Alpha Office Hours 6/16/2022 Agenda & Updates
Pfizer and Moderna vaccine updates for different age groups, Novavax administration, clinical updates, and myocarditis/pericarditis updates were discussed in the Alpha Office Hours meeting scheduled for June 16, 2022. The agenda also included Vaccine Finder and July 4th shipping updates. The timeline for upcoming events, FDA meetings, ACIP, and CDC updates was outlined, with a note that all information is subject to change. Details on Pfizer's vaccine for children aged 6 months to 4 years, including dosing, storage, and administration instructions, were provided along with ancillary kit contents. The importance of completing the full vaccination series for children's protection was emphasized. Disclaimer: This information may change based on upcoming ACIP and CDC meetings.
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LPHA OFFICE HOURS 6/16/2022
Agenda PfizerBioNTech vaccine for 6 months through 4 years Moderna vaccine 12-17 years of age Moderna vaccine 6-11 years of age Moderna 6 months through 5 years Novavax Administration and Clinical updates Myocarditis / pericarditis updates Vaccine Finder updates July 4thshipping updates
Disclaimer All Information subject to change Depending on ACIP and CDC meetings over the next few days
Timeline for the next few weeks FDA/Vaccine and Related Biological Advisory Committee (VRBAC) met 6/7, 6/14 and 6/15 passed ACIP will meet 6/17 and 6/18 CDC will host a call 6/21 Early orders will start 6/20 6/23-29
Pfizer 6 months 4 years Maroon Cap Licensed for 6 months through 4 years Dose is 3mcg/0.2mL Must be diluted with 2.2 mL of sterile 0.9% Sodium Chloride injection 10 doses per vial Store Ultra Low 12 months expires 12 months after the date of manufacture Refrigerator store at 10 weeks Discard 12 hours after first puncture
Pfizer 6 months 4 years Vaccination series 3 Dose Primary Series Spacing of doses Dose 1 & 2 spaced 21 days apart Dose 2 & 3 spaced 8 weeks apart Administer intramuscularly Vastus Lateralis Deltoid- preferred site for 3 years and older CHILD NEEDS ALL 3 DOSES TO ASSURE PROTECTION have a recall reminder plan in place
Pfizer 6 months 4 years Ancillary kits for Maroon Cap will contain Vaccine administration = Needles 1 and 25g / I mL syringes Mixing needles 1.5 and 21-25g / 3 to 5 mL syringes Alcohol pads Vaccination records Face shields and surgical Mask Diluent
Pfizer 6 months 4 years Label of the product Beyond use date is 12 hours not 6 hours Authorized for 6 months through 4 years Information on EUA healthcare provider fact sheet overrides label on box or vial
Items to note Vaccine is ordered in quantities of 100 ( 10 vials containing 10 doses) The shipper cannot be used to store vaccine Vaccines are not interchangeable for age groups Trainings on the presentations available at https://www.pfizermedicalinformation.com/en-us/medical-updates
Moderna 12-17 years of age Dose 100mcg/0.5mL Series 2 doses Spacing Dose 1 and 2 spaced 28 days apart Vial contains 10-11 primary doses 20 punctures total per vial
Moderna 6-11 years of age Primary dose 50mcg 2 doses spaced 28 days apart 2 possible vaccine presentations Vaccine that will be provided Final presentation waiting for FDA approval Storage and handling of vaccine will be the same as the other presentations of Moderna
Moderna 6 months through 5 years Primary dose 25mcg/ 0.25mL 2 doses spaced 28 days apart 10 doses per vial Stored in freezer for until expiration date Stored in Refrigerator for 30 days Room Temperature 24 hours Once vial is punctured use within 12 hours No Other presentations of Moderna should be used for this age group
Storage of Moderna COVID-19 Vaccines Thaw in refrigerator for 2 hours and 30 minute to 3 hours Freezer (-50 to -15 C) or (-58 -5 F) until expiration date Thaw at room temp 1 hour to 1 hour and 30 minutes Refrigerator (2 -8 C) or (36 -46 F) for 30 days Room temperature (46 - 77 F) for 24 hours Thaw in refrigerator for 2 hours Thaw at room temp for 45 minutes
Moderna Items to note Order in quantities of 100 doses Record date and time of 1st puncture on vial Do not dilute Do not refreeze once thawed Do not pool excess vaccines from multiple vials Discard any unused vaccine 12 hours after 1st puncture 20 punctures of vial only No More than 20 Have a method to recall/remind patients 2 doses are needed Vaccine presentation for 6 months -5 years is not interchangeable with other presentations of Moderna Training sessions will start week of 6/21
NOVAVAX Protein Subunit Vaccine Ages 18 years and older Dose is 0.5mL 2 doses spaced at least 3 weeks apart Multi dose vial 10 doses per vial Stored in the refrigerator between 2 - 8 C Will not be available until sometime in August or later
EUAs You must have all current EUAs for the COVID-19 vaccines you are offering Fact Sheets for Patients/Caregivers Fact Sheet for Health Care Provider this EUA will always be more up-to- date than the info on the label of the product or box Vaccinating staff need to be knowledgeable of the products they are using Decreases errors Increase vaccine confidence
When can we start administering First wave of deliveries will start Monday Second wave will take place June 23-29 If you indicated you would be open Monday June 20 you were eligible for wave 1- Make sure someone is there to accept the shipment Regardless if you have vaccine or if you do not have vaccine you will need to wait until the Standing orders are posted before vaccine administration Expect to post early next week Orders will be posted at https://covidvaccine.mo.gov/vaccinators/ and a press release will be issued Make sure you have vaccine on hand before scheduling clinics
Administering the vaccine to 6 months 5 years of age Ancillary kits contain 1 needles are preferred and will be available in all ancillary kits for vaccine administration Gauge 22-25 which is provided in the ancillary kits Sites Anterolateral thigh muscle - 1 needle is needed Deltoid 1 provided or a 5/8 not provided but may also be used for small children
Other vaccine administration items Do not transport vaccine in syringes, transport the vial Transport thawed vaccines in a refrigerated state Punctured vials may be transported Do not pre-draw doses if at all possible Share If you cannot use 100 doses split with other enrolled providers by submitting a request to redistribute COVID-19 vaccine https://covidvaccine.mo.gov/vaccinators/resources/ (redistribution request) Make sure you have stock to offer
Expiration Dates- PfizerBioNTech Products Shelf life when stored in ultra cold for PfizerBioNTech vaccine Orange and Gray cap has been extended to 12 months- Make sure to check your expiration dates in SMV Date printed on box is date of manufacturing- not expiration
Expiration Dates Moderna Moderna vials have a QR code that can be scanned to provide the date of expiration or visit https://eua.modernatx.com/covid19vaccine- eua/providers/vial-lookup?#vialLookUpTool Put in the lot number to find the expiration code The date printed on the box is the date of manufacture
Vaccine Finder Updates Vaccine Finder Reporting is now weekly for providers New adult section and pediatric section will open up on Vaccine finder for COVID-19 vaccines Providers will need to use the Add Vaccine process in the VF portal to add NDCs and location Report Pediatric inventory as soon as it is received New email for support at CARS_HelpDesk@CDC.gov
Vaccine Finder updates NDCs for Pfizer (age< 5) and Moderna vaccines will be available after authorization To Report in Vaccine Finder Use the Add Vaccine process in the Portal to add the NDCs to your location Report as soon as inventory is received Make sure you update the public display Update your Public Display portal for the minimum age in months and years you are vaccinating Manual: Two drop down field for collecting minimum age in months and years Turn on your public display when you are ready to administer the pediatric vaccines
V-Safe All recipients or their caregivers are encouraged to enroll in V-Safe Have the QR code available for patients or their caregivers to sign up during the 15 minute waiting period Parents/caregivers may enroll their child Caregiver will be contacted not the child Bonus a reminder of when the next shot will be sent to the parent A copy of the attached flyer will be made available
Handling Errors Errors that involve expired vaccine Report to VAERS Contact vaccine manufacturer to see if revaccination is needed if they cannot confirm stability you will need to contact the patient and revaccinate immediately Errors that involve too much or too little of the vaccine Repeat dose immediately (no minimum interval). However, if a half-volume formulation of vaccine is administered on the same clinic day to a patient recommended for the full-volume formulation, another half-volume dose can be administered, and the two doses can count as one full dose. Too much vaccine do not repeat All vaccination errors must be reported to VAERS https://vaers.hhs.gov/reportevent.html
Other Items LPHAs should be carry a COVID-19 presentation for each eligible age group Epi Pens for Infants - One brand is available and extremely pricey and limited. Ampules and vials of epi are readily available and much cheaper funds are allowed for ampules or vials of epi purchase No stockpiling of vaccines Only ordering what you can use Should have vaccine for each eligible age group
Myocarditis and Pericarditis update There is more reported myocarditis and pericarditis reported among Moderna recipients than Pfizer These cases are mainly seen in males 18-25 years of age 1-7 days following vaccination Many times this is a mild case and everyone has recovered The data still shows that there is a higher risk of myocarditis following COVID-19 disease than vaccination
Myocarditis and Pericarditis update pediatric Cases involving 5-17 year olds have been 635 cases out of 54.8 million doses Highest Risk generally in 16-17 year olds followed by 12-15 Occurring within the first week following vaccination More often males after the 2nd dose All cases have recovered No cases seen in 5-11 year olds at this time
Myocarditis and Pericarditis update If a case of myocarditis or pericarditis after a dose of mRNA COVID-19 this is a precaution to a subsequent dose of any COVID-19 If after a risk assessment the decision is made to receive a subsequent COVID-19 vaccine dose, the person should wait until after their episode has resolved For men age 18 years and older who choose to receive another COVID-19 vaccine consider Janssen Persons who have a history of myocarditis or pericarditis unrelated to mRNA COVID-19 vaccinations may receive any currently FDA-approved or authorized COVID-19 vaccine after the episode of myocarditis or pericarditis has resolved
July 4th Holiday Pfizer deliveries will not be delivered July 2nd through July 4th If you want to hold deliveries on July 5th you need to contract Pfizer at cvgovernment@pfizer.com June 29th at 8pm McKesson will not deliver July 2nd through July 5th To hold vaccine deliveries for July 1st to request a hold for your orders for Friday, July 1, please call 1-833-343-2703 or email COVIDVaccineSupport@McKesson.com by 12:00 pm EST on Wednesday June 29, 2022. Remember do not schedule any clinics without making sure you have stock
