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Moderna (MRNA) COVID-19 Vaccine Gets Authorization in Europe
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Moderna, Inc. (MRNA - Free Report) announced that the European Commission has granted conditional marketing authorization (CMA) to its mRNA-based coronavirus vaccine candidate, mRNA-1273. This is the second approval for a coronavirus vaccine in the European Union, following a CMA to Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based vaccine BNT162b2, last month. mRNA-1273 can be administered for active immunization to prevent COVID-19 in individuals 18 years of age and older.
The company’s coronavirus vaccine has already received authorization in the United States, Canada and Israel. The vaccine candidate is under review in Singapore, Switzerland and the United Kingdom.
The European Commission’s decision follows a positive opinion adopted by the Committee for Medicinal Products for Human Use, recommending CMA of the vaccine. A CMA allows companies to seek approval for medicines/vaccines that fulfil an unmet medical need based on less complete data than needed. In November 2020, the European Medicine Agency started rolling review in of Moderna regulatory application for full approval of the vaccine in Europe. Please note that the vaccine achieved an efficacy rate of 94.1% during the primary efficacy analysis of the phase III COVE study.
The company already has an agreement to supply 160 million vaccine doses to EU member states in 2021. It is expected to supply vaccine doses to Europe starting next week. Supply agreements worth several tens of millions of doses have also been signed with different countries. The company has partnered with Swiss biotech company, Lonza, for production of mRNA-1273. Meanwhile, Moderna has contracted for fill-finish services with Catalent (CTLT - Free Report) in the United States, and ROVI and Recipharm in ex-U.S. markets
Moderna’s shares have skyrocketed 546.6% in the past year compared with the industry’s increase of 4.3%.
Meanwhile, some experts are now advocating changes in approved dosing regimens as it can help to vaccinate a larger number of people amid rising cases of infections and concerns related to a new, potentially highly contagious strain of the coronavirus. The FDA has opposed any changes to dosing regimens as it may lead to unnecessary risks to public health.
Per a Reuters article, Pfizer’s Germany-based partner, BioNTech, is engaged in discussion with European regulators to increase recommended doses per vial of BNT162b from five to six. The company believes that with proper syringe and needle it is possible to extract an extra dose from every vial of the vaccine. A potential recommendation from the authorities will increase available doses by 20% for BNT162b. Per the same article, Italy has already approved the increase in extraction of doses per vial, overriding European Medicine Agency’s guideline for Europe. Other countries that have taken similar approach for BNT16b include the United States, United Kingdom, Switzerland and Israel.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Shutterstock
Moderna (MRNA) COVID-19 Vaccine Gets Authorization in Europe
Moderna, Inc. (MRNA - Free Report) announced that the European Commission has granted conditional marketing authorization (CMA) to its mRNA-based coronavirus vaccine candidate, mRNA-1273. This is the second approval for a coronavirus vaccine in the European Union, following a CMA to Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) mRNA-based vaccine BNT162b2, last month. mRNA-1273 can be administered for active immunization to prevent COVID-19 in individuals 18 years of age and older.
The company’s coronavirus vaccine has already received authorization in the United States, Canada and Israel. The vaccine candidate is under review in Singapore, Switzerland and the United Kingdom.
The European Commission’s decision follows a positive opinion adopted by the Committee for Medicinal Products for Human Use, recommending CMA of the vaccine. A CMA allows companies to seek approval for medicines/vaccines that fulfil an unmet medical need based on less complete data than needed. In November 2020, the European Medicine Agency started rolling review in of Moderna regulatory application for full approval of the vaccine in Europe. Please note that the vaccine achieved an efficacy rate of 94.1% during the primary efficacy analysis of the phase III COVE study.
The company already has an agreement to supply 160 million vaccine doses to EU member states in 2021. It is expected to supply vaccine doses to Europe starting next week. Supply agreements worth several tens of millions of doses have also been signed with different countries. The company has partnered with Swiss biotech company, Lonza, for production of mRNA-1273. Meanwhile, Moderna has contracted for fill-finish services with Catalent (CTLT - Free Report) in the United States, and ROVI and Recipharm in ex-U.S. markets
Moderna’s shares have skyrocketed 546.6% in the past year compared with the industry’s increase of 4.3%.
Meanwhile, some experts are now advocating changes in approved dosing regimens as it can help to vaccinate a larger number of people amid rising cases of infections and concerns related to a new, potentially highly contagious strain of the coronavirus. The FDA has opposed any changes to dosing regimens as it may lead to unnecessary risks to public health.
Per a Reuters article, Pfizer’s Germany-based partner, BioNTech, is engaged in discussion with European regulators to increase recommended doses per vial of BNT162b from five to six. The company believes that with proper syringe and needle it is possible to extract an extra dose from every vial of the vaccine. A potential recommendation from the authorities will increase available doses by 20% for BNT162b. Per the same article, Italy has already approved the increase in extraction of doses per vial, overriding European Medicine Agency’s guideline for Europe. Other countries that have taken similar approach for BNT16b include the United States, United Kingdom, Switzerland and Israel.
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.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>