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Mar 18 2022
News
Moderna asks FDA to authorize additional booster shot for all adults
Moderna has asked the FDA for an emergency authorization that would allow all adults to receive a second COVID-19 booster, the company announced on Thursday.
Why it matters: The request is likely to intensify an ongoing scientific debate over how long protection from the two most-used vaccines in the U.S. lasts in the face of new variants.
The big picture: The move towards a
Axios
Oct 12 2021
News
Next on FDA’s agenda: Booster shots of Moderna, J&J vaccines
With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it’s their turn.
Federal regulators begin tackling that question this week.
On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the
Associated Press
Apr 28 2022
News
Moderna asks FDA to authorize COVID vaccine for emergency use in children under 6
Moderna asked Food and Drug Administration (FDA) regulators on Thursday to authorize its COVID-19 vaccine for emergency use in children under 6 years of age.
The biotech company said the shot was about 51% effective against the virus for kids under 2 years old and about 37% effective in kids ages 2 to 5.
It added that similar requests are underway with international regulatory
Fox Business
Jan 27 2022
News
How to think about boosters in light of this week's Pfizer and Moderna news
Pfizer and BioNTech announced Tuesday that they're beginning a clinical trial for an Omicron-specific Covid-19 vaccine, and Moderna revealed Wednesday that it has entered Phase 2 of its own trial of a vaccine that targets the variant, which is by far the dominant one in the United States right now.
About 50% of eligible Americans have received a booster shot, according to the US Centers
CNN (Online News)
Dec 15 2020
News
FDA finds Moderna coronavirus vaccine is effective and safe
The Food and Drug Administration released data showing that Moderna's COVID-19 vaccine is safe and effective.
The FDA's review, which was published on Tuesday, confirmed Moderna’s previous assessment that its vaccine had an efficacy rate of 94.1% in a trial of 30,000 people. It noted that potential side effects of the vaccine include fever, headache, and fatigue but added that those
Washington Examiner
Nov 30 2020
News
Moderna to seek emergency FDA authorization for coronavirus vaccine
Moderna will file Monday for an emergency authorization of its coronavirus vaccine from the Food and Drug Administration, becoming the second company to do so.
The vaccine developer said it would simultaneously ask the European Medicines Agency for conditional approval.
The FDA filing would clear the way for the vaccine to be authorized for use in the United States within weeks.
Politico
Jun 14 2022
News
FDA committee recommends Moderna two-dose Covid vaccine for kids ages 6 to 17
Moderna’s two-dose Covid-19 vaccine for kids ages 6 through 17 received the endorsement from the Food and Drug Administration’s committee of independent immunization experts on Tuesday, a key step on the path to distributing it to kids.
The committee unanimously voted to recommend the shots for use in kindergarteners through high schoolers after an all-day public meeting that weighed
CNBC
Oct 29 2020
News
Moderna Receives $1.1B for Launch of Experimental COVID Vaccine
Moderna Inc, one of the front-runners in the race to develop a vaccine for the new coronavirus, said on Thursday it was preparing to launch the experimental vaccine and had already received $1.1 billion in deposits for supply.
The Cambridge, Massachusetts-based company has signed deals with the U.S. government and several other countries, and is in talks with a WHO-led group for supply
Newsmax (News)
Nov 19 2021
News
FDA authorizes Pfizer and Moderna Covid boosters for all US adults
US regulators on Friday opened up Covid-19 booster shots to all US adults, expanding the government’s campaign to shore up protection and get ahead of rising coronavirus cases that may worsen with the holidays.
Pfizer and Moderna announced the Food and Drug Administration’s (FDA) decision after at least 10 states already had started offering boosters to all adults.
The latest
The Guardian
Nov 12 2021
News
Regulator Reviewing Reports of ‘Rare’ and Serious Condition Linked to Moderna Vaccine
Europe’s drug regulator on Thursday confirmed it is investigating reports of a blood condition in recipients of Moderna’s mRNA COVID-19 vaccine.
According to a bulletin posted by the European Medicines Agency (EMA), it is reviewing six cases of capillary leak syndrome, considered a “very rare disorder,” after they were reported in the EMA’s EudraVigilance database.
“At this stage
The Epoch Times