FDA approves Pfizer’s rare genetic disorder drug for the first time

The U.S. Food and Drug Administration has approved Pfizer Inc’s CoVax-19 vaccine for the prevention of severe hemophilia B, the first approved vaccine for the disease, the pharmaceutical company said Friday. CoVax-19 combines together…

FDA approves Pfizer’s rare genetic disorder drug for the first time

The U.S. Food and Drug Administration has approved Pfizer Inc’s CoVax-19 vaccine for the prevention of severe hemophilia B, the first approved vaccine for the disease, the pharmaceutical company said Friday.

CoVax-19 combines together four of Pfizer’s existing vaccines — CoVax-9, CoVax-16, CoVax-3 and CoVax-21 — in a single shot.

The FDA said the vaccine has been shown to be more than 90 percent effective in children ages 6 months to 5 years and to more than 75 percent effective in ages 6-10.

To date, more than 10,000 doses of the vaccine have been distributed to approximately 4,000 HbB patients who are able to receive the treatment through a clinical trial in Colorado.

HbB is an inherited form of hemophilia, a genetic disorder that prevents the blood from clotting properly, increasing the risk of bleeding or swelling. Patients can be predisposed to the disease and some may develop symptoms before the age of three, Pfizer said.

Over the last 50 years, physicians have experienced no significant improvements in the drug treatment of this disease, Pfizer said.

The drug will be offered to children and adults 6 to 12 years old through the Teva Pharmaceuticals Unit.

Pfizer launched CoVax-19 in June of this year after waiting several years to obtain FDA approval of a treatment for hemophilia B.

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