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COVID-19 Vaccine Commercialization FAQs

This webpage is updated regularly with answers to your COVID-19 vaccine commercialization questions. Please also refer to the Commercialization at a Glance: Provider Transition Guide for support and resources. 

Last Revised: 9/13/2023

 

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General Questions

1. What is commercialization?

Commercialization is the transition of COVID-19 medical countermeasures – vaccines, treatments, and test kits – from being purchased by the U.S. Government to private/public payers and established pathways of procurement, distribution, and payment. For more information, please see Commercialization at a Glance: Provider Transition Guide.  

As of September 8, 2023, CDPH inactivated all Providers not participating in the COVID-19 Vaccine Bridge Access Program (BAP) in myCAvax as the U.S. Government COVID-19 program has ended. For further information, see the section titled Bridge Access Program below.  

 

2. How will underinsured and uninsured adults get access to COVID-19 vaccines? 

Vaccines for uninsured and underinsured adult populations will be made available through the HHS Bridge Access Program. For more information about BAP, please see resources listed in the Bridge Access Program section . The White House has also proposed a Vaccines for Adults (VFA) program in the FY2023 and FY2024 Presidential Budgets, which would create a permanent, mandatory program modeled after the successful Vaccines for Children (VFC) program, to cover vaccination at no cost for uninsured and underinsured adults. 

 

 

 

 

 

3. After COVID-19 vaccine commercialization, will COVID-19 vaccines be offered and supplied by the state at no cost, similar to the flu vaccine?  

State-purchased doses of COVID-19 vaccines will only be made available through publicly funded vaccine programs: Vaccines for Children Program and the Bridge Access Program. For more information, please see Vaccine and Clinic Eligibility Guidelines by Funding Source (Coming Soon) 

 

 

 

 

 

4. Now that the California COVID-19 Vaccination Program has ended, are Providers still required to provide the COVID-19 vaccine to patients? 

 

 

 

 

California providers are no longer required to provide COVID-19 vaccine to patients, however CDPH highly recommends that providers continue to provide COVID-19 vaccines to help protect their patients.  

 

5. If a Provider no longer offers the COVID-19 vaccine, where can they refer patients seeking it? 

 

 

 

 

Patients with health insurance will be able to get COVID-19 vaccine at no cost to the patient from their insurance plan. Patients without health insurance or with health plans that do not cover the cost of a COVID-19 vaccine can get a free vaccine from their local health centers; state, local, tribal, or territorial health department; and pharmacies participating in the CDC’s Bridge Access Program. Patients without health insurance or with health plans that do not cover the cost of a COVID-19 vaccine can get a free vaccine from their local health centers; state, local, tribal, or territorial health department; and pharmacies participating in the CDC’s Bridge Access Program. Children eligible for the Vaccines for Children program also may receive the vaccine from a provider enrolled in that program. See COVID-19 Vaccine Access & Ordering infographic and CDC Press Release for more information.  

 

 

 

 

 

6. How will CDPH promote health equity during commercialization? 

CDPH is working with local health departments, federally qualified health centers, rural health centers and other partners to provide federally purchased COVID-19 vaccine to uninsured and underinsured adults in California through the Bridge Access Program.  

 

 

 

 

The California Vaccines for Children program will offer COVID-19 vaccine at no cost to children in California who are uninsured, underinsured, eligible for Medi-Cal, or American Indian or Native Alaskan.  

 

 

 

 

The State of California will continue extensive promotion of COVID-19 vaccine to all Californians, and will work to address health disparities and reach those most impacted by the pandemic

 

 

 

 

 

The Bridge Access Program

For information on program eligibility, enrollment resources and more, see CDPH’s Bridge Access Program Overview page, BAP Resources page, and BAP Implementation Timeline Page

 

7. What is the Bridge Access Program (BAP)? 

On April 18th, 2023, the U.S. Department of Health and Human Services (HHS) announced the HHS Bridge Access Program for COVID-19 Vaccines and Treatments.  The purpose of this program is to help maintain access to COVID-19 care (vaccines and therapeutics) for underinsured and uninsured adults 19 years of age and older, through existing public health infrastructure, HRSA-supported health centers (i.e., Health Centers), and participating pharmacies, via two major components: 

 

 

 

 

  • Provide support for the existing public sector vaccine safety net, implemented and maintained by state immunization programs and HRSA-supported health centers.  
  • Create a funded partnership with pharmacy chains that will enable them to continue offering free COVID-19 vaccinations and treatments. 

 

8. Which providers are eligible to enroll in the BAP? 

 

 

 

 

  • Local Health Departments (LHDs) – LHDs will select additional sites that routinely serve large numbers of uninsured persons. 
  • Federally Qualified Health Centers (FQHCs) / Rural Health Centers (RHCs) 
  • Indian Health Service (IHS) sites and Tribal clinics 

 

9. Which providers are NOT eligible to enroll in the BAP? 

 

 

 

 

  • Providers that do not routinely serve large numbers of uninsured/underinsured patients. 
  • Multi-County entities (MCEs) will not typically be eligible. 

 

10. When will Providers find out if they can participate in the Bridge Access Program? 

Providers we informed of their BAP participation status on September 8, 2023. Providers who did not receive a communication about BAP participation from CDPH are not part of the Bridge Access Program. If a provider believes that this is a mistake, they should contact their Local Health Department (LHD).  

 

 

 

 

 

11. Will correctional facilities be eligible to enroll in BAP? 

CDPH encourages correctional facilities to look at their current systems for purchasing other vaccines and include COVID-19 vaccine in that system. Local Health Department (LHD) may choose to use some of their allocation for correctional facilities.   

 

 

 

 

 

 

 

 

 

12. For how long will HHS Bridge Access Program (BAP) be conducted?  

BAP is a public-private partnership meant to act as a temporary measure to prevent loss of access to free COVID-19 vaccines and treatment for under-and-uninsured persons. It is temporary and began on September 4, 2023, and will end December 31, 2024. 

  

 

 

 

 

13. Who is eligible to receive no-cost COVID-19 vaccines through the Bridge Access Program? 

Adults without insurance and those whose insurance does not provide cost-free coverage for COVID-19 vaccines and treatments are eligible. For more information, please see the BAP Eligibility Based On Insurance Status form.   

 

 

 

 

 

14. Where will eligible people for the Bridge Access Program get vaccinated? 

Eligible people will be able to get vaccinated against COVID-19 at local health jurisdictions (LHJs), federally qualified health centers (FQHCs), Indian Health Services sites, tribal clinics, and some pharmacy locations. 

 

 

 

 

 

15. Will BAP providers be reimbursed for the administration of COVID-19 vaccine to BAP-eligible patients? 

There is currently no source of funding for vaccine administration fees for BAP-eligible providers giving BAP doses, with the exception of funding from HRSA for FQHCs. For more information about the BAP funding going to the FQHCs, please see FY 2023 COVID-19 Bridge Funding for Health Centers | Bureau of Primary Health Care (hrsa.gov)

 

 

 

 

 

16. Do providers that enroll in the Bridge Access Program need to have separate accounts for each clinic site?  

Yes. Providers will have to have separate accounts for each clinic site. CDC requires that COVID-19 vaccines be shipped directly to each clinic location so that BAP sites order and receive vaccines at the location where the doses will be administered. Under BAP, redistribution will no longer be allowed.  

 

17. When will LHDs know the quantity of their BAP allocations? 

CDPH sent BAP allocations on 8/28/23. Allocations are limited and LHDs will be reviewing and approving orders for BAP-eligible providers. 

 

 

 

 

 

 

 

 

 

COVID-19 and Vaccines for Children (VFC) Program

 

18. Will COVID-19 vaccine be part of the VFC Program and, if so, when? 

Yes. In October 2022, ACIP voted to include COVID-19 vaccines in the Vaccines for Children Program (VFC). VFC will make COVID-19 vaccines available for ordering through myVFCvaccines after the transition to commercialization and once doses are available at McKesson, our national vaccine distributor. VFC will send out communications regarding COVID-19 vaccine ordering and timelines once more information is available.  Once COVID-19 vaccines become available to VFC providers they will be required to 

  • offer all immunizations recommended by ACIP to all VFC-eligible children, including COVID-19 vaccines; 
  • maintain an adequate inventory of vaccine for all patients served, including commercial patients; 
  • appropriately schedule and place vaccine orders, rotate vaccine stock properly to ensure adequate vaccine supply, and ensure timely use of short-dated vaccine; 
  • use the same order process used for all current vaccines; instructions for COVID-19 vaccine ordering will be communicated before it begins; 
  • report on-hand inventory, waste, spoiled, and expired COVID-19 vaccine on their myVFCvaccines.org provider accounts; 
  • be subject to Quality Assurance and Compliance Visits from the VFC Program;  

 

 

 

 

 

19. How should providers manage, and track COVID-19 vaccine received through the VFC Program? 

Providers should track doses administered through the California Immunization Registry similar to other routine vaccines. Unused doses that are no longer viable and that cannot be returned to the VFC should be reported as wasted doses. Providers can return unopened non-viable vaccines to the VFC Program by submitting a VFC Return Form on the myVFCvaccines.org website. 

 

 

 

 

 

Vaccine Management

20. Do providers need to continue updating vaccine inventory in Vaccine Finder? 

No. Providers no longer need to continue updating vaccine inventory in Vaccine Finder.  

 

 

 

 

 

21. Will there be changes in ordering through myCAvax after commercialization? 

Yes. Only those who are part of the California Bridge Access Program (BAP) are able to order COVID-19 vaccines in myCAvax. Privately purchased COVID-19 vaccines will need to be ordered either through distributors or directly from the manufacturers.   

 

 

 

 

 

22. Will ancillary kits be shipped with COVID-19 vaccine that is purchased privately? 

No. COVID-19 vaccine products ordered privately or through publicly funded COVID-19 vaccine programs (e.g., Vaccines for Children Program, Bridge Access Program) will NOT include ancillary kits. Providers should look at ancillary suppliers and consider needs post-commercialization to ensure they have adequate supply of ancillary supplies budgeted and planned to purchase. For Moderna & Novavax, providers may contact McKesson Specialty at 833-343-2703 or COVIDVaccineSupport@McKesson.com. For Pfizer,providers may contact McKesson MedSurg at 833-272-6634 or SNSSupport@McKesson.com

 

 

 

 

 

 

 

 

 

23. Should providers dispose of diluent when commercialization begins?  

Providers should always dispose of expired diluent. More information on nonexpired diluent is forthcoming. 

 

 

 

 

 

 

 

 

 

24. After commercialization of COVID-19 vaccines, will the 24-hour reporting deadline to the California Immunization Registry (CAIR) be removed? 

All vaccine reporting to CAIR, including COVID-19 vaccine, will continue to be required. More information regarding reporting deadlines is forthcoming.  

 

 

 

 

 

25. If a provider is NOT participating in BAP or VFC, do they need to maintain a myCAvax profile as a COVID-19 vaccine provider?  

No. If a provider will not be part of BAP, VFC or SGF, they will not need to maintain their myCAvax access once the current program ends. Non-BAP providers will have their myCAvax account inactivated. They will maintain access to My Turn.  

 

 

 

 

 

26. Do new clinics still need to apply to be a COVID-19 vaccine provider if they are not participating in BAP/VFC?  

No. New clinics do not need to enroll sites that will be getting vaccine from the commercial market.  

 

 

 

 

 

COVID-19 Vaccine Accessibility After Commercialization 

27. What will the public pay for COVID-19 vaccine after commercialization? 

Most people will not have any out-of-pocket expenses for COVID-19 vaccines. See COVID-19 Vaccine Access & Ordering infographic. 

 

 

 

 

  • For those with private insurance plans, Advisory Committee on Immunization Practices (ACIP) routinely recommended vaccines, including COVID-19 vaccines, will be fully covered without a co-pay when receiving the vaccine in network, per the Affordable Care Act. There may be fees for out-of-network care.  
  • For Medicare Part B beneficiaries, COVID-19 vaccinations are covered without cost sharing, and this will continue. 
  • Medi-Cal (Medicaid) will continue to cover all COVID-19 vaccinations without a co-pay or cost sharing. 
  • Bridge Access Program (BAP): Uninsured adults may be eligible for BAP and receive COVID-19 vaccines free of charge. See section titled “Bridge Access Program”.  

 

28. Can Providers charge patients any fees for the COVID-19 vaccine ordered through myCAvax? 

Providers may not charge any fees to patients for any publicly funded COVID-19 vaccine they receive. 

 

 

 

 

 

29. Where can I find more information about Medi-Cal reimbursement? 

For more information, please contact DHCS at contactus@dhcs.ca.gov or visit the DHCS COVID-19 Response Website for FAQs.  

 

 

 

 

 

30. How can Providers purchase COVID-19 vaccine products? 

 

 

 

 

  • Moderna: Providers can order through McKesson, Cardinal, and AmeriSource Bergen distributors or directly with Moderna at www.modernadirect.com and 1-866-MODERNA / 1-866-663-3762. CDPH recommends pre-booking to help the manufacturer manage production and distribution, including of pre-filled syringes only available to commercial customers.   
  • Pfizer: Providers may work with wholesalers prior to and post launch of approved products or directly with Pfizer for minimum quantities at https://primecontracts.pfizer.com and 1-800-666-7248.  
  • Novavax: Novavax will be available to order through your dedicated distributor. For more information on product purchasing, email Novavax CA regional Business Director, Nidal Naser at nnaser@novavax.com.  

 

31. What are the updated CPT, NDC, and CVX codes for COVID-19 vaccines? 

Current Procedural Technology (CPT), National Drug Code (NDC), and CVX codes are available for the monovalent COVID-19 vaccines. Download the Fall 2023 COVID-19 Codes on this page or click here.  

 

 

 

 

 

32. What COVID-19 vaccine access programs will be available for Tribal communities post-commercialization?  

Indian Health Services (IHS) sites can enroll in the BAP to provide vaccine for underinsured and uninsured adults in their communities. 

 

 

 

 

 

Pharmacies & The Bridge Access Program

33. Will pharmacies receive doses of COVID-19 vaccine for uninsured patients? 

The retail pharmacy component of the BAP will provide COVID-19 vaccines at no cost to uninsured adults and adults whose insurance does not cover all COVID-19 vaccine costs. CDC has contracts with CVS, Walgreens, and eTrueNorth to supply vaccine doses to areas of lower access or vaccination coverage. eTrueNorth will assist independent or other non-Walgreens and non-CVS pharmacies with participation in this program.  Providers should complete this interest form for general inquiries or to indicate interest in the Bridge Access Program: eTrueNorth/Connect  

 

 

 

 

 

34. When will the federal BAP contracts for pharmacies be completed?  

CDC has contracts with CVS, Walgreens, and eTrueNorth in place now.  

 

 

 

 

 

35. How will pharmacies be reimbursed for commercialized COVID-19 vaccine? 

According to The U.S. Department of Health & Human Services (HHS) Factsheet on the Bridge Access Program, “The Program will provide a per-dose payment to pharmacies in order to facilitate the administration of any COVID-19 vaccines and treatments at pharmacies that will be made available, relying on vaccine manufacturers’ public and private commitments to provide COVID-19 vaccines at no cost for uninsured people.”  

Pharmacies will also be eligible for one-time base payments for each site targeting areas with low rates of access and vaccinations.

 

 

 

 

 

 

 

 

 

COVID-19 Vaccine Formula Fall Transition

36. What is the updated 2023-2024 COVID-19 vaccine formulation? 

On September 11, 2023, the FDA authorized updated mRNA COVID-19 vaccines from Pfizer-BioNTech and Moderna which include a monovalent (single) spike protein sequence from Omicron variant XBB.1.5.   

The updated mRNA vaccines are:    

  • Fully licensed for ages 12 years and older   
  • Authorized under emergency use for ages 6 months through 11 years.   

Please see the FDA News Release and CDPH Provider Communication for more information.  

 

37. Can Emergency Use Authorized (EUA) products be privately purchased? 

Yes, EUA products may be sold on the commercial market.  

 

38. Are the updated COVID-19 2023-2024 vaccine available for purchase in the commercial market? 

Yes, they are available for purchase now.  

 

39. What are the presentations for the updated COVID-19 2023-2024 vaccine products? 

  • Moderna:   
  • Ages 6 months – 11 years:                                  
  • Single-dose vial of .25ml  
  • Ages 12+:     
  • Single-dose vials of .5 ml   
  • Pre-filled syringes of .5 ml (box of 10) *  
  • Pre-filled syringes of .5 ml (blister pack of 10) *  
  • *May not be available in the CDC contract  
  • Pfizer:   
  • 6 months – 4 years (3 mcg)  
  • Multi-dose vial (3 doses) – dilution required.   
  • Minimum order: 30 doses (3×10-vial box)   
  • 5 years – 11 years: (10 mcg)  
  • Single-dose vial   
  • Minimum order 10 doses (1×10 vial box)  
  • Ages 12+: (30 mcg)  
  • Single-dose vial   
  • Limited quantities of prefilled syringe  
  • Minimum order 100 doses (10×10 vial box)  
  • Novavax: Still under FDA review  
  • Anticipate 12+ age indication for fall campaign (pending FDA authorization).  
  • 5 dose vial 
  • Minimum order 10 doses. Two vials per carton.  
  • 0.5ml dose for all authorized indications 
  • Standard refrigeration.   

 

40. How will COVID-19 vaccine products ship? 

  • Moderna:  
  • Ship as a frozen product 
  • Storage and handling will be the same as previous Moderna products. * 
  • Novavax:  
  • Ship as a refrigerated product 
  • Storage and handling will be the same as the original Novavax product. * 
  • Pfizer: 
  •  Pfizer will ship their COVID-19 vaccines at ULT.  Wholesalers may ship Pfizer COVID-19 vaccines at refrigerated temperatures so providers should order accordingly as the vaccines will arrive with just 10 weeks of beyond use date. 
  • Storage and handling will be the same as bivalent Pfizer products. * 

*Information is subject to change. 

 

41. Will diluent need to be purchased separately for Pfizer or will it come in a bundle with the vaccine?  

Pfizer will provide diluent with their commercial and VFC vaccines indicated for patients under 6 years of age. 

 

42. Will commercialized Pfizer COVID-19 vaccine be supplied to store in -70C freezer, -20C freezer, or refrigerated?  

Commercialized Pfizer vaccine will be shipped at ultra-low temperatures (ULT) and will use the same current bivalent vaccine.   

 

Treatments

 

43. When will commercialized Paxlovid be available and which vendors will be offering them?

Pfizer has stated that for Paxlovid, end of the year 2023 at the earliest and mid-summer 2024 at the latest. CDPH is unsure of Merke’s timeline for Lagevrio. Federally purchased product for both Paxlovid and Lagevrio should be available through the end of 2023. More details will be forthcoming. 

 

44. How can Providers order Paxlovid during this time of transition and moving forward?

If a provider is already registered in the Health Partner Order Portal (HPOP) they can let their Local Health Department know that they would like to place an order. CDPH is still processing orders weekly. 

 

45. How will the two Paxlovid products (EUA vs. Commercialized) be identified and/or packaged following commercialization?

EUA Paxlovid is not expected to change current packaging. FDA approved Paxlovid packaging will have an updated internal & external appearance and new NDC’s. Prescribing, labeling, and packaging information, including NDCs for the FDA approved Paxlovid product can be found on their product label

 

46. Will patients continue to pay nothing out-of-pocket for COVID-19 Therapeutics?

California state laws have requirements on most health plans to continue covering COVID-19 tests, vaccines, and treatment from any licensed provider (in-or-out-of-network) with no enrollee cost-sharing or prior authorization. After November 11, 2023, enrollees can continue to get COVID-19 tests, vaccines, and treatment with no prior authorization or cost sharing when they access these services through their health plan’s network. Health plan enrollees can be charged for cost-sharing only if these services are provided out of network after November 11, 2023. For COVID-19 treatments such as Paxlovid and Lagevrio, out-of-pocket expenses for certain treatments may change after these products move to traditional health care models, depending on a person’s health care coverage. 

 

47. How will BAP affect COVID-19 Therapeutics?

The federal government has stated there is ample supply of COVID-19 therapeutics to last for the forseeable future. When the federal supply is exhausted, for Paxlovid, uninsured patients can still have access to free Paxlovid through Pfizer’s Patient Assistance Program (PAP). More informaiton forthcoming for Lagevrio.