reality check 10 13 2021
Avlon: Mandates work. We have the data to prove it
04:00 - Source: CNN

Editor’s Note: Robert Klitzman is a professor of psychiatry and director of the masters in bioethics program at Columbia University. He is author of “Designing Babies: How Technology is Changing the Ways We Create Children.” The opinions expressed in this commentary are solely those of the author. View more opinion articles on CNN.

CNN  — 

“We’re all triply-vaccinated!” friends gleefully told me last week, as they invited me to their home for dinner. They were thrilled. I had rarely seen such big smiles since the Covid-19 pandemic began.

Robert Klitzman

As recipients of the Pfizer vaccine, they became eligible for a booster dose starting in late September. Since then, millions of others have been waiting with great anticipation to know whether the US Food and Drug Administration would approve boosters of other Covid-19 vaccines as well.

This past week, one step closer: Advisers to the FDA recommended the agency authorize additional doses of the Moderna and Johnson & Johnson vaccines for emergency use. In the former, for individuals 65 or older, other adults at high risk for severe Covid-19, and those who live or work in a place that puts them at high risk of complications; and in the latter, for all those 16 and older.

These are important developments, but they arrive at a time when major challenges remain, since about 66 million American adults have still not yet been fully vaccinated. Forty-six percent of Whites, 49% of Hispanics and 54% of Blacks in the country have not yet gotten a single shot. While my friends were delighted to receive extra protections and invite other people to dinner, much of the country remains wary.

To overcome the growing pandemic, we as a nation must all now push to address this widening gap.

Part of the problem is wide public misunderstanding of how science works. It’s extraordinary how quickly scientists developed these shots, which have proven to be enormously effective in preventing severe Covid-19 infection and subsequent death.

Yet vaccine opponents are in fact using the push for boosters to argue that the vaccines are ineffective. The Kaiser Family Foundation recently asked Americans how they viewed the news that some people might need a booster. Roughly two-thirds of all respondents said it shows that scientists are still finding ways to make vaccines more effective – while one-third said it shows the vaccines are not working as well as promised. The vast majority of anti-vaxxers (82%) and the vaccine hesitant (69%) saw this news as an indication the vaccines are not working as promised.

This negative perception of boosters suggests a growing divide that public health leaders, physicians and elected officials need to try to correct.

Just like the SARS-CoV-2 virus is constantly mutating, so, too, is our scientific knowledge of the evolving pandemic. Science is a constantly moving enterprise, involving inherent uncertainties. Researchers rarely know all the answers. Rather, discovery generates more questions – just as removing the outer layers of an onion reveals more layers underneath.

Yet the Pew Research Center found, for instance, that unvaccinated individuals look very negatively at the fact that public health officials have consequently changed their Covid-19 recommendations over time. While two-thirds of the vaccinated think these shifts make sense, since scientific knowledge is constantly being updated, only a third of unvaccinated individuals believe the same. That indicates that these changes leave 75% of unvaccinated people less confident in officials’ statements about the pandemic. And 63% of the unvaccinated end up confused.

Unfortunately, such murkiness makes many people uncomfortable. Difficulties tolerating ambiguity have in fact been associated with increased levels of stress among medical trainees and others.

Political leaders, the FDA, the US Centers for Disease Control and Prevention, public health officials and the vaccine-manufacturing companies themselves thus need to figure out how to communicate about our ever-altering knowledge on Covid and its prevention, and how science often entails uncertainties.

For example, Johnson & Johnson pursued development of a vaccine that required only one shot versus two in order to simplify the logistics of administration. It was an important strategy. Unfortunately, that single dose now appears less effective than Moderna’s or Pfizer’s two-shot approach. The FDA’s advisory committee has not determined whether it would be best for Johnson & Johnson recipients to now get the same shot or a different one. More data is needed. Yet communicating about these uncertainties will be critical.

Officials could point out, for instance, that many vaccines require multiple shots. Vaccines for hepatitis A and varicella (chickenpox) always require two doses; human papilloma virus can require two or three; and hepatitis B can require up to four.

Some scientists are also not convinced there is a definite need for a Moderna booster. While the FDA authorized a third dose of the Pfizer vaccine, the Moderna one is notably different. Research published in the New England Journal of Medicine last month showed that Pfizer was 88.8% effective, while Moderna was 96.3% effective among health care workers. Moderna argues a booster could restore immunity as it declines over time.

But, given the newness of the pandemic, the Delta variant and the vaccine itself, data to support these claims has been somewhat limited. Third shots increase antibodies, which presumably will strengthen the body’s resistance and reduce even mild symptoms, but data showing these differences will probably take weeks or months to accumulate.

While we wait for what the science will bear out, however, critics have also argued that Moderna has placed profits ahead of global public health needs. Most of the company’s vaccines have gone to wealthy countries. The corporation has also charged middle-income countries such as Thailand and Colombia more than the United States or the European Union. (According to The New York Times, Moderna says it’s doing all it can to “make as many doses as possible as quickly as possible,” and that it’s “currently investing” to increase production.)

According to one report, only about 1 million Moderna doses, compared to 8.4 million Pfizer shots and 25 million Johnson & Johnson doses, have gone to lower-income countries. There’s no question that an emergency use authorization for the booster shot would benefit Moderna’s bottom line – especially since almost all of the research and development for the vaccine has already been done. In increasing its sales and profits, Moderna should proceed very carefully, given growing anti-vax sentiment.

In around six months, companies will likely seek FDA authorization for fourth, not just third, shots, a measure already happening in Israel. Given that parts of the public are already wary, companies should be careful not to put profit over public health – to make sure data supports their arguments for ongoing boosters.

We also need to consider not just whether the booster shots are safe enough but how much to push additional shots as opposed to other approaches – particularly as we weigh what else we must achieve to ultimately defeat the pandemic. For example, how much effort and expense should federal, state and local governments spend on getting fully vaccinated people boosters, and do those benefits and costs always outweigh those of getting unvaccinated people their first shot? Local public health officials have told me that they are already confronting these questions.

Uninoculated people include tens of millions of eligible Americans, as well as billions more worldwide. Some critics may argue we should prioritize, by far, getting third shots for Americans. But given how interconnected our world has become and how easily Covid-19 spreads, virulent strains that develop elsewhere will undoubtedly find their way here, too.

Despite the FDA’s decisions, challenges in the global vaccination drive will continue – including the need to communicate and educate people about these realities.

The FDA, the CDC and political and public health leaders should get further input from media, communications and advertising experts to devise messages that are as effective as possible. Those of us who have been vaccinated also undoubtedly know some vaccine refusers with whom we should also try to address these misperceptions.

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    These wholly unprecedented times require not only sound decision-making, but clear and transparent messaging to help all Americans, regardless of politics. The medical community, political leaders and others need to not only assess the ever-expanding and evolving data about boosters, but determine how best to present their decisions in ways that can ultimately enhance the health of individuals on both sides of our nation’s growing vaccine divide.