Trial participants in vaccine limbo

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Aug. 20—Nearly 1,000 vaccine trial participants in Oklahoma are in limbo with more private businesses asking customers and employers to be vaccinated.

Between 500 and 1,000 Oklahomans enrolled in PREVENT-19 — a COVID-19 vaccine candidate clinical trial underway by Novavax, a Maryland-based pharmaceutical company that was awarded $1.6 billion dollars from President Donald Trump's Operation Warp Speed to produce a vaccine for COVID-19.

Despite the Centers for Disease Control stating participants should be considered "fully vaccinated for public health purposes," Oklahoma state health officials do not recognize trial participants as being vaccinated.

The News-Capital directed questions to Saxum, which is an Oklahoma City-based integrated marketing communications agency working for the Oklahoma State Department of Health. The agency replied with answers from Dr. Gitanjali Pai, OSDH Chief Medical Officer.

Pai said if a vaccine is still in the trial phase, then its efficacy is still being studied and its efficacy is not yet proven.

"So for trial participants for vaccines not yet authorized by the FDA, they would not be considered fully vaccinated," Pai said of state guidelines.

Novavax released a statement stating participants should not be treated any differently than those who received an Emergency Use Authorization vaccine.

"Novavax firmly believes that clinical trial participants should not be disadvantaged with respect to providing proof of vaccination," the company wrote.

The trial enrolled 30,000 participants in the United States alone. Other trials are underway in Europe, South Africa, and other countries.

Instead of relying on the body's cells to produce antigens against the virus' spike protein, Novavax uses a lab-made version of that protein, similar to a flu shot and other legacy vaccines.

The trial is a blinded crossover where participants received a total of four shots, two placebos and two of the vaccine candidates between January and May 2021. Participants are to submit health information daily to Novavax through an app as part of the trials.

Despite the vaccine showing 90% overall efficacy, 93% efficacy against predominantly circulating variants of concern and variants of interest, and a 100% protection against moderate and severe disease, the vaccine has not obtained FDA emergency use authorization like Pfizer, Moderna, and Johnson & Johnson.

Novavax stated during an August update that the company will apply for EUA during the fourth quarter.

The CDC provided all Novavax trial participants a vaccine card similar to those who received a EUA approved vaccine, stating the individual listed 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)," it states.

When asked about the CDC vaccine cards and whether schools and businesses can accept it as proof of vaccination, Pai again said the trial participants "would not be considered fully vaccinated."

The COVID-19 trial participant cards list the last two injections received by the participant to keep the study blinded.

Novavax said in a statement that the vaccine development process is complex and it will complete regulatory filings as soon as possible.

Pai also said the state does not track trial participants on the state's weekly epidemiology report where the agency lists breakthrough cases by vaccine brand.

"If they are part of a trial, then they would be tracked as part of the trial, for the duration of the trial, including if they develop any infection," Pai said, referring to tracking by Novavax.

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