Why AstraZeneca and J&J’s Vaccines, In Use Elsewhere, Are Still on Hold in America
By Sarah Jane Tribble
The World Health Organization greenlighted emergency use of AstraZeneca and Oxford’s covid-19 vaccine this month, following in the steps of the United Kingdom, the European Union and others, who are already injecting it as quickly as possible into the masses.
But the United States is still waiting. . .
. . .
This moment — as Americans question why more tested vaccines like AstraZeneca and J&J’s vaccines aren’t approved — punctuates how the FDA’s drug approval process, honed over decades, is independent of other global agencies. Dr. Henry Miller, a senior fellow at the Pacific Research Institute who was the founding director of the FDA’s office of biotechnology, said it’s difficult to compare international vaccine development.
“It’s not like a footrace where everyone begins together,” he said. “From country to country, there are a lot of variables.”
Some are trivial, such as different application processes and whether the companies completed the forms properly. Others are more substantial — while many countries depend on academics on contract, the U.S. relies on full-time staffers who spend their careers focused on drug development, Miller said. . .