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Total 51 results found since Jan 2013.

FDA Clears Second Bivalent COVID-19 Booster for People 65 and Older
WASHINGTON — U.S. regulators on Tuesday cleared another COVID-19 booster dose for older adults and people with weak immune systems so they can shore up protection this spring — while taking steps to make coronavirus vaccinations simpler for everyone else. The Food and Drug Administration said anyone 65 or older can opt to roll up their sleeves again as long as it’s been at least four months since their first dose of the so-called bivalent vaccine that targets Omicron strains. And most people who are immune-compromised can choose another bivalent booster shot at least two months later, with additional dose...
Source: TIME: Health - April 18, 2023 Category: Consumer Health News Authors: Lauran Neergaard/AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

Should You Get Another Covid Booster?
Britain and Canada have authorized another round of booster shots for older and immunocompromised citizens. So far, U.S. officials haven ’t followed suit.
Source: NYT Health - March 24, 2023 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: your-feed-science Coronavirus (2019-nCoV) Vaccination and Immunization Elderly Immune System Food and Drug Administration Source Type: news

FDA Authorizes Updated Covid Boosters That Target Newest Variants
WASHINGTON — The U.S. on Wednesday authorized its first update to COVID-19 vaccines, booster doses that target today’s most common omicron strain. Shots could begin within days. The move by the Food and Drug Administration tweaks the recipe of shots made by Pfizer and rival Moderna that already have saved millions of lives. The hope is that the modified boosters will blunt yet another winter surge. “You’ll see me at the front of the line,” FDA vaccine chief Dr. Peter Marks told The Associated Press shortly before his agency cleared the new doses. Until now, COVID-19 vaccines have targeted the ...
Source: TIME: Health - August 31, 2022 Category: Consumer Health News Authors: Lauran Neergaard/AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

News at a glance: New gene therapy, Europe ’s drought, and a black hole’s photon ring
ARCHAEOLOGY Drought exposes ‘Spanish Stonehenge’ for study Scientists are rushing to examine a 7000-year-old stone circle in central Spain that had been drowned by a reservoir for decades and was uncovered after the drought plaguing Europe lowered water levels. Nicknamed the “Spanish Stonehenge”—although 2000 years older than the U.K. stone circle—the Dolmen of Guadalperal (above) was described by archaeologists in the 1920s. The approximately 100 standing stones, up to 1.8 meters tall and arranged around an oval open space, were submerged in the Valdecañas reservoir after the construction of a ...
Source: Science of Aging Knowledge Environment - August 25, 2022 Category: Geriatrics Source Type: research

News at a glance: Omicron vaccine, colonial-era exploitation, and mapping health equity
IN FOCUS Scientists rallied outside Canada’s Parliament on 11 August, carrying a 70-meter-long letter with more than 7000 signatures. The letter to lawmakers calls for increases in the stipends paid by graduate student scholarships and postdoctoral fellowships awarded by the Natural Sciences and Engineering Research Council of Canada. “We can’t do science if we can’t pay rent,” one rallygoer’s sign read. COVID-19 U.K. OKs anti-Omicron vaccine The United Kingdom this week became the first country to approve an updated COVID-19 booster directed at two different strains of the coronavi...
Source: ScienceNOW - August 18, 2022 Category: Science Source Type: news

British Regulators Authorize Moderna ’ s Updated COVID-19 Booster
LONDON — British drug regulators have become the first in the world to authorize an updated version of Moderna’s coronavirus vaccine that aims to protect against the original virus and the Omicron variant. In a statement on Monday, the Medicines and Healthcare Regulatory Agency said it had given the green light to Moderna’s combination “bivalent” vaccine, which will be used as an adult booster shot. Each dose of the booster shot will target both the original COVID-19 virus that was first detected in 2020 and the Omicron BA.1 variant that was first picked up in November. British regulators said...
Source: TIME: Health - August 15, 2022 Category: Consumer Health News Authors: Maria Cheng/AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

A Fourth COVID-19 Vaccine, From Novovax, Passed a Key Stage in the Authorization Process
American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot. Next, the FDA must decide whether to authorize the protein vaccine made by latecomer Novavax as the nation’s fourth coronavirus shot for adults. It’s made with more conventional technology than today’s dominant Pfizer and Moderna shots and the lesser-used Johnson & Johnson option. Novavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, either for initial va...
Source: TIME: Health - June 8, 2022 Category: Consumer Health News Authors: LAURAN NEERGAARD / AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

FDA Advisers Back a New COVID-19 Vaccine, Made By Novavax
American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot. Next, the FDA must decide whether to authorize the vaccine made by latecomer Novavax, a protein vaccine that’s made with a more conventional technology than today’s U.S. options. Novavax shots are already used in Australia, Canada, parts of Europe and dozens of other countries. But U.S. clearance is a key hurdle for the Maryland-based company. FDA’s vaccine chief Dr. Peter Marks said another choice in the U....
Source: TIME: Health - June 7, 2022 Category: Consumer Health News Authors: Lauran Neergaard / AP Tags: Uncategorized COVID-19 wire Source Type: news

U.S. FDA grants priority review to Roche ’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
If approved,Actemra/RoActemra would be the first U.S. FDA-approvedimmunomodulator for the treatment of COVID-19 inhospitalised patientsSince the beginning of the pandemic, more than one million peoplehospitalised with COVID-19 have been treated withActemra/RoActemra worldwide1Actemra/RoActemra is approved for the treatment of COVID-19 in many territories including the European UnionRoche has established a comprehensive access approach to improve availability ofActemra/RoActemra around the worldBasel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has acce...
Source: Roche Investor Update - April 4, 2022 Category: Pharmaceuticals Source Type: news

COVID-19 Vaccines Are Unlikely to Trigger Rare Inflammatory Condition in Kids
COVID-19 vaccines are unlikely to trigger a rare inflammatory condition linked to coronavirus infection in children, according to an analysis of U.S. government data published Tuesday. The condition, formally known as multisystem inflammatory syndrome in children, involves fever plus symptoms affecting at least two organs and often includes stomach pain, skin rash or bloodshot eyes. It’s a rare complication in kids who have had COVID-19, and very rarely affects adults. The condition often leads to hospitalization, but most patients recover. First reported in the United Kingdom in early 2020, it is sometimes mistaken ...
Source: TIME: Health - February 23, 2022 Category: Consumer Health News Authors: Lindsey Tanner / AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

Pfizer Agrees to Let Other Companies Make its COVID-19 Pill
(LONDON) — Drugmaker Pfizer Inc. has signed a deal with a U.N.-backed group to allow other manufacturers to make its experimental COVID-19 pill, a move that could make the treatment available to more than half of the world’s population. In a statement issued Tuesday, Pfizer said it would grant a license for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53% of the world’s population. The deal excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a...
Source: TIME: Health - November 16, 2021 Category: Consumer Health News Authors: MARIA CHENG/ AP Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news

Pfizer Says COVID-19 Pill Cuts Hospital And Death Risk By 90%
(WASHINGTON) — Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 cut rates of hospitalization and death by nearly 90% in high-risk adults, as the drugmaker joins the race to bring the first easy-to-use medication against the coronavirus to the U.S. market. Currently all COVID-19 treatments used in the U.S. require an IV or injection. Competitor Merck’s COVID-19 pill is already under review at the Food and Drug Administration after showing strong initial results, and on Thursday the United Kingdom became the first country to OK it. Pfizer said it will ask the FDA and international regulat...
Source: TIME: Health - November 5, 2021 Category: Consumer Health News Authors: Matthew Perrone/ AP Tags: Uncategorized COVID-19 wire Source Type: news

Pfizer Says COVID-19 Vaccine Works in Kids Ages 5 to 11
Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11 and that it will seek U.S. authorization for this age group soon—a key step toward beginning vaccinations for youngsters. The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children. For elementary school-aged kids, Pfizer tested a much lower dose—a third of the amount that’s in each shot given now. Y...
Source: TIME: Health - September 20, 2021 Category: Consumer Health News Authors: Lauran Neergaard / Associated Press Tags: Uncategorized COVID-19 Londontime wire Source Type: news

Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2
AbstractA recently published article described the safety, tolerability, and pharmacokinetic profile of molnupiravir (Painter et al. 2021), a novel antiviral agent with potent activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). Here, we report an unprecedented collaboration between sponsor, contract research organization (CRO), and regulatory authorities that enabled accelerated generation of these phase I data, including administration of the first-in-human (FIH) dose of molnupiravir within 5  days of receiving regulatory approval in ...
Source: Trials - August 23, 2021 Category: Research Source Type: clinical trials