Novavax (NVAX) COVID-19 Booster Jab Effective Against Omicron

Novavax NVAX announced initial data evaluating its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant. Per the data, the vaccine’s two-dose regimen demonstrated cross-reactive immune responses against Omicron and other variants. These immune responses increased with the administration of a booster dose of NVX-CoV2373

Novavax noted that following the administration of the third dose of NVX-CoV2373, the anti-spike IgG titers rose to 9.3-fold while the ACE2 inhibition titers increased to 19.9-fold from the peak responses seen after the primary two-dose regimen. Also, significant increases were observed in the wild-type neutralization responses following a booster dose. All these responses suggested that an additional third-dose increased immune responses comparable to or exceeding the levels associated with protection in phase III studies.

We note that the third dose was administered six months after the primary two-dose regimen.

Novavax also announced plans to begin clinical studies on an Omicron-based COVID-19 vaccine in the first quarter of 2022. It expects to start GMP manufacturing of this vaccine in early January.

Shares of Novavax were up 4.8% in the after-market trading session following the announcement of the positive data. In fact, shares have rallied 64.4% so far this year against the industry’s 19.5% decline.

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Novavax also reported data from the pediatric expansion of the phase III PREVENT-19 study, which evaluated the two-dose regimen of NVX-CoV2373 in adolescents. Data from the study demonstrated that the immune responses were 2- to 4-fold higher than adults against all evaluated variants.

On Tuesday, Novavax announced that it initiated dosing patients in an extension of the phase III PREVENT-19 study, which will evaluate the third or booster dose of its protein-based COVID-19 vaccine, NVX-CoV2373

Earlier this month, the company was granted an emergency use listing for two versions of its COVID vaccine by the World Health Organization (WHO) — one marketed by the Serum Institute of India under the trade name Covovax and another version produced by the company that is marketed under the trade name Nuvaxovid. Earlier this week, Nuvaxovid was granted conditional marketing authorization in the European Union, while Covovax was authorized for emergency use in Indonesia and the Philippines last month.

The companyis yet to apply in the United States for an emergency use authorization of its COVID vaccine. Novavax expects to submit the complete chemistry, manufacturing and controls data package to the FDA for the same by 2021-end.

Apart from Novavax, Moderna MRNA and Pfizer PFE/BioNTech BNTX are also evaluating their respective COVID-19 vaccines against the Omicron variant.

Earlier this month, Pfizer and BioNTech announced data from a pseudovirus neutralization test, which demonstrated that three doses of their COVID-19 vaccine, Comirnaty (BNT162b2), neutralizes the Omicron variant.

Pfizer and BioNTech stated that the administration of the third dose of Comirnaty provided a level of protection against the Omicron variant that was comparable to the level achieved against the wild-type virus following the initial two-dose regimen.

In the event of a need for an Omicron-specific booster, Pfizer and BioNTech expect to deliver one by March 2021.

Moderna is also evaluating its multivalent booster and Omicron-specific booster candidates in phase II/III studies. Earlier this week, Moderna announced preliminary data from a pseudovirus neutralization titer assay study, which demonstrated that its COVID-19 vaccine booster increased neutralizing antibody levels significantly against the Omicron variant.

Moderna continues to develop an Omicron-specific booster candidate in case it becomes necessary going forward amid the rising infection cases due to Omicron. The Omicron-specific booster candidate will enter clinical study in early 2022.

Novavax, Inc. Price

Novavax, Inc. Price
Novavax, Inc. Price

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Zacks Rank

Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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