COVID Transmissions for 8-25-2021

A vaccine—which protects you from Delta—is now FDA approved

Aug 25, 2021

Greetings from an undisclosed location in my apartment. Welcome to COVID Transmissions.

It has been 645 days since the first documented human case of COVID-19. In 645, the push and pull of tension between the Caliphate and the Byzantine Empire was in full display when a 300-ship Byzantine fleet appearing at Alexandria caused the residents there to revolt against Muslim rule, liberating the city. It was quickly retaken by the Caliphate, who soon decided it might be a good idea to start building a fleet of its own.

Today we’re going to talk about vaccines and FDA approvals. Nice to be able to say that. Also, some new data on how vaccination protects from Delta.

Bolded terms are linked to the running newsletter glossary.

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Now, let’s talk COVID.

CDC releases new data showing that the unvaccinated are still a lot more likely to get COVID-19 than the vaccinated

A new early release report in Morbidity and Mortality Weekly Report (MMWR) gives us some new Delta-era data from Los Angeles that give us a better sense of how to evaluate infection and hospitalization risk: https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e5.htm

In this dataset, the unvaccinated were 5 times as likely to get COVID-19 and 29 times as likely to be hospitalized, as compared with vaccinated people. I don’t think I can make a better argument than that for vaccination, but let’s get to one possibility now.

The FDA has licensed (aka “approved”) the Pfizer-BioNTech COVID-19 vaccine

For months, vaccine-hesitant people have used the fact that the COVID-19 vaccines are available under Emergency Use Authorization rather than full FDA licensing to either just not get vaccinated or to justify all sorts of of strange claims, like saying that the vaccines are “experimental.” Now, the FDA has provided full regulatory approval to the Pfizer vaccine: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

One thing that this does is get the product the right to a marketed brand name. In this case, the vaccine will be called Comirnaty, which was apparently developed by taking “COVID-19 Immunity” and then sticking the letters for “mRNA” into it so that it sounds sort of like “community.” It’s a pretty silly name, but pharmaceutical branding often is silly. Part of the reason is that drug names, both generic and branded, have to follow a whole host of rules that are intended to prevent confusion with other medicines in things like medical charts and spoken conversations.

I’m hoping that with this approval, we will see more people like this guy: https://www.reddit.com/r/pics/comments/pa6n2b/i_was_waiting_for_the_vaccine_to_be_fda_approved/

Also, I want to take a moment to again talk about why and how the vaccine followed the regulatory path that it followed. There remains the false impression that the scientific process for these vaccines was “rushed,” and that’s really, really untrue. Under normal conditions, vaccine development is a slow process because there’s just no f**ing money to support it moving fast. Vaccines are not the most profitable things that a pharmaceutical company can make, not by a long shot. They are preventive products that patients take, at most, once a year. They don’t cost a lot, relatively speaking—maybe a couple of hundred dollars where a blockbuster cancer product can be tens of thousands per patient per month. So, there just often isn’t a lot of investment to support vaccines. As a result, trials move slowly.

Part of this is because trials are extremely expensive to keep going. You have to enroll patients, and as we’ve learned, it’s hard to find people who are comfortable with vaccines, particularly experimental ones. That means spending a lot on recruitment and advertising, and the faster you want it to go, the more you have to spend. It’s not a linear relationship, either—it’s not unlike how you lose fuel efficiency when you push an engine too far. Except here, the fuel is money.

Likewise, it isn’t always easy to justify doing the next trial, and you have to do a lot of trials to get a vaccine moving. Typically, a few Phase I trials might be conducted, to do all kinds of experiments around dose-finding and safety. It’s not just one trial. Then the results of those trials will need to be published, a process that costs a lot of money also (though nothing by comparison to the cost of the trial) and is not very time efficient. Once it’s clear that the Phase I program worked, there’s the Phase II program, which may involve a couple of trials itself, centered on finding the right dose for efficacy purposes. Those will require a new round of enrollments and then a new round of publications, too. Then you go to Phase 3, if you’re lucky and the business case for your vaccine is still valid—and the Phase 2 also worked. Those trials will need tens of thousands of patients. Fun! Of course, that’s not close to free either. In between, you’ll need to hold dozens of meetings with the FDA, the EMA, and other regulatory agencies to make sure that they will actually like your trial designs and give your product a pathway to licensure.

As you can imagine, this takes an enormous amount of time and money, and there’s never enough invested.

In the case of the COVID-19 vaccines, governments and companies sped things up by throwing a tremendous amount of money at the problem. They were able to set up “seamless” Phase 1/2/3 trial designs that moved patients directly through each phase to retain people recruited for earlier trials. They did this with the FDA giving their trials priority for meetings over many other products, ensuring that they got the attention and feedback that they needed to advance without delay. The companies also dedicated tremendous amounts of money and effort at recruitment. In the case of Pfizer’s vaccine, they recruited almost 40,000 people to their trial in the course of a month. Even under the best of circumstances it’s difficult to recruit 40,000 people to do anything. The answer here was money.

I’m hoping that FDA’s formal approval will put the “rushed” criticisms to bed, but I wanted to make sure to share these points again in the event this argument doesn’t go away. The reality is that the old saying “good, cheap, fast—pick two” applies here, and the companies that made the COVID vaccine decided to throw cheap out the window in favor good and fast.

What am I doing to cope with the pandemic? This:

Watching: Star Trek — Lower Decks

One of the best things to come out of the return of Star Trek to television is the animated comedy Lower Decks. It just released a second season, and I’m eating it up. It’s available on Paramount+.

Carl Fink had a question about how I made elote on Shabbat when I’m not allowed to cook, so I wanted to clarify for those who are interested—I grilled the corn before Shabbat and the rest was just mixing uncooked ingredients :)

Carl also had another comment:

BTW, referring to a previous conversation we had, the Washington Post says today, "Johnson & Johnson, which unlike the two-dose Pfizer-BioNTech and Moderna vaccines is a single-shot vaccine, is expected to announce data soon from a trial testing the effect of adding a second shot." Maybe the ENSEMBLE 2 trial is actually going to report out.

I hope this happens. The two-dose J&J results would be really great to have.

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