What's the upshot of FDA's new covid shot policy
By Lisa Jarvis / Bloomberg Opinion
When news broke that the Food and Drug Administration was rolling out a new plan for covid vaccine approvals, my phone instantly started buzzing. Friends, family members and colleagues all had the same question: Does this mean I can’t get a fall booster?
I wish I had a straightforward answer for them.
Despite an explanation of the new strategy published Tuesday from FDA Commissioner Marty Makary and Vinay Prasad, who oversees vaccines at the agency, public health experts were left guessing about basic details such as how it will affect access to covid shots. Do healthy people have a choice or not? What is the status of shots for kids? For an agency that has vowed to build the public’s trust by offering transparency and an open dialogue, it was a frustrating start.
Here’s what we know: The FDA is adopting a risk-based strategy for approving new covid vaccines that will limit their use to people 65 and older or anyone with a health condition that puts them at risk for severe disease; a group Prasad and Makary estimate accounts for about 100 million Americans. The new policy keeps the current standards for greenlighting vaccines, meaning pharmaceutical companies need only to produce data showing theirs prompts people to produce antibodies against the virus.
https://www.heraldnet.com/opinion/comment-whats-the-upshot-of-fdas-new-covid-shot-policy/