were previously infected.

cnbc.com

EU regulator authorizes Pfizer's COVID vaccine for kids 5-11

The European Union drugs regulator has authorized Pfizer’s coronavirus vaccine for use on children aged from 5 to 11 years.

Israel begins giving COVID shots to children age 5 to 11

Israel has begun administering the coronavirus vaccine to children age 5 to 11.

Morning Briefing Nov. 18, 2021: Gov. Whitmer urges Michigan adults to get COVID booster; New Downriver councilman charged for drunk driving

Here are this morning's top stories.

Boosters for all adults in US closer with panel meeting set

An influential U.S. advisory panel will discuss expanding eligibility for COVID-19 vaccine booster shots to all adults Friday, a move that could make the shots available as early as this weekend.

Western Michigan University gives up lawsuit fight over vaccines for athletes

Western Michigan University has agreed to stop opposing a legal challenge by athletes who declined to get a COVID-19 vaccine.

Vienna to start vaccinating young kids in pilot project

Austrian media are reporting that young children in Vienna can start getting coronavirus vaccinations next week as part of a pilot project.

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Pfizer asks FDA to OK COVID-19 booster shots for all adults

Pfizer is asking U.S. regulators to allow boosters of its COVID-19 vaccine for anyone 18 or older.

Child COVID vaccines: Here’s how to schedule an appointment in Detroit

The city of Detroit is getting ready to start administering COVID-19 vaccinations to children ages 5 to 11 years old following federal authorization for that age group.

Michigan Medicine will begin vaccinating children 5-11 against COVID-19 on Monday

Michigan Medicine will start administering pediatric COVID-19 vaccines on Monday.

Beaumont to open COVID-19 vaccine appointments for kids next week

Beaumont Health is planning to begin offering appointments for parents to get their younger children vaccinated for COVID-19 starting next week.

BioNTech to work with Senegal, Rwanda to make mRNA vaccines

Senegal and Rwanda have signed an agreement with German company BioNTech for the construction of its first start-to-finish factories to make messenger RNA vaccines in Africa.

States can reserve COVID-19 shots for younger kids next week

U.S. health officials are setting the stage for a national COVID-19 vaccination campaign for younger children, inviting state officials to pre-order doses starting next week.

Pfizer requests emergency use authorization for COVID vaccine in children

It’s a move that has been highly anticipated by pediatricians and many parents as coronavirus cases have risen in that age group.

Watch Local 4 News at 5 -- Oct. 7, 2021

Here’s what you missed on Local 4 News at 5:

Pfizer officially requests FDA emergency use authorization of COVID vaccine in kids 5-11

Pfizer and BioNTech have officially submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their COVID-19 vaccine for children aged 5 to 11.

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Pfizer vaccine for kids may not be available until November

Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children but the shots may not be available until November.

Pfizer submits data to FDA as it seeks to use COVID vaccine in children aged 5-11

Pfizer Inc.and BioNTech announced Tuesday they have submitted data to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to 12 years of age.

Pfizer submits data to FDA as it seeks to use COVID vaccine in children aged 5-11

Pfizer plans to request Emergency Use Authorization from the FDA for this age group to receive the vaccine in the coming weeks.

The Latest: Pfizer gives vaccine data from kids 5-11 to FDA

Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children as it moves closer to seeking approval for expanded use of the shots.

Here’s what the FDA is saying about COVID-19 vaccines for young children as of Sept. 10, 2021

The Food and Drug Administration released the following statement Friday, Sept. 10, 2021 as COVID-19 makers are racing to submit clinical data seeking regulatory approval for vaccines in children younger than 12.

Report: Pfizer will seek approval for COVID vaccine use in children 5 and up ‘in coming weeks’

Pfizer-BioNTech soon will be asking approval for use of its COVID-19 vaccine in children aged 5 and up, The New York Times reports.

Can COVID patients donate organs? Are face masks bad for your health?

Since the coronavirus pandemic began, Dr. Frank McGeorge has been keeping viewers up-to-date and informed on all fronts.

EU agency says to focus on vaccines first not booster shots

The European Centre for Disease Prevention and Control is urging countries to ramp up their primary coronavirus vaccine programs and playing down the need for booster shots among the general public.

Taiwan gets first Pfizer-BioNTech vaccines after long delay

Taiwan has received its first Pfizer-BioNTech vaccines after a prolonged purchasing process that gave rise to a political blame game with China.

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Asian shares rise but momentum fizzles on virus worries

Asian shares are gaining, boosted by a near-record rise on Wall Street.

Pfizer’s COVID-19 vaccine ‘Comirnaty’ receives full approval from FDA

On Monday, the U.S. Food and Drug Administration gave full approval to the Pfizer-BioNTech COVID-19 Vaccine, which will now be marketed as Comirnaty.

Morning Briefing Aug. 19, 2021: A look at Michigan’s COVID vaccine coverage by age group, feds say Whitmer kidnapping plotter deserves break

Here are this morning's top stories.

Israel tightens coronavirus restrictions as new cases surge

Israel’s government on Wednesday advanced a raft of new coronavirus restrictions, including sweeping implementation of a digital vaccine passport and tighter restrictions on mass gatherings, as the country struggles with skyrocketing new infections.

Where to get a COVID-19 vaccine in Michigan in August: List of clinics

It’s not too late to get a COVID-19 vaccine in Michigan -- there are clinics planned across the state in August.

List: Washtenaw County Health Department COVID-19 vaccine clinics in August

The Washtenaw County Health Department is still offering free vaccinations to community members at several vaccination pop-up clinics.

Beaumont Health to mandate COVID vaccines for staff, providers

Employees of Beaumont Health will soon be required to get vaccinated for COVID-19, if they haven’t already.

Pfizer hikes 2021 outlook after vaccine boosts sales, profit

Strong sales of its COVID-19 vaccine and other medicines helped Pfizer nearly double its second-quarter revenue and boost its profit an impressive 59%, beating Wall Street expectations.

Washtenaw County nears 70 percent COVID-19 vaccination rate

Washtenaw County residents can rest a bit easier knowing that the county is almost at a 70% vaccination rate against the coronavirus that causes COVID-19.

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BioNTech founders contributing to book on COVID-19 vaccine

The husband and wife team who helped develop the first COVID-19 vaccine are contributing to a book.

US expands use of Pfizer’s COVID-19 vaccine, paving way for children as young as 12 to get shots

On Monday, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

Vaccine maker BioNTech says no need to waive patents

The head of German pharmaceutical company BioNTech said Monday that there is no need to waive patents on coronavirus vaccines because manufacturers will be able to produce enough shots to supply the world over the coming year.

Pfizer, BioNTech seek EU's OK to use COVID vaccine on kids

Pfizer and BioNTech have submitted a request to the European drug regulator for the approval of their coronavirus vaccine to be extended to include children aged 12 to 15 years old, in a move that could offer younger and less at-risk populations in Europe access to the shot for the first time.

Michigan Gov. Gretchen Whitmer receives second dose of COVID-19 vaccine

Michigan Gov. Gretchen Whitmer received a second dose of the Pfizer-BioNTech vaccine on Thursday.

FEMA reimbursing $3.3M to Michigan health department for COVID-19 vaccine scheduling support services

The funding reimburses MDHHS for costs dedicated to COVID-19 vaccine scheduling support services through contracts with Google and Michigan 211.

South Korea inoculates Olympic athletes ahead of Tokyo Games

South Korea has begun administering fast-track COVID-19 vaccines to athletes, coaches and others expected to attend the Tokyo Olympics.

Beaumont expands COVID vaccines to non-patients, adds 3 walk-ins this week

Beaumont Health, the state’s largest hospital system, is expanding COVID-19 vaccines to non-patients, and has added three walk-in clinics this week in Southfield.

The Latest: Health panel urges restarting J&J vaccinations

A U.S. health panel says it’s time to resume use of Johnson & Johnson’s COVID-19 vaccine, despite a very rare risk of blood clots.

University of Michigan hosting COVID-19 vaccine clinic Wednesday for campus community

University of Michigan is running a vaccine clinic for its community, Ann Arbor Public Schools students and families this afternoon.

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