Enlarge (credit: Mario Tama | Getty Images)

On Monday, the US Food and Drug Administration gave formal, full approval to the Covid-19 vaccine made by the drug companies Pfizer and BioNTech. You might’ve already gotten a dose of it, of course; millions of Americans have, thanks to an “ emergency use authorization ” awarded in December 2020. But the new designation was more than just a formality. “If you’re one of the millions of Americans who said they will not get the shot until it has full and final approval from the FDA, it has now happened,” President Joe Biden said when he announced the approval. And, in the same speech: “If you’re a business leader, a non-profit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that—require it.”

Pretty much right away, a lot of places did. Vaccines are safe, effective, and free, but somewhere around 30 percent of Americans haven’t got their shots. Carrots didn’t work; here come the sticks. And they might be able to crush the fourth wave of the Covid pandemic in the US—if they’re done right.

Like the other vaccines still available under EUA, the Pfizer drug is extraordinarily good at keeping people from getting really sick or dying from Covid. But with more than 100,000 people in the hospital with Covid in the US—the most since January—and with the vast majority of them unvaccinated, it’s clear that alone isn’t enough. States, localities, and businesses have tried inducements like prizes, cash, or lotteries , little tricks designed to corral people into doing what’s good for them. In the language of behavioral economics, that’s called a nudge. But in states with low vaccine uptake, those nudges didn’t change the momentum. So now, it’s time for mandates . If you’re one of the 30 percent or so of Americans who haven’t gotten vaccinated yet, get ready for a good hard shove.

Enlarge / COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left). (credit: Drew Angerer / Florian Gaertner / Getty Images)

One of the leading developers of COVID-19 vaccines has now been placed in the ranks of people like Martin Shkreli—the disgraced pharmaceutical executive infamous for jacking up the price of an old, life-saving drug by more than 5,000 percent. He is now serving an 84-month prison sentence from a 2017 conviction on fraud counts unrelated to the drug pricing.

Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. The awards, announced annually for four years now, go to “perpetrators of the ten most egregious examples of profiteering and dysfunction in health care.”

Award judges cited Moderna’s pricing of its COVID-19 vaccine, which was developed with $1 billion in federal funding. Still, despite the tax-payer backing, Moderna set the estimated prices for its vaccine significantly higher than other vaccine developers.

Enlarge (credit: DeFodi Images )

Late Friday, the Food and Drug Administration issued an emergency authorization to a COVID-19 vaccine from a company called Moderna. The move follows an enthusiastic endorsement of the vaccine following an evaluation of clinical trial data by the FDA's Vaccines and Related Biological Products Advisory Committee. Moderna already has millions of doses prepared, and the federal government has pre-issued a large order for more, which will enable more extensive vaccinations than would be possible previously, where the agency had only issued an authorization to the Pfizer/BioNTech vaccine .

The authorization was considered to be a matter of time following the release of safety and efficacy data from a large clinical trial that had enrolled over 30,000 people. Emergency Use Authorizations require that a product or treatment meet a number of criteria, including the declaration of a medical emergency, which was done earlier this year, and the lack of an FDA approved alternative. (FDA approval is distinct from an Emergency Use Authorization, so the authorization of the Pfizer/BioNTech vaccine isn't a barrier to further authorizations.)

Beyond that, the product must be considered likely to be effective, and its potential benefits need to outweigh its potential risks. The votes from the members of the Vaccine Advisory Committee were unanimous that the benefits outweighed the risks, a conclusion that was well supported by the clinical trial data. That cleared the way for Friday's Authorization, which took place on a similar schedule to the authorization of the Pfizer/BioNTech vaccine the week prior.

Enlarge (credit: Aurich Lawson / Getty Images)

As we're waiting for word on the authorization of a second vaccine for use in the US, glitches have been striking the distribution of the first through the federal government's "Operation Warp Speed." This week, the US saw the first use of the vaccine developed by a Pfizer/BioNTech collaboration. But immediately afterwards, many states started saying that orders for shipments in the ensuing weeks were being cut. After some in the federal government had indicated that the problem might be in production, Pfizer issued a statement indicating that it had doses in its warehouse ready to ship out, but no indication of where to ship them too.

All in all, about what you'd expect in the first weeks of a massive undertaking like this.

State of denial

One of the first states to report problems was Illinois, where its governor, J.B. Pritzker, said that it had indications it would only be receiving half the expected doses of the Pfizer/BioNTech vaccine next week. Since then, over a dozen states have indicated that they'll be receiving fewer doses than planned in the second week ( this article seems to have a fairly comprehensive list).

Enlarge / This unassuming building in Massachusetts has taken on remarkable significance in recent weeks. (credit: JOSEPH PREZIOSO / Getty Images )

Earlier this week, the FDA released documents that summarized the data on a second SARS-CoV-2 vaccine candidate, this one from a company called Moderna. That document was the background for a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, which would consider whether the benefits of the vaccine outweigh its potential risks. That question is one of the key considerations for the agency as it decides whether to grant an emergency use authorization similar to the one it gave the Pfizer/BioNTech vaccine .

After an all-day meeting that frequently focused on other topics, the committee was near unanimous: 20 votes for approval, none against, and one abstention.

Emergency use authorizations have a number of requirements once a health emergency hsa been declared. There must be no alternatives that have achieved full FDA approval, there must be reasons to think that the treatment will be effective, and its benefits are considered likely to outweigh its risks. It's that final question—the risk vs. benefit balance—that the advisory committee was called to address.