What the FDA’s Decision on the New COVID Boosters Tells Us






























































Photograph Source: U.S. Army USAG-V by Cristina Piosa – Public Domain

The Food and Drug Administration (FDA) decision to limit its recommendation for Covid boosters to the elderly and people with health conditions raises many interesting issues.

First of all, it should be a reminder that there are multiple vaccines that have been available in the U.S. and around the world. This is an obvious point, but one that is often overlooked in the nuttiness being pushed by the antivaxxers about the dangers of the vaccine.

There is no “the” vaccine. There are at least two mRNA vaccines (Moderna and Pfizer) and a number of different non-mRNA vaccines. In the United States a Johnson & Johnson vaccine was among the first vaccines approved early in 2021. More recently Novavax also has had a non-mRNA vaccine approved. There are many other vaccines approved by various health agencies around the world, using very different technologies.

This point should also be raised when the antivaxxers go on a tirade against “the” vaccine doing all sorts of damage to people and even killing them. Which vaccine are they talking about?

Do they mean all of the vaccines against Covid? If that’s the case, it would be a pretty remarkable claim. Somehow, completely different vaccines cause serious damage to people because of the disease they target? That would likely be too whacky even for RFK Jr.

But aside from exposing the nuttiness of the antivaxxers, the existence of multiple vaccines does raise an important point. All the vaccines have some side-effects.

Even though these may be nothing like the horror stories claimed by the antivaxxers, some percent of people do react badly to some of the shots. In my own case, the mRNA shots (I’ve had both the Moderna and Pfizer vaccine) gave me flu-like symptoms for a day and half. This may not be a big deal in the scheme of things, but if I had the option to take a shot that did not give me flu-like symptoms I would gladly take it.

It would be good to have more open discussions of the side-effects from the various vaccines, but the nuttiness of antivaxxers has made this difficult. Their claims that the vaccine causes heart attacks, sterility, and who knows what else, has largely drowned out efforts to compare real world side-effects of the vaccines for people trying to make informed decisions.

Then there is the issue of who should get the vaccines. Apparently, the FDA is going to only recommend the vaccine for elderly people and people with some medical condition that would put them at high risk from Covid.

I’m not anywhere near expert enough to assess the wisdom of this call, but there is a possibility that otherwise healthy people, who have likely already been vaccinated, as well as having been infected at least once, will gain little additional immunity from another booster. For these people, the side effects could outweigh any benefits from another booster, in which case not recommending a booster could be the right call.

However, there is the problem that many people who are themselves young and healthy may frequently come into contact with older people or people with a serious health issue. For these people, it would be important to try to minimize their risk of getting Covid to avoid infecting someone who is more vulnerable.

By approving the vaccine for people at high risk, the FDA does leave open the option for other people to get the vaccine, since doctors can prescribe any approved drug or vaccine for non-recommended uses. The problem here is that insurers will be unlikely to pay for the shot.

This means that a person who lives with an elderly parent or someone with advanced cancer could still get the vaccine but might have to pay $130 out-of-pocket to cover the costs. This raises the question of why a vaccine costs $130 a shot?

The answer is the patent or other effective monopoly that the government has given the manufacturer. Almost any vaccine will cost less than $10 to manufacture and distribute, and likely less than $5. In fact, Dr. Peter Hotez developed a vaccine that has been distributed to more than 100 million people in India and Indonesia at a cost of around $2.00 a shot.

If the vaccines were being sold in the free market, without patent monopolies or other protections, they would be cheap, and the vast majority of people would be able to pay for them whether or not an insurer covered them. This raises the issue of why the government gives out monopolies that allow the drug companies to make such huge profits on their vaccines.

The answer is that this is supposed to give the drug companies incentive to develop the vaccines in the first place. That logic doesn’t work very well with Covid vaccines. The government directly picked up much of the tab for the development and testing of the vaccine.

In fact, it paid practically all of the costs in the case of Moderna. It paid $483 million for the initial development and cost of preliminary trials and then another $472 for a large-scale clinical trial. In this case, all the risks lay with the government. If it turned out that the vaccine was not safe or effective, Moderna would have earned a nice profit for its efforts and government would be out a bit less than $1 billion.

The government also paid for the bulk of the early research on mRNA technology through grants from the National Institutes of Health, the agency Trump has targeted for large cuts. So, there was an especially good case for Moderna vaccines to be available as cheap generics once the process was completed.

Unfortunately, in a less than artful deal, Trump let Moderna keep control of the vaccine and charge up to $130 a shot. It has made tens of billions of dollars off of the government’s investment.

If we were serious about reducing waste and eliminating corruption, we would actually look to go the opposite path from Trump’s NIH cuts. Instead of cutting research, we should be hugely ramping it up. Then we could make all the drugs and vaccines developed on the government’s dime available as cheap generics from the day they are approved by FDA.

This would also largely eliminate both the incentive and opportunity for drug companies to lie about the safety and effectiveness of their drugs. Since drugs would be selling at free market prices, there would be less incentive than when they are getting markups of several thousand percent on each sale.

We see drug companies push their drugs all the time for this reason, with the opioid crisis being the most extreme case. However, pharmaceutical companies misrepresent the safety and effectiveness of their drugs all the time. This is exactly what any economist would expect when they can sell a drug for thousands or tens of thousands of dollars that cost them a few bucks to manufacture and distribute.

The other point is that if all the funding is coming from the government, we can require that all the findings be fully open. If everyone has access to the same data, it would be much harder for drug companies to misrepresent their findings even if they wanted to.

Finally, if we had gone this route in the pandemic, and shared research findings worldwide, we likely would have access to a wide range of vaccines now, all of whose effects were pretty well understood. But that would have required the government to actually be focused on using its research funding to improve public health, instead of making the rich even richer. That seems very unlikely in the era of RFK Jr. and Donald Trump.

This first appeared on Dean Baker’s Beat the Press blog.

The post What the FDA’s Decision on the New COVID Boosters Tells Us appeared first on CounterPunch.org.