FDA Report Approves New COVID Vaccine, But Not Fully Approved Yet
The United States Food & Drug Administration has been the most difficult hurdle for COVID-19 vaccines over the last year. While most of the Federal Government was helping to facilitate the creation of safe and effective vaccines, the FDA has been obstructionists.
Over the process of approving the first two COVID-19 vaccines, from Pfizer and Moderna, the FDA delayed the approvals for weeks. Pfizer filed for approval on November 20th, but didn't see official approval from the FDA until mid-December. Moderna had to wait more than two weeks to see approval from the FDA on their vaccine as well.
Both of these vaccines had peer-reviewed studies that accompanied their data when it was sent to the FDA. Even with that data, the FDA still delayed the vaccines by nearly a month. Which is much different than the United Kingdom, who's regulatory body was working with the pharmaceutical companies in real time to approve vaccines much faster than the US.
Now we have another example of how poorly the FDA has been addressing the COVID-19 vaccines. The latest vaccine from Johnson & Johnson (J&J) has multiple advantages over the two existing vaccines. Including the fact that the J&J vaccine is a single-shot dose (instead of the two-shot doses from the other approved vaccines), its easier to store, and is easier to transport.
But with all of the need for the J&J vaccine, the FDA announced right away that they would delay approval on this new vaccine by 22 days. Even with all of the peer-reviewed data, the FDA decided to delay this approval for almost a month.
Today, the FDA staff announced that the peer-reviewed data (that wasn't important enough to look at weeks ago) is good to go, and that the vaccine should be approved. However that doesn't mean the J&J vaccine is approved by the FDA yet. There's still a hearing that they will require on Friday.
With the FDA staff approval, now the public has to wait on the panel approval. If that comes on Friday, the vaccine could start being administered in the United States next week.