To face the current pandemic, it has been necessary to join efforts in search of solutions that help prevent more deaths. In addition, it also aspires to achieve an eventual return to daily life as it was known before the health emergency. As a result, a vaccine against this new disease was developed. The current offer includes more than a dozen options from various pharmaceutical companies. Although they all have the same objective, each one is distinguished by aspects such as efficacy or in the case of Johnson & Johnson because it only requires one dose.
Precisely this immunization has already been approved in more than 40 countries and in Mexico it received the endorsement of the Federal Commission for the Protection against Sanitary Risks (Cofepris) since end of May. At least at first it was exclusively used to inoculate the inhabitants of Baja California thanks to a donation from the United States government.
Disputes that have arisen
Since then it has continued its application around the world although it has had to face various adversities. One of the most serious occurred when it was associated with cases of thrombosis. As a consequence Denmark has already completely suspended its application. While Belgium only recommends it in people over 41 years old.
It is also necessary to remember a New York Times report where at least 100 suspected cases of the Guillain Barre syndrome appeared in people who had received the Johnson & Johnson vaccine.
Faced with this situation and due to the high number, the United States Food and Drug Administration (FDA) ordered to modify the warnings on the label of this biological. Since then, a legend was added where it is mentioned that the risk of developing this rare neurological condition can increase.
They identify a new serious side effect and two minor ones
While now the pharmaceutical is in danger again. It is all due to a release of the European Medicines Agency (EMA). What is indicated is that from the review of recent cases it is now recommended to include Immune Thrombocytopenia as possible serious biological side effects.
That is not all because it is mentioned that dizziness and tinnitus are also related to the administration of the vaccine although both are not serious.
During its August plenary meeting, EMA’s safety committee, the #PRAC, discussed the safety of # COVID19vaccines. Read more:
👉https://t.co/n655W6qPKt#SafetyOfVaccines #HealthUnion pic.twitter.com/uXVkpwpx5W– EU Medicines Agency (@EMA_News) August 6, 2021
In reaching this conclusion, the EMA took into account all currently available evidence. This included an analysis of 1,183 cases of dizziness identified as part of spontaneous reports of anxiety-related immunization reactions.
Regarding tinnitus, the EMA investigated six cases observed in clinical trials and 108 cases identified by the company during follow-up of spontaneous reports.
From the above, now the health authorities recommend modifying the product information to add dizziness and tinnitus as adverse reactions. In this way, the population can be alerted to these possible side effects.
While despite all the aforementioned, the EMA emphasizes that the balance of risks and benefits remains the same. Therefore, Johnson & Johnson’s vaccine application around the world should continue smoothly.