COVID-19 vaccine quandary for international students

With 57% of the US population having received at least one dose of a coronavirus vaccine, many colleges and universities are looking forward to a fall semester that looks normal, including in-person orientation activities, full lecture halls, lingering over meals in cafeterias, football games, and, yes, even parties.

To fuel this vision, at least 600 universities and colleges have announced requirements that at least some students or employees be vaccinated before returning to campus.

Even those institutions that have not enacted any requirements are still making efforts to encourage students and employees to be vaccinated, including hosting vaccination campaigns on campus.

One group whose status remains a question as fall semester approaches is international students and scholars.

As state appropriations have decreased across public institutions, enrolment of international students who generally pay full tuition has increased.

Although the pandemic has sequestered some of these students in their home countries over the past year, many are now contemplating and preparing for a return to US campuses.

The return of international students to campus poses two issues. First, these students may not have had access to vaccinations in their home countries. Second, students who have been vaccinated may not have received one of the three vaccines that have been given Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA).

The unvaccinated student

The roll-out of COVID-19 vaccinations in many countries has lagged that in the US. The World Health Organization (WHO) reports that 3.65 billion vaccine doses have been administered worldwide, but distribution has been unequal.

Only 27.2% of the world has received at least one vaccine dose and, in many countries, less than 1% of the population is vaccinated.

Even in countries where vaccinations are proceeding, because of their age, students are usually relegated to the later vaccination phases and thus may not have had the opportunity to be vaccinated.

Universities and colleges should be prepared to vaccinate this subset of students as soon as possible and within the first few days of their arrival on campus. Students should be notified of any university vaccination requirements as far in advance of their arrival as possible.

Regardless of specific requirements, all students should be encouraged to be vaccinated, and clear instructions regarding access should be provided.

Non FDA-authorised vaccines

Of the 108 vaccines currently in clinical development, 20 are being used in at least some countries Download the table as a pdf.

Thus, it is possible that certain international students may arrive on campus having received one or more doses of vaccines that have not received an FDA EUA.

Three vaccines, manufactured by Pfizer/BioNTech, Moderna and Johnson & Johnson, have received an FDA EUA. Pfizer/BioNTech has submitted documents and data for full FDA approval. The WHO has given Emergency Use Listing (EUL) to six products: Pfizer/BioNTech, AstraZeneca-SK Bio/University of Oxford/Serum Institute of India, Janssen, Moderna, Sinopharm and Sinovac.

Data from large, placebo-controlled trials are available for Sinovac, AstraZeneca/University of Oxford, Sputnik V, Pfizer, Moderna, Johnson & Johnson, Sinovac Biotech and the Wuhan Institute of Biological Products/Sinopharm’s product.

The Beijing Institute of Biological Products/Sinopharm’s BBIBP-CorV has unpublished data as does CanSinoBIO/Institute of Biology’s Convidicea, Bharat Biotech’s COVAXIN and the Gamaleya Research Institute’s Sputnik Light.

The vaccines from Bektop/Vector Institute, Anhui Zhifei Longcom, Research Institute for Biological Safety Problems, Shenzhen Kangtai Biological Products and the Chumakov Center of the Russian Academy of Sciences do not have any Phase three study data to date, despite their authorisation in some countries.

While it is tempting to rank vaccines based on their efficacy, there are a few caveats to consider regarding this approach.

Some trials have produced differing results because they used different definitions of severe or moderate COVID disease or tested participants for asymptomatic disease. The populations studied in various trials were often not homogeneous and thus may have resulted in different immune responses based on factors such as age.

Finally, because most studies have been conducted at various time points during the pandemic, variants that may have emerged are likely not to have been accounted for in terms of efficacy. All these differences make it difficult to draw comparative conclusions about the efficacy of different vaccine products.

The Centers for Disease Control and Prevention (CDC) has issued recommendations for people vaccinated outside of the US.

They can be summarised as follows:

• If vaccinated with a US FDA-authorised vaccine and if all doses were given, no additional vaccine is needed.

• If vaccinated with a US FDA-authorised vaccine, but the second dose was not administered, administer the second dose at the recommended time interval or as soon after as possible.

• If vaccinated with a WHO-listed emergency use vaccine and if all doses were given, no additional vaccine is needed.

• If vaccinated with a WHO-listed emergency use vaccine but the second dose was not administered, begin a complete FDA-authorised vaccine series.

• If vaccinated with a vaccine without either FDA-authorisation or WHO-listing for emergency use, begin a complete FDA-authorised vaccine series.

Trials evaluating the efficacy and safety of administering combinations of different vaccine types are under way.The Com-COV2 study is testing various combinations of Pfizer/BioNTech, AZ, Moderna and Novavax vaccines.

All participants will have received the first dose of AstraZeneca/University of Oxford or Pfizer/BioNTech vaccine. They will then randomly receive a second dose of the same vaccine or either the Novavax or Moderna products.

Similarly, another trial is examining the response following a single dose of Sputnik V followed by a second dose of the AstraZeneca/University of Oxford product.

Because of safety concerns regarding the AstraZeneca/University of Oxford vaccine both Germany and France have recommended that people who have received a single dose of the product receive either the Pfizer or Moderna vaccine for their second dose.

Spain is planning to study this approach.

Results from these trials will provide further guidance regarding the safety and efficacy of mixing vaccines in a series.

The role of testing

Testing will likely also continue to play a role in the movement of international students across campuses. COVID-19 testing should be considered for all international students upon entry into the US and arrival at campus.

Currently available COVID-19 screening modalities do not interfere with the efficacy of vaccines nor do vaccines interfere with the accuracy of screening.

Serologic assays are also available to screen for COVID-19 antibodies.

While these assays are available, their exact interpretations remain unclear.

The presence of serum antibodies have not been well correlated to any level of immunity against the virus and, therefore, should not be used as surrogate markers of protection.

Entry to US campuses

While several COVID-19 vaccines have been developed and are available worldwide, only three have received US FDA EUA, while three others have been emergency listed by the WHO.

It is likely that, in the future, more products will gain FDA EUA and/or WHO EUL.

While use of an FDA-authorised vaccine product is considered the standard of care for protection against COVID-19 among US residents, it is appropriate to recognise that international students who have received one of the six WHO EUL products are vaccinated.

It is of paramount importance that university and college administrators document the date of completion of an approved vaccine series and ensure that a sufficient period of time has passed since the last dose (14 days) to achieve maximal efficacy.

Upon entry to the US, it is advisable that students be tested for COVID-19 and offered vaccination with one of the three US FDA-authorised products. Students should be considered unvaccinated if they have not received the full complement of doses for any FDA-authorised or WHO EUL product and if 14 days have not passed since completing a series.

Unvaccinated students should adhere to all masking and distancing requirements set forth by the institution and-or state for these cohorts of individuals. Administrators should pay close attention to CDC and WHO guidelines and modify any campus-based policies, as needed, based upon the most currently available data regarding the status of the pandemic.

Frank Romanelli is Professor and Associate Dean for Academic Programs at the University of Kentucky and College of Pharmacy and Clinical Specialist in HIV/AIDS with the Bluegrass Care Clinic at UK HealthCare. Melody Ryan is Assistant Provost for Global Health for the University of Kentucky and Professor at the University of Kentucky College of Pharmacy.