Several questions were raised regarding the New York State COVID-19 Vaccination program during our weekly Wednesday call with Chapters. While the program continues to evolve, and several questions remain unanswered, responses to the questions we received are outlined below.
Vaccine Side Effects
Side effects are possible with any vaccine. There have been some reports of allergic reaction in people receiving the Pfizer vaccine. The Centers for Disease Control and Prevention (CDC) published "Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 Vaccine." This guidance addresses allergic reactions by advising that "Vaccine providers should observe patients with a history of anaphylaxis (due to any cause) for 30 minutes after vaccination. All other persons should be observed for 15 minutes after vaccination to monitor for the occurrence of immediate adverse reactions." The interim guidance addresses many areas of concern and can be a valuable source of information for anyone with questions about the vaccine.
Q: Will individuals that we serve who live at home with family be considered priority 1A?
A: Phase 1A does not include this population in the distribution plan. The Arc New York is meeting with the Governor's Office to advocate for vaccine prioritization of all individuals with I/DD.
Q: Do the staff at the residence have to be over 65 to be eligible to receive the vaccine through the Pharmacy Partnership?
A: No such criteria has been communicated. The Pharmacy Partnership for Long-Term Care Program identified eligible facilities based on the age of the majority of individuals served (more than 50% of individuals over age 65). This criteria was not applied to the workers who support them.
Several questions have arisen about fees associated with vaccination. The federal government communicated that there will be no cost to people who seek vaccination. This information can be found here and here. Additionally, the Department of Financial Services (DFS) issued an emergency regulation on Wednesday to ensure immediate coverage of the COVID-19 vaccine by health insurers licensed in New York state. Insurers are directed to cover the cost of the COVID-19 vaccine without cost sharing. The DFS press release can be viewed here.
The first three responses were provided by OPWDD's Office of General Counsel
Q: If someone's legally authorized consent giver lives far away, will it be acceptable for staff to note that they provided verbal consent over the phone and mark the form?
Q: Can they prefill the informed consent form and bring it with them to the Points of Dispensing (PODs)?
Q: If they're getting the vaccine from another provider that is using their own form, is the New York State Department of Health (NYSDOH) informed consent form an acceptable alternative, or will they have to use the one provided?
A: They must follow the provider's requirements.
Q: Can we provide guidance for the Informed Consent Committees (ICC) on individual medical considerations when evaluating if granting consent for the vaccine is appropriate? There is concern on their part of ICC members that they may not have sufficient medical history to give an "informed" consent.
A: OPWDD is proposing emergency regulations that would amend Part 633.11 and incorporate the use of an ICC to secure vaccination consents. Under part 633.16, ICCs are used to obtain consent for interventions and medications in the absence of an informed consent provider. We continue to discuss this with OPWDD, and will share additional information as it becomes available.
New York State developed a webpage dedicated to vaccine information. We encourage all Chapters to routinely visit the webpage for updated information on the state's distribution plan and vaccine facts.
Additional Information Regarding Consent
The NYSDOH informed consent form will be used for non-414 sites receiving the Pfizer vaccine. We are expecting additional forms to come out, and will forward those upon receipt. A fact sheet specific to the particular vaccine being administered must be included with the consent form.
OPWDD published an informational update this afternoon, which included a plain language flyer, as well as a video explaining the vaccine. It is also our understanding that OPWDD will be working on a plain language consent revision for use by individuals capable of providing consent.
For all other individuals, Chapters should immediately begin engaging with those who will provide consent. For Willowbrook Class members, all requests for consent should be sent via email to Tawnie Ferguson, Executive Director of the Consumer Advisory Board (CAB) at Antonia.Ferguson@opwdd.ny.gov. Ms. Ferguson requested that we use her as a single contact person at CAB to ensure prompt turnaround.
Chapter residential programs should be preparing now for the arrival of vaccines next week by identifying individuals who:
- can provide their own consent,
- have a legal guardian or active family member (see 633.11 for a list of who can provide consent); or
- are not capable and have no one available to provide consent.
With regard to those who cannot provide consent and have no one to do so on their behalf:
- OPWDD is reportedly preparing to file an emergency amendment to Part 633.11 regulations that would authorize residential providers to utilize ICCs pursuant to 633.16 to provide consent for COVID-19 vaccination.
- Chapters are advised to utilize the individual's PPT (Program Planning Team) to determine, based upon other consent determinations for the individual, whether or not they are capable of providing consent for the COVID-19 vaccine.
- If not, the ICC would be authorized to consent.
- Note: the existing ICC in 633.16 is comprised for behavioral treatment purposes. Chapters should utilize an appropriately qualified professional instead of a psychologist for purposes of COVID-19 vaccination consent (such as a registered nurse).
This process is still under review with OPWDD and other state agencies. We will circulate the Emergency Regulation and accompanying Guidance as soon as they are finalized.
Chapters should be engaging with staff in the Priority 1A category (all staff directly involved in a certified residential facilities, including Direct Support Professionals, residence managers and assistant managers, clinical staff involved at the facility, and relief staff), in strongly encouraging receipt of the vaccine next week or as soon as it becomes available, and in reviewing the DOH consent form. It has been reported that vaccine administration sites may have the capacity to allow staff, and perhaps others, to execute consent forms on site. However, we advise that staff bring their signed consent form with them if possible in order to facilitate effective administration.
Regarding the need for a prescription ordering the vaccination, we believe this issue may still be under review by DOH. In the meantime, you should anticipate that a prescription will be required for all individuals for whom an ICC will provide informed consent.
FDA Advisory Committee Recommends Moderna Vaccine for EUA Approval
This evening, the Moderna COVID-19 vaccine cleared another step toward Emergency Use Authorization (EUA) approval and distribution. The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee voted in favor of advancing the vaccine to the full FDA for review and EUA approval. The EUA will then go to the CDC Advisory Committee on Immunization Practices (ACIP) for discussion on prioritization. Vaccine distribution could begin as early as December 21. CNBC published a detailed story on the committee recommendation that can be read here.
OPWDD COVID-19 Data
OPWDD shared data regarding the number of confirmed cases of COVID-19 and deaths due to COVID-19 within the service system.
As of December 16, 2020:
- 5,428 individuals supported have been confirmed to have COVID-19.
- 4,175 of these cases involve individuals residing in certified residential facilities.
- There have been 497 deaths relating to COVID-19.
- 7,156 staff have been confirmed to have COVID-19.
OPWDD has not yet supplied more detailed data regarding COVID-19 cases by setting. As a reminder, New York state maintains data on cases by county here.
AADMD Statement on Vaccine Allocation
We achieved a great advocacy victory in New York state with Phase 1A allocation of the COVID-19 vaccine for individuals with I/DD in certified residential settings and the staff who support them. However, much needs to be done in our own state and across the country to ensure that all I/DD individuals are given priority access to safe and effective COVID-19 vaccines.
Coverage of the Impact of COVID-19 on People with I/DD and Their Families
The pandemic has been especially difficult for people with disabilities and their families. Reporter Taylor Goebel wrote a story for USA Today about her brother Zach, her mom, who cares for him, and the challenges they face. The family later spoke out in an NBC News segment.
Although these are difficult stories to hear, we know that people with I/DD and their families are confronted with these challenges on a daily basis. We share their story to support our advocacy efforts on behalf of individuals with I/DD, and to let others know that they are not alone during this very challenging time.
Virtual Flame Christmas Concert