The main complaint lodged against Donald Trump’s response to the pandemic is that he didn’t “follow the science.” Joe Biden has promised repeatedly to do so. But when it comes to the pandemic, there is a catch: there are conflicting scientific opinions, and our main governmental institutions in charge are having trouble deciding among them. Faced in the last months with the Delta variant, the Biden administration has not performed so well.
It was late in appreciating the threat that the Delta variant posed. Even though the virus was raging through India by May, the Center for Disease Control (CDC) declared that the vaccinated needn’t wear masks, and Biden called for a “summer of freedom” from COVID, to be celebrated on July fourth. On May first, the CDC stopped trying to track the vaccinated for infection, limiting its data collection to those who were hospitalized, even though there was evidence from India of “breakthrough” cases in which the fully vaccinated were being infected and hospitalized. On May 22, a top CDC official said there was “insufficient data to evaluate with a high degree of confidence whether these lineages are variants of concern.”
By July, the Delta variant had taken hold in the United States, and cases of hospitalization and death were soaring. Those who followed sports knew that breakthrough infections were occurring, but the CDC didn’t seem to take notice until there was a widespread outbreak among gay celebrants in Provincetown in early July. At the same time, in Israel, where 78 percent of the population over age 12 had been vaccinated, a fourth wave of the virus hit. Many of these infected had received two doses of the Pfizer vaccine. By late August 59 percent of the people hospitalized in Israel had been vaccinated — a shockingly high number.
On the basis of Pfizer’s finding that a third dose would increase immunity as much as tenfold, Israel began giving third doses to its citizens, and initial findings showed that the boosters had slowed the rise of the virus. Germany, France, and the UK, citing Israel’s experience, have followed suit. In August, the Food and Drug Administration (FDA) announced that “immunocompromised” Americans could receive the booster, and the White House, supported by the FDA and CDC leadership, announced it would begin offering boosters on September 20 to those who had received the second dose eight months or more before. Reflecting some confusion, that requirement was changed to five and then to six months.
The White House announcement provoked a raging conflict among doctors, scientists and public health officials about whether a booster was needed. The conflict spread inside the FDA itself. Some of the doubts expressed echoed those of the WHO Director-General who called for suspending boosters in the rich countries while the poor countries were unvaccinated. But many of the critics of the White House announcement argued that the United States needed to see evidence in the United States of waning immunity rather than rely on the Israeli data. Marion Pepper, a University of Washington immunologist, told NPR, “I think we need data. I think we need to see, are people actually getting sicker? And I don’t know that anyone has shown that really effectively.”
Pepper seemed to be suggesting that the Israeli data was irrelevant. She also appeared to suggest that what happened to the vaccinated in Israel might not happen in the United States. Her position and that of other critics of the Biden decision recalled that of public health experts who doubted whether the original Wuhan virus would spread to the United States or later whether the Delta variant would take root here. Their criticisms also seemed based on a kind of national turfmanship. Eric Topol of the Scripps Research Institute, a critic of the critics, remarked, “It’s interesting to watch certain FDA scientists and certain public health experts diss or harshly critique waning vaccine effectiveness and third shot data from Israel and the UK when they have no national data of their own.”
At the public meeting of the FDA’s advisory committee last Friday, there were understandable objections to extrapolating the Israeli data, concentrated among older people, to younger people, but there were also less compelling and turf-like objections to taking the Israeli data seriously. Several of the scientists noted that Israel was different from the United States because more of its citizens were vaccinated. To be sure! But Israel’s experience seems to suggest that a fourth wave could break out even among our more vaccinated populations in the Northeast or Far West. Other advisory panel members noted that Israel had a slightly less stringent definition of a “severe” case than the United States did. In view of the fact that almost 60 percent of the hospitalized in Israel had received two doses, that seemed like a quibble.
The panel rejected Pfizer’s request to authorize a booster for everyone over age 16 in favor of limiting the dose to those over 65. That decision itself was peculiar. During the panel discussion, scientists who had opposed the blanket authorization stated their support for a 50-year-old or 60-year-old starting point. The Israeli data for severe illness pointed particularly at those over 60. But the FDA officials who ran the session proposed a vote on the higher 65-year-old limit. That was certainly a beginning, and better than rejecting boosters outright, but viewed from the outside by a layman like myself, it seemed that the United States has continued to play defense rather than offense in battling this virus. The government reacts slowly and partially when the outbreaks finally occur rather than anticipating that they will. It waits, as Pepper advocates, for people “actually getting sicker.”
The decision also applies only to Pfizer recipients, not to those who received the Moderna or Johnson & Johnson doses. That reflects customary procedure. Neither of the other companies have submitted data yet to authorize another dose. But again — viewed from the outside — one has to wonder. There is good evidence that the Moderna vaccine, which came in a larger dose and at a greater interval, has sustained its effectiveness longer than the Pfizer vaccine, but there is also good evidence that the Johnson & Johnson vaccine is significantly less effective than either of those vaccines. In San Francisco, public health experts have allowed Johnson & Johnson recipients to receive a second dose of one of the other vaccines, but nationally, the FDA and CDC have taken no action.
Some of the critics of boosters complained that the government’s priority should be vaccinating the unvaccinated. That’s certainly true, but the numbers of the unvaccinated are not due to a lack of supply, but of demand. The problem can best be met by state and federal mandates that force people who want to enter the public sphere — whether in schools, workplaces, restaurants or airplanes — to be vaccinated. There is, of course, sharp political opposition, but the opponents represent a distinct minority of public officials and voters. If I were to propose a good bipartisan guideline for how the administration should proceed, I would suggest asking themselves, “What would Theodore Roosevelt do?” Roosevelt was president at a time of political ferment and fragmentation in the United States. But he enjoyed great popularity because of his decisiveness.
In its deliberations over the boosters, the FDA excluded discussion of the WHO’s position on giving priority to low-income nations. There is a good national interest argument to be made for increasing the supply to these nations. New waves and mutations of the virus can easily spread from these nations to the United States and other wealthier nations. But many of the vaccine doses that could be used for boosters in the United States are already sitting on shelves in hospitals and drug stores. The global problem can best met by the pharmaceutical companies increasing production. Former CDC Director Tom Frieden remarked on twitter, “We MUST increase global vaccine supply through tech transfer—especially mRNA vaccines. Donations are not enough. So far, the US has failed to increase manufacturing. Neither Pfizer nor Moderna have behaved as good corporate citizens.” The Biden administration might consider invoking the Defense Production Act.
In the debate over boosters, what I heard from critics of the Biden administration’s August decision was a lack of urgency about ending the pandemic. Biden and the administration have themselves displayed a tentativeness. Why not require, for instance, that airline passengers be vaccinated? Why allow a weekly test to substitute for vaccination? Why has the administration still not appointed an FDA director? Biden and the Democrats’ own political future will depend on life in the country getting back to normal. Masks, lockdowns, overflowing ICUs, shuttered small businesses — the shadow over our lives cast by COVID-19 can’t be allowed to go on. That’s a sentiment shared by the vaccinated and unvaccinated alike.