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“Experimental” no more: Full approval imminent for Pfizer vaccine

It’s astonishing, to be honest, that it has taken this long. And it is a perfectly valid criticism of the global health authorities that hundreds of millions of people have been injected, worldwide, with the Pfizer vaccine, and others like it, without the vaccine ever having been given full approval. That was an act of bet-hedging by the authorities that undermined confidence in the vaccine in a meaningful number of people, all in order to save face themselves if something went wrong. They were happy for you to take it, in other words, in the knowledge that if widespread disaster had followed, they could throw their hands up and say “well, we didn’t ever fully approve it, guv”.

Not any more, apparently:

The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning.

Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company. The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time.

An F.D.A. spokeswoman declined to comment.

The agency had recently set an unofficial deadline for approval of around Labor Day.

The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting final regulatory action before putting in effect mandates. Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.

The second part, in bold, is noteworthy, for a couple of reasons. It’s been something of a mainstay amongst vaccine-sceptical commentators to refer (with dubious accuracy) to the vaccines as “experimental vaccines”. They were never experimental. They were, however, under emergency use authorisation. Once this approval comes through, the Pfizer jab, at least, will no longer be an emergency medicine, or an “experimental” one. It will be a fully approved vaccine, on the same level as the flu vaccine, or the rubella vaccine.

Which deprives vaccine-sceptics of an important talking point. And, in fact, puts them in an invidious position: Having spent months arguing for vaccine hesitancy and alternative treatments on the basis that the covid vaccines are “experimental” and “not fully approved”, a subsection of that group will now find itself in the odd position of actually advocating for experimental, and not fully approved for Covid treatments, like Ivermectin, instead of the fully approved vaccine.

None of this will make any difference, of course, to the group of people who feel strongly and passionately that these vaccines are not for them. They will simply move on to another reason not to take them. There is, however, probably a small but meaningful number of people for whom this is very important: People who were wary, saw no real immediate benefit to themselves, and wanted to wait until the vaccines were fully approved before going for one themselves. My own decision to take the vaccine was in that knowledge, and appreciating the risks. Others made a perfectly rational decision to wait for the Government agencies to do their jobs before agreeing to take one. That’s not a thought process that anyone can criticise: These agencies have one job, and it is not unfair to expect them to do it.

But the “experimental” line cuts both ways, too, as the second bolded part in the excerpt above demonstrates. Once these vaccines are fully approved medical treatments which have passed all safety checks, the argument for making them mandatory becomes morally, and legally stronger (which, before anyone jumps on me, is not the same as “right”). It is one thing to refuse to take a treatment which has not been medically approved and declared fully safe. It’s a slightly weaker proposition when you are arguing against taking something which is approved and declared to be safe.

Vaccine Mandates are still wrong, obviously: There are hundreds and thousands of perfectly safe treatments which people should have a right to refuse. Making somebody’s employment conditional on receiving a medical treatment which is not strictly medically necessary for them is foul, and wrong. But that, ultimately, is not going to be how voters see it. As restrictions endure, and the hospitals remain relatively full, more and more attention is going to fall on those who have not been vaccinated. Politicians will be only too eager to blame them for their own illnesses, and, more pertinently, for the continued restrictions afflicting the double-jabbed majority. Whether they currently see it, or do not, the truth is that “anti-vaxxers” are on their way to being the least popular people in the western world, blamed for the endurance of a pandemic which they did not start.

If you are somebody who thinks the Irish public will blame NPHET and the Government for continued restrictions, and not people who have not been vaccinated, then you have not been paying attention. If you think that the Irish people will reject that analysis, and side with the vaccine-hesitant, then you might not have been living on the same planet.

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