IHD response to HHS and FDA comments

COVID-19 Vaccine Screening and Immunization Documentation Form
COVID-19 Vaccination Program
The following questions will help us determine if we should give you the COVID-19 vaccination today. If you answer "yes" to any question(s), we will ask you for additional information to determine when or if you should receive COVID-19 vaccine .
NAME (Please Print):		DOD ID or SSN:		AGE:	DOB:		DATE:
CATEGORY: Service Member ☐ Beneficiary Civilian Employee ☐ Civilian Contractor ☐ Red Cross/Volunteer ☐ Other
Patient: Please answer questions 1-6								NO	YES
1	Are you currently sick, feel ill, or have a fever over 100°?
2	Have you received a COVID-19 vaccine before? If so, which one ? Date
3	Have you had an adverse reaction to a prior COVID-19 vaccine?
4	Are you, or might you be, pregnant?
	Would you like to speak with a health care team member about the COVID-19 vaccine before deciding whether or not to receive COVID-19 vaccine?
	Do you DECLINE to receive a COVID-19 vaccine?
"IStatement Information Vaccine COVID-19 vaccine EUA Fact Sheet for Recipients/Caregivers or current the in information the me to explained had have or read have , as applicable.vaccine." Coronavirus the of risks and benefits the understand I satisfaction. my to answered were they and questions, ask to a chance had also have I Signature: Date:
Below to be completed by Screener
Give COVID-19 vaccine - dose #1 today Give COVID-19 vaccine - dose #2 today Do not give COVID-19 vaccine today Refer to experienced provider for further evaluation			Check box for materials provided COVID-19 Vaccine Information Statement provided □ EUA COVid-19 Vaccine Fact Sheet for Vaccine Recipients/Caregivers
			Screener's Signature			Date:
Below to be completed by Vaccinator
Pfizer COVID-19 vaccine Moderna COVID-19 vaccine AstraZeneca COVID-19 vaccine Johnson & Johnson COVID-19 vaccine Other COVID-19 vaccine			Lot # Expiration Date: Dose: ☐ 0.5 mL ☐ Left / ☐ Right Deltoid OR PLACE STICKER HERE:
COMMENTS:
Administered by:				Date:
ASIMS/MEDPROS/MRRS/AHLTA/MHS GENSIS Entry
Name:				Date:

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stg1

2020-12-17 00:22:50

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Please see CDC guidance on preganncy "https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html" Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 Vaccine | CDC

The Defense Health Agency-Immunization Healthcare Division (DHA-IHD) is available to assist patients and healthcare providers with treatment of health problems before and after vaccinations, and with medical exemptions.

Please contact the DHA-Immunization Healthcare Division 24/7 Support Center at 877-438-8222.

DHA FORM XXX, OCT 2020

stg1

2020-12-16 23:56:42

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Three of the vaccines are given as a 2-dose series, but one is only one dose.

stg1

2020-12-16 23:57:02

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Not aware of any studies assess efficacy of series with different vaccines. One of the four vaccine you have on the first page is a 1-dose shot, the other three are 2-dose series.

stg1

2020-12-17 00:19:50

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We only know about Prizer vaccine and we have no data on risk in pregancy .ACIP recommends women who are pregnant be offered the Pfizer COVID vaccines. We have no recommendation for a pregnancy test before vaccination w Please see CDC clinical considerations for vaccinating pregnant people with the Pfizer vaccine. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html" Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 Vaccine | CDC

Guidance will likely be similar for the Moderna vaccine, but until FDA has issues the EUA and ACIP has voted, we have no recommendation. We also cannot comment on the adenovirus vaccines until those data are made available.

stg1

2020-12-17 00:20:58

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See CDC language on allergic reactions. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-considerations.html" Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 Vaccine | CDC

stg1

2020-12-17 00:18:23

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Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 Vaccine | CDC Please see CDC language.

Information for Healthcare Professionals about the Screening Checklist for Contraindications

1. Are you currently sick, feel ill, or have a fever over 100°?

There is no evidence that acute illness reduces vaccine efficacy or increases vaccine adverse events. People with a

moderate or severe illness should not be vaccinated until their symptoms have improved. Minor illnesses with or without fever or taking antibiotics do not preclude receipt of a COVID-19 vaccine.

2. Have you received a COVID-19 vaccine before?

It is important that COVID-19 vaccine brands not be mixed. The COVID-19 vaccines are new, and studies are not

yet complete evaluating the efficacy of vaccination if the series is not completed using the same brand. It is also important to know the date of the first vaccination, as different brands have different recommended intervals between the two doses in a series.

3. Have you had an adverse reaction to a prior COVID-19 vaccine?

Patients reporting a serious reaction to a previous dose of COVID-19 vaccine should be asked to describe their

symptoms. Immediate – presumably allergic – reactions are usually a contraindication to further vaccination. Flu- like symptoms (malaise, myalgia, other systemic symptoms), and vaccination site reactions have been reported with COVID-19 vaccines. These mild-to-moderate reactions are not a contraindication to future vaccination.

However, moderate-to-severe non-allergic reactions including significant local reactions following vaccination should be evaluated by an experienced provider prior to revaccination.

4. Are you, or might you be, pregnant?

While no evidence exists of risk from vaccinating pregnant women with inactivated vaccines, and live vaccines

pose only a theoretical risk to the fetus, the new COVID-19 vaccines have not yet been thoroughly tested for

safety and efficacy in pregnant women. If an individual is not sure whether or not she is pregnant, she should not

receive a COVID-19 vaccine until her status is verified.

5. Would you like to speak with a health care team member about the COVID-19 vaccine?

COVID-19 vaccination is voluntary. These are new vaccines for which there are, understandably, many questions. The potential vaccinee should be afforded ample opportunity to read the FDA-provided EUA Vaccine Fact Sheet and to ask questions prior to vaccination. Do not hesitate to refer an individual to an experienced healthcare provider to address questions or concerns regarding the vaccine.

6. Do you DECLINE to receive a COVID-19 vaccine?

An individual, after having reviewed the EUA Vaccine Fact Sheet and having had all questions addressed, may decline receipt of a COVID-19 vaccine without any impact upon their future healthcare within the MHS or their military career. For active duty service personnel, document their declination by entering the exemption code MR (medical refused) into their electronic health record and/or Services' Immunization Tracking System.