Food and Drug Administration team endorsed Johnson & JohnsonThe JNJ coronavirus single injection vaccine for emergency use on Wednesday, prompting JNJ shares to rise.
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The team report aims to inform the FDA Vaccine and Related Biological Products Advisory Committee, which will meet on Friday to discuss the J&J coronavirus vaccine. Advisory committees assess the merits and risks of some drugs. They then vote on whether to recommend their approval to the full FDA.
In the report, the FDA team said the J&J test results and safety data were “consistent with the recommendations set out in the FDA’s Vaccine Emergency Use Authorization Guideline to Prevent Covid-19”.
JNJ’s shares rose 1.3% to 162.59 in the stock market today.
JNJ stock rises in positive documents
If authorized, Johnson & Johnson’s coronavirus vaccine would follow dual injection regimens of Pfizer (PFE) with partner BioNTech (BNTX) and Modern (MRNA).
Likewise, the FDA team has endorsed Pfizer and Moderna’s coronavirus vaccines. The FDA authorized vaccines for emergency use the day after the advisory committee’s positive vote. The FDA does not have to follow the committee’s recommendations, but it usually does.
J&J says its vaccine is 66% effective overall in preventing symptomatic Covid-19. The vaccine was 72% effective in the USA, 66% in Latin America and 57% in South Africa.
The last point is optimistic for the JNJ stock, as a variant known as B.1.3.5 – first identified in South Africa – decreased the effectiveness of vaccines.
In addition, Johnson & Johnson said the vaccine prevented 100% of hospitalizations and deaths. There were seven deaths from Covid-19 infection among placebo recipients. Each of the placebo recipients also had conditions that placed them at high risk for severe Covid-19. And they were all in South Africa.
“Although a lower overall (efficacy) was observed in South Africa, where there was a predominance of the B.1.3.5 strain during the period of this study, the severe / critical vaccine (efficacy) against Covid-19 was similarly high across the United States, South Africa and Brazil, “said the FDA team.
No case of anaphylaxis
It is important to note that there were no cases of anaphylaxis, a severe allergic reaction. Following the authorization of the coronavirus vaccine from Pfizer and BioNTech in the UK, there have been several reports of anaphylaxis among healthcare professionals who received the vaccine.
The most common side effects of the J&J vaccine were headache and fatigue. The recipients also reported muscle pain, nausea and fever.
In Wednesday’s news, JNJ’s shares remained in a buying zone, according to MarketSmith.com. The shares surpassed a buying point by 155.57 off a flat base on December 30.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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