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FDA Sees Covid Shots For Kids ‘In The Coming Months,’ But Stocks Stumble

Vaccine stocks fell Friday after the Food and Drug Administration said it expects to authorize Covid shots for children “in the coming months.”




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Before the FDA can authorize vaccines for children, vaccine makers must finish their clinical tests and analyze the results. Then, advisory committees with the FDA and Centers for Disease Control and Prevention will likely meet to discuss the benefits and risks.

Acting FDA Commissioner Janet Woodcock and Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation, cautioned against vaccinating children with already approved or authorized Covid shots from Pfizer (PFE)-BioNTech (BNTX), Moderna (MRNA) or Johnson & Johnson (JNJ).

“It’s important for the public to recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical (studies) of adequate size are completed to evaluate the safety and immune response to a Covid-19 vaccine in this population,” they said in a written statement.

On today’s stock market, BioNTech lost 0.6%, closing at 349.19. Moderna stock fell 1.4% to 449.38. Pfizer stock dipped 1% to 45.59. J&J shares slipped 0.7% to 166.97.

Vaccine Stocks Dip Despite FDA Pledge

The FDA acknowledged the challenge of returning children to school while Covid vaccines are only currently allowed for people ages 12 and older.

Vaccine manufacturers have reported clinical studies of children are underway.

In the U.S., Pfizer’s vaccine is authorized in children beginning at age 12. It has full FDA approval for people ages 16 and up.

Pfizer Chief Executive Albert Bourla said on the July 28 earnings conference call that the company expects to have test results for children in September. Pfizer is testing its shot in children ages 6 months to 2 years, 2-5 years and 5-11 years. That day, the vaccine stock rose 3.2%.

In its R&D Day news release on Thursday, Moderna said its study in children ages 6 months to 11 years old is ongoing. The company has already selected a dose for expanded enrollment in the 6-12 age group. It still hasn’t selected a dose for children ages 6 months to 2 years and ages 2-6. Moderna has already asked for authorization in teens ages 12-17. The shot is currently allowed only in adults. Moderna stock popped 7.8% after its R&D Day.

Johnson & Johnson said in an April news release that it’s testing the single-shot vaccine in teens ages 16-17.

Moderna, BioNTech Restart

Vaccine stocks pulled back in August, though Moderna stock is making a fresh run higher. The White House’s Covid task force set a goal of beginning booster shots for people eight months out from their second dose of the Pfizer-BioNTech or Moderna vaccines on Sept. 20.

The FDA’s vaccines advisory committee will meet Sept. 17 to discuss the Pfizer-BioNTech shot. The committee could convene shortly after to discuss the Moderna vaccine.

This month, Moderna stock has ramped up more than 19%. Vaccine stock BioNTech has ticked north of 6%. Johnson & Johnson and Pfizer shares continued falls that began in August.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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