According to official statistics, the US has lost nearly 570,000 souls to COVID-19-related deaths, and the number continues to climb with each passing day. But the Food and Drug Administration only recommended a temporary strike on one of the potentially life-saving vaccines currently being distributed to millions.
The Johnson & Johnson vaccine has been approved by the FDA under an emergency use authorization. However, its use can now be discontinued.
“We recommend an interruption in the use of this vaccine out of an abundance of caution,” the FDA said wrote in his statement.
Many states and communities responded immediately to the news by canceling the scheduled distribution of the Johnson & Johnson vaccine.
As of 4/12, 6.8 million doses of the J&J vaccine have been administered in the U.S. CDC and FDA, and it reviews the data related to 6 reported U.S. cases of a rare and severe blood clot in individuals after receipt of the vaccine. At the moment, these adverse events seem to be extremely rare
– US FDA (@US_FDA) 13 April 2021
Why they are blocking the vaccine
Why is the FDA taking this step? Because six of the more than 6.8 million Americans who received the Johnson & Johnson vaccine are experiencing severe blood clotting problems, one of which is fatal.
“All six cases occurred in women aged 18 to 48 years, with symptoms developing six to 13 days after they were given the chance,” CNBC said. report. In a statement, Johnson & Johnson said that “no clear causal link” between the vaccine and the blood clots had been identified.
However, health officials are concerned that these types of blood clots can be life-threatening and require treatment other than normal blood clotting. They hope that by taking time to study the possible consequences, they can better inform doctors about what to look for and further analyze any possible risk.
To put the risks in context
Although we assume that the six cases of blood clotting can be directly attributed to the vaccine not established, it is hardly an abnormal risk level for general medicine.
While the Johnson & Johnson vaccine, for example, has a one-to-a-million or less risk for blood clots, based on current reports, common contraceptive drugs are contraceptive holds a 1 in every 1000 coagulation risk. And so rare incidents because the lightning was struck by a comet or killed by a comet, it is significantly more frequent than the blood clotting of the Johnson & Johnson vaccine.
There seems to be a minimal risk that people will have to decide for themselves.
What Johnson & Johnson will stop will mean
Some experts have warned that the government’s decision to halt Johnson & Johnson’s vaccination efforts will significantly hamper the deployment process, and it will take longer before we stop the transfer of COVID-19.
“This will slow down our vaccination efforts,” said Dr. Kavita Patel, an NBC medical news analyst, warned Tuesday. There are two other major vaccines, Pfizer and Moderna, that could eventually get a slack, but she said “it will take time” because “in the next one to three weeks we can not replace them.”
There are also benefits to the Johnson & Johnson vaccine as alternatives.
Unlike Pfizer and Moderna, it uses old-school vaccination technology, not the newfound MRNA technology that some are skeptical about. Thus, while the other two appointments require two weeks apart, the Johnson & Johnson vaccine is administered in a single dose, which is a great logistical benefit for the vaccination.
The “halt” is a major obstacle to getting every American who wants to be vaccinated in time.
The FDA does a very bad cost-benefit analysis
There are no easy solutions in public policy, only compromises. As a result, policy making always requires the costs and benefits carefully. With this latest move, it appears that the FDA has committed the cost-benefit analysis incorrectly.
If you put the Johnson & Johnson vaccine aside for just a few weeks, it can have serious consequences. More spread of COVID-19 will occur than when vaccination is allowed, and it is likely that some individuals who could be protected would die in the meantime.
“The benefits [of the vaccine] at the moment it weighs even heavier than potential risks because we have already lost more than half a million people to coronavirus, ”said dr. Janette Nesheiwat said. tell Fox Business. “For some groups, for some populations such as those over 65, the benefit of this vaccine will still outweigh any potential risk.”
“It is also important to understand again that only six cases of more than six million have been given,” the medical expert continued.
As she rightly points out, the cost of spreading the vaccine is small: only 6 out of millions have reported the negative side effect – and it has not even been proven to be directly related. The damage mitigated by blocking the vaccine basically seems negligible.
“The FDA is really aggressive in ensuring the safety of Americans,” Nesheiwat ended. ‘But as it is now, the benefits [of the vaccine] outweighs the risks. ”
Interestingly, many policy analysts and media commentators from across the political spectrum have drawn the same conclusion: the FDA has clearly misunderstood this one, and the consequences can be deadly.
It’s worth investigating why the government failed here – and why it was predictable.
Unreasonable risk aversion is a feature, not a mistake, of the FDA
The FDA is systematically prone to this type of institutional dysfunction because the incentives it faces reward excessive precaution. In essence, it fails to accurately weigh the costs and benefits, because some costs, such as bad publicity if it allows harmful treatment, are borne directly by the FDA, while others, such as the unseen lives that could be saved, not directly noticed and attributed. to the FDA’s mistakes.
“The FDA has an incentive to delay the introduction of new drugs, because the approval of a bad drug (type I bug) has serious consequences for the FDA, as the failure to approve a good drug (type II error), “said economics professor Alex Tabarrok) explain. ‘In the former case, at least some victims are identifiable and the New York Times write stories about them and how they died because the FDA failed. In the latter case, when the FDA does not approve a good remedy, people die, but the bodies are buried in an invisible cemetery. ‘
The confirmation of this theory, a comprehensive paper investigation into FDA drug approval record found that it is ‘often dramatically too conservative’.
The blunt decision to stop Americans from deciding for themselves whether to take the Johnson & Johnson vaccine is just the latest example of the FDA’s deadly incentive structure. The FDA’s reasonable role would be to disclose all available information about the blood clotting risks associated with the vaccine, and then let Americans make a decision based on their own cost-benefit analysis.
The dominance of individual judgment by government officials in Washington, DC, only replaces effective decision-making with bureaucratic inertia. After this failure, Americans may finally realize the extent to which our inflated federal government regularly stops potential life-saving innovation in its tracks.