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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.

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.

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."

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

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

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

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.

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

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.

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.

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.

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

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

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

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

"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.

"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.

"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.

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.

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

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

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.

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

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.

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

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

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

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.

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

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.

The recommendation comes amid an increase in pediatric hospitalizations.

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

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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

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

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

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.

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

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

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.

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

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

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

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.

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.

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

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

Here are this morning's top stories.

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

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

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

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 start administering pediatric COVID-19 vaccines on Monday.

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

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.

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.

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

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

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.

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

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.

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.

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.

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

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

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

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.

Here are this morning's top stories.

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.

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

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

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

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

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

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.

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 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 received a second dose of the Pfizer-BioNTech vaccine on Thursday.

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

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

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.

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