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FDA Advisors Mull When — Not Whom — To Offer J&J Covid Booster

Food and Drug Administration medical advisors unanimously endorsed a booster shot of Johnson & Johnson‘s (JNJ) Covid vaccine on Friday, helping JNJ stock to rise.




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The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-0 in favor of the booster dose at least two months following the first shot. The measure still has to pass muster at the full FDA. Then, it heads to the Centers for Disease Control and Prevention’s advisory committee.

Committee member Dr. Eric Rubin acknowledged many of the 15 million recipients of the J&J shot were dosed more than two months ago. But it “is going to be fine” receiving a booster dose later than two months, he said. Johnson & Johnson has said a booster dose at six months led to 94% protection against symptomatic moderate to severe Covid. But that was based on an analysis of just 17 people.

On the stock market today, JNJ stock inched up 0.7% to 161.30.

JNJ Stock: Mixing And Matching Shots

Despite a lengthy conversation, the committee held off on making a decision on whether to allow for mixing and matching vaccines — a process scientifically known as heterologous boosting. So far, discussion has been around homologous boosting — receiving a booster dose of the same product.

Early testing suggests there could be a benefit to following the J&J vaccine with a shot from Moderna (MRNA) or Pfizer (PFE). The latter two use a different means of vaccinating through messenger RNA. Johnson & Johnson’s vaccine relies on adenovirus technology.

Committee member Dr. Ofer Levy noted this is already happening.

“Many Americans are taking matters into their own hands” by going to different physicians or not disclosing their initial vaccination series,” he said. “We need to not hide from this.”

Other panelists noted mixing and matching could boost access to vaccines. Further, some people at risk of an allergic reaction or side effect might prefer a different booster. The J&J shot is tied to blood clots in young women — a fact that plagued JNJ stock earlier this year. Young men have experienced heart inflammation following messenger RNA shots.

Some argued for including language in the emergency use authorization to allow for mixing shots.

“But trying to parse it out with each combination, we’re going to be having (advisory committee) meetings for the next several months if we do this,” member Dr. Michael Kurilla said.

Committee Signs Off On J&J Booster

The J&J booster is the third to receive the advisory committee’s endorsement. Moderna’s won that favor on Thursday. Meanwhile, Pfizer’s BioNTech (BNTX)-partnered booster is already authorized. The boosters from J&J and Moderna now head to the Centers for Disease Control and Prevention, which has its own advisory committee.

The discussion surrounding Johnson & Johnson’s booster shot on Friday differed markedly from the discussion for Pfizer’s and Moderna’s shots. In the latter instances, officials opted to boost the elderly and people with higher risk due to preexisting conditions, workplace exposure or institutional living.

But the committee on Friday didn’t limit who should receive a J&J booster. They only said the second shot should be given no earlier than two months after the first.

Dr. Hayley Gans, another committee member, noted the J&J booster will bring recipients up to the protection level seen in recipients of the two-dose Moderna and Pfizer vaccines. Dr. Cohn said the J&J vaccine is “not equivalent” in effectiveness to the two messenger RNA vaccines, especially when considering the booster question.

In a briefing document posted ahead of the meeting, the FDA acknowledged that the J&J shot has consistently underperformed the vaccines from Pfizer and Moderna. But all three still offer strong protection against severe disease. This is key to ensuring hospitals don’t become overrun.

Forming A Flat Base

Now, the J&J matter has to pass the full FDA and the CDC. The latter agency has its own advisory committee.

JNJ stock is forming a flat base with a buy point at 180.02, according to MarketSmith.com. But shares still remain well below their 50-day and 200-day moving averages.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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