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Tag: Coronavirus


FDA, Industry, Regulations, Vaccines

FDA weighs shift in COVID vaccination strategy

January 23, 2023

Via: Biopharma Dive

The Food and Drug Administration is considering shifting to an annual process for updating COVID-19 vaccines to match circulating coronavirus strains, akin to the current approach for influenza. The proposal from agency staff, released Monday ahead of a Thursday meeting […]


Industry, Vaccines

COVID Vaccine Safe for Kids Who’ve Had MIS-C, Small Study Suggests

March 30, 2022

Via: Drugs.com

COVID-19 vaccines appear to be safe for kids who have had a rare complication called MIS-C after being infected by the coronavirus, according to a new small study. Some kids get MIS-C — shorthand for multisystem inflammatory syndrome in children […]


Clinical Trials, Research and Development

10 clinical trials to watch in the first half of 2022

January 3, 2022

Via: Biopharma Dive

One year ago, the biotechnology sector was in the middle of a record run. The successful development of coronavirus vaccines and drugs had helped slow the pandemic and propelled investment into new companies going public at a historic rate. Biotech […]


Industry, Vaccines

COVID vaccines deployed in US highly effective at reducing hospitalizations and deaths

October 28, 2021

Via: Medical News

Researchers in the United States have conducted a large-scale study showing that the two-dose regimen vaccines developed by Pfizer-BioNTech and Moderna to protect against coronavirus disease 2019 (COVID-19) appear to be highly effective and durable in reducing the risk of […]


Industry, Pharma

EMA starts rolling review of Merck’s molnupiravir, continuing rapid regulatory response to COVID-19 antiviral data

October 25, 2021

Via: FierceBiotech

Merck has opened another front in its campaign to get molnupiravir to market, kicking off a process that could lead to the approval of the oral COVID-19 antiviral in the EU. Things have moved quickly since Merck and partner Ridgeback […]


Industry, Vaccines

AstraZeneca files for FDA green light of COVID-preventing antibody

October 5, 2021

Via: FierceBiotech

AstraZeneca has taken another step toward bringing its COVID-19 antibody cocktail to market, filing for emergency use authorization of the long-acting candidate in coronavirus prophylaxis in the U.S. Last month, AstraZeneca delivered evidence that the candidate prevents COVID-19 in people […]


Industry, Vaccines

Sanofi Pivots mRNA Vaccine Program from COVID-19 to Flu, Pathogens

September 29, 2021

Via: Genetic Engineering and Biotechnology News

Sanofi said it is pivoting its messenger RNA vaccine (mRNA) program—acquired over the summer when it bought Translate Bio for $3.2 billion—away from COVID-19 and toward influenza and other pathogens, despite announcing positive Phase I/II data for the vaccine candidate […]


Industry, Vaccines

Second dose of J&J’s coronavirus vaccine increases protection, company says

September 21, 2021

Via: Biopharma Dive

A second dose of Johnson and Johnson’s coronavirus vaccine appears to increase protection from moderate to severe COVID-19, the company said Tuesday after months of questions on how well the efficacy of its single-shot regimen would hold up over time. […]


Industry, Vaccines

Vaccine Study Explores COVID-19 and Autoimmune Disease

August 30, 2021

Via: Genetic Engineering and Biotechnology News

An estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most severely impacted by COVID-19. In addition, higher rates of severe COVID-19 and death have been reported in people with autoimmune […]


Industry, Vaccines

Next-gen COVID vaccine to make persistent neutralizing antibodies

August 30, 2021

Via: Medical News

Scientists and pharmaceutical companies have successfully generated vaccines to fight the coronavirus disease (COVID-19) pandemic. Most of these vaccines are very effective in combating the disease. However, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an RNA virus that has […]


Industry, Vaccines

Uncleavable Spikes: Key to Better SARS-CoV-2 Vaccines

August 26, 2021

Via: Genetic Engineering and Biotechnology News

New research from Japan shows hamsters inoculated with spike gene mutants that lack the protease cleavage site are resistant to subsequent infection with both the parent strain and emerging alpha (UK/B.1.1.7) and gamma (Brazil/P.1) SARS-CoV-2 variants. “SARS-CoV-2 spike gene mutants […]


Industry, Vaccines

Study compares mRNA and adenovirus-based SARS-CoV-2 vaccines against variants of concern

July 26, 2021

Via: Medical News

The development and emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern that could potentially evade a vaccine-induced immune response is an ongoing concern, with the alpha (B.1.1.7), beta (B.1.351), gamma (B.1.248), and delta (B.1.614.2) lineages having […]


Industry, Vaccines

What is behind the inconsistent results of COVID-19 clinical trials?

July 12, 2021

Via: Medical News

With the coronavirus disease 2019 (COVID-19) pandemic causing unprecedented morbidity and mortality, the development of an effective antiviral drug for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global health priority. Although many drug candidates have been identified […]


Industry, Vaccines

Durable antibody response at least 8 months following vaccination with J&J COVID vaccine

July 9, 2021

Via: Medical News

A recent study by a team of scientists at Beth Israel Deaconess Medical Center and Janssen Vaccines & Prevention has demonstrated that humoral and cellular immunity elicited by the coronavirus disease 2019 (COVID-19) vaccine Ad26.COV2.S remains active for at least […]


Industry, Vaccines

COVID-19 vaccines are effective in 94% of cancer patients, shows study

July 1, 2021

Via: Medical News

In a U.S. and Swiss study, nearly all patients with cancer developed good immune response to the COVID-19 mRNA vaccines three to four weeks after receiving their second dose, but the fact that a small group of the patients exhibited […]


Industry, Vaccines

New study may lead to more effective and powerful COVID-19 vaccines

June 17, 2021

Via: Medical News

A new study looking at the way human cells activate the immune system in response to SARS-CoV-2 infection could open the door to even more effective and powerful vaccines against the coronavirus and its rapidly emerging variants keeping the global […]


Industry, Vaccines

World on the brink of ‘catastrophic moral failure’ due to unfair vaccine rollouts, WHO chief says

January 18, 2021

Via: CNBC

The head of the World Health Organization said Monday the equitable distribution of coronavirus vaccines is at “serious risk.” Warning of a “catastrophic moral failure,” WHO’s Director-General Tedros Adhanom Ghebreyesus said “the recent emergence of rapidly-spreading variants makes the rapid […]


Industry, Vaccines

Hospitals scramble to get ready for coronavirus vaccines

November 19, 2020

Via: Biopharma Dive

Hospitals across the country are ramping up their efforts to figure out how to store, track and administer coronavirus vaccine doses as confidence grows that an effective vaccine could soon become available. Hospitals will play a key role once a […]


FDA, Regulations

FDA grants emergency authorisation to Lilly’s COVID-19 antibody

November 11, 2020

Via: Pharma Times

Bamlanivimab is now available under emergency use for the treatment of mild to moderate COVID-19 in adults and paediatric patients 12 years and older who are at high risk of progressing to severe COVID-19 and/or hospitalisation. In a statement, Lilly […]


Industry, Vaccines

Coronavirus vaccine frontrunner Pfizer delivers key trial data – here’s where the other vaccines stand

November 9, 2020

Via: CNBC

Numerous pharmaceutical companies are racing to complete clinical trials and become the first to successfully get U.S. approval for a vaccine to fight the coronavirus, which has infected more than 50.5 million people worldwide in 11 months. A safe and […]