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Home » Topics » COVID-19

COVID-19
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Moderna Recalls Nearly 800,000 Doses of Its COVID-19 Vaccine

April 12, 2022
The recall was issued following a report of a foreign body found in one vial at a vaccination center in Spain. Read More

FDA Updates EUA for J&J COVID-19 Vaccine to Extend Shelf Life

April 12, 2022
As of December 2021, only 17 million doses of the adenovirus-based J&J vaccine were administered in the U.S. Read More

Acuitas Therapeutics Sues Arbutus Biopharma Over mRNA-Delivery Patents

March 22, 2022
In its complaint, Acuitas argues that Arbutus and Genevant had nothing to do with the vaccine’s success and only sued after the Pfizer/BioNTech COVID-19 vaccine achieved “worldwide commercial success.” Read More

Two Companies Hit With FDA Warning Letters for Selling Unapproved and Misbranded Drugs for COVID-19

February 24, 2022
The FDA has accused two overseas companies of selling unapproved and misbranded drugs for COVID-19 to U.S. customers over the internet. Read More

Sanofi, GSK Seek Vaccine Authorization as Both Primary Series and Booster

February 24, 2022
Sanofi and GlaxoSmithKline (GSK) will very soon be taking their COVID-19 vaccine candidate to U.S. and European regulators as both a primary series and booster, touting its 58 percent efficacy against symptomatic disease as proof that the shot works in a world with multiple COVID-19 variants. Read More

Pfizer, BioNTech Delay Seeking COVID-19 Vaccine Authorization in Children Under Five

February 14, 2022
Pfizer and BioNTech announced Friday that they will hold off pursuing an expanded FDA Emergency Use Authorization (EUA) permitting use of their COVID-19 vaccine in children under age five, in order to gather more data on whether a third booster dose is needed. Read More

PhRMA Blasts WHO Efforts to Pause Patent Rights for COVID-19 Medicines

February 7, 2022
In a 269-page submission to U.S. Trade Representative, Katherine Tai, the Pharmaceutical Research and Manufacturers of America (PhRMA) spelled out the group’s objections to efforts by the World Health Organization (WHO) and other organizations to expand COVID-19 vaccines and treatments at the expense of intellectual property rights. Read More

COVID-19 Boosters Slash Risk of Omicron-Related Death in Older People

January 28, 2022
Protection against Omicron-related death in people 50 and older reached as high as 95 percent after a booster dose of a messenger RNA (mRNA) vaccine, the UK Health Security Agency (UKHSA) announced Thursday. Read More

Pfizer, Moderna COVID-19 Booster Dose Effective Against Omicron, CDC Says

January 24, 2022
A Moderna or Pfizer/BioNTech COVID-19 booster dose was found to give highly effective protection against the Delta and Omicron variants, the Centers of Disease Control and Prevention (CDC) said Friday. Read More

GSK and Vir Seek FDA Nod for Intramuscular Version of COVID-19 Antibody

January 18, 2022
GlaxoSmithKline (GSK) and Vir Biotechnology have developed an intramuscular version of their investigational monoclonal antibody infusion, sotrovimab, for the early treatment of COVID-19 and are asking the FDA to expand the drug’s Emergency Use Authorization (EUA) to include it. Read More

CBER Director Peter Marks Says Omicron-Specific Shots Might Not be Needed

January 18, 2022
As the Omicron variant rages, Peter Marks, the FDA’s top vaccine regulator, said that getting a booster dose earlier than six months after initial doses may be the best way to guard against the ubiquitous variant. Read More

Pfizer Hopes for Omicron-Specific Vaccine by March

January 12, 2022
Pfizer is eying March as a potential roll-out date for a hybrid COVID-19 vaccine that would cover both the original Wuhan strain and the highly vaccine-resistant Omicron strain. Read More
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