Califf Final Essay Touts Covid Vaccines
In what may be one of the last actions by FDA commissioner Robert Califf before he resigns his post ahead of the incoming Trump administration’s start date next Monday, the commissioner has posted a comprehensive essay and personal reflection on the safety and effectiveness of Covid-19 vaccines.
Califf’s essay asserts that “vaccination substantially reduced risk and those who received updated vaccinations had fewer of these outcomes (death, hospitalization and long Covid than those who did not receive the updated vaccination. For every recommended booster or updated vaccine, although the magnitude of benefit declined over time, a major benefit was observed over the course of the pandemic for prevention of death and hospitalization.”
Califf’s essay also examines the Covid vaccine’s effect against “long Covid,” which he says has “affected millions of Americans, including many children, with well-documented and devastating consequences for quality of life. Analyses consistently show that vaccinated persons have a substantially lower rate of long Covid than unvaccinated people; further, those who received vaccine updates/boosters had lower rates of long Covid than did those who did not receive the updates… The absence of effective treatment for long Covid reinforces the importance of preventing it.”
Regarding the vaccine’s safety, Califf addresses the occurrence of myocarditis and pericarditis that are most frequently observed in young men. “However, to date, long-term outcomes appear favorable compared with other types of myocarditis and pericarditis,” he writes. “This safety signal emerged early in the deployment of the vaccines, particularly after a second dose. Importantly, across the age spectrum, the overall rate of cardiovascular events is lower in people who have been vaccinated compared with those who have not been vaccinated and lowest in people who have received the updated vaccine.”
Addressing what the future holds after losing almost 1.2 million U.S. citizens to the disease, Califf says the evolving virus continues to cause serious illness and death globally, and in the U.S. While Covid was still a top 10 cause of death in 2023, it will likely drop out of the top 10 with 2024 is fully analyzed, he says. “After a recent lull in viral activity, we are experiencing a resurgence, which in tandem with the upswing in influenza and respiratory syncytial virus, in addition to the threat of H5N1 transmission, could portend a risky winter,” he writes. The low acceptance of the current updated booster vaccination this year will likely leave many people vulnerable this year, he says, adding that it is incumbent upon clinicians to recommend updated annual vaccinations.
Califf recommends that based on the majority of Americans not choosing to receive the updated vaccines or boosters, it might be time to conduct a large trial comparing the next proposed update with placebo ad obtain an updated benefit-risk calculation and “specific information about populations that have been the source of most intense skepticism.” He also calls for more focus on the “clinical epidemiology of vaccine-associated adverse outcomes to sort out when the events are caused by the vaccine versus events that would have occurred anyway, to better understand risk factors for these events and to devise effective interventions. Similar continued focus on long Covid is also essential because of the enormous toll it is taking across the age spectrum.”