COVID-19 vaccine developers to pledge against rolling out shots prematurely
In light of the havoc wreaked by COVID-19, governments around the world have become more than willing to fast-track regulatory approvals and launch promising vaccines, anti-virals, and tests for their citizens. Russia has already cleared a two-month-tested vaccine as part of this push, but US's top vaccine makers have no plan to rush their shots without being completely sure about their working. Here's more.
Pledge to confirm safety and efficacy before approvals
According to a report in The Wall Street Journal, leading pharma companies engaged in COVID-19 vaccine development are preparing a 'joint safety pledge.' Under this, they plan to release a joint statement promising the world that they will not apply for regulatory approvals from their governments until the safety and efficacy elements of their shots are firmly established.
Pfizer, Moderna to sign the statement
The companies will also emphasize in the pledge that they will stick to the highest scientific and ethical standards to make sure that the testing and manufacturing of the vaccines is not affected. The Journal's sources say that the statement is still being prepared and could be released next week with at least three prominent companies on board: Pfizer, Moderna, and Johnson & Johnson.
US appears to be prepping for premature approvals
The report of the pledge comes as there have been widespread concerns that the Trump administration wants to have the vaccine ready before the November 3 elections and might give approvals even without complete data on safety/efficacy. Both Moderna and Pfizer are expected to share the interim results of their vaccines' late-stage trials next month, while the full data should be released by December.
Will consider approval before Phase-3 completion: FDA
That said, despite the timelines involved, the US government clearly appears to be gearing up to grant approvals. The Food and Drug Administration (FDA) has already said that it will consider vaccines for emergency use authorization before the completion of the Phase-3 trials, while simultaneously the US CDC has asked states to allow necessary permissions for vaccine distribution by November 1.
