Even before the new Covid booster shots arrived, the arguments about them got shrill.
There’s a dizzying kaleidoscope of defensible opinions about the new Covid shots, which are designed to match the BA.5 strain of the virus that currently accounts for 9 in 10 Covid cases in the U.S.
Some argue that the Food and Drug Administration and the Centers for Disease Control and Prevention were too fast to approve the new shots without new human data — yes, these shots really are tested mainly in mice. Some experts worry that instead of being more effective than the primary series of shots they could be less. Still others worry that the vaccine campaign is too broad, and should instead focus only on people at higher risk of severe disease.
And, of course, there are other opinions online that are indefensible — ridiculous and untrue. Vaccines have not been useless in recent variant waves. There is no evidence they’re making the pandemic worse. They are not causing a quarter of children who take them to become too weak to play.
This social media-driven cacophony risks drowning out the most important message about the booster shots: quite simply, that most people should get one right now. Even those who criticize the decision to go with a BA.5-matched booster because of a lack of data say people need at least three shots of the Pfizer or Moderna vaccine to be fully protected. Half of eligible people in the U.S. have not received a booster. A quarter have not been vaccinated at all.
The rest of this article is going to wade through some of the controversies surrounding the new shots, but those who have not had at least three shots of vaccine can stop now and make an appointment. During the spring, death rates among unvaccinated people were eight times higher than among those who had at least three doses of vaccine – down from 20 times higher between January and March. The new BA.5 booster, practically speaking, is what’s available. Not getting a third dose is risking your life to spite the feds. And a fourth shot? We’ll get to that, but many experts think it’s a good idea.
Quickly, what happened with these boosters? Throughout the pandemic, Pfizer and its partner BioNTech as well as Moderna have been conducting small clinical trials to test whether vaccines matched to current strains of the SARS-CoV-2 virus performed better than the original vaccine. Generally speaking, they have at least resulted in antibodies that were more effective at neutralizing the new viral strains in the lab.
The most recent human trials for variant vaccines were for the BA.1 version of the Omicron strain. Trials of both the Pfizer and Moderna vaccines showed that combining vaccine antigen from BA.1 and the original strain resulted in better levels of neutralizing antibodies, which should mean better protection. Some countries, including Canada and those in the European Union, have ordered millions of doses of bivalent vaccine that include BA.1 and the original Wuhan strain. That is, in fact, what the World Health Organization recommends.
But the U.S. has chosen to go its own way. In June, the FDA held a meeting of its expert advisers, and they voted overwhelmingly (19-2) that the agency should ask Pfizer/BioNTech and Moderna to make Omicron-containing vaccines. But the panelists largely seemed to agree that it would be better to have the shot include the BA.5 strain. For the most part, they thought it made more sense to target the current strain than to wait for human data. This is similar to what the U.S. has done when ordering influenza shots for decades.
Here’s where the FDA made a mistake, one that is telling for what has gone wrong with communication throughout the pandemic. While it had the panel vote on whether there should be an Omicron-containing booster, it did not ask for a vote on whether that booster should contain antigen for BA.1 or BA.5 – it simply asked panelists to discuss that topic. That decision gives the agency flexibility, but makes it much harder to communicate the decision to the public. This has been a repeated error by the FDA over the past few years, with the worst example being the decision to approve the Alzheimer’s drug Aduhelm even though an FDA panel was basically screaming that the FDA should not do that. Medicare refused to pay for the drug and its maker decided to all but stop spending money to sell it.
But, again: I watched the panel, and it was very clear that the panelists were planning on a BA.5 booster. Calls that the FDA should have had a second panel are misguided. That was when the decision on which vaccines to order was made; it’s not realistic to expect that Pfizer and Moderna will scrap the vaccine they made for the U.S. over the past few months and make a new batch with a different composition.
Is a fourth shot needed? During the Omicron wave that hit in the spring, CDC data show the risk of death for people over 50 who received two boosters – a total of four shots – was three times lower than those who received three.
Not everyone thinks the benefit of the new shots is clear, though. Paul Offit of the Children’s Hospital of Philadelphia, who for decades has been one of the loudest defenders of childhood vaccination, was one of the FDA panelists who voted no. He’s worried that a vaccine combining smaller amounts of the BA.5 and Wuhan antigens will be less effective than the original shot, and about the paucity of human data on the efficacy of the vaccines. He says he has had a total of three shots of the original vaccine and was recently infected with Covid, and does not plan to get a fourth vaccine.
The other question about the new vaccines is whether their safety will be different from the original versions. This is possible, but unlikely. It’s also not something that would have been detected by the kinds of studies that were being run on new variant vaccines. The serious side effects that have been seen with Covid vaccines have been incredibly rare – think 1 case in 100,000 or 1 million. They emerge only when a vaccine is in wide use. At this point, the mRNA vaccines have been given to billions of people.
This is, incidentally, the mistake made by the Wall Street Journal’s recent op-ed calling out liberals who were worried President Trump would approve vaccines too quickly for not being upset about the BA.5 boosters. Some of them, no doubt, are upset, but there’s a big difference between authorizing a new version of an mRNA vaccine without human data and rushing the first mRNA vaccines ever. Two years ago, we had no idea whether they would prove safe.
The side effect most clearly linked with the mRNA vaccines is a condition called myocarditis, an inflammation of the heart. Serious cases are rare, but seem to occur most often in males in their late teens and early twenties. It’s fair to ask if young men should wait longer between booster doses, and it’s also fair to ask if the Pfizer and Moderna vaccines have different risks here. The FDA and CDC do not believe there is a difference, but some other countries use the Pfizer vaccine preferentially in boys and men in this age group.
But for most people, these issues are quibbles. With many debates during the pandemic — remember the complaints that the FDA wasn’t moving fast enough to approve vaccines? — the answer has turned out to be that a decision had to be made and we had to live with it.
What is true is that we should be getting better explanations of myocarditis and how to prevent it. And someone should be running a good randomized controlled trial so that we know whether the BA.5 boosters are better than the BA.1 boosters are not. Likewise, it seems awfully early to be talking about whether people should get annual boosters from now on
The problem with a lot of the discussion about the vaccines is that it takes studies, commentaries, or, God forbid, memes, and isolates them from what’s really known. This springs from our social media networks, from our politics, from the increasingly fragmentary nature of our society, from a need to see everything in black and white. The only comfort is that it’s not new.
A hundred years ago, shortly after his pregnant wife became ill during another once-in-a-century pandemic, William Butler Yeats wrote a poem about how everything seemed to be falling apart in the wake of World War I. “Things fall apart; the centre cannot hold,” he wrote. And later: “The best lack all conviction, while the worst are full of passionate intensity.” It felt, literally, like the end of the world. “What rough beast, its hour come at last, slouches toward Bethlehem to be born?”
It wasn’t the end of the world. The center can hold. Less poetically? Even if mistakes were made, we still need these vaccines. Don’t be afraid to roll up your sleeve.