Regulators to Biden: Moderna isn't ready for the boosters yet

Regulators to Biden: Moderna isn't ready for the boosters yet
AP Photo/Rogelio V. Solis

We already discussed the political pressure being applied to scientists to meet Joe Biden’s arbitrary September 20th target for making COVID booster shots widely available. It was enough to cause a couple of them to resign. Yesterday, Allahpundit asked why the various players in the administration, the FDA and the CDC can’t seem to get on the same page for a policy that will potentially impact the health of hundreds of millions of people. Well, that 9/20 deadline was dealt another blow last night. FDA regulators have come out and said that it’s doubtful that Moderna can be approved for third shots by then. (NBC News)

U.S. regulators don’t expect to meet the Biden administration’s Sept. 20 timeline of making booster shots widely available to those who received the Moderna Covid vaccine, said a person familiar with the process.

Top health officials informed the White House they will need more time to review the Moderna application because the data the company submitted Sept. 1 was “found inadequate and needs strengthening,” the person said.

But officials believe regulators are still on track to make a decision on boosters for Pfizer’s vaccine by Sept. 20. The FDA has an advisory committee meeting scheduled to discuss the Pfizer boosters Sept. 17, the person said.

Right from the beginning of this process, Moderna has had a lot more trouble with its applications and paperwork than either Pfizer or Johnson & Johnson. And it sounds like their documentation of the trials for booster shots is no different. That means that if the federal government tells America that September 20 is the time to start signing up for boosters, millions of people either won’t be able to comply if they received Moderna originally or they’ll have to switch over to Pfizer.

Question number one: Has anyone completed thorough trials on patients switching vaccines? And if not, are they at least working on that? We’ve already seen reports of people lying about their initial shots in their desperation to go get a third one. If the entire country wasn’t being stampeded into a panic by the horrendous messaging campaign coming out of the White House, perhaps we could be approaching these questions in a bit more rational fashion.

Also, keep in mind that it really isn’t the CDC or the FDA that’s conducting these trials. It’s the pharmaceutical companies themselves in conjunction with medical providers around the world. The government just collects the data from them so they can determine what the policy should be.

Now let’s look at the second half of that announcement. You’ll note that it says federal regulators “believe regulators are still on track to make a decision on boosters for Pfizer’s vaccine” by the time they meet to discuss it on September 17. That’s three days before the White House deadline. You know what that means, right? Pfizer’s boosters haven’t even been approved yet. And yet everyone has a deadline looming in a little over two weeks that’s apparently in place because Joe Biden picked a date out of thin air.

Is any of this sounding familiar? When Joe Biden selected August 31st as the date we needed to be out of Afghanistan he was warned by defense and intelligence aides that it was probably too soon. But having publicly announced the date once, he was obviously terrified of missing the deadline for purely political reasons. We all saw what happened after that.

Is that how we’re going to handle the next phase of the vaccination rollout? Once Biden announces a date, that’s when we go and the science can be damned? If the pharmaceutical companies can’t make the date, then they can’t make the date. The results of the clinical trials are the only thing that should be determining the schedule. I’m no longer sure who is actually running the show over at 1600 Pennsylvania Avenue, but they need to pull their heads out of the sand and start practicing what they preach when it comes to “following the science.”

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