J&J passes US exam, “the benefits outweigh the risks”

by time news

Time.news – I Centers for Disease Control and Prevention (Cdc), US health authorities recommend resuming Johnson & Johnson serum vaccinations arguing that “the benefits outweigh the risks”.

The recommendation, voted 10 yes to 4 no, paves the way for a green light by the Food and Drug Administration (FDA) and the resumption of single-dose J&J vaccines as early as this weekend. Immunizations they had been discontinued after a few rare cases of thrombosis.

The advisors of the CDC recommend that the FDA report the risk of rare complications with thrombosis in women under the age of 50 in the J&J vaccine leaflet, with a move similar to that of the European Union.

“We agree on the introduction of a warning in our leaflet and in the documentation for doctors with the description of these rare cases, including early symptoms so that they can be immediately identified, diagnosed and treated, ā€¯comments Johnson & Johnson Chief Medical Officer Joanne Waldstreicher.

These symptoms include severe headaches, abdominal pain, leg pain, and shortness of breath within three weeks of vaccination. Doctors are also advised to do not administer heparin, common in cases of thrombosis, because it risks worsening the situation.

In the medical instructions, the link between the J&J vaccine and these rare cases of thrombosis that can even lead to death is defined as “plausible”, especially among women between 18 and 49 years old. The advisor panel’s recommendation will now have to be approved by CDC director Rochelle Walensky and then by the FDA.

Administration of the J&J vaccine had been suspended early last week e there are about 9.5 million stored doses ready to be distributed.

To date they have been 15 cases of these rare thromboses have been ascertained, of which 13 in women between 18 and 49 years, with the age group most at risk identified between 30 and 39 years. Out of 8 million Americans who received this vaccine 3 deaths and 7 hospitalizations were recorded, including 4 in intensive care.

The other five have recovered and have left the hospital. The CDC therefore recommend the resumption of vaccinations in all adults aged 18 and over, underlining how the benefits “clearly outweigh the risks” because with the resumption of immunizations 2,200 deaths and 1,400 hospitalizations in intensive care can be averted (in the same time frame studied for the risks).

Joe Biden’s administration ordered Pfizer and Moderna vaccines in quantities that could immunize all adult Americans even without J&J assistance.

.

You may also like

Leave a Comment