Once again, the FDA and the CDC have joined forces to shit the bed when it comes to managing the COVID pandemic. On April 13th, the two agencies issued a joint statement recommending a pause in administering the Johnson & Johnson COVID vaccine. Their recommendation comes after learning that out of over 6.8 million doses of the vaccine being administered, there have been six cases reported of patients developing serious blood clots with one death.
If the statistical odds those numbers present weren’t enough to make you righteously angry, the six cases in question give some clues as to who needs to be concerned. All six cases were in women between the ages of 18 and 48 who were reportedly on hormone-based birth control. Instead of issuing guidance to that specific group of people, the FDA and CDC decided that administering the J&J vaccination to any person needed to be delayed until further notice out of “an abundance of caution” while also noting that the adverse side effects are “very rare.”
The surprise announcement has created nothing short of a disaster -- the J&J vaccine is vital to getting access to rural and low-income areas that lack the infrastructure for transportation and storage of the mRNA vaccines, and mobile vaccination sites also rely heavily on the J&J vaccine. And it is not only those rural or low-income areas that will suffer; colleges and universities who received stock of the J&J vaccine to administer to students before they leave campus for summer vacation had to put those plans on hold. The J&J vaccine is particularly attractive to college students, as a one-shot vaccine eliminates the logistical concerns of having to schedule a second dose before leaving campus.
And of course, the J&J vaccine is the most appealing option for those who are not comfortable with the mRNA options, or who can’t commit to a two-dose vaccine regime for health or scheduling reasons. Mass vaccination sites and pharmacies have offered to switch patients to one of the mRNA vaccines while the FDA and CDC complete their research but that is not an ideal solution for most patients who chose the J&J vaccine over the two-dose mRNA options.
On top of creating chaos for those who already had appointments for the J&J vaccine, the announcement has caused public trust in that vaccine to drop 15 points per a YouGov survey of opinion on the J&J vaccine pre-and-post announcement. Before the announcement public perception of the J&J vaccine was at 52% safe to 26% unsafe, after the announcement public perception dropped to 37% safe to 39% unsafe. This should come as no surprise to anyone who is aware of how the general public consumes news; typically only the topmost layer of a story makes it into the public consciousness, for this story that layer is “the government halted the J&J vaccine because it is bad.”
The decision to halt administering the J&J vaccine doesn’t solely affect those in the US -- the decision is deepening skepticism of the vaccine worldwide. The J&J vaccination is the one that global health advisors were counting on to help vaccinate those in poorer countries where mRNA vaccines are not practical options. For those counties, many already fighting an uphill battle against vaccine hesitancy, the decision by the FDA and the CDC is a major setback.
If the goal is to reopen nationwide this summer, April and May are the critical months for mass vaccination. At a time when overcoming vaccine hesitancy should be the top goal of any messaging coming out of the federal government, this senseless halting of the J&J vaccine to everyone is borderline suicidal to the cause of getting as many jabs into arms as possible.
I can understand the FDA and the CDC want to take a cautious approach but there was a way to do that without causing a panic -- simply release an announcement alerting everyone to the six cases, urging vaccine providers to use already existing communications methods to push the information to those who had J&J vaccinations scheduled, and let individual patients choose to either reschedule or go forward with the vaccine. That’s it. It was that simple.
Instead, the two government agencies that bear the brunt of the responsibility for letting COVID get out of hand in the US are now hamstringing the efforts to bring the pandemic to an end. Once this pandemic is over -- and I still believe that will come sooner rather than later -- there has to be a reckoning and a deep overhaul for both the FDA and the CDC. Their failures during the COVID pandemic have been too large and too consequential for anything else to be acceptable.