The United States Federal health agencies – The Food and Drug Administration and the Centres for Disease Control and Prevention on Tuesday recommended an immediate pause in the use of Johnson & Johnson’s single-dose Coronavirus vaccine, over cases of rare blood clots within two weeks of vaccination.
There have been six cases of rare and severe blood clot reported in over 6.8 million recipients of the Johnson & Johnson vaccine according to the FDA.
All six recipients were women aged between 18 and 48. One woman is dead and the second has been hospitalized in a critical condition.
Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
— U.S. FDA (@US_FDA) April 13, 2021
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
Scientists with the F.D.A. and C.D.C. will jointly investigate possible links between the vaccine and the disorder and determine whether the F.D.A. should continue to authorize the use of the vaccine.
In a news release, Johnson & Johnson said: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.” Janssen is the name of Johnson & Johnson’s division that developed the vaccine.
300,000 to 600,000 people a year develop blood clots in the United States alone, according to C.D.C. data. But the particular blood clotting disorder known as cerebral venous sinus thrombosis developed by the vaccine recipients is extremely rare.
The concern about Johnson and Johnson COVID-19 vaccine is similar to that of AstraZeneca expressed in Europe which led to the suspension of the vaccine in several countries last month.
On Tuesday, the Australian government announced it would not purchase Johnson & Johnson vaccines citing the use of an adenovirus, the same platform used by AstraZeneca
222 out of the 34 million people who received AstraZeneca vaccine in Britain, the European Union and three other countries experienced blood clots linked with a low level of platelets.
Regulators in the European Union after an investigation concluded that direct disorder is a rare side effect of the vaccine.
Similarly, researchers in Germany and Norway on 9th April suggested that the rare cases of blood clots can be associated with the AstraZeneca vaccine.
However. the regulators argued that the benefits of the vaccine which can keep people from being infected or keep those who are infected out of hospitalization greatly outweighs the risk.
Several countries continued to give the AstraZeneca vaccine to older people who face a higher risk of severe disease and death from COVID-19 why restricting the vaccine for younger people.
Ifunanya Ikueze is an Engineer, Safety Professional, Writer, Investor, Entrepreneur and Educator.
