As several SARS-CoV-2 vaccine candidates approach the end of their respective final phase trials, there is a growing concern over their overall safety. As such, regulators such as the United States Food and Drug Administration has expressed an intent to enforce a more rigorous approval process. However, the proposal has been shot down by White House officials. Given there were no alarming results reported over the course of several clinical testing stages, there appears to be no reason to justify the change.
Amid the health crisis, there have been adjustments made to help biotech companies develop treatments or inoculations against COVID-19 in a shorter amount of time. Normally, the process would take years, but scientists have attempted to innovate certain aspects that would reduce the length it normally takes from pre-clinical to manufacturing and distribution. Meanwhile, the U.S. government's Operation Warp Speed initiative was instrumental the entire time.
What the FDA suggested involves an extended period of observation of at least two months for trial participants. This will supposedly allow researchers to verify if the vaccine provides long-term protection against the 2019 novel coronavirus. Moreover, they would be able to observe if any of the volunteers develop any side effects moving forward. Jabs that meet the previous criteria would then be approved for emergency use, reports The New York Times.
According to a representative from the White House, these are unnecessary and there is "no clinical or medical reason" to do so. FDA Commissioner Stephen Hahn, on the other hand, does not agree with the decision made by politicians. Instead, he believes it should be those in the scientific and medical field who should have the final word regarding these types of decisions.
"Science will guide our decisions. FDA will not permit any pressure from anyone to change that," he stated. "I will put the interest of the American people above anything else." It seems the Trump administration views the extension request as politically motivated after a spokesperson hinted before that a vaccine might possibly be available before next month's polls. Nevertheless, sources claim the White House intends to help pharmaceutical firms deliver a safe and effective COVID-19 vaccine as soon as possible.