Opinion | Why the FDA made the right call on Covid booster shots

Opinion | Why the FDA made the right call on Covid booster shots

A Food and Drug Administration advisory group on Friday voted against calling for all adults to get a Covid-19 booster shot, after President Joe Biden announced last month that booster shots would be made widely available starting Sept. 20. At the time, he also said federal health authorities were considering approving a shortened timeline for boosters to allow Americans to receive a third dose of the Moderna or the Pfizer vaccines as soon as five or six months after full vaccination.

To give one powerful and overlooked example of the destruction Covid is causing beyond illness and death, consider what’s happened to girls who are forced to endure female genital mutilation.

The idea of ramping up booster shots has come under sharp criticism from scientific authorities around the globe, including the director-general of the World Health Organization and leading journals such as Nature and Science, due to extreme global vaccine inequity and the unclear benefits of providing booster shots on such a wide scale. Hopefully the decision on Friday, though not binding, will cause Biden to rethink his plans.

Though the White House has said it’s a false choice between boosters and vaccines going abroad, since U.S. vaccine donation plans continue, the fact remains that as of now, the 52 least-wealthy places have 20.5 percent of the world’s population but still only 3.4 percent of the vaccines. Meanwhile, the U.S. has 4.6 doses for every American.

The U.S. has countered criticism by pointing to efforts to increase vaccine manufacturing capacity abroad and focusing on long-term financial investments. These steps are helpful, but the most useful action to control the pandemic is increasing total global vaccination immediately.

A more targeted approach to distributing boosters is better than distributing boosters to all Americans given that the existing vaccination regimen is still extremely effective in preventing severe disease, while the evidence in favor of booster shots is either lacking or incomplete. The data is evolving on how much immunity wanes and what the utility and benefits of an additional shot will ultimately mean. Meanwhile, when fully vaccinated Americans get Covid, those without additional risk factors overwhelmingly experience only mild versions of the disease.

Mindful of this reality, at the beginning of September, both the FDA and the Centers for Disease Control and Prevention recommended scaling back Biden’s planned booster rollout to focus on groups most likely to benefit from the extra shot, such as older adults and immunocompromised individuals, for now. The FDA panel backed that targeted approach again on Friday.

On the other hand, the data is clear that primary vaccination is vital: vaccinated people are eight times less likely to be infected and 25 times less likely to experience hospitalization or death. Prioritizing boosters for all Americans over international donations amounts to choosing a potentially marginal benefit for the world’s rich over the very lives, health and well-being of the world’s poor.

The U.S. decision also has human rights consequences beyond the ravages of the disease itself. To give one powerful and overlooked example of the destruction Covid is causing beyond illness and death, consider what’s happened to girls who are forced to endure female genital mutilation or cutting.

The United Nations calculates that 2 million additional instances of the practice, in which the external genitalia of young girls are removed or injured for nonmedical reasons, will occur in the next decade due to the pandemic’s disruptive effect on schools and programming that works to diminish its use. These programs — which, when rooted in local culture, make a significant difference in decreasing the practice — cannot operate in a pandemic, and the longer it goes on, the more girls are stranded at home and at risk.

Multiple studies have shown that female genital mutilation can cause lasting physical and psychological damage, such as perineal tears, pain while urinating, difficulties giving birth, post-traumatic stress disorder, anxiety and depression. Unfortunately, many of the countries with the highest prevalence (western, eastern and northeastern regions of Africa, as well as some countries in the Middle East and Asia) have very little vaccine supply. Somalia, where 98 percent of women between the ages of 15 and 49 have undergone this procedure, has a population of which only about 1 percent is vaccinated; Burkina Faso, with 76 percent prevalence of the practice, has only about half of a percent of its population vaccinated.

It’s hard to argue that protecting already vaccinated Americans from the possibility of contracting mild Covid should outweigh the lives of people in poorer countries, as well as their human rights and physical safety — like those of young girls at risk of female genital mutilation. It also is dangerously shortsighted: New variants rise from places with low vaccination rates and spread around the world.

The Biden administration must shift from a widespread domestic booster campaign to a more targeted one — focusing on providing booster shots to vulnerable individuals in the United States such as the immunocompromised or elderly, and emphasize providing efficient and widespread coverage abroad.

More than 175 health experts in August urged the administration to scale up U.S. production of vaccines, to help set up manufacturing hubs around the world and to export 10 million vaccines a week via global vaccine-sharing programs (far exceeding the administration’s August total of 110 million doses donated so far).

Following the FDA recommendation is both smart science and would show that the U.S. commitment to human rights will not wane even in difficult times. We are still the wealthiest country in the world, and it is both naïve and unconscionable to let the least enfranchised among us — including girls whose very bodily integrity is under threat — suffer while we enjoy excess.

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