If all goes well, the first doses of a coronavirus vaccine might become available in early 2021.
But with this rushed timeline, how do we know its safe?
At an advisory panel meeting a few weeks ago, the FDA discussed all three.
The FDA has approved plenty of vaccines in its time, andguidelines for the process can be found here.
The FDA has laid out the specifics on what its looking for in a COVID-19 vaccine app inthis document.
Whichever vaccine we get, it will probably go through this process sooner or later.
So regulators are considering two other pathways that could make the vaccine available sooner.
It can also be rescinded if further research shows that the risks or harms outweigh benefits.
The FDA releasedguidelinesfor vaccine manufacturers with their criteria for granting an EUA.
Should they be told they got the placebo, and allowed to get the newly-authorized vaccine?
Or should they remain enrolled, so as to keep collecting placebo-controlled safety and efficacy data?
The potential benefits of the treatment still have to outweigh the potential risks.
Trust isnt just an issue from a vanity perspectivehonestly, who cares if the FDAs feelings are hurt?
Whats important is that if people think a vaccine isnt trustworthy, they wont want to get it.
And what good is a vaccine that nobody takes?
According to the FDA, their requirements for an EUA will be similar to those for full approval.
The difference will be in things like paperwork and factory inspections, not safety data.
The flu shot ranges from 30% to 60% effective depending on the year.
Regulators are currently planning multiple ways of monitoring vaccine recipients for safety issues.
Second, there is already a system called the Vaccine Adverse Event Reporting System, orVAERS.
Anyone can file a report if they think they were harmed by a vaccine.
(Regulators sometimes refer to VAERS as a hypothesis generating system since the reports in it arent necessarily verified.
Like VAERS, this system has been used for other vaccines, including the HPV and flu vaccines.
There are more plans, which you canread about here on the CDC website.
