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US panel backs Moderna, Pfizer COVID shots for youngest kids

Infants and toddlers in the U.S. are now able to be vaccinated against COVID-19 after shots from Moderna Inc. and Pfizer Inc. won support from health advisers on Saturday.

Tribune News Service

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

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

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Moderna Plans COVID-19 Vaccine Trial For Infants: WSJ

Moderna Inc (NASDAQ: MRNA) is reportedly planning to evaluate its COVID-19 vaccine in infants aged three months to 6 months.

Benzinga

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.

Tribune News Service

FDA Committee Backs Moderna's COVID-19 Shot For Kids, Adolescents: Report

Moderna Inc's (NASDAQ: MRNA) COVID-19 vaccine received unanimous backing from the FDA's committee of independent immunization experts for children ages 6 through 17.

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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Moderna's COVID-19 Shot Likely Related To Higher Heart Inflammation Risk Than Pfizer's: Reuters

Moderna Inc's (NASDAQ:MRNA) COVID-19 vaccine may relate to a higher risk of heart inflammation in some age groups than Pfizer Inc (NYSE:PFE) - BioNTech SE's (NASDAQ:BNTX) shot, Reuters reported citing the Centers for Disease Control and Prevention. Citing recent data, CDC said that the findings on myocarditis and pericarditis, types of heart inflammation linked to both the…

Benzinga

Moderna shot 'works in kids 6 months and up'

Moderna Inc's Covid-19 vaccine is effective in children and adolescents, with mostly mild to moderate side effects, the United States Food and Drug Administration staff said.

Bangkok Post

Moderna data show vaccine works in kids 6 months and up, FDA says

Moderna Inc.’s COVID-19 vaccine is effective in children and adolescents, with mostly mild to moderate side effects, the U.S. Food and Drug Administration staff said.

Tribune News Service

Moderna’s omicron-targeted shot bolsters antibodies in trial

Moderna Inc. said its COVID-19 vaccine that targets omicron generated a “superior” immune response against the variant compared to its original shot in a widely awaited study that could pave the way for another round of boosters in the fall.

Tribune News Service

Moderna's Updated COVID-19 Shot Boosts Omicron Protection

Moderna Inc (NASDAQ: MRNA) has

Benzinga

Moderna says Omicron-targeted COVID shot shows better response

Moderna Inc said on Wednesday a new version of its coronavirus vaccine produced a better immune response against Omicron than the original shot, as the drugmaker pursues a booster against a surge in infections in the fall season.

Reuters

Moderna delays COVID vaccine deliveries to EU by several months

Moderna Inc said on Thursday it has agreed to push back some COVID-19 vaccine deliveries to the European Union by several months to later in 2022 or early next year.

Reuters

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Reuters

Japan study shows women more likely to get skin rash from Moderna shot

A study in Japan found that women were significantly more likely than men to develop rash-like side effects after a first dose of Moderna Inc's COVID-19 vaccine.

Benzinga

This Famed Company Is Working On A Potential Monkeypox Vaccine

As cases of monkeypox continue to rise, Moderna Inc (NASDAQ: MRNA) is probably working on its platform towards finding a vaccine shot against the disease.

Benzinga

Moderna's Chairman Defends Executive Hiring Process After Firing New CFO In Just One Day

Moderna Inc’s (NASDAQ: MRNA) chairman comes forward with a determined defense of the board’s executive hiring process after being forced to fire its new chief financial officer just a day after taking charge.

Benzinga

Biden Says US Ready To Share COVID-19 Vaccine Related Technology

President Joe Biden said that the U.S. will share technologies used to make COVID-19 vaccines through the World Health Organization and is working on expanding rapid testing and antiviral treatments for hard-to-reach populations. "We are making available health technologies that are owned by the United States government, including stabilized spike protein that…

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Benzinga

Moderna Concludes FDA Submission For Its COVID-19 Shot In Adolescents, Kids

Reuters reported that Moderna Inc (NASDAQ:MRNA) had made required submissions to the FDA for emergency use authorization of its COVID-19 vaccine in adolescents and children. An advisory panel of experts to the U.S. drug regulator will meet in June to review the request. Related: FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For…

Benzinga

Why Did Moderna CFO Exit Just A Day After Taking Charge

Moderna Inc (NASDAQ:MRNA) announced that its recently appointed Chief Financial Officer, Jorge Gomez, has departed the company, effective immediately. The announcement follows the public disclosure by Gomez's former employer, Dentsply Sirona Inc (NASDAQ:XRAY), of an ongoing internal investigation into some issues, including financial reporting. The audit investigates Dentsply Sirona's "use of incentives to sell products to…

Benzinga

Why Moderna Shares Are Trading Lower Following Novavax's Earnings Report

Moderna Inc (NASDAQ: MRNA) shares are trading lower by 3.15% at $131.52.

Benzinga

Moderna Files Motion To Dismiss COVID-19 Vaccine Related Patent Claims: WSJ

Moderna Inc (NASDAQ: MRNA) is trying to fight off rival companies’ patent infringement claims related to its COVID-19 vaccine, arguing that the companies may only pursue their claims by seeking royalties from the federal government.

Benzinga

Here's Why Moderna Shares Are Trading Higher After Q1 Earnings Today

Moderna Inc (NASDAQ:MRNA) reports a Q1 EPS of $8.58, compared to the $2.84 posted a year ago, handsomely beating the consensus estimate of $5.21. Total revenue was $6.1 billion compared to $1.9 billion in Q1 FY21, primarily due to increased product sales. The revenue consensus was $4.43 billion. Product sales were $5.9…

Benzinga

Moderna Bullish On COVID-19 Vaccine For Younger Kids To Be Ready Next Month: Reuters

Moderna Inc's (NASDAQ:MRNA) chief medical officer said that its COVID-19 vaccine for children under six years old would be ready for review by the FDA panel when it meets in June. "I think the FDA now has all of the core fundamental data they need to be able to begin an application review.…

Benzinga

FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA

The FDA has set up June meeting dates to review COVID-19 vaccine submissions, noting that the dates are tentative as none of the submissions are complete. The agency reserved June 8, 21, and 22 for virtual meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review Moderna Inc (NASDAQ: MRNA) and Pfizer Inc (NYSE: PFE)…

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