FDA

Trial Updates: Novavax Approved, Potatoes Work

James Bailey1 Comment

I’m usually the one writing the papers, but I recently did two studies as a participant / guinea pig. Both just released major positive updates.

I joined the Novavax trial in late 2020 to have the chance to get a Covid vaccine sooner; at the time Pfizer had just got emergency approval but wasn’t available to the general public. The smart bio people on Twitter also seemed to think it was likely to be safer, and perhaps more effective, than other Covid vaccines (it delivers relevant proteins directly, rather than using mRNA or a viral vector). The trial results were published over a year ago now, and were in fact excellent:

Results from a Phase 3 clinical trial enrolling 29,960 adult volunteers in the United States and Mexico show that the investigational vaccine known as NVX-CoV2373 demonstrated 90.4% efficacy in preventing symptomatic COVID-19 disease. The candidate showed 100% protection against moderate and severe disease

As usual the FDA dragged its feet, even as other agencies around the world like the European Medical Agency and the World Health Organization approved the US-made Novavax. But last week it finally gave emergency authorization, and yesterday the CDC recommended Novavax. Of course, by now almost everyone who wants a Covid vaccine has one, and this approval is only for adults. But this will be a great option for boosters, as well as for anyone who was genuinely just concerned with the new technologies in the other vaccines (rather than just afraid of needles, or preferring to cut off their nose to spite authority’s face). As the CDC put it:

Protein subunit vaccines package harmless proteins of the COVID-19 virus alongside another ingredient called an adjuvant that helps the immune system respond to the virus in the future. Vaccines using protein subunits have been used for more than 30 years in the United States, beginning with the first licensed hepatitis B vaccine. Other protein subunit vaccines used in the United States today include those to protect against influenza and whooping cough….

Today, we have expanded the options available to adults in the U.S. by recommending another safe and effective COVID-19 vaccine. If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated

I’m glad I was in this trial- I got a Covid vaccine several months before I otherwise could have, I made a few hundred dollars, and I learned a lot. But it would have been much better if they found a way to do fewer blood draws, and if FDA approval had come quicker. I’ve been in a weird gray area with respect to vaccine mandates for the last year; almost everyone ended up accepting my vaccine card, but I never knew if they were going to say “no, you need an FDA approved one”. I ended up getting Pfizer for a booster even though I think it’s a worse vaccine, partly for this reason, and partly because Novavax said they’d only give me the booster if I did another blood draw and I was tired of that.

The all-potato diet trial I wrote about here also released its results this week. This trial was much less formal, much smaller, and had no control group, so the results aren’t a slam-dunk the way Novavax is. But I think they’re still impressive. I lost 8 pounds in the 4-week trial, but it turns out the average participant who did all 4 weeks did even better:

Of the participants who made it four weeks, one lost 0 lbs…. Everyone else lost more than that. The mean amount lost was 10.6 lbs, and the median was 10.0 lbs.

Their summary also explains other costs and benefits of the diet, showing lots of data as well as many quotes from participants, including two from me. They conclude with some fascinating speculation about potential mechanisms from the boring (literally, lower variety makes eating boring so you eat less) to the speculative (low lithium? high potassium? weird lithium-potassium interactions), check it out if you’re interested in why obesity rates keep rising or if you’re considering doing the potato diet.

I’m glad I was in these two trials- what to try next?

Institutions Getting Smarter on Covid

James BaileyLeave a comment

Two weeks ago I argued for 4 non-coercive anti-Covid policies I thought were under-rated. I haven’t generally been impressed by the institutional response to the pandemic, and so I wasn’t expecting the policies I mentioned to get traction any time soon. But some did!

I argued for:

  1. Full vaccine approval
  2. Emergency vaccine approval for children
  3. Ventilation
  4. Outpatient treatments that work

Since then, the big news is that the FDA fully approved the Pfizer vaccine. This seems to have increased the pace of new vaccinations.

I really wasn’t expecting the FDA to move that fast- they have generally learned to be slow because Congress has been much more likely to complain about them approving a bad drug than about them denying or slow-walking a good drug. But Congress itself seems to be changing in response to Covid, with 108 House members pushing the FDA for a timeline on approving vaccines for 5 to 11 year-olds.

I don’t know of a good way to gauge progress on ventilation overall, but I was pleased to see HEPA filters show up in the classrooms at Providence College:

Likewise, I don’t know if Fluvoxamine prescriptions are up in the weeks since a good sized study showed it reduced Covid hospitalizations 31%, but the popular press articles about it keep coming (don’t be deterred by “Vox”, the linked article is by Kelsey Piper and its excellent).

So some institutions seem to be getting smarter, and perhaps coincidentally, we seem to be at the peak of the Delta wave. According to Covidestim.org, Rt is now below 1 in 31 states, and falling in 45 states, including all of the Southern states hit hardest by Delta. Barring a new twist (another worse variant? Winter Delta wave in the North?), things just get better from here.

Anti-coercive ways to fight Delta

James Bailey2 Comments

Two weeks ago I predicted that Covid cases would continue to spike for at least two weeks due to the Delta variant, but argued against general shutdowns as a way to combat this spike. Two weeks later cases have indeed spiked, and while localities and organizations have been mandating masks and vaccines, we have largely avoided new lockdowns, at least in the US (Australia is reverting to its roots as a prison). In the last post I mostly said what we shouldn’t do to fight Delta, so today I want to show what a better response looks like.

The tendency of authorities to reach first for coercive solutions is a natural product of their incentives, but I’ve been disappointed to see the same tendency among the chattering classes. I think this is due to polarization- people are most interested in debating solutions that are identified with a specific side in politics or the culture war. Masks became blue-coded, so many reds oppose them even though they probably work. Likewise with vaccines, even though they definitely work well and funding them early was the greatest achievement of the Trump presidency. Meanwhile certain medications became red-coded, leading blues to oppose them before the evidence even came in. But many of the best non-coercive and anti-coercive solutions barely get discussed because they have no political valence, or a mixed one.

Fully Approve the Vaccines Already!

The Covid vaccines are still being distributed under an emergency use authorization. This lack of full approval is a source of vaccine hesitancy. More concretely, it also means that pharmaceutical companies aren’t allowed to advertize their vaccines, even though they are much more effective than the typical pharmaceutical you see advertized. The randomized control trials testing the vaccines have been complete for months, we are just waiting on the FDA to do their job.

Authorize Vaccines for Kids

The FDA still bans children under 12 from receiving the vaccine, saying they are waiting for more trial data. Last week, the American Academy of Pedicatrics argued that we have enough data to justify an Emergency Use Authorization for children aged 5-11 given, you know, the emergency. The government is going to make my 5 year old wear a mask to kindergarden won’t allow me (or my physician wife!) to get him a vaccine which would protect him and others much better than a mask.

Ventilation

Opening windows, modifying HVAC systems to bring in more outside air, and using air purifiers is about as effective as requiring masks and is definitely less of an imposition on people. But we don’t talk about it, partly because people took so long to recognize that Covid is spread through the air more than through droplets, and partly because it is less of an imposition on people and so never became a culture-war debate. Ventilation might be too boring to advocate but I think staying alive is very exciting.

Outpatient Treatments that Work

Repurposing existing drugs to fight Covid is a great idea that has not yet lived up to its promise, aside from the widespread use of Dexamethasone for inpatients with severe cases. The core problem is that it takes large randomized controled trials to really prove that a drug works, and these are expensive. Worse, pharmaceutical companies don’t want to pay for these expensive trials once their drug has gone off patent. This means that many promising treatments have been ignored, while a few have been over-promoted on the basis of observational studies and tiny RCTs (and worse, still promoted once large RCTs showed they probably don’t work). But the British government stepped up to fund the large trials that found Dexamethasone effective last year, and private donors have funded mid-size trials that just found Fluvoxamine reduced Covid hospitalization by 31%. This is excellent news because Fluvoxamine is a cheap and relatively safe anti-depressant that people can take at home. There are other promising treatments that have yet get funding for large RCTs; this is exactly the sort of thing that NIH should be throwing money at. While we’re waiting on compentent government, you can ask a doctor about outpatient treatment if you do get Covid.

Overall, many of our best tools for fighting Covid are being ignored despite, or perhaps because of, the fact that they maintain or increase our freedom.