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J&J (JNJ) Gets First Full Approval for COVID Jab in Canada

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J&J (JNJ - Free Report) announced that its adenovirus-based single-shot vaccine has been granted full approval by Health Canada for the prevention of COVID-19 disease in individuals 18 years of age and older.

J&J’s vaccine is presently approved for emergency use in some countries. Canada is the first country to have given full approval to J&J’s vaccine. The full approval of a COVID vaccine is likely to instill additional confidence in citizens of that country to get vaccinated and also allows companies and institutions to mandate its use.

The full approval in Canada was based on initial data the phase III ENSEMBLE study, which showed that the vaccine was 66% effective overall at preventing moderate-to-severe COVID-19, 28 days after vaccination. The vaccine was 85% effective overall in preventing severe disease. It also offered protection against COVID-related hospitalization and death as well as against different variants.

A booster shot of J&J’s vaccine was granted emergency use authorization (EUA) by the FDA last month for adults aged 18 and older and who have completed at least two months after the initial dose.

J&J’s single-dose COVID-19 vaccine generated sales of $766 million in the first nine months of 2021.

This year so far, J&J’s shares have risen 1.8% compared with an increase of 15% for the industry.

 

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Among other COVID vaccine makers, Canada has given full approval to Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna’s (MRNA - Free Report) COVID vaccines. While Pfizer/BioNTech’s Comirnaty is approved for people 5 years and older, Moderna’s vaccine is approved for use in individuals 12 years and older.

Pfizer/BioNTech’s Comirnaty is the only jab that enjoys a full approval from the FDA for the prevention of COVID-19 disease in individuals 16 years of age and older. Comirnaty continues to be available under EUA for individuals 12 through 15 years of age in the United States. It is also authorized for emergency/conditional use in several countries around the world

Moderna initiated a rolling submission of a formal biologics license application (BLA) to the FDA for its COVID-19 Vaccine, mRNA-1273 in June. Meanwhile, its vaccine remains available for emergency/conditional use in several countries. Moderna’s vaccine is authorized for use in adolescents in Europe, Canada and many more countries. A similar authorization in the United States is expected in January 2022. 

Last week, the FDA expanded the EUA of Pfizer/BioNTech and Moderna’s COVID vaccine boosters to allow its use in all adults. The FDA authorized a single booster shot of either the Moderna or Pfizer-BioNTech vaccine to all individuals 18 years of age and older after the completion of primary vaccination with either of the three approved/authorized COVID-19 vaccines made by J&J, Pfizer and Moderna. In September, the FDA had granted EUA to a booster dose of Pfizer/Moderna’s vaccines for individuals 65 years and older and those in high-risk groups but did not approve it for the entire population for which the companies were seeking approval.

J&J currently carries 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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