According to the linked in the article, the restriction is a requirement to revise the warnings
WASHINGTON (AP) — The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.
In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients.
I don’t see any indication that the vaccines are not approved other than that the accompanying documentation must be changed. The companies have now had several months to make the required changes.
The linked article suggests that the conduct of the FDA and resulting requirement to change the documentation was inappropriate. But there is no restriction other than the requirement to update the documentation. Or am I missing something in the article?
Thanks. I see that is in the linked article. My mistake was to read the article linked in the first paragraph: with the link text ‘restricted the approval’, thinking that was the details of the restriction.