We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
J&J (JNJ) Seeks Emergency Approval for Coronavirus Vaccine
Read MoreHide Full Article
Johnson & Johnson (JNJ - Free Report) announced that it has filed a regulatory application with the FDA requesting emergency use approval (“EUA”) for its coronavirus vaccine candidate, JNJ-78436735 (also known as Ad26.COV2.S).
We expect the FDA to provide an update on the application in the next few weeks as previously seen with Pfizer (PFE - Free Report) and Moderna (MRNA - Free Report) whose vaccine candidates were approved for emergency use last year. J&J stated that it will start supply of its vaccine immediately following an approval. It expects to supply 100 million doses of its vaccine candidate to the United States in the first half of 2021.
Please note that J&J’s 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’s (AZN - Free Report) COVID-19 Vaccine (formerly AZD1222), are approved with two-dose dosing regimen separated by three/four weeks. A single dose will require lesser vaccine production and will reduce hassles for people. This may lead to higher demand for J&J’s vaccine. The World Health Organization also considers the one-shot vaccine to be the best option in pandemic settings. However, production capacity may limit the supply of vaccine doses.
J&J plans to submit a regulatory application seeking conditional marketing authorization for the vaccine candidate in Europe in the coming weeks. The company has also initiated rolling submissions seeking approval for the candidate in several other countries.
Shares of J&J have increased 9.1% in the past six months compared with the industry’s rise of 2.9%.
The regulatory application includes data from the recently completed phase III study — ENSEMBLE — evaluating the candidate for protecting against moderate-to-severe COVID-19. The candidate was found to 66% effective in preventing moderate-to-severe COVID-19 after 28 days following vaccination including participants who were infected with an emerging viral variant of the virus. Moreover, the vaccine candidate was 85% effective in preventing severe COVID-19 disease in adults aged 18 years and above, 28 days post vaccination.
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.
With increasing numbers of approved vaccines or treatment for the COVID-19 being available, the world economies may return to normalcy by the end of this year.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
Image: Bigstock
J&J (JNJ) Seeks Emergency Approval for Coronavirus Vaccine
Johnson & Johnson (JNJ - Free Report) announced that it has filed a regulatory application with the FDA requesting emergency use approval (“EUA”) for its coronavirus vaccine candidate, JNJ-78436735 (also known as Ad26.COV2.S).
We expect the FDA to provide an update on the application in the next few weeks as previously seen with Pfizer (PFE - Free Report) and Moderna (MRNA - Free Report) whose vaccine candidates were approved for emergency use last year. J&J stated that it will start supply of its vaccine immediately following an approval. It expects to supply 100 million doses of its vaccine candidate to the United States in the first half of 2021.
Please note that J&J’s 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’s (AZN - Free Report) COVID-19 Vaccine (formerly AZD1222), are approved with two-dose dosing regimen separated by three/four weeks. A single dose will require lesser vaccine production and will reduce hassles for people. This may lead to higher demand for J&J’s vaccine. The World Health Organization also considers the one-shot vaccine to be the best option in pandemic settings. However, production capacity may limit the supply of vaccine doses.
J&J plans to submit a regulatory application seeking conditional marketing authorization for the vaccine candidate in Europe in the coming weeks. The company has also initiated rolling submissions seeking approval for the candidate in several other countries.
Shares of J&J have increased 9.1% in the past six months compared with the industry’s rise of 2.9%.
The regulatory application includes data from the recently completed phase III study — ENSEMBLE — evaluating the candidate for protecting against moderate-to-severe COVID-19. The candidate was found to 66% effective in preventing moderate-to-severe COVID-19 after 28 days following vaccination including participants who were infected with an emerging viral variant of the virus. Moreover, the vaccine candidate was 85% effective in preventing severe COVID-19 disease in adults aged 18 years and above, 28 days post vaccination.
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.
With increasing numbers of approved vaccines or treatment for the COVID-19 being available, the world economies may return to normalcy by the end of this year.
Johnson & Johnson Price
Johnson & Johnson price | Johnson & Johnson Quote
Zacks Rank
J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>