On October 22nd, the Department of Health and Human Services’ (HHS) Assistant Secretary for Preparedness and Response (ASPR) hosted a Strategy Briefing for stakeholder organizations to update us on the COVID-19 Operation Warp Speed (OWS) Vaccine Distribution plan. Dr. Michael Blaiss, ACAAI executive medical director, participated in this webinar on behalf of the College.
OWS is a partnership among various federal agencies, including HHS, the Department of Defense(DOD), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA). State and territorial representatives and representatives of the private sector are also part of the OWS team.
Currently, OWS is working with 11 drug manufacturing companies to produce 800 million doses of six different COVID-19 vaccines, five of which are in Phase III clinical trials. By prepurchasing and premanufacturing these vaccines prior to approval, the vaccine distribution plan can be activated and supplies delivered within 24 hours of any of the vaccines receiving FDA approval.
According to officials on the call, several of these vaccines are expected to seek FDA approval within the coming week. They have informed their distribution partners to expect activation of the distribution plan in December.
Vaccines will be distributed using distribution kits which will include 100 preloaded syringes per kit. Kits will include needles of various gauges, alcohol swabs, masks/shields and vaccination cards to record the specific vaccine administered to the individual recipients. Neither gloves nor sharp containers will be included in the kits. There will be adult kits, pediatric kits, and mixed kits. Nearly 4 million kits have been produced. Manufacturers are awaiting authorization to place pre-loaded syringes of approved vaccines into the kits.
McKesson has been awarded the central distribution contract and will coordinate the 20 subcontractor distribution facilities located in various parts of the country. These subcontractors will in turn handle vaccine distribution to state and local facilities.
It was noted that there are differences in the cold storage requirements for the various vaccines which will affect distribution.
The vaccine distribution will be a phased roll out as there will be limited doses at the beginning.
Initial distribution (Phase I) will be targeted to health care providers and high-risk patient populations/communities. Hospitals, nursing homes or other health care facilities will be distribution/administration points for providers and high-risk patients. OWS has told the distributors to expect delivery of 30 – 40 million approved vaccines by the end of December.
Phase II distribution will consist of vaccine kits to doctor’s offices and pharmacies for community-wide distribution.
Most of the candidate vaccines (five of the six) will require a second dose at 21 or 28 days. OWS will hold ample supply to cover the second dose for the initial vaccine recipients. Which vaccines are selected and when they will be distributed will be determined by the FDA after review of all the efficacy and safety data.
The CDC and FDA are making sure that vaccine safety protocols are in place, including new platforms added to existing systems for safety monitoring. These agencies are concerned about public perception and plan to implement strategies to protect communities at risk for under-vaccination, empower families to initiate discussions with their physicians about the vaccine, and stop misinformation from eroding public trust.
Lastly, the OWS said that all vaccinations would be free and there would be reimbursement to providers through patient’s insurance. They did not have an answer for payment for administration of the vaccine to the uninsured.
The College will continue to participate in these sessions and keep you informed as more information on vaccine development and distribution becomes available.