Here’s something that I bet you know, but that it seems our government and news media — in large measure that’s redundant — don’t know: A lot of people are afraid of shots. They head the other way when the needle comes out.
You know such people. Maybe you are such a person.
We’re constantly hearing from every government official and almost every news commentator that unless more people get vaccinated against SARS-CoV-2, the virus that causes the disease called COVID-19, we’re doomed. Doomed, I tell you!
Those who do not get vaccinated, we’re told, are villains. The most villainous of all are those who do not trust the vaccine for one reason or another. It has been noted, accurately, that when the government and its news lackeys say that you should wear a mask even if you’ve been vaccinated, they’re undercutting their own case for vaccination because it makes the vaccine seem ineffective.
But let’s leave that discussion for another day and begin with the assumption that the available vaccines are safe and effective.
There’s still that other issue, the fact that there are people who refuse to get anything that is delivered by injection.
How many people share this concern, which ranges from mild distaste to flat-out phobia? Actually, that’s been quantified, at least to some extent. Researchers in England published a study in June which found that from 10 to 25 percent of the people in Great Britain are hesitant to get the SARS-CoV-2 vaccine because they’re afraid of needles. “Across the adult population, blood-injection-injury fears may explain approximately 10% of cases of COVID-19 vaccine hesitancy,” they concluded. There’s no reason to think that the American figures would be remarkably different.
As of last Friday, about 58 percent of Americans had received at least one dose of the injected vaccine, and about 50 percent had received two doses. Still others are immune because they’ve had and recovered from the disease. There comes a point at which the percentage of those vaccinated becomes so high that those who haven’t been immunized are effectively protected, because the virus can’t jump from person to person as readily as it could before people were vaccinated. This is called “herd immunity,” and its requirements vary from disease to disease according to the World Health Organization (which has gotten a great deal wrong in the current pandemic, but its numbers are in the ball park here). To prevent a polio outbreak, about 80 percent of the population needs to be vaccinated. Measles is far more virulent, and to prevent its spread 95 percent of the people need to be immunized. (This fact gets proved regularly in anti-vaccination communities.) Says WHO: “The proportion of the population that must be vaccinated against COVID-19 to begin inducing herd immunity is not known.”
When the noise dies down we’re likely to have learned that a mutation, the “delta” variant that emerged in India, is far more virulent — easily spread — than the previous strains of SARS-Cov-2, and that means that the percentage of people who need to get vaccinated before herd immunity is achieved has risen. The near-60 percent we have comes close with the regular virus, but with delta it probably won’t do the trick.
If only there were a way to get those needle-averse people vaccinated!
Maybe there is.
Vaxart, a California biotech company specializing in orally delivered vaccines, has developed a SARS-Cov-2 vaccine that comes as a series of three pills. Part of the original “Operation Warp Speed” — awful name — project, the oral vaccine did very well in initial testing, with more tests soon to begin. The company says at least one of its two immune mechanisms makes it especially effective against viral variants.
A reason that some vaccinations have traditionally been delivered by needle is that our stomachs’ powerful gastric juices digest oral vaccines before they can get to the small intestine, where they do their good. (You would not believe how important the small intestine is to the immune system.) “By targeting the small bowel,” the company says, “the vaccines engage the finely-tuned immune system of the gut to generate broad systemic and mucosal immune responses for robust, persistent immunity.”
If what the company says is true, and I have no reason to doubt it, Vaxart has come up with a way to get their vaccines safely past the stomach: “The enteric coating protects the active ingredient from the acidic environment in the stomach.”
This could have enormous implications that extend far beyond the current pandemic. For example, we’re encouraged each year to get a flu shot. Influenza kills from thousands to tens of thousands of people in the U.S. each year. Our defense against it has come in the form of an injection. (There is also a flu vaccine that comes as a nasal spray. It involves weakened live flu virus and is not approved for use in those more than 49 years old, so it is literally not for everyone.) And each year, fewer than half the people 18 years old and older receive the flu vaccine, despite the publicity campaigns encouraging them to do so.
The Vaxart company has, until SARS-CoV-2, specialized in influenza and related diseases. Its work in those areas, too, has been promising. If the British study is at all accurate, the availability of a flu vaccine pill would likely increase the number of people being immunized by from 10 to 25 percent. By herd immunity reasoning, this would make everyone less likely to get the flu — herd immunity is not like a light switch, it is a scale: if you’re immune, you’re unlikely to pass the illness on to someone else. At some point, so many people have gotten immunized that the virus has a hard time surviving at all. Each person who gets immunized increases the likelihood that even the non-immunized won’t get the bug because they won’t be exposed to it from their vaccinated neighbors. (That’s how smallpox was driven virtually extinct, except that the government kept some because of course it would.)
Now imagine the possibility of taking a pill or course of pills each year that immunizes you from that year’s likely flu strains, as well as SARS-CoV-2 and other serious illnesses that normally would require multiple shots — “jabs,” as the Brits say — to achieve the same protection. Pretty cool, huh? Even cooler, pun intended, is that the pills require no trick refrigerators or special storage. Such a polyvalent — effective against multiple strains and perhaps multiple diseases — vaccine is not far over the horizon.
And there would be no needles involved.
I spoke briefly Monday with Vaxart’s Mark Herr, who said that the FDA had just approved phase I trial of a second SARS-CoV-2 vaccine aimed especially at the spike protein that enables the invading virus to attach itself to healthy cells. Additional testing of the company’s vaccines is expected to begin this fall, with approval “in the best of all cases sometime in 2022.
“If we’re successful in bringing it to market, it would have profound implications” here and in undeveloped parts of the world where specialized refrigeration and widespread availability of physicians don’t exist, he said.
“We did a survey earlier this year that showed that a substantial number of Americans, about one in four, are afraid of needles,” Herr continued. “And when we asked them, if you had a choice to get vaccinated with a pill would you, they said yes, we would. Based on that, extrapolated to the rest of the United States, about a third of the Americans who haven’t gotten vaccinated would, which would yield another roughly 20 million Americans.”
The Third World implications are obvious, he said. “If you could get a pill in the mail and all you had to do was find some water and take that pill, that puts you way ahead” over the complicated distribution systems involved in the current vaccines.
Though Vaxart’s oral vaccine work was part of Operation Warp Speed, with the change of administration came a refocusing of “COVID-19” money toward things that aren’t COVID-19, and a lot of promising research is no longer supported. In my opinion this is a pity, at least, and out and out malfeasance at worst.
Meanwhile, the pandemic is still with us and is by some lights potentially getting worse. A large part of the population won’t get vaccinated if the vaccine comes in a needle. There is much discussion of forcing people to get the shots. While getting a vaccine from idea to distribution in well under a year has been a tremendous achievement, the job isn’t done when up to a quarter of the country is left behind despite alternatives that would take their hesitancy into consideration. The evidence favoring an oral vaccine is conclusive, it seems to me.
“There are disparities in different groups getting vaccinated,” said Herr, “and what our polling found is, based on the responses we got, more than 4 million black Americans, more than 3 million rural Americans, more than two million Hispanic Americans, and more than 1.5 million Asian Americans would get vaccinated who are now saying we don’t really want to do that [by way of a needle].
“So not only do you get closer to herd immunity, not only do you get more Americans vaccinated, but you make inroads in vaccine inequity. We wish everybody recognized this.”
We’ve seen it before. The Salk vaccine did much to reduce the spread of polio, a terrifying disease, but it was not until the arrival of the orally delivered Sabin vaccine that polio was effectively eliminated.
To me, and I think to the millions who are needle averse (if they knew about it, but they don’t unless they’re reading this column), this is a very big deal.
A couple of things that I should note: First, I have no financial interest in Vaxart and in fact had never heard of the company until I began researching this column. Second, Vaxart isn’t the only company working on an oral SARS-CoV-2 vaccine — not far behind is Oramed, an Israeli company.
The real question is why, if the government and media are so eager to get everyone vaccinated, we haven’t heard about all this. If the goal is achieving herd immunity, this would be a way to get more than 10 percent closer in one fell swoop. Why isn’t the oral vaccine being accelerated as the injectable ones were?