The much-awaited coronavirus vaccine is likely to be available for emergency use by mid-December. Several pharma bigwigs as well as biotech companies have been working relentlessly to bring a vaccine to stop the COVID-19 pandemic, which has affected millions of people and resulted in lockdowns, taking a huge toll on world economy.
Pfizer and its Germany-based partner BioNTech witnessed an efficacy rate of 95% for their mRNA-based vaccine candidate, BNT162b2, in the final analysis. The companies have already requested for an Emergency Use Authorization (“EUA”) to the FDA. Pfizer/BioNTech are closely followed by Moderna. Moderna has reported 94.5% efficacy rate from first interim analysis of the phase III study evaluating its coronavirus vaccine candidate, mRNA-1273 and is expected to announce final data by the end of the month. The candidate is also anticipated to gain EUA by mid-December. Another close contender is AstraZeneca candidate, AZD1222.
Although millions of doses of coronavirus vaccines are expected to be available next year with strong manufacturing capabilities of Pfizer and Moderna, the anticipated requirement of several billions of doses worldwide will likely create opportunities for other vaccine-makers who are currently lagging in the race. Here we discuss four small biotech companies that are developing a coronavirus vaccine and may gain in the coming months.
Inovio Pharmaceuticals Inc ( INO Quick Quote INO - Free Report)
The company joined the coronavirus vaccine development race early in March. However, a partial hold imposed by the FDA on its phase II/III study in September hindered its progress. The company is developing a DNA vaccine candidate, INO-4800, for battling SARS-CoV-2. Earlier this month, the FDA however removed its partial hold from the phase II part of the study. The partial hold on phase III part of the study will be removed after addressing questions regarding the Cellectra device meant to deliver the DNA vaccine. Moreover, the U.S. Department of Defense will be funding both phases of the study, suggesting no funding related mishap going forward.
The company’s shares have gained 214.8% so far this year.
Novavax, Inc. ( NVAX Quick Quote NVAX - Free Report)
The company’s coronavirus vaccine candidate, NVX-CoV2373, was granted Fast Track designation by the FDA earlier this month. The designation will help the company to gain accelerated review of its potential regulatory application for a FDA approval/EUA. The company is already conducting a phase III study in the United Kingdom onits candidate. Interim data from this study is expected in early first-quarter 2021. A late-stage study is expected to start by the end of November. The clinical studies are being conducted by the company with the help of almost $2 billion in funding received from various sources including the U.S. government. The company has multiple supply agreements with different countries for NVX-CoV2373 already in place.
Shares of Novavax have skyrocketed 2477.9% so far this year.
Translate Bio, Inc. ( TBIO Quick Quote TBIO - Free Report)
Though the company is lagging in the coronavirus vaccine race, it has a strong partner in Sanofi. Last month, the company and its partner announced promising pre-clinical data on their coronavirus vaccine candidate, MRT5500. A phase I/II study is expected to start in the first quarter of 2021. The early-stage nature of the vaccine development will likely create opportunity for increase in its share price on potential positive study data readouts and initiation of advanced studies.
Translate Bio’s shares have gained 124% so far this year.
Vaxart, Inc. ( VXRT Quick Quote VXRT - Free Report)
It is another company with an early-stage coronavirus vaccine candidate in its portfolio. The company started a phase I study on its oral tablet vaccine candidate, VXA-CoV2-1, in October. The first clinical data from the study is anticipated in the coming weeks. Positive data should drive share prices higher. Pre-clinical data had shown that the vaccine was able to generate both immune responses as well as a strong mucosal immune response against SARS-CoV-2. Please note that the company’s candidate is part of the U.S. government’s Operation Warp Speed (OWS) program and receives funding for its clinical development.
Vaxart’s shares have surged 1726% so far this year. The company carries a Zacks Rank #3 (Hold). You can see
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