The US Federal Government has told states to prepare for a coronavirus vaccine which will be ready for distribution by November 1. Until now, the timeline had raised concern among public health experts about an “October surprise” – a vaccine approval driven by political considerations ahead of a presidential election, rather than science. The health officials have been asked to work out now which groups to prioritize for a vaccine, identify providers who will administer the vaccine, and take other steps. The vaccines are in two doses, and each is given a month apart. Experts, however, told the leading media newswire that they did not understand how there could be adequate data on whether the vaccines work and are safe before November 1.
FDA Commissioner Stephen Hahn had previously said the agency wouldn’t cut corners in evaluating vaccines, though it would aim to expedite its work. But he told the Financial Times this week that it might be “appropriate” to approve a vaccine before clinical trials were complete if the benefits outweighed the risks. But there are skeptics like Ashish Jha, dean of Brown University’s public health school. He says that unlike a therapeutic that is given to sick people who may have no alternative, a vaccine is given to healthy people, “so you have a much higher burden of proof.”
