The United States Sanitary Authorities will inform you this March that students are aware of a relationship between Johnson & Johnson’s and the extremely rare cases of blood clots that he presented during his application. Although the announcement of a break in its use is likely to generate an alert, we will explain some reasons why we should not be alarmed.
Scientists from the Food and Drug Administration of the United States and the United States Prevention Centers will announce this March that they will jointly study the possible angles between the Johnson & Johnson vaccine against the COVID-19 and the common law of comons. Although the announcement can be made later, there are reasons to warn.
The director of the FDA’s Center for Biological Evaluation and Investigation, Peter Marks, and principal deputy director of the CDC’s, Anne Schuchat, assured a joint meeting that would recommend “a break in the use of this precautionary weapon,” he said. the Scientific Committee to Analyze the Evidence, insisting that “at the moment, these adverse events appear extremely rare”.
Today the FDA a @CDCgov issued a statement regarding the Johnson & Johnson # COVID-19 vaccine. We recommend an interruption in the use of this vaccine out of caution.
– US FDA (@US_FDA) 13 April 2021
The announcement does not mean that North American sanitation authorities are concerned about the safety or efficacy of the Johnson & Johnson vaccine, but that it is part of a fundamental and necessary process in the emerging market that will address the world: pharmacological vigilance. In other words, it does not matter how many rarities can be the potential adverse events, can not be ignored. Requires investigation and transparency.
In this particular case, of the cases there are millions of persons who have received the Johnson & Johnson vaccine in the United States, it has now been reported only in cases where the recipients develop a small coma that involves blood clots. The six cases were presented during the two weeks following the vacancy and in women between 18 and 48 years. At the moment, the relationship with the vaccine has not been tried.
It is recorded that the vacancies were approved by the Emergency Situations in the middle of a situation without precedent, which means that, just now, only partial information on the results of its application. In addition, he administers persons who do not represent the exact manner in which the voluntary practice is performed in the clinical trials. Thus, while continuing and increasing its use, we also record the data on its efficiency, security and on the possible adverse events attributable to the vacancy (ESAVIS).
“Given the magnitude of the population that is being evacuated, it is increasing the probability of detecting rare events and cobra importance the detailed observation of all the mentioned factors, from which the entities that carry out the follow-up to the ESAVIS will save This information is intended to clarify with more clarity the profile and directions of use of the vacancies ”, assured the experts of the DIME project. For this reason, if you have a suspicion of an adverse effect, the sanitary authorities will take a break to monitor each other carefully, make sure they have a relationship with the vaccine and discard any type of dudas.
For these reasons, FDA scientists and CDCs will jointly examine the possible angles between the vaccine and the potential effect identified. If you are allowed to make more informed decisions, as for example, if the FDA can approve the use of this vaccine in all adults, then limit its authorization to a specific population. It will also be possible to provide more information about the mechanism that could cause this type of effect, in order to better deal with the rare cases in which it is likely to be present.
“Having completed this process, we recommend this break. It is important to ensure that the medical attention testing community is aware of the potential of these adverse events and can plan the treatment required with this type of blood clot, ”the FDA assured.
At present, the clinical studies of this vaccine have shown that it can be effective at 66% in the prevention of liver failure and up to 85.4%, in serious cases of severe disease.
In addition, the FDA claims that the vaccine offers protection against the diseases of South Africa and Brazil, and that in clinical trials in the United States it has an efficacy of 85.6%, with a rate of 81.7% in South Africa and the 87.6% of Brazil.