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Moderna Completes Enrollment in Phase II Coronavirus Study
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Moderna, Inc. (MRNA - Free Report) announced that it has completed enrollment in the phase II study evaluating its mRNA-based vaccine candidate, mRNA-1273, for COVID-19 patients.
The study is evaluating two doses — 50 μg or 100 μg — of the vaccine candidate in two patient groups — younger adults (aged 18-55 years) and sentinel group of older adults (aged 55 years and above). The study is evaluating the candidate for safety, reactogenicity and immunogenicity of two vaccinations of either doses of mRNA-1273 administered 28 days apart.
Safety data of the vaccination is likely to be promising in the sentinel group as the Data and Safety Monitoring Committee of the study recommended continuation of enrollment following a review of the safety data in that group on Jun 25.
The company also announced that enrollment in two cohorts — older adults (aged 56-70) and elderly adults (aged 71 and above) — of the phase I study on mRNA-1273 conducted by the National Institutes of Health (“NIH”) has also been completed.
Moderna’s shares have rallied 214.9% in the year so far compared with the industry’s growth of 11.8%.
Apart from completing enrollment in the phase II study, the company also announced that it has finalized protocol for the phase III design to evaluate mRNA-1273 based on the FDA’s feedback. The late-stage study will evaluate 100 μg dose of the vaccine candidate in approximately 30,000 participants. The company will conduct the study in collaboration with the National Institute of Allergy and Infectious Diseases, part of NIH. Although the company anticipates to begin the study by the end of July, it is still subject to regulatory approval.
Meanwhile, Moderna has completed manufacturing of the vaccine candidate required for evaluation in the phase III study. The company stated that it is on track to deliver 500 million doses of 100 μg dosage of mRNA-1273 per year, which can possibly increase up to 1 billion doses per year, beginning 2021.
Last month, the company signed a manufacturing agreement with drug delivery specialist, Catalent, Inc. (CTLT - Free Report) for large-scale, commercial fill-finish manufacturing of mRNA-1273.
Given the severity of the pandemic and the urgency of a vaccine, most companies are gearing up to keep doses ready even before the safety and effectiveness of the candidates are proved.
Currently, there are no approved treatments or vaccines for COVID-19. Big drug makers like AstraZeneca Plc (AZN - Free Report) and Johnson & Johnson (JNJ - Free Report) among others are developing vaccines to make these available as fast as possible. Pfizer is also expected to initiate a phase II/III study on its mRNA-based vaccine candidate this month.
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Last year's 2019 Zacks Top 10 Stocks portfolio returned gains as high as +102.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
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Moderna Completes Enrollment in Phase II Coronavirus Study
Moderna, Inc. (MRNA - Free Report) announced that it has completed enrollment in the phase II study evaluating its mRNA-based vaccine candidate, mRNA-1273, for COVID-19 patients.
The study is evaluating two doses — 50 μg or 100 μg — of the vaccine candidate in two patient groups — younger adults (aged 18-55 years) and sentinel group of older adults (aged 55 years and above). The study is evaluating the candidate for safety, reactogenicity and immunogenicity of two vaccinations of either doses of mRNA-1273 administered 28 days apart.
Safety data of the vaccination is likely to be promising in the sentinel group as the Data and Safety Monitoring Committee of the study recommended continuation of enrollment following a review of the safety data in that group on Jun 25.
The company also announced that enrollment in two cohorts — older adults (aged 56-70) and elderly adults (aged 71 and above) — of the phase I study on mRNA-1273 conducted by the National Institutes of Health (“NIH”) has also been completed.
Moderna’s shares have rallied 214.9% in the year so far compared with the industry’s growth of 11.8%.
Apart from completing enrollment in the phase II study, the company also announced that it has finalized protocol for the phase III design to evaluate mRNA-1273 based on the FDA’s feedback. The late-stage study will evaluate 100 μg dose of the vaccine candidate in approximately 30,000 participants. The company will conduct the study in collaboration with the National Institute of Allergy and Infectious Diseases, part of NIH. Although the company anticipates to begin the study by the end of July, it is still subject to regulatory approval.
Meanwhile, Moderna has completed manufacturing of the vaccine candidate required for evaluation in the phase III study. The company stated that it is on track to deliver 500 million doses of 100 μg dosage of mRNA-1273 per year, which can possibly increase up to 1 billion doses per year, beginning 2021.
Last month, the company signed a manufacturing agreement with drug delivery specialist, Catalent, Inc. (CTLT - Free Report) for large-scale, commercial fill-finish manufacturing of mRNA-1273.
Given the severity of the pandemic and the urgency of a vaccine, most companies are gearing up to keep doses ready even before the safety and effectiveness of the candidates are proved.
Currently, there are no approved treatments or vaccines for COVID-19. Big drug makers like AstraZeneca Plc (AZN - Free Report) and Johnson & Johnson (JNJ - Free Report) among others are developing vaccines to make these available as fast as possible. Pfizer is also expected to initiate a phase II/III study on its mRNA-based vaccine candidate this month.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank
Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Top 10 Stocks for 2020
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2020?
Last year's 2019 Zacks Top 10 Stocks portfolio returned gains as high as +102.7%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
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