Pfizer and BioNTech updated rolling submission for EUA of COVID-19 caccine in children 6 months through 4 years of Age
On Feb. 11, 2022, Pfizer and BioNTech announced plans to extend their rolling submission to the U.S. Food…
WHO granted prequalification of Actemra/RoActemra for patients with severe or critical COVID-19
On Feb. 11, 2022, Roche announced that Actemraﾮ/RoActemraﾮ (tocilizumab) intravenous (IV) had been granted World Health Organization (WHO)…
WHO prequalified first monoclonal antibody – tocilizumab ﾖ to treat COVID-19
On Feb. 11, 2022, the WHO announced the addition of tocilizumab, a monoclonal antibody, to its list of…
Gilead reported phase 2/3 interim data evaluating safety, tolerability and clinical outcomes of Veklury (Remdesivir) in pediatric patients with COVID-19
On Feb. 11, 2022, Gilead Sciences announced new data from an interim analysis of its ongoing, Phase 2/3…
Veklury (Remdesivir) retained antiviral activity against Omicron, Delta and other emergent SARS-CoV-2 variants
On Feb. 11, 2022, Gilead Sciences announced new data from an interim analysis of its ongoing, Phase 2/3…
Novavax announced positive results of COVID-19 vaccine in pediatric population of PREVENT-19 phase 3 clinical trial
On Feb. 10, 2022, Novavax announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness…
Moderna announced new supply agreement with Colombia for additional 10.8 million doses of COVID-19 vaccine
On Feb. 8, 2022, Moderna announced a new supply agreement with the government of Colombia for 10.8 million…
Merck and Ridgeback announced 3.1 million courses of molnupiravir investigational oral antiviral COVID-19 medicine supplied to U.S. Government
On Feb. 8, 2022, Merck and Ridgeback Biotherapeutics announced that a total of 3.1 million courses of molnupiravir,…
Study suggested COVID-19 vaccines do not reduce fertility
On Feb. 8, 2022, a research team led at Boston University School of Public Health reported on links…
NIH-funded study suggested COVID-19 increased risk of pregnancy complications
On Feb. 4, 2022, the NIH announced a study that showed pregnant women with COVID-19 appeared to be…
COVID-19 infections increased risk of heart conditions
On Feb. 7, 2022, researchers at Washington University School of Medicine in St. Louis announced an analysis of…
Research collaboration launched to focus on repurposing existing anti-viral therapies to treat COVID-19
On Feb. 4, 2022, a new ﾣ1.6m collaborative project was launched to rapidly identify new treatments for COVID-19….
How sneezing hamsters sparked a COVID outbreak in Hong Kong
On Feb. 4, 2022, pet hamsters probably carried the Delta variant of SARS-CoV-2 into Hong Kong and sparked…
CDC’s ACIP issued recommendation for use of Moderna COVID-19 vaccine in adults aged =18 years
On Feb. 4, 2022, the Advisory Committee on Immunization Practices (ACIP) issued a standard recommendation for use of…
UK MHRA granted Conditional Marketing Authorization for Novavax COVID-19 vaccine in Great Britain
On Feb. 3, 2022, Novavax announced that the Medicines and Healthcare products Regulatory Agency had granted conditional marketing…
T2 Biosystems T2SARS-CoV-2 panel detects Omicron subvariants
On Feb. 3, 2022, T2 Biosystems announced that its T2SARS-CoV-2 Panel detected Omicron COVID-19 subvariants BA.1, BA.2, and…
New Zealand’s Medsafe granted provisional approval for Novavax’ COVID-19 vaccine
On Feb. 3, 2022, Novavax announced that New Zealand’s Medsafe had been granted provisional approval of NVX-CoV2373, Novavax’…
Pfizer and BioNTech initiated rolling submission for EUA of COVID-19 vaccine in children 6 months through 4 years of age
On Feb. 1, 2022, Pfizer and BioNTech announced that following a request from the U.S. Food and Drug…
Moderna received full U.S. FDA approval for COVID-19 vaccine Spikevax
On Jan. 31, 2022, Moderna announced the U.S. Food and Drug Administration (FDA) had approved the Biologics License…
Novavax submitted request to U.S. FDA for Emergency Use Authorization of COVID-19 vaccine
On Jan. 31, 2022, Novavax announced that it had submitted a request to the U.S Food and Drug…
InteliSwabﾮ COVID-19 rapid tests receive U.S. FDA authorization for pediatric use
On Jan. 31, 2022, OraSure Technologies announced that its InteliSwabﾮ COVID-19 rapid tests had been authorized by the…
Veru announced FDA Grant of Fast Track Designation for Sabizabulin for treatment of hospitalized COVID-19 patients
On Jan. 31, 2022, Veru announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track…
Novavax and Israel announced advance purchase agreement for supply of COVID-19 vaccine
On Jan. 28, 2022, Novavax and Israel’s Ministry of Health announced an agreement for the purchase of NVX-CoV2373,…
WHO and Viamo provided critical access to COVID-19 information to the next billion digital users via their mobile phones
On Jan. 28, 2022, the WHO announced that COVID-19 information had reached 1,292,209 people through Viamoﾒs 3-2-1 Platform…
Merck and Ridgeback’s Molnupiravir, investigational antiviral COVID-19 medicine, demonstrated activity against Omicron variant
On Jan. 28, 2022, Merck and Ridgeback Biotherapeutics announced data from six preclinical studies demonstrating that molnupiravir, an…
Cocrystal Pharma selected two lead antiviral drug candidates for COVID-19 oral drug program
On Jan. 27, 2022, Cocrystal Pharma announced that it had selected two investigational novel antiviral drug candidates for…
Hyperimmune intravenous immunoglobulin does not improve outcomes for adults hospitalized with COVID-19
On Jan. 27, 2022, NIAID announced that a clinical trial found that the combination of remdesivir plus a…
COVID-19 | FDA | Life Science History | NIH
Mix-and-match trial found additional dose of COVID-19 vaccine safe, immunogenic
On Jan. 26, 2022, the NIH announced that adults who had previously received a full regimen of any…
Pfizer and BioNTech initiated study to evaluate Omicron-based COVID-19 vaccine in adults 18 to 55 years of age
On Jan. 25, 2022, Pfizer and BioNTech announced the initiation of a clinical study to evaluate the safety,…
University of Missouri researchers identified mutations of Delta, Delta Plus variants
On Jan. 25, 2022, researchers at the University of Missouri announced they had identified the highly prevalent, specific…