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J&J (JNJ) COVID-19 Vaccine Gets Conditional Approval in Europe
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Johnson & Johnson’s (JNJ - Free Report) single-dose COVID-19 vaccine candidate was granted Conditional Marketing Authorization (“CMA”) by the European Commission, making it the fourth COVID-19 vaccine to be available in Europe. The CMA for J&J’s vaccine is also valid in Norway, Iceland and Liechtenstein.
The CMA followed positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) yesterday.
Other available vaccines in Europe include Pfizer/BioNTech’s (BNTX - Free Report) BNT162b2, Moderna’s (MRNA - Free Report) mRNA-1273 and AstraZeneca’s (AZN - Free Report) COVID-19 vaccine. However, J&J has a competitive advantage. Its vaccine is the only COVID-19 vaccine to be approved for single administration while other are approved with two-dose dosing regimens three or four weeks apart.
The approval was based on interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. Based on this study data, J&J’s vaccine was granted Emergency Use Authorization by the FDA last month. The vaccine was also granted Interim Order authorization in Canada last week.
Interim efficacy and safety data from the ENSEMBLE study released in January showed that J&J’s vaccine candidate was 66% effective overall at preventing moderate-to-severe COVID-19, 28 days after vaccination. Meanwhile, the single-shot vaccine was 72% effective in the United States and 85% effective overall in preventing severe disease. Importantly, the protection against severe disease was observed across geographies and against multiple rapidly emerging infectious virus variants including the South African variant.
J&J plans to start supply of its vaccine to Europe in the second half of April. The company is committed to supply 200 million doses of the vaccine to Europe as well as Norway and Iceland in 2021. In the United States, J&J has an agreement to supply 100 million doses in the first half of 2021.
The company has also begun rolling filings in other countries. It has also filed for Emergency Use Listing with the World Health Organization for its vaccine.
This year so far, J&J’s shares have risen 1.2% against a decrease of 0.5% for the industry.
Meanwhile, there have been rising concerns about different strains of coronavirus that are potentially more contagious and severe. Moreover, effectiveness of available vaccines against these strains as well as some adverse events following vaccination is worrying. The FDA has issued guidelines for testing of vaccines against new strains with Pfizer and Moderna releasing encouraging results against some strains. However, adverse events have led to backlash against the available vaccines, which may lead to citizens refusing inoculation. With more dangerous strains in sight, this will likely be a major concern.
Per the director of the Center for Infectious Disease Research quoted in a yahoo !finance article, declining trend in new COVID-19 infection cases and hospitalizations in the United States may reverse and climb faster to a new high if the variants spread in the country, primarily due to those who haven’t been vaccinated yet.
Moreover, several countries are yet to receive a vaccine and carry the risk of rising infections cases and deaths. Approvals to new vaccines, sufficient production, efficient supply and proper vaccination awareness programs will help to fight the battle against the pandemic across the globe.
With super high data speed, it will make current cell phones obsolete and unlock the full potential of big data, cloud computing, and artificial intelligence. In the next few years this industry is predicted to create 22 million jobs and a stunning $12.3 trillion in revenue.
Today you have an historic chance to pursue almost unimaginable gains like Microsoft, Netflix, and Apple in their early phases. Zacks has released a Special Report that reveals our . . .
Image: Bigstock
J&J (JNJ) COVID-19 Vaccine Gets Conditional Approval in Europe
Johnson & Johnson’s (JNJ - Free Report) single-dose COVID-19 vaccine candidate was granted Conditional Marketing Authorization (“CMA”) by the European Commission, making it the fourth COVID-19 vaccine to be available in Europe. The CMA for J&J’s vaccine is also valid in Norway, Iceland and Liechtenstein.
The CMA followed positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) yesterday.
Other available vaccines in Europe include Pfizer/BioNTech’s (BNTX - Free Report) BNT162b2, Moderna’s (MRNA - Free Report) mRNA-1273 and AstraZeneca’s (AZN - Free Report) COVID-19 vaccine. However, J&J has a competitive advantage. Its vaccine is the only COVID-19 vaccine to be approved for single administration while other are approved with two-dose dosing regimens three or four weeks apart.
The approval was based on interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. Based on this study data, J&J’s vaccine was granted Emergency Use Authorization by the FDA last month. The vaccine was also granted Interim Order authorization in Canada last week.
Interim efficacy and safety data from the ENSEMBLE study released in January showed that J&J’s vaccine candidate was 66% effective overall at preventing moderate-to-severe COVID-19, 28 days after vaccination. Meanwhile, the single-shot vaccine was 72% effective in the United States and 85% effective overall in preventing severe disease. Importantly, the protection against severe disease was observed across geographies and against multiple rapidly emerging infectious virus variants including the South African variant.
J&J plans to start supply of its vaccine to Europe in the second half of April. The company is committed to supply 200 million doses of the vaccine to Europe as well as Norway and Iceland in 2021. In the United States, J&J has an agreement to supply 100 million doses in the first half of 2021.
The company has also begun rolling filings in other countries. It has also filed for Emergency Use Listing with the World Health Organization for its vaccine.
This year so far, J&J’s shares have risen 1.2% against a decrease of 0.5% for the industry.
Meanwhile, there have been rising concerns about different strains of coronavirus that are potentially more contagious and severe. Moreover, effectiveness of available vaccines against these strains as well as some adverse events following vaccination is worrying. The FDA has issued guidelines for testing of vaccines against new strains with Pfizer and Moderna releasing encouraging results against some strains. However, adverse events have led to backlash against the available vaccines, which may lead to citizens refusing inoculation. With more dangerous strains in sight, this will likely be a major concern.
Per the director of the Center for Infectious Disease Research quoted in a yahoo !finance article, declining trend in new COVID-19 infection cases and hospitalizations in the United States may reverse and climb faster to a new high if the variants spread in the country, primarily due to those who haven’t been vaccinated yet.
Moreover, several countries are yet to receive a vaccine and carry the risk of rising infections cases and deaths. Approvals to new vaccines, sufficient production, efficient supply and proper vaccination awareness programs will help to fight the battle against the pandemic across the globe.
Johnson & Johnson Price
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Zacks Rank
J&J currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5G Revolution: 3 Stocks to Make Your Move
With super high data speed, it will make current cell phones obsolete and unlock the full potential of big data, cloud computing, and artificial intelligence. In the next few years this industry is predicted to create 22 million jobs and a stunning $12.3 trillion in revenue.
Today you have an historic chance to pursue almost unimaginable gains like Microsoft, Netflix, and Apple in their early phases. Zacks has released a Special Report that reveals our . . .
Download now. Today the report is FREE >>