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CureVac (CVAC) Begins Pivotal Study on COVID-19 Vaccine
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CureVac N.V. (CVAC - Free Report) announced that it has dosed the first participant in the pivotal phase IIb/III study — HERALD — evaluating its mRNA-based COVID-19 vaccine candidate, CVnCoV. The study will evaluate a two-dose schedule of the candidate of 12 microgram each for its safety and efficacy.
Besides the primary safety objective, the two-part study will evaluate two primary efficacy objectives — efficacy of CVnCoV in preventing first episodes of confirmed cases of COVID-19 of any severity, and preventing moderate-to-severe confirmed cases of COVID-19 in participants with no prior SARS-CoV-2 infection. The study will include almost 35,000 participants, primarily from Europe and Latin America.
The company plans to monitor the participants in a one-year extension study, following the completion of the HERALD study for long-term safety of CVnCoV, as well as duration of persistence of antibodies to SARS-CoV-2 and vaccine efficacy.
We remind investors that CureVac started trading on the New York stock exchange after its initial public offering on Aug 4, 2020.
Shares of CureVac were up 2.5% on Dec 14 following the news. Moreover, the stock has gained 116.6% since it started trading compared with the industry’s increase of 2.2%.
Last month, CureVac reported positive interim data from the phase I study, which demonstrated that the candidate induced strong antibody responses and the immune response was comparable to naturally recovered COVID-19 patients. Moreover, data also showed that the candidate was well tolerated. A phase II study is also evaluating the coronavirus vaccine candidate. Initial data from the phase II study is expected by year-end.
The company announced last month that CVnCoV remained stable at a standard refrigerator temperature (5°C) for at least three months and for up to 24 hours at room temperature as ready-to-use vaccine. The storage and distribution of vaccines has been in the news since coronavirus vaccine race leaders, Pfizer (PFE - Free Report) and its partner BioNTech (BNTX - Free Report) , announced that their coronavirus vaccine, BNT162b2, needs to be stored at ultra-low temperatures. Such low temperatures require sophisticated storage and distribution options.
Another leading coronavirus vaccine contender, Moderna’s (MRNA - Free Report) mRNA-1273 can be stored at -20°C for up to six months at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours. Both BNT162b2 and mRNA-1273 are mRNA-based vaccines like CVnCoV. With a standard refrigerator temperature requirement for CVnCoV, it is unlikely to face any logistical hurdle and can also lead to reduced transportation costs for the vaccine.
CureVac is expected to earn up to 252 million euros for the development of its COVID-19 vaccine candidate from Germany’s Federal Ministry of Education and Research.
Meanwhile, the company has a purchase agreement for its COVID-19 vaccine candidate with the European Commission (EC). With this contract, CureVac is looking to supply up to 225 million doses of the vaccine to all EU-member states upon approval with an option to deliver an additional 180 million doses. Moreover, the company is also strengthening its manufacturing capacity through collaborations. It plans to supply up to 300 million doses by end of 2021 and up to 600 million doses in 2022, primarily in Europe.
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Although marijuana stocks did better as the pandemic took hold than the market as a whole, they’ve been pushed down. This is exactly the right time to get in on selected strong companies at a fraction of their value before COVID struck. Zacks’ Special Report, Marijuana Moneymakers, reveals 10 exciting tickers for urgent consideration.
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CureVac (CVAC) Begins Pivotal Study on COVID-19 Vaccine
CureVac N.V. (CVAC - Free Report) announced that it has dosed the first participant in the pivotal phase IIb/III study — HERALD — evaluating its mRNA-based COVID-19 vaccine candidate, CVnCoV. The study will evaluate a two-dose schedule of the candidate of 12 microgram each for its safety and efficacy.
Besides the primary safety objective, the two-part study will evaluate two primary efficacy objectives — efficacy of CVnCoV in preventing first episodes of confirmed cases of COVID-19 of any severity, and preventing moderate-to-severe confirmed cases of COVID-19 in participants with no prior SARS-CoV-2 infection. The study will include almost 35,000 participants, primarily from Europe and Latin America.
The company plans to monitor the participants in a one-year extension study, following the completion of the HERALD study for long-term safety of CVnCoV, as well as duration of persistence of antibodies to SARS-CoV-2 and vaccine efficacy.
We remind investors that CureVac started trading on the New York stock exchange after its initial public offering on Aug 4, 2020.
Shares of CureVac were up 2.5% on Dec 14 following the news. Moreover, the stock has gained 116.6% since it started trading compared with the industry’s increase of 2.2%.
Last month, CureVac reported positive interim data from the phase I study, which demonstrated that the candidate induced strong antibody responses and the immune response was comparable to naturally recovered COVID-19 patients. Moreover, data also showed that the candidate was well tolerated. A phase II study is also evaluating the coronavirus vaccine candidate. Initial data from the phase II study is expected by year-end.
The company announced last month that CVnCoV remained stable at a standard refrigerator temperature (5°C) for at least three months and for up to 24 hours at room temperature as ready-to-use vaccine. The storage and distribution of vaccines has been in the news since coronavirus vaccine race leaders, Pfizer (PFE - Free Report) and its partner BioNTech (BNTX - Free Report) , announced that their coronavirus vaccine, BNT162b2, needs to be stored at ultra-low temperatures. Such low temperatures require sophisticated storage and distribution options.
Another leading coronavirus vaccine contender, Moderna’s (MRNA - Free Report) mRNA-1273 can be stored at -20°C for up to six months at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours. Both BNT162b2 and mRNA-1273 are mRNA-based vaccines like CVnCoV. With a standard refrigerator temperature requirement for CVnCoV, it is unlikely to face any logistical hurdle and can also lead to reduced transportation costs for the vaccine.
CureVac is expected to earn up to 252 million euros for the development of its COVID-19 vaccine candidate from Germany’s Federal Ministry of Education and Research.
Meanwhile, the company has a purchase agreement for its COVID-19 vaccine candidate with the European Commission (EC). With this contract, CureVac is looking to supply up to 225 million doses of the vaccine to all EU-member states upon approval with an option to deliver an additional 180 million doses. Moreover, the company is also strengthening its manufacturing capacity through collaborations. It plans to supply up to 300 million doses by end of 2021 and up to 600 million doses in 2022, primarily in Europe.
CureVac N.V. Price
CureVac N.V. price | CureVac N.V. Quote
Zacks Rank
CureVac currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Although marijuana stocks did better as the pandemic took hold than the market as a whole, they’ve been pushed down. This is exactly the right time to get in on selected strong companies at a fraction of their value before COVID struck. Zacks’ Special Report, Marijuana Moneymakers, reveals 10 exciting tickers for urgent consideration.
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