New COVID-19 booser shots are scheduled to be released by Joe Biden’s Food and Drug Administration (FDA) several months before human trials are completed.
The FDA predicted to approve the controversial vaccine boosters without completed trials on humans, accepting instead data from testing the new booster on mice. That means the approval will come “without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.”
FDA head Robert Califf posted a statement on the agency’s Twitter account explaining how the decision is likely to be made on granting emergency use authorization (EUA) to pharmaceutical giants Pfizer and Moderna.
Califf said the FDA would go with the “totality of the available evidence” that would include data from previously approved vaccines along with “clinical and non-clinical data.”
He added that the FDA believes the boosters will be safe because “real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe.”
Califf went on to explain that the FDA will not hold a meeting about the new booster, in that the agency “feels confident” about the discussions that have been held in prior months.
Pfizer and Moderna have reportedly begun some human trials of the new boosters, but they are not expected to be completed until sometime in the spring of 2023.
The departure from common scientific testing standards when the Biden administration’s goal seems to be winning the public’s trust is counterproductive, but Biden seems to be going about most of his policies in the most ineffective way possible — why not carry on that strategy here?