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J&J (JNJ) Seeks Conditional Nod for COVID-19 Vaccine in EU
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Johnson & Johnson (JNJ - Free Report) filed a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency, seeking approval for its single-dose COVID-19 vaccine candidate. The application is based on interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. J&J said it is ready to start distributing its vaccine in the European Union from the second quarter, if authorization is received.
Earlier this month, J&J had filed an application to the FDA seeking Emergency Use Authorization (EUA) for the vaccine. J&J will distribute the vaccine to the U.S. government immediately after receiving approval. It also has an agreement to supply 100 million doses to the United States in the first half of 2021. The company has also begun rolling filings in other countries.
Last month, J&J announced interim efficacy and safety data from the ENSEMBLE study. The candidate met all primary and key secondary endpoints in the study. The 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. No significant safety concerns were reported, and the vaccine was well-tolerated.
This year so far, J&J’s shares have risen 4.8% compared with 2.1% growth.
J&J’s COVID-19 vaccine follows Pfizer (PFE - Free Report) /BioNTech, Moderna (MRNA - Free Report) and AstraZeneca’s (AZN - Free Report) , all of which were launched in some countries last year. However, J&J has the competitive advantage that its vaccine, if approved, will be the only COVID-19 vaccine to be approved for single administration. Other approved vaccines globally, including Pfizer’s BNT162b2, Moderna’s mRNA-1273 and AstraZeneca COVID-19 Vaccine are approved with two-dose dosing regimen separated by three/four weeks. A single dose will require lesser vaccine production and it also provides patient convenience.
Notably, the vaccine is expected to remain stable for two years at -20°C, at least three months of which can be at temperatures of 2-8°C. The company will be able to use its existing cold-chain technologies to transport the vaccine.
Meanwhile, J&J is also conducting studies on its two-dose COVID vaccine with data expected in the back end of the year.
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J&J (JNJ) Seeks Conditional Nod for COVID-19 Vaccine in EU
Johnson & Johnson (JNJ - Free Report) filed a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency, seeking approval for its single-dose COVID-19 vaccine candidate. The application is based on interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. J&J said it is ready to start distributing its vaccine in the European Union from the second quarter, if authorization is received.
Earlier this month, J&J had filed an application to the FDA seeking Emergency Use Authorization (EUA) for the vaccine. J&J will distribute the vaccine to the U.S. government immediately after receiving approval. It also has an agreement to supply 100 million doses to the United States in the first half of 2021. The company has also begun rolling filings in other countries.
Last month, J&J announced interim efficacy and safety data from the ENSEMBLE study. The candidate met all primary and key secondary endpoints in the study. The 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. No significant safety concerns were reported, and the vaccine was well-tolerated.
This year so far, J&J’s shares have risen 4.8% compared with 2.1% growth.
J&J’s COVID-19 vaccine follows Pfizer (PFE - Free Report) /BioNTech, Moderna (MRNA - Free Report) and AstraZeneca’s (AZN - Free Report) , all of which were launched in some countries last year. However, J&J has the competitive advantage that its vaccine, if approved, will be the only COVID-19 vaccine to be approved for single administration. Other approved vaccines globally, including Pfizer’s BNT162b2, Moderna’s mRNA-1273 and AstraZeneca COVID-19 Vaccine are approved with two-dose dosing regimen separated by three/four weeks. A single dose will require lesser vaccine production and it also provides patient convenience.
Notably, the vaccine is expected to remain stable for two years at -20°C, at least three months of which can be at temperatures of 2-8°C. The company will be able to use its existing cold-chain technologies to transport the vaccine.
Meanwhile, J&J is also conducting studies on its two-dose COVID vaccine with data expected in the back end of the year.
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.
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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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