Earlier this week, the Food and Drug Administration called for a break in using the Johnson & Johnson Covid-19 vaccine, to assess its association with extremely low risks of serious blood clots. Wednesday, this the break was effectively extended for another seven to ten days. Many fear that the FDA’s decision to temporarily halt distribution in the first place has unnecessarily sidelined a key vaccine in the midst of a pandemic. It slows down the rate of vaccination and potentially increases reluctance to vaccinate, which makes it more difficult to reach the threshold of herd immunity, even if Johnson & Johnson is subsequently cleared for use.
But what critics lack is that difficult decision suspending Johnson & Johnson’s vaccination while assessing safety concerns may, counterintuitively, help United States defeats Covid-19. This incident should Inspire confidence among Americans that the FDA takes seriously all safety concerns, no matter how rare or unlikely. Increased confidence in the system would allow the FDA to be more effective regulator and help bring the pandemic under control, even if it comes at the expense of confidence in Johnson & Johnson vaccine. In addition, the potential fallout from the hiatus can be mitigated in several ways, which will also have positive spillover effects on combating the pandemic and improving public health in general.
It is important to remember the FDA larger objective. The agency is responsible for regulating medical, cosmetic and food products, the use or consumption of which, for the most part, cannot be canceled. If the FDA has to revoke an authorization or approval, the fallout could be big—Both in terms of FDA reputation and impact on US consumers. In order to feel confident enough to get the vaccine in the first place, most people should be sure that the authorization or approval decision will not be overturned in the future. Even the occasional reversal could make people much more nervous about getting the vaccine. So it makes sense for the FDA to act very cautiously and take even seemingly extreme measures, such as delaying a decision, to avoid having to do so. In light of these considerations, the FDA’s decision to suspend Johnson & Johnson while it conducts a data review is justifiable.
An efficient FDA relies heavily on trust, which is difficult to find if lost. Few Americans have the time or the expertise to self-assess the scientific evidence on the safety and effectiveness of vaccines. Being prudent in a transparent and predictable way makes it easier for the public to interpret and feel confident about FDA decisions, which in turn drives uptake of licensed and approved vaccines. Suspend Johnson & Johnson vaccinations while data is reviewed, despite potential repercussions of canceled vaccination appointment, sends a clear message that the FDA takes all safety concerns seriously. An assessment could have been done quietly or without interrupting vaccinations, but transparency, even in the face of bad news, or especially in the face of bad news, inspires confidence in the system.
It is also essential to keep in mind that Johnson & Johnson is not the only vaccine under the supervision of the FDA. Any misstep affecting trust in the agency would therefore be extremely costly, affecting the perception of Americans. all Covid vaccines. Carelessness in addressing safety concerns for one vaccine could undermine confidence in other approved vaccines, most of which we will rely on long after the pandemic is over. Not to mention that the FDA is also responsible for all drugs, medical devices, cosmetics, and the food supply, so the ripple effects of a loss of confidence could spread widely and harm the public health of countless ways on the road.
So what is at stake in the Johnson & Johnson decision is more important than most people realize. Failure to stop when perceived to be necessary would tarnish the reputation of the FDA and undermine confidence in its other decisions. Sacrificing consumer confidence in the Johnson & Johnson vaccine to preserve or even increase confidence in other licensed Covid-19 vaccines would be an interesting compromise.
The fact that we are in the midst of a pandemic raises the issues of FDA decisions but does not change the fundamental balance of those considerations. the Emergency use authorization This pathway allows vaccines to be authorized for use in a public health emergency before the full approval process is complete. Deviating from the norm, a trusted EUA process could increase the likelihood of a later reversal of the decision, potentially undermining trust in the FDA when we need it most. A short delay, then, is worth it: we have imperfect substitutes for vaccines, but there is no substitute for reliance on the FDA.