FDA to require more data from COVID-19 vaccine companies before granting emergency approval
TAMPA, Fla. - Scientists and drug makers are moving quickly to develop a COVID-19 vaccine.
Vaccine development typically takes years, but the government has invested billions to accelerate the process and help multiple drug makers prepare multiple candidates.
Tuesday, the Food and Drug Administration (FDA) laid out updated safety standards for the makers of potential vaccines to make sure the companies take the necessary amount of time to ensure safety and effectiveness.
The FDA says those trials need to follow participants for at least two months before the vaccine makers seek emergency approval.
“We knew the sequence of the virus in January and we’re gonna have a product by the end of the year,” said Dr. Michael Teng with USF Health. “I mean, that’s incredibly fast.”
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The FDA's revised guidelines say vaccine producers should collect information and data from at least half of their trial participants for two months after the last dose of the vaccine is administered.
The agency wants to ensure there are no major side effects or health problems.
“It’s a biologic that you're actually putting into a healthy person, so the most important thing is safety, you want to make sure that it’s safe,” Teng said.
In a statement, the FDA said, in part, “In addition to outlining our expectation for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety, and efficacy for any vaccine that is authorized or approved.”
To meet the FDA’s threshold, a company likely will not be approved for emergency use authorization until at least mid-November or December.
“I think it’s a good thing that they’re sticking by their guns and this seems like a reasonable balance between speed and safety,” said Teng.
Vaccines that receive emergency authorization will likely be reserved for healthcare workers and people at higher risk for contracting COVID-19. Full FDA approval for the public requires more data and is not expected until mid-2021.