The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined that the recommended pause regarding the use of Johnson & Johnson COVID-19 Vaccine in the US should be lifted and use of the vaccine should resume.
The announcement by the Food and Drug Administration and the Centers for Disease Control and Prevention, came after an advisory committee to the CDC recommended the United States to resume use of the vaccine without any restrictions on who should be offered it, CDC said in a statement.
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine, the statement read.
“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work–identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices,” said Janet Woodcock, M.D., Acting FDA Commissioner.
“We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,” said Woodcock.
“Above all else, health and safety are at the forefront of our decisions,” said CDC Director Dr Rochelle P. Walensky.
(With ANI inputs)