Vaccine Updates: CDC Webinar, Clarification on Consent Process, New Guidance on Extra Pfizer Doses, and More
CDC Webinar on Pfizer-BioNTech and Moderna COVID-19 Vaccines
The Centers for Disease Control and Prevention (CDC) held a webinar on Fri., Dec. 18th regarding the newly authorized Pfizer and Moderna COVID-19 vaccines. This summary contains just a portion of the presentation. Members may want to access the recording and fully captioned video and edited transcript on the CDC website. Please note that this webinar is specific to the Moderna and Pfizer mRNA vaccines only.
Some general information about the two vaccines, their likenesses, and differences was initially provided. Both vaccines offer 95 percent effectiveness in protection from the virus. The Pfizer vaccine is authorized for individuals age 16 and older and requires two doses administered 21 days apart. The Moderna vaccine is authorized for individuals age 18 and older and is administered in two doses 28 days apart. The vaccines are not interchangeable, and live virus is not used in the vaccines.
Clinical trials revealed an imbalance of Bell’s palsy cases after the vaccine for both products, but within an acceptable range. Both vaccines may result in some local and systemic reactogenicity, particularly after the second dose. Protection is not immediate after vaccination but is effective one to two weeks after the second dose.
The CDC recommends that all current guidance and protocols to protect individuals from infection (i.e., social distancing, masking, and infection control protocols) be continued given the limited information regarding the efficacy of the vaccine, the current lack of information on whether the vaccine stops transmission, and how long protection lasts.
The webinar included discussion of an algorithm chart that provides information regarding triage of persons considering the vaccine based on an individual's conditions and allergies. The CDC presenting clinicians recommended not administering the vaccine to those with a history of severe allergic reaction, including anaphylactic symptoms, to any components/ingredients of the two vaccines. Those with a history of severe allergic reaction to another vaccine or injectable may receive the vaccine on a precautionary basis but should be observed for anaphylactic symptoms.
Facilities and vaccinators should be prepared for potential management of anaphylactic response:
- Early recognition of symptoms
- Medication and supplies
- Management at site
- Potential activation of EMS
- Patient counseling
- Reporting of anaphylaxis
In these circumstances, the CDC generally recommends administration of epinephrine and contacting emergency services (911).
The CDC recommends 30 minutes of observation for persons with severe allergic reactions due to any cause and 15 minutes of observation for others receiving the vaccine.
Should those who have had COVID-19 be vaccinated?
The short answer is yes. However, the CDC recommends that those with COVID-19 who are acutely ill with symptoms and in isolation not receive vaccination until after they have recovered and ended isolation. Reinfection with COVID-19 is uncommon within 90 days after infection. Individuals who have had COVID-19 may defer the vaccine until after this 90-day period if they prefer.
What if a person receives Dose 1 and prior to Dose 2 is symptomatic with COVID-19 or is asymptomatic with a positive PCR test?
The CDC recommends that those acutely ill with symptoms and in isolation not receive vaccination until after they have recovered and concluded isolation. This strategy prevents transmission of the virus to vaccinating personnel; it is not an issue of vaccine safety. The CDC states that vaccination of long term care facility residents in quarantine is still acceptable.
How should facilities/vaccinators identify severe versus non-severe allergic reaction to the vaccine?
Those with a history of severe allergic reaction to any component/ingredient of vaccine should not receive it. One example is polyethylene glycol; clinicians use this in laxatives or chronic bowel prep. If a person is allergic to this ingredient, vaccination is not advised.
The CDC recommends that anyone who experiences anaphylaxis at Dose 1 not receive Dose 2.
The CDC recommends that individuals allergic to any other vaccine or injectable take precaution, but they may receive the vaccine as long as they are observed for a 30-minute period. Anyone with anaphylactic or severe allergic reactions should be observed for 30 minutes. All others should be observed for 15 minutes.
What are the best practices for observation?
30 minutes for those with a history of anaphylactic or severe allergic reactions, 15 minutes for all others. Keep a close eye on dementia patients, who may not be able to communicate symptoms of anaphylaxis.
On-site preparation for anaphylactic symptoms:
- Recognize signs and symptoms
- Administer epinephrine and call 911
- Monitor vitals
Note of caution: some individuals, especially those with certain cardiac issues (i.e., hypertension or arthrosclerosis disease), are more at risk for cardiac side effects associated with epinephrine. The CDC cautions that epinephrine should not be administered unnecessarily or used prophylactically.
Members should note that there have been only a handful of anaphylactic cases, all associated with the Pfizer vaccine.
Certain persons should consult with a physician:
Pregnant, lactating, and post-partum patients should consult with a physician, but may receive vaccine. It is unlikely that mRNA vaccines pose a risk. It was noted that COVID-19 poses a greater risk to these individuals, especially those working in high-risk settings. The American College of Obstetricians and Gynecologists has issued a practice advisory on the CDC site.
Immunocompromised individuals should also consult with their physician prior to vaccine administration.
What if someone has received COVID-19 therapies for treatment?
As a precautionary measure, if an individual has received monoclonal antibodies or convalescent serum, they should delay vaccine until 90 days after that treatment.
Is there flexibility regarding time intervals between doses?
- Pfizer vaccine – 21-day interval between Doses 1 and 2
- Moderna vaccine – 28-day interval between Doses 1 and 2
A four-day grace period before the second dose is acceptable for both vaccines if administered early. There is no maximum interval between Doses 1 and 2. If there is a delay in receiving the second dose, administer as soon as possible. The series does not need to be restarted.
Can the influenza vaccine or other vaccines be administered at the same time as the COVID-19 vaccine?
It is not recommended. The CDC advises that the COVID-19 vaccine be administered alone with a minimum 14-day interval before and after administration. If the COVID-19 vaccine is inadvertently administered within 14 days of another vaccine, there is no need to restart the series.
What do providers need to do to carry out the vaccination process?
- Review vaccine provider agreement regarding storage, handling, and administration.
- Be prepared to medically manage reactions.
- Recipients should receive fact sheet.
- Vaccine record card should be provided to each patient with second dose date listed.
- Staff should document vaccine in medical record within 24 hours.
- Report to jurisdiction (New York State Immunization Information System (NYSIIS) or Citywide Immunization Registry (CIR)) no later than 72 hours after administration (pharmacies will report as part of federal Pharmacy Partnership for Long Term Care (Partnership)).
Adverse Event Reporting: What is Reportable? (Adverse events to be reported to Vaccine Adverse Event Reporting System (VAERS))
- Vaccine administration errors, even with no associated adverse event
- All serious adverse events (regardless of whether vaccine is related)
- Multi-system inflammatory syndrome in children and cases of COVID-19 resulting in hospitalization or death following vaccination
- Any clinically significant events, even if relation to vaccine is uncertain
Clarification on Vaccine Consent Process
LeadingAge NY has received some clarification on the various options permitted for the consent process for the federal Partnership. Pharmacy contacts have clarified that in addition to the triplicate consent forms normally used, electronic versions of the consent form may be utilized and emailed back to facilities with signatures and then stapled to the CVS triplicate form. In addition, CDC and pharmacy partners will accept verbal consent for vaccination from guardians or families by telephone as long as staff documents the verbal consent on the paper triplicate consent form. LeadingAge NY also recommends creating a written record of verbal consent by emailing the consenting party to confirm their consent. Facilities should also document verbal consent in the medical record as well. Pharmacies will also require a photocopy of the insurance card of the resident or staff. Members should let LeadingAge NY know if they have any other concerns or questions relating to the consent process.
New Guidance on Extra Pfizer Vaccine Doses
On Dec. 18th, the Department of Health (DOH) issued guidance addressing the extra doses that are available in the Pfizer vaccine vials. Vials were originally expected to contain only five doses; however, vaccinators are finding that some contain up to seven. The State is allowing the extra doses to be utilized. The extra vaccine fluid from one vial may not be combined with that of another vial to produce a dose due to lack of preservatives in the vaccine. The guidance notes that certain syringes may allow only five doses to be drawn from a single vial.
The guidance also provides instructions for entering the additional doses on the NYSIIS registry. Long term care facilities do not need to follow these reporting instructions during the federal Partnership, as pharmacy partners will be reporting the vaccine in registries on their behalf. The guidance will, however, become relevant once facilities engage in vaccine administration through the State Vaccination Program, when they will be administering and reporting on their own.
New Vaccine-Related Questions in HERDS Survey
This week, DOH released additional questions related to vaccine administration in the daily Health Emergency Response Data System (HERDS) survey for nursing homes and adult care facilities (ACFs). The vaccine-related questions are set forth in two sections. The first section addresses vaccines administered in the “yesterday” time frame (i.e., 12 a.m. to 11:59 p.m. the previous day) and requests information pertaining to the administration to residents and staff respectively within that time period, whether on-site or off-site. Staff is defined to include anyone working on the facility’s premises, including those working full-time or part-time, contract and per-diem staff, and medical residents and trainees. Hospital-based nursing homes that share staff with the hospital should report staff who were vaccinated by the hospital as having been vaccinated off-site.
The second section requests the cumulative numbers of in-house residents and current staff vaccinated as of the time of the survey submission. This section does not include residents who received their first dose in-house, were discharged, and later returned for a second dose, nor does it include staff who have separated from employment. DOH recognizes that staff may work at more than one facility and that there may be some double reporting, with one facility reporting that a staff member was vaccinated on-site and another reporting that the same staff member was vaccinated off-site. DOH suggests that facilities pull down the questions and develop a tool/process for gathering and tracking this information. Facilities that have not yet begun vaccinating residents or staff should insert zeroes in the applicable spaces.
DOH Starts Regional Vaccination Efforts; Member Involvement Is Encouraged
On Dec. 18th, DOH Commissioner Dr. Howard Zucker issued a letter to all health care providers urging participation in the implementation and planning process of the safe and equitable distribution and administration of the COVID-19 vaccine in the 10 Economic Development Council Regions across the state.
Each Regional Vaccination Network is headed up by a major hospital or anchoring organization that will act as the hub organizer and convenor of community stakeholders, local governments, health care, faith-based organizations, and other community stakeholders who will work together to develop a plan for orderly and equitable distribution and administration of the vaccine.
Hubs are responsible for:
- Supporting the formation and activities of Regional Vaccination Networks in their respective regions;
- Leading the formation of and convening a Regional Advisory Task Force that includes, but is not limited to, representatives from local government, health care, faith-based organizations, and other community stakeholders to assist in the development of the Regional Implementation Plan;
- Working with members of the Regional Advisory Task Force and other stakeholders on the development of Regional Implementation Plans;
- Coordinating operations and logistics stakeholders and supporting local emergency management activities; and
- Ensuring that daily regional situational updates are distributed to all stakeholders and the public.
We encourage all members to reach out to their hub anchor organization to ensure participation in this regional process as well as advocate for prioritization of your staff, patients, and residents for vaccination. While long term care facilities are participating in the federal Partnership to vaccinate staff and residents, it is unlikely that all staff will be vaccinated under this program. Further, our vertically integrated long term care members have several populations that will need to be prioritized in the queue for vaccination. Members will be the most appropriate advisors to the regional networks regarding how, when, and where to best to vaccinate our long term care populations and staff and the many elderly, frail, and disabled individuals living in the community.
LeadingAge NY will continue to communicate and advocate at the state level for prioritization of older adults and people with disabilities, and the people who serve them, as this process unfolds.
New York State Executive Order on Vaccine Administration
On Dec. 13th, the Governor issued Executive Order (EO) 202.82 to facilitate administration of the COVID-19 vaccine. The order includes a variety of provisions to enable the administration of the COVID-19 and flu vaccines in accordance with non-patient-specific orders and to authorize non-nursing health care professionals and paraprofessionals to administer flu and COVID-19 vaccines. The EO also authorizes physicians and nurse practitioners to issue a non-patient-specific regimen to nurses, physician assistants, specialist assistants, pharmacists, or other persons authorized by the EO and consistent with guidance as may be issued by the Commissioner to collect throat, nasal, and nasopharyngeal swabs; to collect blood specimens for the diagnosis of COVID-19; and to perform tasks under the supervision of a nurse to the extent necessary to provide care for individuals with COVID-19 or the flu. These authorized personnel include licensed practical nurses (LPNs), pharmacists, dentists, nurse midwives, dental hygienists, emergency medical technicians (EMTs), and podiatrists, and students in these programs, provided certain conditions are met. These personnel must first receive training in: (1) techniques, indications, precautions, contraindications, and infection control practices; (2) use of personal protective equipment (PPE) sufficient to provide the basic level of competence for such tasks; and (3) a current certificate in basic cardiopulmonary resuscitation (CPR), which at a minimum must include a certification in basic CPR by an online program that has received accreditation from the American Nurses Credentialing Center, the Accreditation Council for Pharmacy Education, or the Accreditation Council for Continuing Medical Education. The EO also waives certain record-keeping requirements and reporting to attending physicians regarding vaccine administration but requires reporting to the CIR or NYSIIS as applicable.
The EO permits nurse practitioners to provide specified medical services without a written practice agreement or collaborative relationship with a physician, including, but not limited to, administering COVID-19 and influenza vaccine and medically supervising points of dispensing (POD) or other types of vaccination sites, as permitted by the EO. It requires that any licensed physician, licensed physician assistant, and certified nurse practitioner medically supervising POD sites or other types of vaccination sites, as permitted by the EO, have a current certification in CPR.
The EO suspends the requirement that adults consent to have their immunization information reported to NYSIIS or the CIR, so that adult immunization information for COVID-19 may be included in NYSIIS or the CIR, without the consent of the individual, and all influenza and COVID-19 vaccinations for any individual (child or adult) may be required to be reported to the NYSIIS or CIR, as applicable, within 24 hours of administration of such vaccine.