Tag Archives: Moderna

CDC Issues Final Approval For New COVID Boosters

CNN reports: Everyone ages 6 months and older should get an updated Covid-19 vaccine, the US Centers for Disease Control and Prevention said Tuesday, to help lower the risk of severe illness, hospitalization or death from the coronavirus. Dr. Mandy Cohen, director of the agency, signed off on recommendations from the Advisory Committee on Immunization Practices or ACIP, a panel …

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FDA Approves New Pfizer And Moderna Boosters

Via press release from the FDA: Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and …

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Moderna: New Booster Effective Against Latest Variant

Reuters reports: Moderna on Wednesday said clinical trial data showed its updated COVID-19 vaccine will likely be effective against the highly-mutated BA.2.86 subvariant of the coronavirus that has raised fears of a resurgence of infections. The company said its shot generated an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86, which is being tracked by the World Health Organization …

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WH To Urge Public To Get Coming COVID Booster Shot

Reuters reports: The Biden administration plans to urge all Americans to get a booster shot for the coronavirus this autumn to counter a new wave of infections, a White House official said on Sunday. The official said that while the CDC is reporting an increase in infections and hospital admissions from the virus, overall levels remain low. On Thursday, Moderna …

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FDA Okays Pfizer And Moderna Anti-Omicron Boosters

CBS News reports: The Biden administration’s planned fall COVID-19 booster campaign cleared a key regulatory hurdle, after the Food and Drug Administration announced Wednesday it has authorized updated shots adapted for the Omicron variant of the virus for Americans as young as 12 years old. People could get the new booster as little as 2 months after their last shot …

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Moderna Sues Pfizer For mRNA Patent Infringement

Bloomberg Law reports: Moderna Inc. said it’s suing Pfizer Inc. and BioNTech SE, claiming the technology in the partners’ Covid-19 shot infringes on its patents, a move that sets the stage for a massive legal clash between the three vaccine titans. Moderna, in a statement Friday, accused Pfizer and BioNTech of violating intellectual property protecting key elements of Moderna’s messenger …

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Britain First To Approve Booster That Targets Variants

Reuters reports: Britain has become the first country to approve a COVID-19 vaccine that targets both the original and Omicron variant of the virus. The the UK medicines regulator (MHRA) approved the so-called bivalent vaccine made by U.S. drug company Moderna as a booster for adults. The MHRA also cited an exploratory analysis in which the shot was also found …

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Moderna May Create mRNA-Based Monkeypox Vax

ABC News reports: Amid growing concerns over the potential threat of monkeypox, executives from Moderna said Wednesday they have initiated a research program to consider whether the company could create a monkeypox vaccine with mRNA technology. “We’re obviously very aware of the monkeypox concern and obviously very sensitive to recent announcements,” Moderna President Stephen Hoge said during an investor call. …

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Moderna Seeks Vax Approval For Children Under Six

The Associated Press reports: Moderna on Thursday asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer. Frustrated families are waiting impatiently for a chance to protect the nation’s littlest kids as all around them people shed masks and other public …

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FDA Approves Second Booster For People Over Age 50

USA Today reports: People age 50 and up are now eligible for a second booster dose of COVID-19 vaccine at least four months after their first, the Food and Drug Administration said Tuesday. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk …

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Moderna Seeks FDA Vax Approval For Children Under 6

NPR reports: Moderna is hoping to get the green light to administer a pediatric, low-dose COVID-19 vaccine for children ages 6 months to under 6 years of age, it said in a statement. The pharmaceutical company will submit a request to the Food and Drug Administration “in the coming weeks” for authorization for a two-dose, 25 microgram-each shot. That’s 25% …

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Moderna Seeks Fourth Dose Okay For Those Over 18

USA Today reports: Moderna on Thursday requested emergency use authorization from the Food and Drug Administration for a fourth dose of its COVID-19 vaccine as a booster for people 18 and over — a broader request than Pfizer made days ago for its vaccine. Currently, a single booster dose of Moderna’s mRNA vaccine is authorized for emergency use on top …

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FDA Grants Full Final Approval To Moderna Vaccine

The Washington Post reports: The Food and Drug Administration has granted full approval to Moderna’s coronavirus vaccine, the agency announced Monday. Moderna’s vaccine, now known as Spikevax, was previously available under emergency use authorization and is the second coronavirus vaccine to get full FDA approval. Pfizer and BioNTech’s product was approved in August. Moderna, a biotechnology company, said Monday that …

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Moderna Plans Combined Annual COVID/Flu Booster

Politico Europe reports: Moderna hopes to market a combined booster vaccination for COVID-19, influenza and RSV — a common respiratory virus — as soon as the fall of 2023, CEO Stéphane Bancel said Monday. Bancel, speaking on a panel at the World Economic Forum, said the combination vaccine would enable people to get broad protection against illnesses caused by respiratory …

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Moderna Booster Highly Effective Against Omicron

CNBC reports: Moderna announced Monday that a third dose of its mRNA vaccine against Covid-19 appears to provide significant protection against the omicron variant. Moderna said that its currently authorized booster can “boost neutralizing antibody levels 37-fold higher than pre-boost levels,” which it described as reassuring. However, it also said that a double doze of the booster shot — 100 …

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AP: Vaccine Makers Racing To Update Their Shots

The Associated Press reports: Vaccine makers are racing to update their COVID-19 shots against the newest coronavirus threat even before it’s clear a change is needed, just in case. Experts doubt today’s shots will become useless but say it’s critical to see how fast companies could produce a reformulated dose and prove it works — because whatever happens with omicron, …

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Moderna: Omicron Vax May Be Ready In Early 2022

Bloomberg News reports: Moderna Inc. Chief Medical Officer Paul Burton said he suspects the new omicron coronavirus variant may elude current vaccines, and if so, a reformulated shot could be available early in the new year. “We should know about the ability of the current vaccine to provide protection in the next couple of weeks,” Burton said Sunday on the …

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FDA Approves Pfizer, Moderna Boosters For All Adults

The Washington Post reports: Federal regulators on Friday authorized Pfizer-BioNTech and Moderna coronavirus vaccine boosters for all adults, a one-size-fits-all strategy designed to shore up Americans’ defenses against a tenacious virus and reduce confusion over guidelines that have varied based on people’s age, occupation and where they live. The Food and Drug Administration cleared the boosters for people 18 and …

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CDC Approves Fourth Shot For Immuno-Compromised

Axios reports: The Centers for Disease Control and Prevention said in updated guidelines Tuesday that some immuno compromised people who have received either Pfizer or Moderna’s COVID-19 vaccines will be able to get a fourth shot. People over 18 who are “moderately to severely immuno compromised” and have received three doses of an mRNA vaccine may get a fourth shot …

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STUDY: Moderna Vaccine Effective In Kids Ages 5-11

NPR reports: Moderna says a study in kids 6 to 11 found two doses of the company’s COVID-19 vaccine given 28 days apart produced a strong antibody response. The study, conducted in collaboration with the National Institutes of Health, used shots containing a 50 microgram dose of the vaccine, half the dose of the Moderna shots authorized for adults. More …

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