First genetically engineered vaccine approved by FDA – a “new era for vaccine production”

Commercial production of the first genetically altered vaccine for humans was approved by the FDA on July 24, 1986, “opening what Federal officials called a new era for vaccine production.”

The new genetically engineered hepatitis B vaccine, “is to be marketed as Recombivax HB by Merck, Sharpe & Dohme” and avoids the use of human blood – a concern in an era of HIV. “Hepatatis B is often called ”serum hepatitis” because it is primarily transmitted through infected blood and blood components, as in blood transfusions or contaminated needles.” but can also be transmitted through infected saliva or semen.

“A milder and more common form of the disease, hepatitis A, is spread largely by contaminated food and water or personal contact.”