Health Advisory Committee – Public Statements
Statement Regarding the Differences Between the Traditional Vaccine Approval Process and Emergency Use Authorization
The Emergency Use Authorization (EUA) is a tool of the Food and Drug Administration to expedite the availability of medical products, drugs, and vaccines during a public health emergency. An EUA can only be granted when no adequate, approved, available alternatives exist and when the known and potential benefits outweigh the risks. Read about the traditional approval process and emergency use authorization.
Here’s a comparison table for Emergency Use Authorization (EUA) versus the normal FDA approval process for vaccines. This table simplifies the comparison by focusing on key differences and similarities between the two approval pathways, making it easier to understand how vaccines are approved under normal circumstances versus during emergencies.
| Aspect | Normal FDA Approval (BLA) | Emergency Use Authorization (EUA) |
| Purpose | Long-term, full market approval for vaccines | To provide swift access to medical products during public health emergencies |
| Development Time | Typically takes 10-15 years, median about 8 years | Significantly reduced; specific to the emergency, can be months |
| Safety and Efficacy Data | Extensive, includes all phases of clinical trials with long-term data | Based on available data, often from initial or incomplete phases of clinical trials |
| Clinical Trial Phases | Full completion of Phases 1, 2, 3, often with Phase 4 follow-up | Phases 1, 2, and partial or complete Phase 3, with ongoing monitoring after authorization |
| Approval Criteria | Must meet rigorous standards for safety, efficacy, and quality | Benefits must outweigh known and potential risks, no adequate alternatives available |
| Post-Approval Monitoring | Continuous and rigorous, includes Phase 4 trials and surveillance systems | Mandatory safety monitoring, ongoing studies for full approval, additional surveillance |
| Legal & Liability | Standard liability for manufacturers | Provides immunity from liability under certain conditions (PREP Act) |
| Public Input | Typically involves VRBPAC for expert review | Often involves VRBPAC or similar advisory committees, public meetings for transparency |
| Manufacturer Requirements | Full documentation, manufacturing process validation, and long-term follow-up | Similar, but with emphasis on speed; must continue studies for full approval |
| Patient Informed Consent | Standard consent for approved drugs/vaccines | Special consent forms emphasizing emergency use, potential risks, benefits, and options |
| Example Scenario | Typical vaccine introduction without urgent public health need | Used during pandemics like H1N1, Ebola, or for rapid response to emerging threats like COVID |
References:
- US Department of Health and Human Services Investigational New Drug (IND) Application
- Emergency Use Authorization
- Federal, Food, Drug, and Cosmetic Act (FD+C Act)
- Public Readiness and Emergency Preparedness (PREP) Act
- Vaccine Development, Testing, and Regulation
- Vaccines and Immunizations. New Vaccines are developed and approved for use
- Vaccine Development-101
- Vaccine Research and Development
Statement Regarding Engineering Controls on the Prevention of Communicable Diseases
High-efficiency particulate air (HEPA) filters can be installed in portable air purifying machines to provide supplemental air filtration, beyond what occurs within the building’s central air handling unit, for a single room. Upon analysis of peer-reviewed scientific literature, there is limited evidence suggesting portable HEPA filters reduce the spread of respiratory communicable diseases. Multiple studies have shown that portable HEPA filters can significantly reduce the number of viral particles within a room, but the correlation to a reduction in respiratory infections is still relatively unproven. The Livingston County Health Advisory Committee does not believe that portable HEA filters should be instituted as a main intervention to address respiratory pathogen concerns. Rather, portable HEPA filters could be considered as a supplemental measure to support a more comprehensive infection prevention strategy.
References:
| Study | Country | Study Type | Setting | Sub-Setting | Results | Conclusions |
|
Banhdzer N. Jent P, Bittel P, Zurcher K, Furrer L, Bertschinger S., Weingartner E, Ramette A, Egger M. Hascher T, Fenner L. Air cleaners and respiratory infections in |
Switzerland | Observational | School | Secondary School | Portable HEPAs associated with decreased particle concentration, fewer absences due to respiratory illness, less frequent coughing. | While air quality and respiratory infection decreased, SARS-COV-2 detection in airborne particles was rare, suggesting COVID-19 may not be a significant airborne threat. |
|
Falkenberg T, Wasser F, Zacharias N, Mutters N. Kistemann T. Effect of portable HEPA filters on COVID-19 period prevalence: an observational quasi-interventional study in German kindergartens. BMJ Open 2023 Jul 30 |
Germany | Observational | School | Kindergarten | Portable HEPAs not associated with decreased cases of COVID-19. | Authors attributed the lack of HEPA effectiveness due to the close contact interactions that are typical with kindergarten age children. Cases of COVID-19 in this study were likely due to direct droplet transmission. Authors do not refute the effectiveness of HEPA removal of particles. |
|
Lu FT, Laumbach RJ, Legard A, Myers NT, BlackKG, Ohman-Strickland P, Alimokhtari S, de Resende A, Calderon L, Mainelis G, Kipen HM. Real-World Effectiveness of |
USA | RCT | Home | Primary and Secondary Rooms | Portable HEPAs associated with decreased particles in primary room and secondary rooms. | Portable HEPAs could be a useful means to reduce viral load within a house if an infected individual is under self-quarantine. Additional factors, including the house ventilation system could affect results. |
|
Huang CH, Bui T, Hwang D, Shirai J, Austin E, Cohen M, Gould T, Larson T, Novosselov I, Tan S. Fox J, Seto Assessing the effectiveness of portable HEPA air cleaners for |
USA | Observational | Homeless Shelter | Sleeping dorms and main activity areas | Portable HEPAs associated with decreased particles in rooms during times of HEPA operation. | Portable HEPAs could be useful in reducing particle/viral loads in rooms larger than residential rooms. Keeping the HEPAs running at appropriate times is an important consideration. |
Statement Regarding Community Based or Population Based Masking for the Containment of Respiratory Viruses
The Health Advisory Committee does not recommend community based or population based masking for the containment of respiratory viruses in Livingston County at this time. (More information to be added shortly.)
References:
- Buckler, P. (2023). The Book on Masks. Monee, IL: B & W.
- Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database of Systematic Reviews 2023, Issue 1. Art. No.: CD006207. DOI: 10.1002/14651858.CD006207.pub6. Accessed 19 February 2025.