American parents are justifiably wondering why the United States hasn’t authorized Covid-19 vaccines for children under 12. Given the spread of the Delta variant and the recent increase in Covid-19 cases among children in the United States, their concerns are growing more urgent by the day.
Hospitalizations represent pain and suffering for children and their families and further strain hospitals and I.C.U.s. The Food and Drug Administration rightly responds that children are not adults and that dosing needs to be considered carefully for young children’s smaller, different bodies. There’s also concern over possible rare side effects like heart inflammation. Less convincing, given the fast spread of Delta, are the F.D.A.’s requests for up to six months of child vaccine clinical trial safety data, rather than two, and larger sample sizes. (Pfizer-BioNTech said on Monday that its vaccine is safe and effective in children 5 to 11 years old and that it will apply for emergency authorization by the end of the month.)
The F.D.A.’s critics, including the American Academy of Pediatrics, have called on the agency, when deciding on the authorization of the children’s vaccines, to consider the data that’s already produced, because the threat of Delta is so severe. But they miss the central problem, namely the disconnect between what the US public health system is built for and the threat that Covid-19 poses.
There’s a reason that America’s system of drug development and approval has been emulated the world over. Drug approval is not an on-off switch that allows a treatment with known, measurable benefits simply to be released to work its magic. It’s a process in which the very benefits of the treatment get discovered and, beyond that, specified so that when the drug becomes available, it’s the best version possible. Drugs and vaccines don’t work unless they are given at the right dose and people trust the process — and the F.D.A. — enough to take them.
Covid-19 has exposed a structural weakness in this system. Health authorities in the United States usually approve drugs and vaccines for diseases that are much better understood than Covid-19, such as bacterial infections, heart disease and cancer. When new treatments emerge for these diseases, there are generally adequate existing treatments or more time than Covid-19 allows. This is a different beast. No systemwide pathogenic assault on American society like Covid-19 had appeared since the Spanish flu of 1918.
The system the United States developed is not adapted to Covid. Vaccine authorization started with the 1902 Biologics Control Act and evolved through a set of institutional developments, including phased studies that progressively examine questions of safety, efficacy and dosing and that were initially developed for drugs and treatments like antibiotics and chemotherapy. The emergency use authorization mechanism, or E.U.A., was used to release Covid-19 vaccines, but even that was a makeshift solution to a different problem. The E.U.A. was created after Sept. 11 and was set up to respond to biological warfare. If terrorists released a pathogen, the thinking went, the United States could quickly authorize a preventive drug or treatment. As the nation has seen, the E.U.A. mechanism can be subject to abuse, as it is vulnerable to interference by political appointees and sometimes the president.
Diseases like Covid-19 require a strategy designed for pandemics, which can become massive and diffuse extremely quickly. A pandemic-centered authorization policy could draw upon E.U.A.-like quick decisions but do at least three things more.
First, recognize that demands for data before authorization should be adapted to the severity of the crisis. The major roadblock to the authorization of vaccines for American children is not the F.D.A. sitting on data it already has; it’s the required length of the clinical trials and number of children needed to examine the safety and efficacy of the vaccines for kids. Congress should create an authorization track that explicitly recognizes the need for flexibility in a pandemic.
Second, the F.D.A. should have the power to push drug companies to test new vaccines in adolescents and children as soon as possible. Covid vaccine trials for children should have started much earlier, in the spring or summer of 2020, which would have allowed for more than six months of safety data. Giving the F.D.A. or another agency power to compel testing of a new vaccine earlier in children — including the ability to issue hefty fines for noncompliance — would align companies’ incentives with the health needs of the public.
Third, a new approval system should address any resource shortages at the Center for Biologics Evaluation and Research, the F.D.A. division that reviews vaccines. In part because the F.D.A. receives fees from pharmaceutical companies that seek to have new drugs approved — and there’s a larger pipeline for drugs than for vaccines — Congress has invested more in the drug division than the biologics division. The center has experienced greater turnover and reduced hiring relative to its drug counterpart. Congress should either greatly increase the set of permanent scientists available to approve vaccines or, in true emergency mobilization style, create a force of reserve scientists who can be called into action to review new drugs and vaccines in the event of a pandemic or other crisis.
What Congress should not do is give credence to claims that the F.D.A. is too cautious or that the agency is holding on to some gilded past in which it shielded the country by not approving thalidomide, a drug that was available in many other countries and was later tied to birth defects.
These interpretations anthropomorphize a complex organization operating under the rule of law in our democratic republic. That very organization and that very republic have provided Americans with a trustworthy marketplace for therapeutics, one in which innovations can thrive precisely because they are credible. Claims that the F.D.A.’s caution is killing us risk enabling a darker agenda of ideologically driven deregulation.
None of this is to take the F.D.A.’s leadership off the hook. If agency officials continue to insist on up to six months of safety data while Delta rages, they deserve every ounce of criticism that will rain upon them. But America needs a system that recognizes Covid-19 as a different kind of threat.
The New York Times
