This listing includes accelerated approvals (AAs) for infectious disease indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.
Indications may remain on this page until FDA updates product labeling or publishes a Federal Register notice regarding a change in status.
Ongoing 1 Infectious Diseases Accelerated Approvals
Total approval time was adjusted based on management decision. This is a legacy practice and is no longer exercised.
|Drug Name||Accelerated Approval Indication||Accelerated Approval Date||AA PMR||Original Projected Completion Date|
|Bexsero (meningococcal group B vaccine)||Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Meningococcal Group B Vaccine is approved for use in individuals 10 through 25 years of age||1/23/2015||PMR 1: To conduct the ongoing study V102_16 to assess the performance of immunologic assays for evaluating the breadth of coverage against diverse Neisseria meningitidis serogroup B strains.||3/20/2016|
|Bexsero (meningococcal group B vaccine)||Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Meningococcal Group B Vaccine is approved for use in individuals 10 through 25 years of age||1/23/2015||PMR 2: To conduct study V72_72 of BEXSERO among persons 10 years through 25 years of age in the US to confirm effectiveness against a panel of diverse Neisseria meningitidis serogroup B strains.||12/31/2018|
|Fluad (influenza virus vaccine, adjuvated)||For active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and B contained in the vaccine.||11/24/2015||PMR 1: To conduct the confirmatory study (V118_18) to assess efficacy of Fluad aQIV as compared to an active control Tdap vaccine (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Boostrix]) in adults 65 years of age and older||8/31/2019|
|Fluad Quadrivalent (influenza vaccine, adjuvanted)||For active immunization of persons 65 years of age and older against influenza disease caused by seasonal influenza virus subtypes A and types B||2/21/2020||PMR 1: To conduct Study V118_24, a clinical disease endpoint trial in subjects 65 years of age and older with Fluad Quadrivalent.||9/30/2024|
|Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)||To add prevention of oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV)||6/12/2020||PMR 1: To conduct Study V503-049 to evaluate the efficacy of a three-dose regimen of GARDASIL9 in the prevention of oral persistent infection with HPV types 16, 18, 31, 33, 45, 52 or 58 in men 20 through 45 years of age.||9/30/2026|
|Prevnar 20 (pneumococcal 20-valent conjugate vaccine)||For active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older and the prevention of pneumonia caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older||6/10/2021||PMR 1: To conduct a study to assess the effectiveness of Prevnar 20 in adults = 65 years of age in preventing community acquired pneumococcal pneumonia caused by pneumococcal serotypes 8, 10A, 11A, 12F, 15B 22F and 33F in the vaccine. The original protocol for this study entitled "A Phase 4 Study Using a Test-Negative Design to Evaluate the Effectiveness of a 20-valent Pneumococcal Conjugate Vaccine Against Vaccine-Type Radiologically-Confirmed Community Acquired Pneumonia in Adults = 65 years of age" (Study B7471015) was submitted on January 15, 2021.||11/30/2027|
|Vigiv 2 (vaccinia immune globulin intravenous (human))||Treatment and/or modification of the following conditions, which are complications resulting from smallpox vaccination: eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions, aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.||5/2/2005||PMR 1: Work with the FDA, and other public agencies as appropriate, to design and implement a clinical study protocol to include VIGIV dose ranging, and conduct a study to describe the treatment and clinical course of patients receiving VIGIV for complications of vaccinia infection when such a study is feasible, due to the actual or impending widespread use of VIGIV.|
- 1"Ongoing" refers to accelerated approval (AA) applications that have not yet converted to full approval, and not to the status of the AA postmarketing requirement (PMR).
- 2This PMR does not have a target completion date as it is dependent on when such a study is feasible, due to the actual or impending widespread use of VIGIV.