WASHINGTON (dpa-AFX) - Russia has become the first nation to have approved a vaccine for COVID-19, formally registering it on August 11.
Named Sputnik V, this genetically engineered vaccine, developed by the Moscow-based Gamaleya Research Institute, contains a combination of two replication-defective adenovirus vectors Ad5 and Ad26. The vaccine is said to provide immunity against the novel coronavirus for at least two years from the time of injection.
The speedy regulatory approval of Sputnik V is raising eyebrows because the phase I trials of that vaccine were started only in June and experts doubt if it would have gone through the whole gamut of tests needed for approval. Countries like China, the US, and Europe, which launched the phase I clinical trials of their respective vaccines as early as March, have advanced only into phase II or phase III testing.
The 'Draft landscape of COVID-19 candidate vaccines', a database maintained by the WHO, still mentions the status of the COVID-19 vaccine developed by the Gamaleya Research Institute as phase I.
Commenting on the Russian vaccine, Dr. Bruce Aylward, a senior adviser to WHO's director-general, said, 'We don't have sufficient information at this point to make a judgment. We're currently in conversation with Russia to get additional information to understand the status of that product, the trials that have been undertaken, and then what the next steps might be.'
Sputnik V is expected to be rolled out by the end of this month, according to reports.
As of this writing, 21.24 million people around the world have been diagnosed with COVID-19, and there have been 766,488 fatalities, according to the Johns Hopkins University. The worst-hit country, U.S., has reported 5.31 million cases and 168,462 deaths.
Now, let's take a look at how the stocks of some of the companies working on coronavirus treatments/vaccines/diagnostic tests have fared since March, i.e., the month when COVID-19 was declared a pandemic. We have listed below only 4 stocks that have notched gains in excess of 1,000 percent year-to-date.
1. Novavax Inc. (NVAX)
Novavax is developing a vaccine that is designed to provide protection against COVID-19. The vaccine named NVX-CoV2373 has successfully completed the phase I portion of its phase I/phase II trial, being conducted in Australia. The phase II clinical trials are expected to begin this month.
The company is collaborating with the UK government on the phase III trial of the vaccine, which is scheduled to commence in the UK this quarter.
Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
NVAX was trading in the range of $6 to 14 in March, and there has been no looking back since then, with the stock touching an all-time high of $189.40 on August 5. The stock has shed some of its gains and trades around $146.
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2. Altimmune Inc. (ALT)
Altimmune's investigational therapeutic program for COVID-19 is T-COVID, an intranasal immune modulator for the treatment of outpatients with early COVID-19.
The FDA has given clearance to initiate a phase I/II clinical trial of T-COVID, dubbed EPIC, and enrollment is said to commence imminently. The phase I/II trial of T-COVID is funded by the U.S. Army Medical Research & Development Command (USAMRDC).
The company is also developing a vaccine for COVID-19 by the name AdCOVID, which is under preclinical studies at the University of Alabama at Birmingham (UAB). AdCOVID is expected to advance into phase I safety and immunogenicity study next quarter.
ALT, which was trading in the range of $2.50 to $3.80 in March and April, jumped to $12 in June and continued to climb further. The stock, which touched a high of $35.10 on July 20, has erased some of its gains since then and trades around $24.
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3. Vaxart Inc. (VXRT)
Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines that are delivered in tablet formulation rather than as injection.
In January, the company initiated a program to develop an oral COVID-19 vaccine based on its VAAST platform and in May, selected its lead COVID-19 vaccine candidate to move into clinical trials. Its oral COVID-19 vaccine was selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, in June.
An Investigational New Drug application, seeking clearance to initiate a phase I trial of its COVID-19 vaccine candidate, was filed with the FDA as recently as August 10.
VXRT was trading in the range of $1.08 to $4.12 between March and the most part of June. The stock picked up steam from the last week of June and went on to touch a high of $17.49 on July 14. VXRT has now shed most of its gains and trades around $9.00.
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4. Co-Diagnostics Inc. (CODX)
Co-Diagnostics is involved in developing COVID-19 tests and equipments. Logix Smart COVID-19 test, the company's SARS-CoV-2 Test, is CE marked and has received Emergency Use Authorization from the FDA, and is currently available to all clinical laboratories in the U.S. and many other countries.
In the last 4 months since Co-Diagnostics received emergency use authorization from the FDA, the company has successfully grown its business. The net income in the second quarter of 2020 was $12.6 million or $0.43 per share on total revenue of $24.04 million. This compares with net loss of $1.34 million or $0.08 per share and revenue of $0.61 million in the year-ago quarter.
Co-Diagnostics is confident that the widespread acceptance of its tests will continue to support its sales and profitability.
CODX was trading below $1 in the beginning of January. The stock crossed the $1 mark on January 13 and has steadily increased since then. CODX, which touched a high of $30.99 on August 3, has erased nearly half its gains and trades around $16.
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