Biden administration wants NO vaccine development standards? Why? What is going on? Biden admin allocates $5 billion for new COVID vaccines with little manufacturing guidance
by Paul Alexander
The initiative, known as Project NextGen, has left manufacturers confused about whether they are even eligible for funding. pharmaceutical manufacturers are not receiving guidance about standards
‘The Biden administration is issuing grants from a $5 billion program to expedite the next generation of COVID-19 vaccines, but pharmaceutical manufacturers are not receiving guidance about vaccine standards as the development process returns to its normally slower pace.’
For example, the Pennsylvania-based company Ocugen, which is developing an inhaled vaccine, said it was unable to receive guidance about whether it was eligible for the funding. The company said its vaccine may not have undergone enough advanced testing to qualify for the grants.
"Everyone is clamoring for clarity," University of Washington biochemist Neil King said.
Food and Drug Administration spokesman Michael Felberbaum said that the agency plans on publishing guidance within the next few months. "The agency is committed to remaining flexible in its approach to the data," he said.