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51 FDA Approved Medical Countermeasures Backed by BARDA

Many health security threats involve bacteria or chemicals for which clinical trials cannot be performed in humans. To overcome this hurdle, U.S. Biomedical Advanced Research Projects Agency (BARDA) works closely with the Food and Drug Administration on a path for approval using the Animal Rule. BARDA also invests in reduced business risk and costs not just by providing non-dilutive funding and deep technical assistance but also by focusing on products that could have multiple uses and commercial uses.

In some cases, BARDA has sponsored development for new indications of approved products like Seizalam and Silverlon. Midazolam was an approved sedative and became the first approved as an anti-seizure drug to treat prolonged seizures caused by chemical exposure. Silverlon was cleared initially as a silver-impregnated wound dressing and became the first product cleared in the U.S. for use in treating chemical burns from mustard gas.

Description

# Medical Countermeasure Threat Area Company Sponsor Year
1 H5N1 vaccine Antigen-alone formulation Influenza sanofi pasteur 2007
2 Fluzone® H1N1 influenza vaccine adult Influenza sanofi pasteur 2009
3 Fluvirin® H1N1 influenza vaccine Influenza Novartis 2009
4 FluMist® H1N1 influenza vaccine Influenza MedImmune 2009
5 FluLaval® H1N1 influenza vaccine Influenza GlaxoSmithKline 2009
6 Afluria® H1N1 influenza vaccine infants Influenza Commonwealth Serum Laboratories 2009
7 Afluria® H1N1 influenza vaccine adult Influenza Commonwealth Serum Laboratories 2009
8 XPERT FLU® H1N1 Influenza POC diagnostic Influenza Cepheid 2011
9 LIAT®Influenza A/B Rapid diagnostic Influenza A/B Rapid diagnostic Influenza Iquum / (Roche) 2011
10 Veritor® Influenza A/B Rapid diagnostic Influenza Becton Dickinson 2012
11 Simplexa® Point-of-care diagnostic device Influenza Focus/3M 2012
12 Flucelvax® Seasonal cell-based influenza vaccine Influenza Novartis 2012
13 Aura® Next generation portable ventilator Influenza Covidien 2012
14 Raxibacumab® Anthrax antitoxin Anthrax GlaxoSmithKline (formerly HGS) 2012
15 FluBlØk® Seasonal recombinant-based influenza vaccine Influenza Protein Sciences 2013
16 HBAT Botulinum heptavalent antitoxin Botulism Emergent (formerly Cangene) 2013
17 Q-PAN® H5N1 Pandemic influenza vaccine with adjuvant Influenza GlaxoSmithKline 2013
18 Sophia® Influenza A/B Rapid diagnostic Influenza Quidel (Nanogen) 2013
19 PharmaJet Needleless Flu Shot Stratis Influenza PharmaJet 2014
20 Rapivab® (peramivir) Influenza antiviral drug IV Influenza BioCryst 2014
21 Anthrasil™ (AIG) Anthrax antitoxin Anthrax Cangene 2015
22 Neupogen® (filgrastrim) ARS anti-neutropenia cytokine RAD/NUC Amgen 2015
23 Neulasta (GM-CSFpeg) ARS anti-neutropenia cytokine Rad/Nuc Amgen 2015
24 BioThrax® (post-exposure prophylaxis indication) Anthrax Emergent 2015
25 Fluad (with adjuvant) Influenza vaccine for seniors Influenza Sequris (CSL – Novartis) 2015
26 Anthim Anthrax Monoclonal Anthrax Elusys 2016
27 Flucelvax Quadrivalent Influenza Virus Vaccine Influenza Seqrius 2016
28 Flucelvax Quadrivalent Influenza Virus Vaccine (Pediatric Indication) Influenza Seqirus 2016
29 Q-Pan H5N1 AS03-Adjuvanted Pandemic Influenza Virus Vaccine for Pediatrics Influenza GSK 2016
30 Flublok Quadrivalent Influenza Virus Vaccine Influenza Protein Sciences Corporation 2016
31 Vabomere (Carbavance) BSA MEDCO 2017
32 Rapivab® (peramivir) Influenza antiviral drug IV Influenza BioCryst 2017
33 Cobas LIAT C. Diff POC diagnostic CBRN Roche 2017
34 Roche LightMix Zika Molecular Diagnostic Zika Roche 2017
35 Leukine® (sargramostim) ARS anti-neutropenia cytokine RAD/NUC sanofi aventis 2018
36 ZEMDRI Plazomicin BSA Achaogen 2018
37 Procleix Zika Virus Assay Zika Hologic/Grifols 2018
38 Arestvyr®ST-246 (Tecovirimat) Smallpox antiviral drug Smallpox SIGA 2018
39 Xerava BSA Tetraphase 2018
40 Flucelvax Process 3.0 Influenza Seqirus 2018
41 Seizalam Chemical Meridian 2018
42 RECELL Burn Avita 2018
43 QMS Plazomicin Immunoassay BSA Achaogen (Thermo Fisher) 2018
44 FluChip-8G Influenza A+B Assay Influenza InDevR 2019
45 InBios International Manual Zika IgM assay Zika InBios 2019
46 ADVIA Centaur® Zika test Zika Siemens 2019
47 Trilogy Evo Universal (K181170) ventilator Influenza Phillips 2019
48 Silverlon Chemical Argentum Medical 2019
49 IMVAMUNE® Smallpox MVA Vaccine Smallpox Bavarian Nordic 2019
50 Applied Biosystems™ Bacillus anthracis Detection Kit Anthrax Applied Biosystems 2019
51 OraQuick Ebola Rapid Antigen Ebola OraSure 2019

Over the past 12 years, BARDA has partnered with more than 300 companies, from micro and small businesses to global pharmaceutical corporations. Learn more about partnering with BARDA and start a conversation with them by requesting a meeting.

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