Coronavirus

COVID-19, Vaccine Development Trends at JPM21

by Samantha McGrail

Every January the J.P. Morgan Healthcare Conference is a major event for the pharmaceutical industry, as it brings together experts from across the sector and covers important announcements from top...

HHS Buys 1.25M More Doses of Regeneron’s COVID-19 Antibody Cocktail

by Samantha McGrail

Roche recently announced that HHS and the Department of Defense (DoD) will purchase additional doses of Regeneron’s COVID-19 antibody cocktail, casirivimab and imdevimab. Under the agreement,...

Kaiser to Track Serious Adverse Events From COVID-19 Vaccination

by Samantha McGrail

Kaiser Permanente Vaccine Study Center, part of the company’s Northern California Division of Research, recently announced that it will oversee electronic patient records and uncover any adverse...

HHS Distributes $22B to States for COVID-19 Testing, Vaccinations

by Samantha McGrail

HHS recently announced that it will provide more than $22 billion in funding to states, localities, and territories to support COVID-19 testing and vaccination.  Over $19 billion of the funding,...

NIH Initiates Trial to Evaluate COVID-19 Antibody Therapy

by Samantha McGrail

The National Institutes of Health (NIH) recently announced that a Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal COVID-19 antibody therapy. The trial, ACTIV-2,...

EU Grants Emergency Use for Moderna’s mRNA COVID-19 Vaccine

by Samantha McGrail

Moderna recently announced that the European Commission (EU) granted conditional marketing authorization (CMA) for its mRNA COVID-19 vaccine.  The authorization of COVID-19 Vaccine Moderna,...

AstraZeneca’s COVID-19 Vaccine Gains Emergency Use in 6 Countries

by Samantha McGrail

AstraZeneca recently announced that its COVID-19 vaccine has been granted emergency use authorization in India, Argentina, Dominican Republic, El Salvador, Mexico, and Morocco. The authorization of...

FDA Warns Against Half-Dosing Pfizer, Moderna COVID-19 Vaccines

by Samantha McGrail

FDA is warning health officials to follow the authorized dosing schedules for COVID-19 vaccines as the first round of recipients become eligible to receive their second dose.  Despite discussions...

Moderna Ups COVID-19 Vaccine Manufacturing Estimate to 600M in 2021

by Samantha McGrail

Moderna recently released a COVID-19 vaccine manufacturing update for its mRNA-based vaccine, mRNA-1273. The company announced that it is increasing its base-case global production estimate from 500 to...

UK Authorizes Emergency Use of AstraZeneca’s COVID-19 Vaccine

by Samantha McGrail

AstraZeneca recently announced that its COVID-19 vaccine has been approved for emergency supply in the United Kingdom (UK).  This is the first emergency authorization for COVID-19 Vaccine...

HHS Unveils 3-Part Plan for Supporting COVID-19 Testing Efforts

by Samantha McGrail

HHS recently announced three ways the federal government will continue to support COVID-19 testing efforts by states and authorities into 2021.  The initiative builds upon over $31 billion in...

Pfizer Provides Data From German Trial of COVID-19 Vaccine

by Samantha McGrail

Pfizer and BioNTech recently announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 clinical trial of its COVID-19 vaccine candidate in Germany.  Specifically,...

CA Launches Campaign for Safe, Fair COVID-19 Vaccine Distribution

by Samantha McGrail

California Governor Gavin Newsom recently launched a campaign for safe, fair, and equitable distribution of a COVID-19 vaccine in all 58 counties of the state. The “Vaccinate All 58”...

HHS Doles Out Additional $227M for COVID-19 Vaccine Preparedness

by Samantha McGrail

HHS recently announced that the CDC will award an additional $227 million for COVID-19 vaccine preparedness and response activities. Specifically, $140 million will be used for vaccine preparedness...

More Positive Data Released for Pfizer-BioNTech COVID-19 Vaccine

by Samantha McGrail

A two-dose regimen of Pfizer and BioNTech’s mRNA COVID-19 vaccine, BNT162b2, elicited 95 percent protection against the coronavirus in individuals 16 years of age or older, according to a recent...

FDA Issues EUA for Abbott’s At-Home COVID-19 Antigen Test

by Samantha McGrail

FDA recently issued an emergency use authorization (EUA) for Abbott’s COVID-19 antigen test, the BinaxNOW COVID-19 Ag Card Home Test, for use by patients with a prescription.  The test is...

FDA Issues Second COVID-19 Vaccine EUA to Moderna for mRNA Shot

by Hannah Nelson

The Food and Drug Administration has issued the second emergency use authorization (EUA) for a COVID-19 vaccine to Moderna, allowing for national distribution. All available data show that the vaccine...

US Buys Extra 100M Doses of Moderna’s COVID-19 Vaccine

by Samantha McGrail

The Trump Administration, through HHS and the Department of Defense (DoD), will purchase an additional 100 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273.  mRNA-1273 would...

FDA Authorizes First At-Home, OTC COVID-19 Diagnostic Test

by Samantha McGrail

FDA recently issued an emergency use authorization (EUA) for the first over-the-counter (OTC), at-home COVID-19 diagnostics test. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test,...

Canada Opts to Double Doses of Moderna’s COVID-19 Vaccine

by Samantha McGrail

Moderna recently announced that the Canadian Government will now acquire an additional 20 million doses of its mRNA COVID-19 vaccine, bringing the total to 40 million doses.  The updated...