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J&J (JNJ) Updates COVID Jab Label to Include Blood Clot Risk

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Johnson & Johnson’s (JNJ - Free Report) has updated the label of its COVID-19 vaccine to mention the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare syndrome characterized by blood clots and low platelet count.

J&J’s decision to update its label came on the heels of the FDA’s announcement on May 5 to limit the authorized use of its vaccine due to the risk of TTS. The FDA limited the use of J&J’s vaccine to adults (18 and older) for whom other COVID-19 vaccines are not accessible or clinically appropriate or those who choose to get J&J’s vaccine because they would otherwise not get jabbed. The FDA said the symptoms of TTS are visible approximately one to two weeks following administration.

A similar recommendation was also issued by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) in December last year. The committee recommended that Pfizer (PFE - Free Report) /BioNTech’s (BNTX - Free Report) and Moderna’s (MRNA - Free Report) mRNA vaccine should be preferred over J&J’s COVID-19 vaccine, which is an adenovirus-based vaccine, both for primary vaccination as well as boosters due to the risk of TTS.

J&J’s vaccine has faced concerns over blood clots since last year. In April last year, the FDA and CDC jointly recommended a temporary pause in the use of J&J’s vaccine in the United States as rare and severe blood clots accompanied by low levels of blood platelets were identified in some individuals who received the vaccine. Back then, the European Medicines Agency (“EMA”) safety committee had also conducted a review to assess reports of blood clots in a few individuals who had taken the vaccine. 

J&J’s single-shot COVID-19 vaccine was approved for emergency/conditional use in some countries in 2021. A booster shot of the vaccine was authorized for all adults in October 2021. The COVID-19 vaccine generated sales of around $2.4 billion in 2021 and $457 million in the first quarter for J&J.

This year so far, J&J’s shares have risen 3.7%, in line with the industry.

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The mRNA-based vaccines of Pfizer/BioNTech and Moderna have witnessed considerable success.

Pfizer/BioNTech’s Comirnaty is approved for emergency/temporary in several countries worldwide and fully approved in the United States. The vaccine was approved for younger patients (5-17 years) while a booster vaccine dose was also authorized in the United States in 2021. A second booster dose was authorized by the FDA in March 2022. Pfizer and BioNTech are also working on a new Omicron-based vaccine candidate and a bivalent COVID-19 vaccine candidate.

For Pfizer, direct sales and alliance revenues from Comirnaty were $13.23 billion in the first quarter of 2022. Pfizer expects $32 billion in revenues from Comirnaty in 2022

Moderna’s Spikevax is also authorized for use in adults in multiple countries. The vaccine is also fully approved for use in adults in the United States. The vaccine is authorized for use in adolescents and in kids in Europe and some other countries. Two booster doses of Moderna’s vaccine are authorized in the United States. Spikevax generated $5.93 billion in revenues for Moderna in the first quarter of 2022 and the company expects revenues of $21 billion from the vaccine in 2022.

Moderna is also developing an Omicron-specific booster dose and a bivalent booster candidate for better efficacy and durability of protection than the authorized booster dose.

Zacks Rank and Stocks to Consider

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.

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