Biden admin allocates $5 billion for new COVID vaccines with little manufacturing guidance
The initiative, known as Project NextGen, has left manufacturers confused about whether they are even eligible for funding.
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.
Project NextGen dwarfs Operation Warp Speed, its $18 billion 2020 predecessor that hastened COVID vaccine development. The latest project, launched with COVID deaths at their lowest level, does not have Warp Speed's funding nor authority.
Health and Human Services Secretary Xavier Becerra in May lamented the lack of funding allocated to NextGen unlike the vast amount given to Warp Speed.
"We’ve got some really innovative approaches and therapies in the works," Becerra also said, according to Politico.