Shared from the 6/15/2021 Star Tribune eEdition

Novavax adds 4th vaccine to arsenal against COVID


WILSON RING • Associated Press IN VERMONT: Gov. Phil Scott announced on Monday that the state had reached its goal of vaccinating 80% of the eligible population, so all remaining COVID-19 restrictions were ended.

Novavax, a small American company buoyed by lavish support from the U.S. government, announced Monday the results of a clinical trial of its two-dose COVID-19 vaccine conducted at 119 sites, including the University of Minnesota.

In the 29,960-person trial, the vaccine demonstrated an overall efficacy of 90.4%, on par with the vaccines made by Pfizer-BioNTech and Moderna, and higher than the one-shot vaccine from Johnson & Johnson. The Novavax vaccine showed an efficacy of 100% at preventing moderate or severe disease.

Despite these impressive results, the vaccine’s future in the United States is uncertain and it might be needed more in other countries. Novavax says it may not seek emergency authorization from the Food and Drug Administration until the end of September. And with a plentiful supply of three other authorized vaccines, it’s possible that the agency may tell Novavax to apply instead for a full license — a process that could require several extra months.

The company’s CEO, Stanley Erck, acknowledged that Novavax would probably win its first authorization elsewhere. The company is also applying in Britain, the European Union, India and South Korea.

“I think the good news is that the data are so compelling that it gives everybody an incentive to pay attention to our filings,” Erck said.

In Minnesota, nearly 3 million people already have received COVID-19 vaccine — amounting to 53.9% of the state’s total population and 63.8% of eligible people 12 and older. However, Dr. Susan Kline — who led the U arm of the Novavax trial — said the new option might fill a niche in the effort to shield Minnesota from a coronavirus that has caused 603,876 known infections and 7,517 COVID-19 deaths in the state.

First-dose vaccination rates in Minnesota range from 74% of people 12 and older in Hennepin County to 36% in Todd County — with many other rural counties having similarly lower rates. Ultracold storage requirements for other vaccines limit their distribution and the time frames in which they must be administered once thawed, but Kline said the Novavax option doesn’t require freezing and can be sent to small rural clinics.

“It will help the primary care clinic supply in more rural areas that don’t have the freezer capacity,” she said. “Clinics could stock it and not have to worry about thawing a whole batch that they may or may not use in time.”

The U launched recruitment for its arm of the trial in late December, finding that many senior citizens and longterm care facility residents were content to wait for limited supplies of approved vaccines for which they had been prioritized. However, Kline said others who didn’t have immediate access to those options were eager to enroll — with 318 people in the U trial receiving the experimental vaccine or a non-medicating placebo injection for comparison.

Staff writer Jeremy Olson contributed to this report.

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