Federal health advisers recommended Tuesday that the government approve the first bird flu vaccine as a stopgap measure, despite evidence it wouldn’t protect most people.
In separate votes, the outside panel said the vaccine was both safe and effective. A vaccine must meet both standards to win FDA approval. The votes came after Food and Drug Administration officials said the Sanofi Aventis SA vaccine still could play an important role in protecting against the increased likelihood of a pandemic, despite its limited effectiveness.
“I am of the view that anything is better than nothing,” said panel member Dr. Robert Couch, of Baylor College of Medicine in Houston, prior to the vote.
In a clinical trial, the two-shot series appears to provide protection to just 45 percent of adults who received the highest dose. An earlier, interim analysis of the same study had suggested it prompted a protective immune response in 54 percent of patients, when measured 28 days after getting the second of two shots. The FDA said it would like to see a response in at least 70 percent of those vaccinated against bird flu.
“The more antibodies, the better. But even at lower levels, there is a possibility of protection,” Goodman told reporters on the sidelines of the meeting..
Well, I’d take a 45% shot at a response over zero. For now.