The rollout of Johnson & Johnson’s (J&J) COVID-19 vaccine can resume in the US after regulatory authorities approved to lift the hold placed on the jab, following concerns over very rare cases of blood clots in a small number of recipients.
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to resume use of J&J’s vaccine during a meeting held last Friday.
The resumption applies to the vaccines current indication under the US Food and Drug Administration’s (FDA) emergency use authorisation, with the jab being approved in individuals aged 18 years and older.
The FDA and CDC recommended the pause after reports of six cases of a rare and severe type of blood clot in recipients of J&J’s vaccine.
The regulators examined available data to assess the risk of thrombosis involving the cerebral venous sinuses (CVST) and other sites in the body, along with low blood platelets (thrombocytopenia).
Both the FDA and CDC have ‘confidence’ that the J&J vaccine is safe and effective in preventing COVID-19, adding that the vaccine’s known and potential benefits outweigh its known and potential risks.
“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,” said Janet Woodcock, acting commissioner of the FDA.
“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,” she added.
Last week, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also confirmed the overall benefit-risk profile of J&J’s COVID-19 vaccine.
