Thread by @michaelzlin

FDA #VRBPAC meeting on Novavax is today. We'll see soon enough but the single voting question looks like a softball, simply whether benefits outweigh risks. Since there's benefit similar to RNA with lower risks, should be an easy yes.

Wouldn't be surprised if there were a few myocarditis cases here, but there could be ascertainment bias, and the rate is already much lower than RNA, so the benefit/risk ratio is better. Novavax stated that the rate is 0.007% vs 0.005%, barely different

ir.novavax.com/Novavax-Statem…

Meaning barely different between 0.007% vaxxed vs 0.005% placebo. This appears similar to the risk with Pfizer (HR = 1.34x vs unvaccinated, mixed population) and lower than Moderna (HR = 3.9x). People still get to choose between these per their preference.
bmj.com/content/375/bm…

#VRBPAC voted: 21 yes on the question of Novavax benefits outweighing risks. 0 no.

Pretty obvious and should have had that in December.

https://twitter.com/anitamulero/status/1534255901565231108?t=fL3nCvjwHQyaB3ulg9G7Eg&s=19

RNA vax will finally have competition in the US where eventually the flu+sarscov2 mixed shot sounds very useful. Outside US, Novavax only requires refrigeration like AZ but doesn't cause VITT unlike AZ. Now they have to show they can make and test variant boosters quickly.

It seems manufacturing issues caused both the 6-mo delay in Novavax filing (12/2021 rather than 6/2021) and the 6-mo FDA review. FDA said it was a complex app. As clinical and immunological datasets were smaller than for other vaxxes, the complexity was clearly in manufacturing.

FDA clearly has manufacturing documentation requirements that no other country has, since Novavax has been approved everywhere else with just a few weeks of review. But Novavax at least could have saved themselves 6mo prior to submission, ironically by simply doing less.

In 2020, Novavax set up plants in the US, UK, and Europe, but my impression is those were essentially a big waste and ended up delaying the app. Novavax continued claiming they would useful throughout 2021, but then every application used either India's SII or Korea's SKBio.

Novavax refused to answer who would supply US doses, but it was only after their FDA application on 12/31/2021, delayed 6 months, that they revealed SII to be the supplier again. It's still not clear to me why they couldn't have applied in 7/2021 with SII as the supplier.

Were they thinking costs would be lower from their other factories (seems unlikely)? Did they committ SII batches to other countries/entities and couldn't use them until some orders were cancelled? Perhaps people with better knowledge of the situation can chime in.