All Vaxxed Up and Nowhere to Go

As tens of thousands of Americans — myself included — have discovered, getting a pair of COVID-19 vaccination shots isn’t an instant all-access ticket to pandemic freedom. We’re stuck in limbo because we participated in clinical trials of vaccines that haven’t yet been authorized for use in the U.S.

Computer systems, foreign nations, universities, and a cruise line refuse to believe we’ve been vaccinated. We’re facing workplace hassles, worrying about international travel, and wondering if we can attend sports events, conferences, and performances. Some of us have even gotten re-vaccinated with authorized vaccines even though no one knows if double-dipping is a good idea.

“The whole thing is a ridiculous mess,” virologist John P. Moore, PhD, of Weill Cornell Medicine in New York City, told MedPage Today. “Trial participants can really be in a gray area — an intersection between bureaucracy and the real world.”

Like 30,000 others in the U.S. and Mexico, Moore was a participant in a Novavax COVID-19 vaccine trial and received a pair of injections earlier this year, along with two doses of a placebo. The company has touted study results that seem impressive. But its vaccine is not yet authorized for use anywhere in the world, and it does not appear on the World Health Organization’s (WHO) influential list of COVID-19 vaccines authorized for emergency use.

The 30,000-plus U.S. participants in an AstraZeneca trial are in a similar pickle. Their vaccine is not authorized in the U.S., although it is reportedly authorized in 119 countries and by the WHO.

Both Novavax and AstraZeneca have begun distributing vaccine cards — they’re specially modified in Novavax’s case — but it remains to be seen if governments, workplaces, and venues will accept them as proof of vaccination. Meanwhile, vaccination requirements for health workers and others are rapidly becoming more common across the country.

No One Seems to Have Seen This Coming

No one seemed to have anticipated travel and workplace hassles when Novavax began recruiting for vaccine trials in the second half of 2020. The 31-page consent form I signed in January to take part in the Novavax trial said nothing about the prospect that much of the world would consider my study vaccination to be invalid. Yet that’s exactly what happened, sparking a bitter backlash on social media.

Earlier this year, many Novavax trial participants were already miffed because of uncertainty over whether they had actually been vaccinated. Some asked to be unblinded, while others “self-unblinded” themselves by taking antibody tests. Now, vaccination mandates around the world have spawned a second wave of outrage on social media as trial participants realized that the Novavax vaccine isn’t officially authorized or, in many cases, recognized.

This fall, the University of California system, for example, will require students, faculty, staff, and others to be vaccinated with vaccines authorized in the U.S. or listed by the WHO. There’s no exception for trial vaccines like Novavax. Royal Caribbean International has the same policy for its passengers. Other vaccination mandates are in the works.

The outcry has been especially loud in the U.K., where thousands of participants in a Novavax trial there haven’t been able to travel abroad during the busy summer months because a government computer system would not recognize them as vaccinated. As one study participant wrote in The Telegraph on July 14, they “will now be subject to either severe quarantine restrictions upon entry or face an outright ban on visiting several countries altogether. Not quite the ‘you will not be left at a disadvantage’ promise we were assured before opting to take part in the trial.”

Even the U.K.’s “vaccine tsar,” biochemist Dame Kate Bingham, reportedly can’t go abroad because she took part in the Novavax trial and didn’t get a pair of authorized jabs.

Modified Vaccine Cards Aren’t an Instant Fix

Novavax is issuing modified vaccine cards to participants after intense nagging. The cards are titled “COVID-19 Vaccine Trial Participant” and say, “the individual can be considered ‘fully vaccinated’ for public health purposes. However, this does not imply that the vaccine has been authorized by the FDA, or is recommended by CDC or ACIP [Advisory Committee on Immunization Practices].”

In an undated email to Novavax study participants that I received on July 22, the company’s CEO and president, Stanley C. Erck, MBA, wrote that “we … firmly believe that clinical trial participants should not be disadvantaged with respect to providing proof of vaccination … This card will serve as documentation of your participation in the study, and that you have been vaccinated against COVID-19.”

AstraZeneca is also issuing vaccine cards to participants like Madelyn Beck, an Idaho public radio reporter, who received the vaccine instead of a placebo. She spent weeks trying to get the company to send her a vaccine card to show that she’s been vaccinated. “It’s frustrating not having extremely clear communication from AstraZeneca about what they’ll be providing and when they’ll be providing it,” she told MedPage Today. Her vaccine card finally arrived last week, nearly 8 months after she first got the shots.

Unlike the modified vaccine cards from Novavax, Beck’s card looks like a standard vaccine card and doesn’t note that she was part of a trial. It’s not clear if this is standard for all AstraZeneca’s vaccine cards. A company spokesperson declined to answer a list of questions from MedPage Today and only said that AstraZeneca is working to distribute vaccine cards.

‘Anxiety-Inducing’ Tests Required Before Trip

The Novavax vaccine cards aren’t making things easier for some study participants. In Southern California, a research administrator encountered trouble when her university required proof of vaccination and the computer system was unable to confirm that she’d gotten her shots. The administrator, who asked to be anonymous, worked that out. Then her insurer, Kaiser Permanente, wanted to know the dates of her vaccinations, which would have required her at that time to drop out of the trial in order to be unblinded. She had to work that out too.

“I have not yet attempted to travel overseas or attend a concert in a stadium or go to any place that requires proof of vaccination other than work,” she told MedPage Today. “I hope and expect that the CDC card [the modified Novavax card] will probably be accepted in those situations, but I don’t know for sure.”

Earlier this month, Melissa Henriquez, a marketing specialist for a medical tech company in Dallas, and her husband had to show negative PCR tests before traveling to El Salvador, even though they’d been vaccinated in the Novavax trial. “When I reached out to the U.S. embassy before we left, they couldn’t promise the CDC card would be accepted since Novavax isn’t an approved vaccine,” she told MedPage Today. “It was the only time I felt disadvantaged for being in the study, as I had to have the test done in the event our cards weren’t accepted. The test was free, but it was a pain to arrange and anxiety-inducing to wait for the results, knowing we had both been vaccinated for months.”

El Salvador ultimately accepted the couple’s modified Novavax vaccine cards, Henriquez said.

Trial participants are likely to face obstacles elsewhere too. In Europe, for example, visitors to France from the U.S. who only received the Novavax vaccine don’t count as officially vaccinated and therefore can’t travel there without restrictions. They generally must present the results of a negative COVID-19 test taken within the previous 72 hours.

California’s Message to Me: ‘You’re Not Vaxxed, Buddy’

What’s next? Novavax and AstraZeneca trial participants could choose to endure any hassles until the FDA gives the vaccines temporary authorization or full approval. Last month, Novavax said that it plans to submit data to the FDA seeking authorization between July and September. A company spokeswoman declined to provide an update about this timing. Novavax had earlier expected to file data in the second quarter.

As for AstraZeneca’s vaccine, the Wall Street Journal reported in May that the company may seek full FDA approval instead of an emergency use authorization, a process that would take more time.

Moore, the New York virologist who got vaccinated through the Novavax trial, doesn’t want to wait around for official FDA authorization. He fears that vaccination requirements could prevent him from visiting his elderly mother in the U.K. in case of a medical emergency. He also doesn’t want to get re-vaccinated with an authorized vaccine: “It’s not authorized and it’s not medically necessary,” he noted.

Moore said he just contacted an official at the WHO to urge the agency to declare that the Novavax vaccine card is “acceptable documentation” of vaccination. Then, presumably, international authorities — plus airlines and cruise lines — will follow suit. “This needs more attention further up the food chain,” he said. “That’s what needs to happen.”

But there could be more obstacles to overcome. For example, in California, where I live, the state doesn’t consider me to have been vaccinated despite my confirmed pair of Novavax shots.

Not every impact of this is major. For instance, I’m not eligible for the Golden State’s “Vax for the Win” lottery program and its $1.5 million grand prizes since my vaccination isn’t FDA-authorized. Bummer. And Krispy Kreme may not be willing to give me a free vaccination doughnut, although that didn’t stop a Florida trial participant from successfully getting one by flashing her modified vaccine card. (“It was decent,” she told me after posting in a social media group, “but not hot off the line.”)

More seriously, I can’t utilize California’s virtual vaccine card system because it has no record of my Novavax vaccination. That means I can’t attend any event or visit a venue that chooses to rely on the virtual record’s QR code to confirm vaccination. (Your results may vary: many states have reportedly banned jurisdictions and even some businesses from requiring the use of “vaccine passports.”)

Double-Dipping on Vaccines: We Don’t Know Much

For now, however, many Novavax trial participants have noted on social media that they went ahead and got vaccinated a second time with an authorized vaccine in order to travel abroad or meet other vaccination requirements.

Beck, the Idaho public radio reporter, said she’s considered this option, although she knows that she could potentially have side effects again. Her first AstraZeneca dose left her fatigued for a day, feeling as if she had run a marathon.

But she’s more worried about lasting impacts on her body: “As a young woman of child-bearing age, which is the demographic that’s had more complications in terms of blood clots, I don’t know if I’m putting my health at risk by doubling up on vaccines.”

Scientists don’t know much yet about the risks of double-dipping. On the bright side, “basic immunology tells us that additional vaccine doses would improve immune responses,” Brianne Barker, PhD, an immunologist at Drew University in Madison, New Jersey, told MedPage Today.

On the other hand, those who choose to double dip may have a worse experience the second time around. “Some of the side effects are due to memory immune responses. We might expect those to be more likely the second time around as you will have a larger memory immune response,” Barker noted.

Indeed, people reported more side effects after the second doses of the Pfizer and Moderna vaccines.

What about mixing and matching vaccines? “Some studies, particularly animal studies, have suggested that having two doses of two different vaccine types can induce better immune responses than having two doses with the same vaccine,” Barker said. “This hasn’t been borne out by other studies.”

But this scenario doesn’t apply to trial participants like me. I’ve had two doses of the Novavax vaccine, and I’ll need to get another two doses of the Pfizer or Moderna vaccines (or one dose of the Johnson & Johnson vaccine) to be considered fully vaccinated by the state of California.

That’s not an appealing option, especially considering the possibly heightened risk of side effects. I’m hoping the state’s standards evolve so I don’t need to get double-vaxxed. Once is great, and once is enough.