N.B. Concurrent with the posting of this article, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (“FDA”) has decided to recommend to the FDA that the FDA approve the emergency use authorization applications submitted by Pfizer and BioNTech. It is being reported that the FDA may formally approve the applications as soon as tomorrow, Friday, December 11, 2020. More detail regarding the recommendation and the FDA’s decision will be discussed in a follow-up article.
On Monday, December 7, 2020, California Governor Gavin Newsom announced that, “Hope is on the horizon with the [COVID-19] vaccination. We continue to accelerate our planning and preparedness for a safe and equitable vaccine distribution.” As noted by the Governor, California expects to receive a little more than two million doses of the vaccine this month including 327,000 doses from pharmaceutical company, Pfizer, and 2.6 million doses from biotechnology maker, Moderna.
Now that there are estimated dates of delivery for both Pfizer’s and Moderna’s COVID-19 vaccines and it appears that the FDA – possibly as soon as tomorrow, Friday, December 11, 2020 – will be granting an emergency use authorization to Pfizer and BioNTech for the distribution of their COVID-19 vaccines based upon today’s recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee, California’s vaccine distribution plan (“Plan”) has claimed the public spotlight.
The following reviews California’s vaccine distribution strategy and highlights the populations receiving priority status for vaccination with the first round of vaccine doses scheduled to be delivered to California this month.
CALIFORNIA’S VACCINE DISTRIBUTION PLAN AND ALLOCATION GUIDELINES FOR COVID-19 VACCINE
During a December 3, 2020 online press conference, Governor Newsom described California’s “COVID-19 Vaccine Distribution Plan” (the “Plan”) and the California Department of Public Health (“CDPH”) “Allocation Guidelines for COVID-19 Vaccine During Phase 1A” (the “Allocation Guidelines”) as putting healthcare workers and vulnerable patient populations at the front of the line for vaccination.
A. Vaccination Priorities: A Tiered Vaccine Distribution Blueprint
According to the Allocation Guideline’s tiered vaccine distribution blueprint, vaccines will first be provided to (i) residents of skilled nursing facilities, assisted living facilities, and similar long-term care settings for older or medically vulnerable individuals; and (ii) healthcare workers who come into direct contact with patients positive for COVID-19 and those at the highest risk of exposure – e.g., paramedics, emergency medical technicians, and healthcare workers at acute care, correctional and psychiatric hospitals and nursing homes. Next, healthcare workers in intermediate care facilities, home settings, and primary care clinics (e.g., federally qualified health centers, rural health centers, correctional facility clinics, and urgent care clinics) will be given access to the vaccine. Finally, the Allocation Guideline’s “third tier” healthcare workers in less risky healthcare settings – e.g., dental offices, laboratories, and specialty clinics – will be eligible for vaccination.
Once vaccine is distributed to healthcare workers based upon the foregoing priority categories, the Plan directs the State to broaden vaccination access to other groups including essential workers – e.g., farm laborers, police officers, child care staff and teachers – and communities at increased risk of COVID-19, including minority communities disproportionately affected by COVID-19. During a November 23, 2020 press conference, Governor Newsom said, “mass vaccinations are unlikely to occur anytime soon. For the back of the envelope purposes, March, April, May, June, July, where we start to scale, and we start getting into the subsequent phases (of vaccine distribution).”
B. Distribution Of Vaccine – The Mechanics.
According to the Plan, the State-wide distribution of vaccine will be based upon a multi-level and multi-step process designed to promote the equitable distribution of the vaccine and to protect, “California’s critical and vulnerable populations, especially during the early phases when vaccine supply will be limited.” See, Plan, pg. 35.
As outlined by Governor Newsom during his December 3, 2020 press conference, California’s distribution process is comprised of six distinct steps as set forth below:
Step One Enroll Vaccine Providers and Establish Allocation Guidelines. The first step involves enrolling healthcare providers to conduct vaccinations and developing guidelines for the allocation of the initial 327,000 doses of Pfizer’s vaccine among six vaccine regions. As established by CDPH, the six regions and their respective allocation of Pfizer vaccine doses are as follows:
- Region I (126,750): Los Angeles, Orange, San Diego, San Luis Obispo, Santa Barbara, Ventura;
- Region II (80, 497): Alameda, Contra Costa, Del Norte, Humboldt, Lake, Marin, Mendocino, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Shasta, Solano, Sonoma;
- Region III (8,592): Butte, Colusa, Glenn, Lassen, Modoc, Plumas, Santa Cruz, Sierra, Siskiyou, Sutter, Tehama, Trinity, Yuba;
- Region IV (35,145): Alpine, Amador, Calaveras, El Dorado, Nevada, Placer, Sacramento, San Joaquin, Stanislaus, Tulare, Tuolumne, Yolo;
- Region V (16,706): Fresno, Kern, Kings, Madera, Mariposa, Merced; and
- Region VI (59,910): Imperial, Inyo, Mono, Riverside, San Bernardino.
As noted above, the Allocation Guidelines were adopted and distributed by the CDPH on December 5, 2020. In addition, the CDPH has identified the following hospitals as participating in the vaccination process: Cedars Sinai Medical Center, Los Angeles; Mercy Medical Center, Redding; Rady Children’s Hospital, San Diego; UCD Health, Sacramento; UCSF Medical Center, San Francisco; Valley Children’s Healthcare, Madera; and Zuckerberg San Francisco General Hospital. According to CDPH, these facilities were chosen based on their ultra-cold storage capabilities, as the Pfizer vaccine must be stored in negative 80-degree freezers, at large “highest-risk” healthcare population and/or their willingness to redistribute vaccines outside their facility and network. The final criteria was one of geography, as the Department said these places were chosen to be spread across the state as evenly as possible.
Step Two Review Vaccine Orders Submitted by Local County Departments of Health. Under the Plan, local county departments of health are obligated to submit distribution plans for their respective geographic regions. Such plans must include various elements including a description of the region’s “vaccine administration capacity” – such capacity being determined based upon multiple factors including the number of registered vaccination providers in the region; the number of “point of dispensing” (“POD”) sites available to vaccinate emergency responders and critical infrastructure personnel in the region; and the COVID-19 vaccine storage capacity at each POD.
Steps Three and Four Local County Orders. Steps 3 and 4 involve the process of preparing and filling of the local county orders.
Step Five Vaccine Delivery Logistics. Shipping companies like UPS and FedEx will drop off the vaccine to hospitals and vaccine providers who already have approved cold-chain storage units. To increase storage capacity, the State has purchased additional cold storage units for providers to use.
Step Six Vaccine Administration. Once again, the 327,000 Pfizer vaccine doses will be distributed and administered in accordance with the Allocation Guidelines as described above. As explained by Governor Newsom, notwithstanding the initiative of the vaccination process, mask and social distancing rules will remain in place. Over time, this will change; however, as an initial matter, it is still unclear as to whether vaccinated individuals are still capable of spreading the virus to others.
A CLOSER LOOK: VACCINE DISTRIBUTION CHALLENGES.
As noted above, the execution of the Plan and the delivery of vaccine to the priority populations identified in the Allocation Guidelines fall on the shoulders of the local county departments of health. Although each county will experience its own unique challenges during the vaccination process – such challenges could vary significantly from one county to the next given the extreme demographic, geographic and other differences between the counties – experts have identified certain common challenges that will likely create significant hurdles for all counties to overcome.
1. “Colder than Winter in Antarctica.”
As has been widely reported and discussed, the Pfizer vaccine needs to be kept extremely cold: minus 70 degrees Celsius, which is, “colder than winter in Antarctica.” By contrast, Moderna has said that its vaccine needs to be frozen too, but only at minus 20 Celsius, more like a regular freezer.
Given the need to maintain the Pfizer vaccine at ultra-low temperatures, the storage and transportation of the vaccine presents significant logistical challenges. In order to meet this challenge, counties and healthcare providers in California and elsewhere have been scrambling to get their hands on ultra-cold freezers. For example, in the case of Los Angeles County (“LAC”), the LAC Department of Public Health purchased five ultra-cold freezers in addition to three from the State and eight purchased by the LAC Department of Health Services. These 16 freezers will be placed in strategic locations across LAC; however, the eight LAC Department of Health Services freezers will be dedicated to staff and patients at the LAC’s four public hospitals and 27 health clinics.
2. Multi-Dose Vaccines and Compliance Challenges.
In addition to the cold storage and transportation challenges described above, both the Moderna and the Pfizer vaccines present significant challenges as multi-dose vaccines – i.e., vaccines that require more than one dose to reach maximum effectiveness.
Multi-dose vaccines present a number of challenges that will likely complicate the vaccination process. For example, vaccines with two-dose regimens will require careful tracking of doses and follow up with each individual receiving the vaccine to ensure they receive the same vaccine, with the second dose given at the proper time. The CDC and local jurisdictions are in the process of implementing a new vaccine tracking system to monitor COVID-19 vaccine administration and help with multiple dose tracking, but it is unclear if, or how, the new system will integrate with existing immunization information systems.
In addition to the technical/logistical challenges posed by multi-dose vaccines, research has shown that many patients who receive their first dose of a multi-dose vaccine often fail to return for their second dose. For example, studies conducted in both the US and UK on the hepatitis B vaccine — which, like the Pfizer and Moderna Covid-19 vaccines, is supposed to have around a one-month period between the first and second doses — found that roughly 50% of patients failed to get their follow-up shot within a year after their first. By failing to obtain the second dose, a patient may experience little or no protective effect from the vaccine. Therefore, to the extent that the goal of vaccination in this case is to bring the current public health emergency to an end, the public will need to be educated as to why the second dose of the vaccine is as much an imperative as the first dose. For this reason, many have argued that public education is an indispensable element of any successful vaccination plan.
We will continue to monitor State and local implementation of the Plan, the Allocation Guidelines, and the general progress of California’s efforts to distribute vaccine in California.
This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand. This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.