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The Latest Breaking News from Pfizer

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Nod For Kids As Young As Six Months

The FDA has granted emergency use authorization (EUA) to Pfizer Inc (NYSE:PFE) and BioNTech SE's (NASDAQ:BNTX) COVID-19 Vaccine as a three 3-µg dose series for children six months through 4 years of age. Based on safety, tolerability, and immunogenicity data, the 3-µg dose was carefully selected as the preferred dose for children under five. The EUA…

Benzinga

US authorizes first Covid vaccines for infants and preschoolers

FDA’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer

The Guardian - US

US approves Covid-19 vaccines for children under five

Parents will be able to book vaccine appointments for their children as early as June 20, the White House says

Evening Standard

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FDA clears Moderna, Pfizer COVID shots for children 5 and under

COVID vaccines for children ages 5 and under from Pfizer Inc. and Moderna Inc. received authorization from U.S. regulators, meaning almost all of the American population can soon get protected against COVID-19 disease.

Tribune News Service

FDA authorizes 1st COVID-19 shots for infants, preschoolers

U.S. regulators have authorized the first COVID-19 shots for infants and preschoolers

The Independent UK

Why the kids' vaccine took so long

One and a half years after the adult COVID-19 vaccine, a kids' shot is here. This is why it took so much longer

Salon

DeSantis defends state decision not to order COVID vaccines for young kids

Gov. Ron DeSantis on Thursday defended the state’s decision not to preorder COVID-19 pediatric vaccines for children under 5, saying that parents who want the shots can access them without the state’s help.

Miami Herald

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Pfizer and Moderna COVID-19 vaccines are on the verge of approval for US kids under five. When could it happen in Australia?

After US regulators took a major step towards approving COVID-19 vaccines for kids under five, here's what you need to know about the possibility of something similar happening in Australia.

ABC News

The Daily Biotech Pulse: Roche's Alzheimer's Drug Fails, Advisors Back Pfizer, Moderna Shots For Youngest Kids, Valneva Settles COVID-19 Pact With UK

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

The best time to make a major life decision, according to science

In this edition of Inverse Daily, read about the tarantula nebula, making decisions using science, and more.

Inverse

Akero Therapeutics Shares Surge After Equity Investment From This Famed Large Cap Biopharma

Akero Therapeutics Inc (NASDAQ:AKRO) announced a $25 million equity investment by Pfizer Inc (NYSE:PFE) at $9.90 per share. The company also announced a term loan facility providing Akero with access to up to $100 million from Hercules Capital Inc (NYSE:HTGC), of which $10 million will be drawn at transaction close. Together with existing cash, proceeds will support…

Benzinga

A major pandemic hurdle is being crossed with young kids getting vaccine access

Parents of infants and toddlers are a major step closer to having front-line protection against COVID after a key FDA committee on Wednesday unanimously recommended authorizing vaccines for kids as young as six months.

Axios

US FDA panel backs first Covid-19 jabs for children under five

The first COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday.

France 24

FDA panel recommends COVID vaccines for little kids, but questions remain about where they’ll be available

CHICAGO — Mary MacMillan is eager to get her 2-year-old son vaccinated against COVID-19, once vaccines are authorized for young kids. But she has a lot of questions about how to get the shots.

Chicago Tribune

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Roll Call

FDA panel gives green light to pediatric COVID-19 vaccines - Roll Call

Those under 5 are the last group eligible for the Moderna and Pfizer vaccines, and shots could go out as soon as next week.

ABC News

America's FDA panel backs Moderna and Pfizer COVID-19 vaccines for children under five. Here's what that means

Advisors to US federal regulators are backing two COVID-19 vaccines for children as young as six months old, with the final decision to be watched closely by Australian health officials, along with parents eager to put pandemic concerns behind them.

Tribune News Service

Moderna’s COVID shot for youngest children gets FDA panel’s support

Moderna Inc.’s COVID-19 vaccine for infants and toddlers won the support of a panel of U.S. regulatory advisers, putting parents one step closer to being able to protect their youngest against COVID-19 for the first time.

Inverse

FDA just authorized Covid-19 vaccines for kids under 5. Here’s what parents need to know

An outside panel of experts for the FDA recommended both the Moderna and Pfizer vaccine for kids under 5. Shortly after, the FDA granted a EUA.

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Axios

FDA committee recommends COVID shots for kids as young as 6 months

Children younger than 5 are the last group without access to the shots.

Roll Call

Access, hesitancy loom over COVID-19 vaccine rollout for toddlers - Roll Call

Adults had plenty of opportunities to get their COVID-19 vaccines. But it won't be as easy for those under age of 5.

The Independent UK

FDA advisers weigh COVID-19 shots for babies, young children

U.S. government advisers met Wednesday to decide whether to endorse COVID-19 shots for the youngest children, moving the nation closer to vaccinations for all ages

Benzinga

The Daily Biotech Pulse: FDA Committee Backs Moderna Shot For 5-17 Years, 180 Life Sciences Stock Plunges, Pfizer's Posts Disappointing Paxlovid Data

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Pfizer Halts Enrollment In Paxlovid COVID-19 Trial In Standard-Risk Population

Pfizer Inc (NYSE:PFE) shared additional data from the Phase 2/3 EPIC-SR study of Paxlovid (nirmatrelvir and ritonavir tablets) in patients at standard risk for developing severe COVID-19. In previously reported interim analyses, the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met. Non-significant 70% relative…

Tribune News Service

What's hot in life sciences? Bio International Convention looks at what's next as pandemic recedes

It's no secret that during the COVID-19 pandemic, the global life sciences industry shined. It ramped up development of everything from diagnostic tests to new vaccines — including two based on previously unproven messenger RNA technology —all within months instead of years.

Benzinga

EU Urges Pfizer To Further Delay COVID-19 Vaccine Deliveries: Reuters

Amid lower demand, Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) agreed to delay supplies of their Covid-19 shot to the European Union. Doses to be shipped from June to August would be sent in September and Q4. Reuters reports that the bloc is putting heat on Pfizer to restrict supplies further. The move comes two weeks after…

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