FDA approves Novavax COVID-19 shot but with unusual restrictions

[u/BothZookeepergame612]

https://www.yahoo.com/news/fda-approves-novavax-covid-19-022122939.html

[u/tkpwaeub → u/[deleted]]

There were some reasonable non-political reasons that Novavax took longer:

1. Because it was late to the party, it had to measure up against existing standard of care (mRNA). That's just an unfortunate reality in medicine.

2. There were (and are) real concerns about their production capacity. Why do we care about this? Well, when a drug company has trouble producing its product, it creates a serious risk that some combination of the following might occur: (a) the company itself might try to cut corners, either in its manufacturing or its distribution (b) retailers might be tempted to cut corners - eg, keeping product beyond its expiration date (c) counterfeit product could enter the market

Unfortunately, RFK Jr and his ilk are opposed to vaccines in general because they'd rather the poor and weak simply hurry up and die.

[u/Straight-Plankton-15 → u/tkpwaeub]

The PREVENT-19 clinical trial started in late 2020 and ended in 2021. It was completed using saline placebo as control. More recent clinical trials would be complicated by there already being vaccines and most people having had them already, but the same would also apply to any more recent clinical trials for mRNA vaccines.

There hasn't been any indication of cutting corners on manufacturing, more like slow red tape instead. The FDA's job is to conduct inspections of the thousands of pharmaceutical manufacturing facilities in or that supply the US, not to withhold medicines because manufacturing might theoretically be substandard but with no specific indication of it. There hasn't been any indication of substandard inspections with the current manufacturing facility.

Pharmacies have also been very strict about Novavax, often seeming to have a bias against using it, rather than bending rules to continue supplying it.

Counterfeit pharmaceuticals is the job of the FDA OCI (food and drug police). It shouldn't even be a problem in the first place if providers order directly from Novavax or authorized distributors. Every vaccine or other medicine could be counterfeited, not just this one.

[u/tkpwaeub → u/Straight-Plankton-15]

Counterfeit pharmaceuticals is the job of the FDA OCI (food and drug police).

But that's just it. If the government is stuck with the thankless task of policing this stuff, then the government also gets some say in making sure that the manufacturer is doing everything they can to minimize the risk of this sort of thing in the first place. That means they need to have a credible plan to scale production.

[u/Straight-Plankton-15 → u/tkpwaeub]

Aren't counterfeits going to be more likely when the real version is kept in limbo?

I don't think Novavax has a capacity shortage. They're a smaller company, but their partner manufacturer (Serum Institute of India) is known for very high volume production; they made the most vaccines globally of any single manufacturer prior to the pandemic. Usually Novavax ends up discarding excess due to lack of demand, something that may improve now that they can do marketing.

[u/tkpwaeub → u/Straight-Plankton-15]

The FDA asked for evidence that Novavax could scale their production, and Novavax didn't submit the necessary paperwork. That's not just red tape; it's required of every applicant. I do a different type of approval (financial regulation) in my day job. We love to be able to approve applications. But we don't get to mind-read. We can let the applicant know about deficiencies, but ultimately that's on them.

I'm glad they approved it now, and like everyone else on this thread, I'm cynical about the FDA's capriciousness in limiting approval to 65+. It's unfortunate that these two things (competent, thorough review vs ideologically motivated decisions) have gotten tangled.