Foreign COVID Vaccinations and Clinical Trials? What Employers Need to Know

By Fiona W. Ong - Shawe Rosenthal LLP

September 8, 2021

An issue that we’ve run into recently is what to do about employees who are vaccinated – but not with one of the FDA-approved vaccines (whether under Emergency Use Authorization (Moderna and J&J) or regular approval (Pfizer-BioNTech)). Perhaps they are participating in a clinical trial or maybe they were vaccinated in another country. Employers are wondering – is this really a valid vaccine? Can we require employees to go get a “real” vaccine?

Well, the Centers for Disease Control and Prevention has actually provided some assistance on this issue. As you may know, the CDC has issued guidance for fully vaccinated individuals, which it has revised several times.  In a sneaky update to their guidance on September 1, 2021 (which, by the way, also now recommends a booster mRNA shot for those with moderately to severely compromised immune systems), the CDC added a little, but significant, footnote:

This guidance applies to COVID-19 vaccines currently authorized for emergency use by the U.S. Food and Drug Administration: Pfizer-BioNTech, Moderna, and Johnson & Johnson (J&J)/Janssen COVID-19 vaccines.  This guidance can also be applied to COVID-19 vaccines that have been listed for emergency use by the World Health Organization (e.g. AstraZeneca/Oxford).

(Emphasis added). Which leads to the obvious question, what vaccines has the WHO approved for emergency use, beyond AstraZeneca/Oxford (which, oddly, is not listed by that name)? You can see the list here, and as of September 8, 2021, it consists of the following: BioNTech-Tozinameran COMIRNATY, AstraZeneca-SKBio, Serum Institute of India COVISHIELD, Janssen-Cilag International NV, AstraZeneca-EU Approved Sites, BIBP/Sinopharm, Sinovac CoronaVac, AstraZeneca-MHLW Approved Sites, and AstraZeneca-TGA Approved Sites.

So, according to the CDC, employees who received any of those vaccines can be considered to be as fully-vaccinated as those who have received one of the FDA-approved vaccines. But the CDC’s language is not mandatory, so from a technical standpoint, I suppose an employer could decide that those vaccines aren’t sufficient and require the employee to go back for a FDA-approved vaccine (as if it wasn’t hard enough to get folks to get the first round of shots). Subject to medical approval – since it’s unclear what interactions could happen when you mix and match vaccines…

Now as to the clinical studies, there are a lot of vaccines that were part of Operation Warp Speed, and some are still being tested (although, honestly, at this point, it seems that they really missed their chance). As my doctor husband noted, if someone is in a clinical study, they cannot get a different vaccine and stay in the study – that would really defeat the purpose of the study. But, more importantly, the CDC, again, has provided specific guidance on clinical trials:

• If the employee is part of a trial in which they received a WHO-approved-but-not-FDA-approved vaccine, they can be considered fully-vaccinated, in conformance with the guidance discussed above. The CDC says the AstraZeneca vaccine meets this standard.

• If the employee is part of a trial in which they received a vaccine that has not been approved by either WHO or the FDA, it’s important to confirm that the employee  did not get a placebo and was, in fact, vaccinated with the study product. It is also important that the efficacy of the vaccine has been confirmed. If this is the case, then the employee can be considered fully-vaccinated two weeks after they have completed the full series. According to the CDC, the Novavax vaccine (requiring two shots) meets these criteria.

In either instance, the employer should reach out to the study organizers to confirm that the employee did, in fact, receive all doses of the vaccine in question. If not, then they are not fully-vaccinated and the employer can require them to get an FDA-approved vaccine, according to the CDC. But even if they are, like above, there is nothing that prevents an employer from requiring the employee to be re-vaccinated with an FDA-approved vaccine (other than it may seem excessive to the employee, may be medically contra-indicated, or may require them to be booted from the study).

To paraphrase the Baha Men – WHO let the vaccines out!