[MCOH-EH] [External] Accepting COVID vaccinations not FDA approved for international workers?

[Hartley, Patrick]

We will offer those employees who completed a primary series of a WHO-emergency use listed COVID-19 vaccine a booster with the Pfizer-BioNTech COVID-19 Vaccine at 6 months following completion of the primary series.

That being said, some employees have indicated to us that, instead of considering their vaccine series received outside the US to be the primary series, they want to (re)start their primary series with one of the FDA authorized mRNA vaccines. When that pathway was pursued, it was certainly less complicated in terms of documenting their vaccine status (and particularly if your employee health electronic health record interfaces with a State Immunization Registry).

Pat

Patrick G. Hartley,  M.B., B.Ch., B.A.O., M.P.H.
Professor (Clinical) of Internal Medicine
Division of Pulmonary Diseases, Critical Care and Occupational Medicine
Medical Director: University Employee Health Clinic & UIHC Occupational Medicine Clinic
Carver College of Medicine
University of Iowa
Iowa City, IA 52242-1009
319-353-7072 (Office)
319-353-6406 (Fax)
patrick-hartley at uiowa.edu

From: Thorne, Craig <Craig.Thorne at YNHH.ORG>
Sent: Wednesday, January 5, 2022 3:20 PM
To: Hartley, Patrick <patrick-hartley at uiowa.edu>; MCOH-EH <mcoh-eh at mylist.net>
Subject: RE: [External] [MCOH-EH] Accepting COVID vaccinations not FDA approved for international workers?

Thank you Pat, what about boosters for these WHO-approved (non FDA-approved) vaccines?

From: Hartley, Patrick [mailto:patrick-hartley at uiowa.edu]
Sent: Wednesday, January 5, 2022 4:19 PM
To: MCOH-EH <mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>>
Cc: Thorne, Craig <Craig.Thorne at YNHH.ORG<mailto:Craig.Thorne at YNHH.ORG>>
Subject: RE: [External] [MCOH-EH] Accepting COVID vaccinations not FDA approved for international workers?

We follow CDC guidance on this topic, and have the following information in our COVID-19 vaccine FAQ for employees:

If I received a non-FDA authorized or FDA approved vaccine, am I eligible to receive a booster?
People who completed all of the recommended doses of a COVID-19 vaccine which is listed for emergency use by the WHO but is not approved or authorized by FDA, or people who completed a heterologous (mix and match) series composed of any combination of FDA-approved, FDA-authorized, or WHO emergency use listed COVID-19 vaccines:
•       Are considered fully vaccinated.
•       Under the Emergency Use Instructions (EUI), moderately or severely immunocompromised people aged ≥12 years should receive an additional primary dose of Pfizer-BioNTech COVID-19 Vaccine (30 µg formulation [purple cap]) at least 28 days after receiving the second vaccine dose of their primary series.
•       Under the EUI, people aged ≥18 years (including moderately or severely immunocompromised people who received an additional primary dose) should receive a single booster dose of Pfizer-BioNTech COVID-19 Vaccine (30 µg formulation [purple cap]) at least 6 months after completing their primary series.

WHO has listed the following COVID-19 vaccines for emergency use:
•       Pfizer-BioNTech COVID-19 Vaccine (e.g., BNT162b2, COMIRNATY, Tozinameran)
•       AstraZeneca-Oxford COVID-19 Vaccine (e.g., [ChAdOx1-S (recombinant)], AZD1222, Covishield, Vaxzevria)
•       Janssen (Johnson & Johnson) COVID-19 Vaccine (e.g., Ad26.COV2.S)
•       Moderna COVID-19 Vaccine (e.g., mRNA 1273, Takeda, Spikevax)
•       Sinopharm-BIBP COVID-19 Vaccine
•       Sinovac-CoronaVac COVID-19 Vaccine
•       Bharat Biotech International COVID-19 Vaccine (e.g., BBV152, COVAXIN)

Pat

Patrick G. Hartley,  M.B., B.Ch., B.A.O., M.P.H.
Professor (Clinical) of Internal Medicine
Division of Pulmonary Diseases, Critical Care and Occupational Medicine
Medical Director: University Employee Health Clinic & UIHC Occupational Medicine Clinic
Carver College of Medicine
University of Iowa
Iowa City, IA 52242-1009
319-353-7072 (Office)
319-353-6406 (Fax)
patrick-hartley at uiowa.edu<mailto:patrick-hartley at uiowa.edu>



-----Original Message-----
From: MCOH-EH <mcoh-eh-bounces at mylist.net<mailto:mcoh-eh-bounces at mylist.net>> On Behalf Of Thorne, Craig via MCOH-EH
Sent: Wednesday, January 5, 2022 5:16 AM
To: mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>
Cc: Thorne, Craig <Craig.Thorne at YNHH.ORG<mailto:Craig.Thorne at YNHH.ORG>>
Subject: [External] [MCOH-EH] Accepting COVID vaccinations not FDA approved for international workers?

Happy new year All,

Does anyone have experience and an approach to whether you accept COVID vaccine series for international workers coming into the US who have received non-FDA approved vaccine brands?

Thank you,
Craig D. Thorne, M.D.
Sent from my iPhone



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