Coronavirus

Why hasn't the FDA officially approved the coronavirus vaccines?

All current covid-19 vaccines are currently listed for 'emergency use,' the FDA hasn't yet fully approved a single one.

0
Why hasn't the FDA officially approved the coronavirus vaccines?
Javier Torres AFP

What's the difference?

Due to the covid-19 pandemic, a US public health emergency was announced. This allowed the FDA to authorise emergency use of new drugs, treatments and vaccines without having to go through the full approval process.

That's not to say the vaccines are unsafe, there is still a rigorous testing procedure that is carried out. For emergency authorization, the FDA requires two months of safety data versus six months for full approval for the currrent vaccines in circulation.

How do vaccines usually get fully approved?

Usually the process takes up to ten months before a vaccine is fully approved. However, both Pfzier and Moderna have applied for special consideration for a "serious and unmet medical need." Even with this qualifier, the process could take up to six months. For Moderna, this means that their vaccine could be fully approved at the turn of the new year. The Pfizer vaccine is expected to receive full FDA approval by labor day at the latest due to the rapid increase of Delta variant cases.

Why is it taking so long?

Apart from consideration for if fully approved drugs do their job, there are also political and financial barriers to traverse. Former President Donald Trump heavily criticised the organisation and there have been doubts, and an ongoing investigation, surrounding the approval of an Alzeihmer's drug called Aduhelm.

If it were proved in the future that there were serious side-effects to the covid-19 vaccines and the FDA had fully approved them, there were be huge financial and legal repercussions for the organisation and the US government. It's simply a risk they won't take.

Does it matter?

In the short term it doesn't really. As long as people are taking up the vaccine then it makes no material difference whether a vaccine has been fully approved or not.

However, there has been some recent polling which could indicate that one of the primary reasons people are hesitant to take up the vaccine is because they are not fully approved.

This issue may need to be addressed, but there are work-arounds. With other factors, such as a restriction on the ability to fly, included, a stick-over-carrot policy could be beneficial to pick up the stalling vaccination rate. Currently the attempt to increase the vaccination rate includes a $100 thank you gift.