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Novavax (NVAX) Commences COVID-19 Vaccine Booster Study
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Novavax (NVAX - Free Report) announced that it has 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.
The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373. The primary endpoint of the study is the first occurrence of polymerase chain reaction-confirmed mild, moderate or severe COVID-19, with onset at least seven days after the third or booster dose of the vaccine.
Per the company, the third dose will be identical to the two-dose regimen of NVX-CoV2373 administered to participants in the phase III PREVENT-19 study. Novavax recommends administering the third dose at least six months after the initial two-dose regimen. All participants in the PREVENT-19 study who were administered the primary two-dose series of Novavax’s COVID vaccine are eligible to participate in this extension study.
This extension study will also evaluate two additional groups who are eligible to receive a booster dose — one group that participated in the previous PREVENT-19 study, which initially received placebo but subsequently received a different COVID vaccine; and another group in which the participants of the PREVENT-19 study were unblinded after receiving the vaccine but did not subsequently receive another vaccine.
Shares of Novavax have rallied 71.4% so far this year against the industry’s 19.5% decline.
Image Source: Zacks Investment Research
In a separate press release, Novavax announced that the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for the use of the company’s COVID vaccine. While SAGE recommends the primay two-dose regimen of NVX-CoV2373 in people aged 18 years and older, it recommended administering a third dose of the vaccine to immunocompromised persons after one to three months of the second dose of NVX-CoV2373.
Earlier this month, the company was granted an emergency use listing for two versions of its COVID vaccine by WHO — one marketed by the Serum Institute of India under the trade name Covovax and another version produced by NVAX that is marketed under the trade name Nuvaxovid. Nuvaxovid was granted conditional marketing authorization in the European Union this week. Covovax, marketed with the Serum Institute of India, was authorized for emergency use in Indonesia and the Philippines.
Novavax is already lagging quite behind the COVID-19 vaccine race. 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.
Please note that vaccine developing companies Johnson & Johnson (JNJ - Free Report) , Moderna (MRNA - Free Report) , and Pfizer (PFE - Free Report) have already secured FDA approvals for authorizations for not only their COVID vaccines but also their respective vaccine boosters.
In October 2021, J&J’s booster dose was the first to receive authorization in all adults who have completed at least two months of their primary vaccination with J&J’s single-shot COVID-19 vaccine.
Last month, the FDA expanded the emergency use authorization (EUA) previously granted to the mRNA vaccine boosters developed by Pfizer and Moderna for administering in all adults. Earlier, the booster doses of Pfizer’s Comirnaty and Moderna’s mRNA-1273 were granted EUA for use in people aged 65 years or older and in immunocompromised adults.
The booster doses of vaccines developed by J&J, Moderna, and Pfizer are authorized for homologous as well as heterologous administration. Heterologous or mix-and-match administration allows the administration of booster doses of any of the vaccines, irrespective of the primary vaccination regimen.
Image: Shutterstock
Novavax (NVAX) Commences COVID-19 Vaccine Booster Study
Novavax (NVAX - Free Report) announced that it has 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.
The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373. The primary endpoint of the study is the first occurrence of polymerase chain reaction-confirmed mild, moderate or severe COVID-19, with onset at least seven days after the third or booster dose of the vaccine.
Per the company, the third dose will be identical to the two-dose regimen of NVX-CoV2373 administered to participants in the phase III PREVENT-19 study. Novavax recommends administering the third dose at least six months after the initial two-dose regimen. All participants in the PREVENT-19 study who were administered the primary two-dose series of Novavax’s COVID vaccine are eligible to participate in this extension study.
This extension study will also evaluate two additional groups who are eligible to receive a booster dose — one group that participated in the previous PREVENT-19 study, which initially received placebo but subsequently received a different COVID vaccine; and another group in which the participants of the PREVENT-19 study were unblinded after receiving the vaccine but did not subsequently receive another vaccine.
Shares of Novavax have rallied 71.4% so far this year against the industry’s 19.5% decline.
In a separate press release, Novavax announced that the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for the use of the company’s COVID vaccine. While SAGE recommends the primay two-dose regimen of NVX-CoV2373 in people aged 18 years and older, it recommended administering a third dose of the vaccine to immunocompromised persons after one to three months of the second dose of NVX-CoV2373.
Earlier this month, the company was granted an emergency use listing for two versions of its COVID vaccine by WHO — one marketed by the Serum Institute of India under the trade name Covovax and another version produced by NVAX that is marketed under the trade name Nuvaxovid. Nuvaxovid was granted conditional marketing authorization in the European Union this week. Covovax, marketed with the Serum Institute of India, was authorized for emergency use in Indonesia and the Philippines.
Novavax is already lagging quite behind the COVID-19 vaccine race. 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.
Please note that vaccine developing companies Johnson & Johnson (JNJ - Free Report) , Moderna (MRNA - Free Report) , and Pfizer (PFE - Free Report) have already secured FDA approvals for authorizations for not only their COVID vaccines but also their respective vaccine boosters.
In October 2021, J&J’s booster dose was the first to receive authorization in all adults who have completed at least two months of their primary vaccination with J&J’s single-shot COVID-19 vaccine.
Last month, the FDA expanded the emergency use authorization (EUA) previously granted to the mRNA vaccine boosters developed by Pfizer and Moderna for administering in all adults. Earlier, the booster doses of Pfizer’s Comirnaty and Moderna’s mRNA-1273 were granted EUA for use in people aged 65 years or older and in immunocompromised adults.
The booster doses of vaccines developed by J&J, Moderna, and Pfizer are authorized for homologous as well as heterologous administration. Heterologous or mix-and-match administration allows the administration of booster doses of any of the vaccines, irrespective of the primary vaccination regimen.
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Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.