Novavax Counting on COVID-19 Vaccine U.S. EUA by May

Novavax_STR/NurPhoto via Getty Images

STR/NurPhoto via Getty Images

Novavax Chief Executive Officer Stanley Erck believes the U.S. Food and Drug Administration (FDA) could grant Emergency Use Authorization (EUA) for its COVID-19 vaccine by May.

In January, the Maryland-based company shared positive interim data from a Phase III study in the United Kingdom that shows its vaccine candidate demonstrated 89.3% efficacy against the virus. The results include the most common strain of the novel coronavirus, as well as some viral variants, including the U.K. variant and the South African variant.

The company is currently conducting a 30,000-patient Phase III study in the United States, but is hoping the data from its U.K. study can be used to support its EUA application, which it plans to file next month, Erck told CNBC. However, if the regulatory agency opts to wait for the results of the U.S. study, that timeline could be pushed back, he said, according to the report. Interim data is expected from the U.S. study in the second quarter.

In its earnings report released Monday, Novavax said it is engaged in ongoing dialogue with the FDA and anticipates filing for EUA in the second quarter of 2021. The company initiated rolling submissions with the U.K. Medicines and Healthcare products Regulatory Agency and also anticipates filing for EUA in that country in the early part of the second quarter of 2021.

The topline data reported in January showed Novavax’s vaccine candidate could become a potent weapon against the coronavirus. Overall efficacy of its NVX-CoV2373 vaccine was 95.6% against the original strain of the coronavirus and 85.6% against the U.K. variant.

Phase IIb data from a South African study that included the virulent strain that is dominant in that country showed an overall efficacy of 60%. However, that study included patients who were HIV-positive. Among those immuno-compromised patients included in the study, the efficacy against the South African strain dropped to 49%. The company said 90% of the reported COVID cases in that study were associated with the more virulent strain.

What may be concerning is one-third of the patients included in this study were previously infected with the SARS CoV-2 virus. These data suggest that prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant, however, vaccination with NVX-CoV2373 provided significant protection, the company said.

NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant. Phase I data from a Phase I/II study showed that NVX‑CoV2373 produced antibodies in healthy patients, a sign the vaccine is working as intended. The vaccine was also well-tolerated in those patients, the company said.

If the Novavax vaccine is authorized in the U.S., that would provide a fourth vaccine option in this country. Pfizer and BioNTech and Moderna were the first to receive EUA for their mRNA vaccines and this past weekend, the FDA authorized Johnson & Johnson’s single-dose vaccine. Erck told CNBC he is not worried about demand for his company’s vaccine in the U.S. With supply issues hampering rollouts, Erck said there is still significant need for a vaccine in the U.S. Plus, he noted “it’s a big world.”

Through a partnership with what was previously known as Operation Warp Speed, Novavax struck a deal with the U.S. government to supply 110 million doses. The company could complete those shipments around June or July, Erck said. The company also has deals with multiple governments to provide hundreds of millions of doses, including a 200 million dose deal with Canada. The company also partnered with the Serum Institute of India to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX Facility.

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