Pfizer Wants FDA to Approve Its Vaccine for Lyme Disease — But Does It Have a Shot?

by Brenda Baletti, Ph.D.

Pfizer said Monday that it plans to submit its experimental Lyme disease vaccine to the U.S. Food and Drug Administration (FDA) for approval, even though the drug failed to show conclusively that it was effective at preventing the disease.

Pfizer and its partner, French biotech company Valneva, said in a press release that late-stage trial results for the vaccine showed more than 70% efficacy in preventing infection.

However, they also said the drug failed to meet its primary endpoint — a standard clinical trial benchmark set in advance to determine whether a treatment is effective — to show that the efficacy claim was statistically robust.

Although the drug failed to meet the company’s own statistical cutoff for success, Pfizer said it plans to go ahead and submit the vaccine to the FDA because the results are “clinically meaningful,” and the company is “confident in the vaccine’s potential.”

Critics argue that redefining success after the drug failed the trial raises red flags…

READ FULL ARTICLE HERE… (childrenshealthdefense.org)

 

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