FDA Approves First Phase III For HIV Vaccine

The first large-scale clinical trial of any HIV vaccine got a green light this month from the Food and Drug Administration. And VaxGen Inc. of South San Francisco, Calif., announced that it would begin almost immediately Phase III clinical trials of its bivalent gp120 vaccine. The approval did not come without VaxGen fighting criticism and negative speculation ( M. E. Watanabe, The Scientist, 12[12]:1, June 8, 1998, and The Scientist, 11[22]:1, Nov. 10, 1997). This concern was conveyed in an a

Myrna Watanabe
Jun 21, 1998

The first large-scale clinical trial of any HIV vaccine got a green light this month from the Food and Drug Administration. And VaxGen Inc. of South San Francisco, Calif., announced that it would begin almost immediately Phase III clinical trials of its bivalent gp120 vaccine.

The approval did not come without VaxGen fighting criticism and negative speculation ( M. E. Watanabe, The Scientist, 12[12]:1, June 8, 1998, and The Scientist, 11[22]:1, Nov. 10, 1997). This concern was conveyed in an article in The Wall Street Journal (R. T. King Jr., June 3, 1998, B1): "Some respected researchers have already dismissed Dr. Francis's [ Donald Francis, president of VaxGen] vaccine--called Aidsvax--as ineffective. ...[A] growing body of research indicates that protective immunity against HIV ... can't be won by a traditional vaccine alone."

But VaxGen's Francis points out to The Scientist, "Once the experts see the data, uniformly they have...

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