Six ‘unusual’ cases of thrombosis detected among almost seven million vaccinated with the Janssen formula (Johnson & Johnson) in the United States have put the distribution of immunization on hold .
This Tuesday, the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have recommended a precautionary suspension of the distribution of these vaccines while the incidence of these “extremely rare” adverse reactions is studied . Hours later, the pharmaceutical company has announced that it is delaying its first delivery of vaccines to Europe until the link between thrombi and vaccine is clarified.
US stops vaccination with Janssen for blood clots
The ‘crux’ of the debate is the same again. Some strange clinical pictures characterized by the appearance of brain clots combined with a low platelet count detected in a very minor fraction of patients vaccinated against covid-19.
As explained by the US authorities in an initial statement and in a subsequent telephone press conference, the pharmacovigilance devices detected six cases of thrombosis in women between 18 and 48 years old who had been vaccinated in the previous two weeks with Janssen. One of them has died and another is in critical condition.
These unusual cases of thrombosis have been detected in six women between the ages of 18 and 48 about two weeks after the injection.
The US health authorities , following the usual protocol, have already opened an investigation to clarify whether there is a relationship between the drug and these clinical pictures. This Wednesday an emergency meeting of the external advisory committee of the CDC, made up of independent experts, is scheduled to analyze the casuistry of these events.
Although a specific timetable has not been announced regarding the next steps, Dr. Janet Woodcock, acting commissioner of the FDA, has assured that the process will be “agile” and has shown her confidence that the pause will be “a matter of days. ” .
Other medicines that also have a risk of thrombosis (and are safe)
One of the keys to the stoppage of the Janssen vaccine, they argue from the United States, is the time factor. Given that these types of thrombi are extremely rare, it is necessary for doctors and hospitals to be prepared to identify and treat these types of clinical pictures, as they require a different treatment than other clotting phenomena.
In fact, as several FDA specialists have warned on Tuesday, the use of common medications to treat thrombi (such as heparin) can worsen the prognosis of this type of patients.
The stoppage of the vaccine also helps doctors and hospitals prepare to diagnose and treat these types of ailments
The temporary suspension of the Janssen vaccine in the country is not a mandate, as the final decision depends on each state. Likewise, as Dr. Peter Marks, another of the FDA’s specialists who has spoken out on the issue, has remarked, there is also some room for maneuver in cases in which a doctor and a patient individually assess the pros and cons for go ahead with vaccination with Janssen.
Europe also investigates the incidence of thrombi
The Janssen stoppage is reminiscent of what happened just a few weeks ago with the AstraZeneca and Oxford vaccine , when the European Medicines Agency (EMA) paused the distribution of the drug to study “atypical” cases of cerebral venous thrombosis.
After several weeks of exhaustive review of all available safety data, the agency’s expert committee concluded that this type of thrombosis could be a “very rare side effect” of the vaccine . According to the most recent balance on the matter, in fact, 86 cases of thrombosis have been detected so far (62 brain and 24 abdominal) among the 34 million vaccinated between Europe and the United Kingdom.
So far, 86 cases of thrombosis have been detected among the 34 million vaccinated between Europe and the United Kingdom
While the US health authorities are facing this debate, Europe is also opening a parallel investigation on this vaccine. Asked about this issue, a spokesman for the Pharmacovigilance Risk Assessment Committee (PRAC) assures that the EMA has initiated a scientific review of these cases, the conclusions of which will be transferred to the 27 national agencies.
According to the information released at the moment, then, the final decision on how to regulate the distribution of these formulas will be in the hands of each country.
Pending the first delivery of single-dose against covid-19
Europe awaited the arrival of the first doses of Janssen this Wednesday; just one month after the formula was approved by health agencies and the European Commission. According to the agreement signed with the pharmaceutical company, throughout 2021 a total of 200 million doses should be distributed throughout Europe.
Spain expected 300,000 single-dose injections this week and five million more before June . These single-dose immunizations were to be distributed among the 3,960,045 citizens between 70 and 79 years old; an age group that the immunization plan had not yet reached.
Neither the Ministry of Health nor the regional councils have spoken on how this temporary halt will affect immunization plans, but it is possible that tomorrow, after the Interterritorial Health Council, there will already be an answer.
Janssen vaccine: side effects, effectiveness against covid, dose and where it is from
The Minister of Health, Carolina Darias, has admitted that Spain is “expectant” but “ready” to receive this vaccine; the fourth formula against covid-19 available in the country and the first that works as a single dose . Likewise, Darias recalled that the Spanish Agency for Medicines and Health Products is in permanent contact with the European Medicines Agency to know the verdict of its investigation.
“We are prepared to receive the vaccine and administer it to the group between 70 and 79 years old,” the minister stressed this Tuesday at the government control session in the Senate. In fact, the first estimates suggest that when those over 70 are vaccinated, and hospitalizations will drop as much as 45%.
Health authorities must weigh the benefits and risks of this vaccine against covid-19.
The future of Janssen’s COVID-19 vaccine hinges on a delicate balance. As with any other medicine, you have to weigh the benefits and risks . All drugs have side effects (even the always reliable paracetamol includes, among its rare adverse effects, the possibility of developing a thrombosis).
The question is whether the remote possibility of suffering any of them outweighs the benefits that their consumption brings. In the case of vaccines against covid-19, this equation also has to take into account the danger posed by the spread of the pandemic .