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  1 11 January 2022 UN

1 11 January 2022 UNMD recommendations for utilization of Moderna vaccine for the UN System-wide vaccination programme Disclaimer - This guidance does not imply that Moderna is the only option for booster doses within the context of the COVID-19 vaccination series but refers specifically to situations where the Moderna vaccine is an available option for boosters. - This advice is based on currently available evidence on the possible use of Moderna vaccine either as a primary SARS-COV2 immunization tool or as a mix/match second dose of a primary immunization cycle (heterologous vaccination) or as a booster dose of a completed primary immunization cycle. - Where scientific evidence of above uses of Moderna vaccine has been judged weak or unavailable, a risk averse peer review process has informed the technical recommendation. - Homologous vaccination (i.e., same vaccine) schedules are considered standard practice based on substantial safety, immunogenicity, and efficacy data available for each WHO EUL COVID-19 vaccine - Heterologous vaccination (i.e., mixed vaccines) with any two WHO EUL approved vaccines1 is considered a complete primary series2. - Advice regarding additional dosing for non-WHO EUL COVID-19 vaccines is less well established and should be based on an individual risk assessment. - As new information will be available, the recommendations presented in this document will be adjusted accordingly. Rules for use of Moderna - Moderna as a 1st dose is full dose (0.5ml) - Moderna as 2nd dose (and 3rd dose for selected immunocompromised individuals) is always full dose 4 weeks after the initial dose. - Moderna as booster dose is always half dose (0.25ml) and given 6 months (or less depending on local health authority policies) after the completion of the last dose - Note that for primary immunization with non-WHO EUL approved vaccines a new primary schedule should commence at least 4 weeks after the last dose administered.3 - Delay in receiving the second dose in a series does not affect the timing of the booster4 1 https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials 2 https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-heterologous-schedules 3https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#foot-04 4 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines- us.html? (...) CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fclinical-considerations.html#Appendix-A 2 WHO EUL approved vaccines Vaccine type Initial schedule Moderna dose When to give Comment Viral vector (Astra Zeneca, Janssen) Complete Half 6 months5 after 2nd dose Heterologous vaccine replacement for 3rd (booster) dose Incomplete Full 4 weeks after 1st dose Heterologous vaccine replacement for 2nd and subsequent doses Inactivated virus (Sinopharm, Sinovac) Complete half 6 months5 after 2nd dose Normal Moderna ‘booster’ schedule Incomplete Full 4 weeks after 1st dose Heterologous vaccine replacement for 2nd and subsequent doses mRNA (Moderna, Pfizer) Complete Half 6 months5 after 2nd dose Normal Moderna ‘booster’ schedule Incomplete Full 4 weeks after 1st dose Heterologous vaccine replacement for 2nd and subsequent doses Protein subunit (Novavax) Complete Half 6 months5 after 2nd dose Normal Moderna ‘booster’ schedule Incomplete Full 4 weeks 1st dose Heterologous vaccine replacement for 2nd and subsequent doses Non-WHO EUL approved vaccines Sputnik, Soberana, Abdala Commence a new primary schedule at least 4 weeks after the last dose administered.

Score: 1469575.8 - https://www.un.org/sites/un2.u...r_un_vaccination_programme.pdf

  UNITED NATIONS | DEP

I received the first and/or second dose but still did not receive a certificate. What do I do? (...) Am I eligible for the second dose under UN System Wide Vaccination program? Yes, you are eligible to receive the second dose through the UN System Wide Vaccination program. (...) You will need to register, indicate that you wish to be vaccinated and accept the invitation only after the recommended time has passed from the first dose (depending on the vaccine type). Finally, you will be required to show your certificate at the clinic and the certificate that will be issued via email will only be for the second dose. 25.

Score: 1420042.7 - https://www.un.org/sites/un2.u...sers_registration_platform.pdf

  Microsoft Word - 2021.01.25 FAQ UN COVID-19 Vaccination Programme.docx

In particular with regard to any subsequent doses: • Depending on product availability, countries implementing WHO EUL inactivated vaccines for initial doses may consider using WHO EUL vectored or mRNA vaccines for subsequent doses. • Depending on product availability, countries implementing WHO EUL vectored vaccines for initial doses may consider using WHO EUL mRNA vaccines for subsequent doses. UN SYSTEM-WIDE COVID-19 VACCINATION PROGRAMME - FAQ 6 UNITED NATIONS | DEPARTMENT OF OPERATIONAL SUPPORT • Depending on product availability, countries implementing WHO EUL mRNA vaccines for initial doses may consider using WHO EUL vectored vaccines for subsequent doses. (...) This depends on the type of vaccine you are given. With most COVID-19 vaccines, you will need two doses in order for them to work, with a few weeks in between.

Score: 1403689.4 - https://www.un.org/sites/un2.u...les/coronavirus_vaccinefaq.pdf

  UNITED NATIONS | DEP

As such, the sooner people register to receive the vaccine the better their chances that they will be fully vaccinated (having received both doses) from the current supply of vaccine doses on hand. High priority individuals who delay in registering may therefore have to wait until future shipments of vaccine arrive for their second or even first dose, depending upon availability. 3. Once all high priority candidates have been invited to register on the Vaccination Platform multiple times, expand the invitation to medium and low priority groups. 4. (...) The Global Vaccine Deployment Support Team remains committed to supplying further doses to LVDTs in time for the second shots. However, to avoid vaccine wastage and depending on demand, the LVDT may want to set aside enough vaccine to provide the second shot to all those who received their first dose of vaccine 8 weeks prior to the vaccine’s expiration date. 5.

Score: 1391596.5 - https://www.un.org/sites/un2.u...ith_short_expiration_dates.pdf

  1 Updated 14 October

It identifies the key elements that should be addressed in COVID-19 vaccination and suggests approaches depending on a number of criteria, such as age, dosing schedules, vaccine types, and authorizations and approvals given by regulatory authorities. (...) Rules for use of Moderna - Primary schedule age 12-17 and 18 and above: administer dose#1 and dose#2 as full dose monovalent (100 μg) - Primary schedule age 6-11: administer dose#1 and dose#2 as half dose monovalent (50 μg) - Moderna as 2nd dose (and 3rd dose for selected immunocompromised individuals) should be administered 4-8 weeks after the initial dose (8-week interval recommended for mRNA-only primary vaccination to further increase effectiveness and further reduce rare risk of myocarditis18). - Booster doses age 18 and above: monovalent or bivalent half dose (50 μg) given 4 to 6 months (or less depending on local health authority policies) after the completion of the last dose. - Booster doses age 12-17: monovalent half dose (50 μg) given 4 to 6 months (or less depending on local health authority policies) after the completion of the last dose. - Note that for primary immunization with non-WHO EUL approved vaccines a new primary schedule should commence at least 4 weeks after the last dose administered19. - Delay in receiving a dose after the recommended interval does not require additional dose20. 16 https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials 17 https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-heterologous-schedules 18 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html 19 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#foot-04 20 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines- us.html? (...) CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fclinical-considerations.html#Appendix-A 5 Table 2: Primary and booster Moderna vaccination schedule options (age 12 and above) WHO EUL approved vaccines Vaccine type Primary schedule Moderna dose When to give Comment Viral vector (Astra Zeneca, Janssen) Complete Half 4-6 months21 after 2nd dose Heterologous vaccination replacement for 3rd (booster) dose Incomplete Full 4 weeks after 1st dose Heterologous vaccine replacement for 2nd and subsequent doses Inactivated virus (Sinopharm, Sinovac) Complete Half 4-6 months18 after 2nd dose Heterologous vaccination replacement for 3rd (booster) dose Incomplete Full 4 weeks after 1st dose Heterologous vaccine replacement for 2nd and subsequent doses mRNA (Moderna, Pfizer) Complete Half 4-6 months18 after 2nd dose Normal Moderna ‘booster’ schedule Incomplete Full 8 weeks after 1st dose Heterologous/Homologous vaccine replacement for 2nd and subsequent doses Protein subunit (Novavax) Complete Half 4-6 months18 after 2nd dose Normal Moderna ‘booster’ schedule Incomplete Full 4 weeks after 1st dose Heterologous vaccine replacement for 2nd and subsequent doses 21 Or less depending on local health authority policies 6 Non-WHO EUL approved vaccines Sputnik, Soberana, Abdala Commence a new primary schedule at least 4 weeks after the last dose administered.

Score: 1368457.8 - https://www.un.org/sites/un2.u...doses_covid-19_vaccination.pdf

  UNITED NATIONS | DEP

Current COVID-19 vaccines require two doses to be administered X-Y weeks apart (depending on product type). (...) Receiving entities will receive a sufficient supply of doses to vaccinate all persons will two doses. The second dose series should be received within X days of the recommended X-Y-week time interval. 44. (...) It will further allow to record the number of vaccine doses allocated to each vaccination site. 46. Once vaccine doses have been allocated to a particular vaccination site, the LCD Team records the information (number of doses per site) on the vaccination portal, i.e., Everbridge.

Score: 1366776 - https://www.un.org/sites/un2.u...programme_for_un_personnel.pdf

  Interim statement on the use of additional booster doses of Emergency Use Listed mRNA vaccines again

Within a given priority-use group, primary series vaccination will have greater impact per dose than additional doses. Across priority-use groups, the benefits of additional doses for higher priority-use groups versus primary series doses for lower priority-use groups depends on country conditions, including supply and roll-out timelines, past epidemic dynamics and infection-induced immunity, vaccine product, vaccine effectiveness, and waning of protection. (...) The optimal interval between completion of a primary series and administration of additional doses has yet to be determined, and depends on epidemiological setting, vaccine product, targeted age groups, background seroprevalence, and circulation and frequency of specific variant of concerns (VoC). (...) The relative vaccine effectiveness depends upon the initial VE provided by 3 doses and how much subsequent waning has occurred. 

Score: 1361833.8 - https://www.who.int/news/item/...mrna-vaccines-against-covid-19

  ICD10ClinicalDiagnosis.PDF

For example, alcohol may have apparently stimulant effects on behaviour at lower dose levels, lead to agitation and aggression with increasing dose levels, and produce clear sedation at very high levels. (...) The following five-character codes may be used to indicate whether the acute intoxication was associated with any complications: F1x.00 Uncomplicated Symptoms of varying severity, usually dose-dependent, particularly at high dose levels. (...) F1x.22 Currently on a clinically supervised maintenance or replacement regime [controlled dependence] (e.g. with methadone; nicotine gum or nicotine patch) F1x.23 Currently abstinent, but receiving treatment with aversive or blocking drugs (e.g. naltrexone or disulfiram) F1x.24 Currently using the substance [active dependence] F1x.25 Continuous use F1x.26 Episodic use [dipsomani] F1x.3 Withdrawal state A group of symptoms of variable clustering and severity occurring on absolute or relative withdrawal of a substance after repeated, and usually prolonged and/or high- dose, use of that substance.

Score: 1344905.6 - https://www.who.int/substance_...ogy/ICD10ClinicalDiagnosis.pdf

  gva-2021-072.pdf

Score: 1324928.5 - www.un.org/en/internalj...s/undt/orders/gva-2021-072.pdf

  COVAX Facility ‘Principles of Participation’: Consultation with the self-financing group

COVAX Facility ‘Principles of Participation’: Consultation with the self-financing group COVAX: Policy and Allocation of vaccines: update, status and next steps Speed, Scale, Access 1 2 We have developed an Allocation Mechanism for Vaccines Phase 1: Proportional allocation up to 20% of population Phase 2: Weighted allocation beyond 20% (if supply severely constrained) Countries receive doses proportionally to their total population given the ubiquity of the threat • Countries progressively receive doses until all countries reach 20% of their population (or less if they so requested). • The pace at which countries receive vaccines depends on country readiness1 and the availability of doses (not on threat and vulnerability) • The allocation moves on to phase 2 once all countries have reached 20% coverage (or less if they so requested). • Phase 2 may start ahead of this if available doses are unable to be allocated due to lack of readiness, funding or territory issues Timing may be based on consideration of vulnerability and COVID- 19 threat: • In the case of a severely restricted supply, the timing of country shipments would be based on a risk assessment based on Threat and Vulnerability • Countries with a higher risk would receive the doses they need faster than others, although all countries will receive some doses in each allocation round • Threats and Vulnerabilities will be based on metrics defined closer to the end of phase 1, potentially related to the country's vulnerability to severe disease and its healthcare system. • All countries will receive the total doses they have requested as rapidly as possible in phase 2. 1. Readiness will be assessed using a very limited set of objective criteria (e.g., regulatory approval) 3 The allocation will run in successive ‘rounds’ Illustrative example for Phase 1 of multiple rounds of allocation with increasing supply TimeSuccessive allocation rounds (in % of population covered) Proportionality: All countries cover the same share of their population at the same time (where possible) Timing: In theory, all countries that requested 20% or more reach 20% coverage at the same time Country A 20% coverage reached Country B 20% coverage reached Country C 20% coverage reached Country D 20% coverage reached Country E Coverage requested 40% 40% 30% 20% 10% 10% coverage reached End of phase 1 Dose request: Countries that chose to request less than 20% will stop receiving further doses beyond this Rounds: Each allocation round is done in advance of production based on forecasts. (...) Is this product below the price cap (21.2$/dose)? General Product-specific 7Speed, Scale, Access 7 Thank you

Score: 1315849.5 - https://www.unicef.org/supply/...-logistics-meeting-Nov2020.pdf