Coronavirus

Pfizer-BioNTech COVID-19 Vaccine 100% Effective in Adolescents

by Samantha McGrail

Pfizer and BioNTech recently announced that its COVID-19 vaccine, BNT162b2, demonstrated 100 percent efficacy and robust antibody responses in adolescents with or without prior SARS-CoV-2...

Real-World Evidence Confirms Efficiency of mRNA COVID-19 Vaccines

by Samantha McGrail

A new CDC study used real-world evidence to find that mRNA COVID-19 vaccines are highly effective in preventing SARS-CoV-2 infections among healthcare personnel, first responders, and other essential...

Children Produce More COVID-19 Antibodies, Study Finds

by Samantha McGrail

A recent JAMA Network Open study found that there are distinct COVID-19 antibody response profiles that vary based on age. The cross-sectional study used 31,426 COVID-19 antibody test results from...

Moderna Studies COVID-19 Vaccine Candidate in Pediatric Population

by Samantha McGrail

Moderna recently announced that the first participants were dosed in the Phase 2/3 study of its COVID-19 vaccine candidate, mRNA-1273, in children six months to up to 12 years of age.  The study,...

COVID-19 Antigen Tests Prove More Accurate in Symptomatic Patients

by Samantha McGrail

A recent study found that COVID-19 antigen test sensitivity is higher in individuals with signs and symptoms of the coronavirus, rather than in those without symptoms present.  In individuals...

AstraZeneca COVID-19 Vaccine 76% Effective in Phase 3 Trial

by Samantha McGrail

AstraZeneca recently announced that its COVID-19 vaccine was 76 percent effective against the coronavirus and 100 percent effective at preventing severe disease and hospitalization in a Phase 3...

FDA Grants First Marketing Approval for COVID-19 Diagnostic Test

by Samantha McGrail

FDA recently granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) COVID-19 diagnostic test.  BioFire RP2.1 is used for the simultaneous qualitative detection of multiple...

Eli Lilly’s COVID-19 Antibody Reduces Hospitalizations by 87%

by Samantha McGrail

Eli Lilly & Company recently announced new data showing that its combination COVID-19 antibody therapy significantly reduced COVID-19 hospitalizations and deaths in high-risk coronavirus...

COVID-19 Hospitalizations Spark Overuse of Antibiotic Concerns

by Samantha McGrail

A recent Pew Charitable Trusts study found that over half (52 percent) of COVID-19 hospitalizations during the first six months of the pandemic included antibiotic...

FTC Takes New Approach to Analyzing Pharmaceutical Mergers

by Samantha McGrail

The Federal Trade Commission (FTC) recently launched a working group to update its approach to analyzing the effects of pharmaceutical mergers and acquisitions.  The joint project will adopt...

GSK COVID-19 Antibody Elicits 85% Drop in Hospitalizations, Deaths

by Samantha McGrail

Vir Biotechnology and GlaxoSmithKline (GSK) are stopping a Phase 3 clinical trial of its COVID-19 antibody early after data shows “profound efficacy,” according to a recent announcement...

Real-World Evidence Confirms Pfizer COVID-19 Vaccine Effectiveness

by Samantha McGrail

The Israel Ministry of Health (MoH), Pfizer, and BioNTech recently shared real-world evidence showing that the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, elicited lower incidence rates of coronavirus...

UK and EU Reaffirm Safety of AstraZeneca’s COVID-19 Vaccine

by Samantha McGrail

The Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) recently reaffirmed the benefits of AstraZeneca’s COVID-19 vaccine. The agencies stated that...

PhRMA Seeks IP Protections for COVID-19 Vaccine Developments

by Samantha McGrail

In an official letter to President Joe Biden, PhRMA and over 30 leaders in the biopharmaceutical warned that eliminating intellectual property (IP) protections in COVID-19 vaccine development could...

FDA Authorizes Sequencing-Based COVID-19 Diagnostic Test

by Samantha McGrail

FDA recently issued an emergency use authorization for a sequencing-based COVID-19 diagnostic test. The T-Detect COVID Test, developed by Adaptive Biotechnologies, is intended to identify individuals...

FDA Authorizes First At-Home Molecular COVID-19 Diagnostic Test

by Samantha McGrail

FDA recently issued an emergency use authorization for an at-home and over-the-counter (OTC) COVID-19 diagnostic test. The Cue COVID-19 Test for Home and OTC Use test is a molecular nucleic acid...

GE Gets $41M to Accelerate Vaccine Manufacturing, Distribution

by Samantha McGrail

GE Research and a multi-disciplinary team are receiving up to $41 million over the next five years to boost nucleic acid-based vaccine manufacturing and distribution.  The Defense Advanced...

US Buys More Doses of Eli Lilly’s COVID-19 Antibody Therapy

by Samantha McGrail

Eli Lilly & Company recently announced that the US government has agreed to purchase a minimum of 100,000 doses of its COVID-19 antibody therapy combination for $210 million.  The COVID-19...

Merck to Manufacture Johnson & Johnson COVID-19 Vaccine for US

by Samantha McGrail

The Biden Administration recently announced a historic collaboration between Johnson & Johnson and Merck to expand production of Johnson & Johnson’s COVID-19 vaccine,...

AstraZeneca Furthers COVID-19 Vaccine Rollout Through COVAX

by Samantha McGrail

AstraZeneca recently announced that the first doses of its COVID-19 vaccine through the COVAX initiative have begun arriving in low and middle-income countries globally.  The first shipments were...