Why the new COVID vaccine boosters are safe and likely very effective

In case you haven’t heard, there’s now a new set of vaccine booster shots that protect against the latest variant of Covid-19, BA.5. This new variant is highly infectious, and the original vaccine doesn’t protect people against it as well as it protected against earlier variants.

Now, before someone takes that last sentence out of context, let me emphasize that the original Covid-19 vaccines are still highly effective at preventing severe disease and hospitalization. Anyone who isn’t vaccinated would be well-advised to get one of those, if that’s their only option.

But the new vaccines protect against two different strains of Covid-19: the original strand and the latest Omicron variant, BA.5. BA.5 just emerged in August, and it’s spreading extremely fast–it now accounts for 88% of the cases in the U.S. The FDA authorized these “bivalent” boosters on August 31.

My main point today is to explain how this happened so quickly, and why it didn’t involve many months of clinical trials the way that the original vaccines did. Some people have expressed suspicion about the speed with which these boosters appeared, but those suspicions are entirely unfounded.

First of all, we do have data showing that the new vaccine boosters are safe: a study showing these data for the Moderna booster just appeared in the New England Journal of Medicine. That study also showed that people generated robust antibodies against the BA.1, BA.4, and BA.5 Omicron variants after getting the new booster.

Second, to explain why that’s all the data we need, let me explain something about the flu vaccine. Many people are well aware that we have a new influenza vaccine every year–but what they might not know is that each year’s vaccine contains a different strain of the flu virus from the previous year. (Actually, it has up to four different strains, and any or all of them could be new.)

And yet we don’t run large, months-long clinical trials of the flu vaccine each year to measure it’s efficacy. Why not? Well, the basic designs of the flu vaccines (there’s more than one) have been tested in large clinical trials, and we know they’re safe. Replacing the vaccine strain with a new one doesn’t affect the safety of the vaccine, as decades of experience with the flu vaccine have now demonstrated. And because flu mutates quickly, we need to change the vaccine strain every year if we want the vaccine to work.

So that’s what we do: we change the flu vaccine strain to match whatever seems to be circulating, but everything else about the vaccine design remains the same.

This is exactly what scientists have done with the new Covid-19 booster shots from Pfizer/BioNTech and Moderna: they simply added a new strain, in this case to match the latest Omicron variant.

Both of the new boosters are mRNA vaccines, which means the vaccine contains a tiny bit of genetic code (mRNA) with instructions on how to make the “spike” protein from SARS-CoV-2, the Covid-19 virus. When you get the vaccine, your own cells follow those instructions to make a limited number of copies of the spike protein–but nothing else. The virus itself can’t be created without many other genes, and the spike protein alone can’t form a virus.

But your immune system recognizes that an invader is present–that spike protein–and it generates antibodies against it. After that, your immune system is primed to recognize and defeat Covid-19, if it ever infects you.

So the new boosters contain mRNA from the BA.5 spike protein as well as the original spike protein, and now you get protection from both old and new strains. Other than that, it’s the same vaccine as before.

The vaccine makers have produced safety data showing that the booster is just as safe as the original vaccine (see that NEJM article I mentioned above). But the FDA didn’t require them to prove that the booster really works better against BA.5, because that would require months of trials, and by that time the virus could mutate again. So while it’s possible that the boosters won’t help against BA.5, it’s very, very likely that they will.

One of the big advantages of mRNA vaccines is precisely this: we can swap out the mRNA easily, allowing us to respond quickly to mutations in circulating viruses. That’s a good thing, and it might be our only path to controlling Covid-19.

The bottom line is that the new boosters should be very safe, and they will likely provide much better protection against the current strains of the Covid virus. I’ve already gotten my booster, and I hope everyone else will too.

Covid patent fight is about greed, not human health

I suppose I shouldn’t be surprised: one of the companies that developed mRNA vaccines for Covid-19, Moderna, has just sued the companies who make the competing mRNA vaccine, Pfizer and BioNTech, claiming that Pfizer/BioNTech is violating its patents.

Pfizer was surprised though, according to news reports. (Or at least they said they were.)

Moderna had announced, back in 2020, that they wouldn’t enforce patents on their vaccine during the pandemic, but they seem to have changed their mind. Apparently, billions of dollars in profits isn’t enough: they’ve decided the time is right to try to grab even more money.

Let’s make no mistake here: this is purely about greed. Apparently Moderna understands this, since they proudly advertised their earlier plans not to enforce patents on the Covid-19 vaccine. They realized that the public good will generated from such an announcement was valuable.

Not that valuable, apparently.

It’s not even clear that Moderna should have been given the patents it holds. According to a recent story in Science, the key technology behind one of Moderna’s patents was invented, and patented, years earlier by two scientists, Drew Weissman and Katalin Karik√≥, at the University of Pennsylvania. Their work discovered a way to modify the RNA in the vaccine that would make it much more effective. (Here’s a link to the patent.)

As I wrote last year, patenting the Covid-19 vaccine is unethical. At the time, the US had announced support for a “vaccine waiver” that would allow any country to develop vaccines against Covid-19 without licensing the technology from one of the companies that currently holds a patent. That policy sounded too good to be true–and apparently it was, because no such waiver is in effect now.

The patent system is a creation of modern governments, and they don’t have to let companies get away with this. The profits of a few companies are far, far less important than the lives of millions of people. Allowing companies to restrict Covid-19 vaccine development is, crudely put, defending money over human lives. Maybe it’s time for the international community to institute the vaccine waiver, at least until the pandemic is truly over. 

And make no mistake: even though we have vaccines now, they still need improving, and better vaccines will save lives. Patent disputes will slow down or even prevent work on better vaccines, since the patent holders will have a monopoly. Even the threat of a lawsuit can stymie progress; after all, why would someone invest time and effort on a vaccine that they might never be able to deploy?

Moderna is far from the first company or institution to let greed guide their actions: way back in 2010, I wrote about how MIT and Harvard had filed a patent that was, as I wrote at the time, both inappropriate and harmful. In that case, MIT and Harvard had an incredibly broad patent on a human gene, NF-kB, which plays a key role in our immune system’s response to infections. Granting a patent on NF-kB, as the US Patent Office did, was akin to granting a patent on all drugs that affect nearly any human gene. The universities licensed the patent to Ariad Pharmaceuticals, who filed a lawsuit the day the patent was granted. Neither Ariad nor MIT developed any treatments, but they initially won $65.2 million just because of the patent. (Need I point out that the Harvard and MIT work was mostly funded by the public?)

Fortunately, in the 2010 case, an appeals court threw out the patent, ruling that people and companies cannot patent human genes, because genes are products of nature, not inventions. The mRNA patents, though, don’t fall in this category.

Should I also mention that much of the basic research behind mRNA vaccines was also funded by the public? Or that NIH (and therefore the US government) has patent rights to some of the technology behind the Moderna vaccine?

Moderna, Pfizer, and BioNTech looked like heroes when they first announced their vaccine results–and in some ways, they were. The world was desperate for vaccines against Covid-19, and the mRNA vaccines have saved millions of lives.

But my message to Moderna is simpler: you’re already making billions in profits on the Covid-19 vaccine, so don’t be such greedy assholes. And don’t be evil: drop the lawsuit.