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Influenza vaccine updates
The following information has been distributed to partners in the National Influenza Vaccine Summit as well as to health care professionals across the United States.
Summit updates and any other influenza related material will be posted on this page as rapidly as possible.
2006 updates
National Influenza Vaccine Summit issues informational statement on FDA warning letter to sanofi pasteur (PDF, 79KB)
Sanofi statement on FDA warning letter (PDF, 11KB)
FFF Enterprises announcement of MyFluVaccine.com (PDF, 38KB)
HIDA brief on distribution of influenza vaccine in the 2005-2006 season (PDF, 419KB)
Information from MedImmune clarifying current status of FluMist®
Increase in CMS reimbursement for administration of influenza vaccine
Nov. 1, 2004 update featuring information from the October ACIP meeting
American Medical News features story advising physicians on vaccine reallocation plan
CDC releases its screening tool; long-term care facilities and pharmacists consensus statement released!
Summit update — Oct. 22, 2004
AMA provides tool to screen for those requiring influenza vaccination
CDC releases antivirals guidance, Oct. 19, 2004
PKIDS provides fact sheet on influenza prevention
CDC press release Oct. 15, 2004
Summit update — Oct. 13, 2004
Summit update — Oct. 11, 2004
Information from MedImmune on FluMist®
MedImmune has announced that they are currently out of doses from the first lots that they produced, which were approx. 1.1 million doses. They are now making an additional 2 million doses and they believe these doses will be released around mid-November.
There is availability for these new doses. MedImmune is currently taking new orders and will be fulfilling them on a first come, first serve basis. There is no limit on the number of doses that customers can order but there is an issue with vaccine storage, which may account for the rumors circulating that only 50-70 doses can be purchased.
The rumored limit of 50 - 70 doses may be due to the fact that the freezebox that stores the vaccine can only hold 80 doses, that is, 8 boxes of 10. If there is a -20oC (or colder) freezer that is not self defrosting, the freezebox is not needed and more doses can be ordered and stored appropriately. However, in the absence of such a freezer, the FDA requires the use of the freezebox and thus the order limit of 50-70 doses. This may be particularly noticeable for individual providers who are more likely to need to use the freezebox.
MedImmune is in discussion with the FDA about the need for freezeboxes based on stability data but for now they need to be used. A plan should be finalized shortly.
MedImmune's allocation plan is to prioritize doses to primary care providers, public health, and hospitals since their TIV orders have been cut by 50 percent.. They are asking interested customers to call (877) FluMist. The (877) FluMist phone number has been tested to work and more lines and people have been added. If there is a problem with the above number, customers should call (877) 633-4411.
Note: This information is provided for your convenience and does not imply endorsement of MedImmune or FluMist® by the National Influenza Vaccine Summit or the American Medical Association.
Increase in reimbursement for administration of influenza vaccine
CMS has released a press release (PDF, 79KB) announcing increase of the reimbursement rate for administration of influenza vaccine from approximately $8 to about $18 for the next influenza season.
Influenza vaccine reallocation plan — update from October ACIP Meeting
Julie Gerberding, MD, MPH
Dr. Julie Gerberding provided an introduction to the influenza discussion at the Oct. 2004 ACIP meeting. She mentioned that over nine million doses would be shipped out by the end of the week ending Oct. 29 under the reallocation plan. This is in addition to over 2 million doses shipped out the previous week under the plan.
She emphasized that the principle of the reallocation plan is equity. Thus, a lot of emphasis is being placed on identifying where gaps in vaccine availability exist in the United States. Several methods are being used to do this.
First, manufacturers and distributors have made available to state and local health officials, over a secure Internet network, proprietary information regarding the orders for influenza vaccine that have been received. This will allow these health officials to identify who has ordered Aventis versus Chiron vaccine and reallocate as best they can.
Second, a survey is ongoing with long term care facilities to discovertheir needs and assure distribution of vaccine to these facilities.
Third, local health departments are accumulating data through a laborious phone survey of their providers of influenza vaccine to further elucidate wherethe gaps lie at the local level.
Finally, a purchase tracking system called BioSense is also being used to track vaccine distribution and supply across the US.
It was mentioned that Aventis anticipates shipping out about 3 million doses of vaccine a week, with final shipments occurring the week of Dec. 19th.
L.J's note: Based on this, it is critical that expectations of both providers and patients are kept realistic. A high-priority provider will receive vaccine, if s/he is identified as such, but it will take some time. So patience and persistence on the part of both patients and providers is essential.
Dr. Gerberding also wanted to remind clinicians and their patients that anti-virals are available and may be useful to alleviate the severity of disease if used early.
Lance Rodewald, MD, MPH
Dr. Rodewald provided some background on the issues facing influenza vaccination before and after Oct. 5th. Chiron supplies their vaccine entirely through seven distributors while Aventis distributes directly to about 85 percent. of their customers; Aventis also partially ships some vaccine to al customers.
Of note, he mentioned that before Oct. 5th, Aventis had shipped 33 million doses to more than 34,000 customers. Primary care physicians represented the highest percentage of providers receiving vaccine, hospitals were second and health departments were third. Because of Aventis' shipping policy, all providers ordering from Aventis had some vaccine on October 5th.
Dr. Rodewald mentioned that the number of high risk patients have been reduced from 185 million to 95 million by the interim ACIP recommendations.
Gaps in distribution are thus defined by those who ordered from Chiron. What this had created is minimal large-scale geographic disparities in supply but extreme dichotomization at the local level.
The public health challenge is to reallocate the remaining 25 million Aventis doses to fill the distribution gaps. The CDC is working with local public health departments and immunization collations to identify providers for high-risk patients, redistribute the vaccine accordingly, and reduce inappropriate vaccination.
Jeanne Santoli, MD, MPH
Dr. Santoli gave a wonderful summary (PPT, 334KB) of the reallocation plan, its goals and its current progress.
In summary, the goal is to distribute a scarce resource to the providers most likely to be able to reach high risk patients.
This will occur via a two-step approach:
- National level efforts to allocate vaccine to providers serving priority groups;
- State and local public health efforts to refine allocation within their jurisdictions based on information about local supply and number of high risk patients
Step 1
Step 1 includes two phases; Phase I includes orders that were immediately identifiable on Oct. 5, 2004 while Phase II includes orders that required identification and enumeration.
Separation into two phases allowed resumption of shipping to begin reaching ACIP priority groups as quickly as possible. Work on both phases is simultaneous.
It is the plan's objective to fill the following orders at 100 percent. levels. As can be seen, only orders, except VFC orders, that were placed with Aventis can be immediately identified and shipped at 100 percent.:
| Provider type | Order/vaccine type | Original order placed with… |
| Providers who care for children | VFC orders | AvP, Chiron |
| Preservative-free | AvP | |
| Direct orders from pediatricians | AvP | |
| LTC facilities and hospitals | Direct orders | AvP |
| VA | Federal contract | AvP |
| Indian health services | Via VA federal contract | AvP |
The new reallocation plan has the following providers' orders filled at less than 100 percent.:
| Provider type | Order/vaccine type | Original order placed with… | New percentage filled |
| Community Vaccinators | Direct Orders | AvP | 75 percent. |
| Visiting Nurse Association of America (VNAA) |
| AvP, Chiron distributors | 50 percent. |
| Office-based customers (primary care providers and specialists) | Direct Orders | AvP | Up to 50 percent. |
| State and local public health | Federal contracts | AvP, Chiron distributors | 50 percent. |
| State or multi-state contracts | AvP, Chiron distributors | 50 percent. |
The following activities will be part of the Phase II efforts at the national level:
- Canvassing of orders placed with a Chiron distributor conducted collaboratively by CDC, AvP, and the Chiron distributors;
- Identify providers serving substantial numbers of patients in priority groups;
- Focus on the following provider/order types:
- Long term care facilities;
- Hospitals;
- Pediatricians and other primary care providers (FP, IM, OB/GYN, GP);
- Local public health departments who ordered directly from Chiron distributor;
- Collect information about number of doses and geographic distribution of these orders;
- Follow-up with state and local public health regarding additional needs;
- Further exploration of some providers whose orders may have been placed differently than anticipated
The following activities are occurring at the local level:
Flu Vaccine Finder: Secure database of doses distributed available via the Internet to state health officers and will be "live" as of 10/25/04. This site will be updated weekly and used by state and local public health officials to monitor and manage vaccine supply and to determine unmet needs for vaccine.
Current timeline for Step 1
- Shipping resumed in the second week of October and is anticipated to continue through December 19;
- Total weekly shipments of ~ 3 million doses;
- All large orders are filled with partial shipments;
- Shipment of Phase II vaccine will begin once the allocation plan for these orders is complete.Shipment of orders in Phase II will overlap with shipments from Phase I.
Step 2: State and Local PH efforts
- Pivotal role with respect to:
- Relationships with providers, facilities (including licensing);
- Emergency powers
- Identify and address gaps in distribution, large emphasis on Chiron customers;
- Detailed data made available by Aventis Pasteur and Chiron distributors to state and local public health official is critical;
- Multiple approaches may be taken, depending of local circumstances - approaches include monitoring of supply, direct administration of vaccine, reallocation of vaccine or patients as needed, and communication.
In the meantime, the CDC and FDA are looking for vaccine from other countries.
On that note, please refer to the recent press release from the DHHS regarding the procurement of up to 5 million additional doses of influenza vaccine from other countries. It is likely that these doses will be administered in the US under an IND protocol.
American Medical News story on reallocation plan
AMNews has published a story on the influenza vaccine reallocation plan with some advice on steps providers should pursue to ensure that their high-risk populations get vaccinated.
CDC screening tool, LTC consensus statement released!
CDC has released a screening tool to help health care providers identify those people who should be receiving vaccine during the current vaccine shortage situation. Additonally, a consensus statement has been released by long-term care facilities on how to best utilize the vaccine in such facilities and for such populations.
CDC screening tool (PDF, 130KB)
Long-term Care Facilities and Pharmacists Consensus Statement (Word, 32KB)
Summit update - Oct. 22, 2004
The following information is based on notes taken from two calls held on October 21, 2004. The first was a briefing Secretary Tommy Thompson conducted for the governors' state representatives; the second was the CDC conference call with ASTHO, CSTE, APHL, AIM, and NACCHO.
From the Secretary's call
- All states should be notified on or about Oct. 29, 2004 of the amounts and timing of their vaccine shipments.
- CDC continues to follow the ACIP recommendations about high-risk groups and is not recommending any sub-prioritization among these groups.
- States on the call continued to reiterate their need to obtain the most specific data possible about the location of vaccine that has been shipped and will be shipped into their state.
From the CDC call
- CDC will provide additional written clarification concerning its two-phased influenza vaccine distribution plan. This information will be shared with partners as soon as it becomes available. Phase 1 and Phase 2 plans should not to be considered as occurring incrementally, there will be overlap between the two phases.
- Aventis will notify their private customers this week about the anticipated 6-7 week delivery schedule for their phase 1 vaccines; Aventis will confirm these specific order deliveries one week in advance of each shipment. CDC will send a letter with all future Aventis shipments asking those receiving vaccine to contact health departments to let them know they have vaccine.
- CDC will notify immunization grantees (states and directly funded locals) this week about their anticipated 6-7 week delivery schedule for phase 1 vaccines; Aventis will confirm these specific order deliveries one week in advance of each shipment.
- CDC continues discussions with Aventis about the possible release of vaccine distribution data. Aventis has provided state-specific and some county-specific data to CDC. It is increasingly apparent that more detailed data will not be forthcoming. CDC is working with Aventis to develop a policy about sharing these data with states. CDC has not received information on specific shipments to private providers. [Note: CDC does understand the desire of state and local public health officials for the most specific distribution data possible.]
- HHS is examining options in relation to the possible importation of influenza vaccine from other countries, most notably Canada. CDC is attempting to assess what uptake there might be for such imported vaccine as an IND (investigational new drug). If any vaccine such is imported, it most likely would not be available before January 2005.
AMA influenza vaccination screening tool
The AMA has created a screening tool to help health care providers screen for those who are most vulnerable to complications from influenza infection.
CDC releases influenza anti-virals guidance
CDC interim guidance on use of influenza antivirals (Word, 215KB)
Influenza prevention techniques
The Pediatric Infectious Diseases Society has released a fact sheet (Word, 47KB) on how to prevent catching influenza in the absence of vaccine. This fact sheet emphasizes the importance of frequent hand washing, covering your cough, stayingat home when sick, and seeking vaccinations for other infectious diseases. The AMA supports all these concepts and also recommends that where possible, hands and fingers should not be placed into the mouth, nose, and eyes to further prevent transmission of pathogens.
CDC press release Oct. 15, 2004
The CDC has issued a press release (PDF, 99KB) detailing the initial release of 2 million doses of vaccine.
Summit update Oct. 13, 2004
FDA inspectors are in Liverpool doing a full GMP inspection of plant. At this time, Chiron's focus is to make certain that their UK license will be restored so that they will ready for influenza vaccine production for next year's season.
The Redistribution plan (Word, 29KB)
The CDC press release is accurate in its statement that "private providers who care for young children" will be allocated over the next 6-8 weeks through their Aventis Pasteur contracts directly.
If these health care professional need to ascertain their status with respect to their vaccine shipment, they should call their vendor directly. For most, this will be Aventis itself; otherwise call the bulk purchasing pharmacy, hospital, or other vendor, that the vaccine was ordered through. It may be necessary to reinforce the fact that high risk patients are served by the practice.
For Chiron customers: – Aventis is working with the top 7 distributors of Chiron vaccine to attempt to plug the gaps. Health care professionals who ordered Chiron vaccine should let their distributor know that they have priority patients and the number of doses needed as exactly as possible. The distributor will then work with Aventis to fulfill the needs as best as possible.
The CDC is also telling the local public health depts. that once they are done with vaccinating high-risk patients they should be aggressively looking for providers locally to get them vaccine. NACCHO is working with local health departments and CDC on this effort. Should the local PH dept. not be aware of this, let them know that CDC and NACCHO are working on this and that it is coming down the pipe.
The intent is that VFC and LTC orders will be filled in their entirety. It is our understanding is that LTC orders through Aventis will be filled in Phase 1 of the plan (that is, the first 14 millions doses). LTCs that ordered through Chiron are in the same boat as providers who ordered from Chiron – Aventis will be working with distributors to try to identify them, and they will be a priority for Phase 2
Please report price gouging to the state's attorney general's office with a cc to Jim Harrison at the CDC. As of today, the CDC has 55 reports of price gouging. ASTHO is contacting the National Association of States Attorneys General to get information on how to connect with your state's attorney general, and will share what they find out.
MedImmune is working with CDC on its distribution plan, since care-takers of children <6 months and health care workers are two priority groups that are encouraged to get FluMist if they are in the labeled indication (healthy, 5-49, non-pregnant). Also, are filling an additional million doses for a total of 2.1 million doses
Additionally, CMS has just informed us that the current reimbursement price of $10.10 for vaccine was based upon the Aventis AWP.
Finally, we've attached a product from PKIDS (Word) detailing how to protect yourself from influenza without the vaccine. It touches on some of the hand hygiene issues that were discussed earlier.
Summary of the reallocation plan
As announced on Oct 12, phase one of the allocation plan involves approximately 14 million of the 22 million doses that were undistributed as of Oct 5. The doses to be distributed in this first phase include all doses ordered via the VFC program, all preservative-free doses (licensed for use in children < 36 months), 50 percent. of the non-VFC doses ordered by state health departments, doses ordered by Aventis providers who care for young children or who represent long term care facilities or hospitals, doses ordered by the military, and doses ordered by the Veteran's Administration.
Phase two involves a canvassing of all public and private sector orders placed via Aventis or the Chiron distributors in order to determine which represent providers serving a significant number of high risk patients and to assess the quantity of doses needed according to ACIP's recommended priority groups (which are reduced from the recommendations in effect when the original orders were placed). This canvassing is being carried out collaboratively by CDC, Aventis, and the Chiron distributors and will help to determine the need for influenza vaccine that will not be addressed by phase 1 activities.
Given the current shipping capabilities, it is likely that the timing of orders considered to be in phase 1 will overlap with orders considered to be in phase 2. In addition, Aventis will fill all orders with partial shipments as vaccine becomes available to minimize geographic disparities in distribution.
It is important that patients and their health care providers on the prioritization list realize that vaccine is on its way but it will take about 2-3 weeks for vaccine to begin to arrive, if the health care provider is in Phase I, and about 3-6 weeks, if the health care provider is in Phase II of the plan.
Summit update Oct. 11, 2004
The FDA has approved redistribution of influenza vaccine:
Anticipated shortages of influenza vaccine this flu season constitute emergency medical reasons, within the meaning of Section 503(c)(3)(B)(iv) of the Food, Drug, and Cosmetic Act (FDC Act), as determined by FDA. It is therefore permissible under the FDC Act for a hospital or health care entity to redistribute influenza vaccine to alleviate shortages this flu season.
When redistribution occurs, the hospital or health care entity that is redistributing influenza vaccine, should document and maintain the following information:
- vaccine brand name
- manufacturer and distributor
- lot number
- number of doses transferred
- recipient's name and address
In any such redistribution, the influenza vaccine and its transfer must comply with FDA's current good manufacturing requirements. Information on proper handling, storage, and shipping can be found online.
The CDC anticipates having a screening tool available soon to assist you in your implementation of the interim ACIP recommendations. While your Executive Committee has also created a screening tool, we have decided to hold off releasing it to ensure that it is consistent with the tool being developed by the CDC. Additionally, talking points are being developed by the CDC and hopefully will also be available soon.
Maxim Healthcare has also created some tools that they are willing to share. Maxim only serves adults so the pediatric recommendations are not on their tools.
Maxim screening tool (Word, 33KB)
Maxim CDC recommendation fact sheet (PDF, 51KB)
The ACIP/CDC will also be releasing interim guidance on the use of anti-virals later this week. While not directly within the scope of the Summit, the guidance may help you address any questions that you may encounter in the field.
Currently, we understand that plans are being developed by the CDC in conjunction with Aventis to address the issue of prioritizing remaining doses of influenza vaccine for the high risk populations. As soon as news become available on this matter, we will update you.
The Summit Executive Committee are also working to facilitate any reallocation efforts. ASTHO and NACCHO will be working together on some ideas and we will update you as well when more is known.
Finally, bear in mind that the CDC recommendations do NOT prioritize the high risk populations in any order. The Summit needs to reemphasize this fact to support those who are doing the right thing and vaccinating any high risk individual in the interim recommendations and not prioritizing within that listing. Should the ACIP decide to prioritize within that list, then we will accommodate that accordingly.
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