US Lifts Pause on Johnson & Johnson’s COVID Vaccine

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Johnson & Johnson COVID-19 Vaccine
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CDC and FDA have lifted the temporary pause on Johnson & Johnson’s COVID Vaccine, allowing vaccinations to resume without any restrictions.

In February, the US Food and Drug Administration (FDA) and the Centres for Disease and Infection Control (CDC) approved Johnson & Johnson’s COVID vaccine for emergency use. But a short while later, they placed a temporary pause on the use of the vaccine across the country. The occurrence of a dangerous blood clot, cerebral venous sinus thrombosis (CVST), among vaccine recipients caused the implementation of the pause.

As a result, the CDC conducted a review of the cases and the vaccine’s safety monitoring data. However, the report by CDC’s Advisory Committee for Immunization Practices (ACIP) found the vaccine safe and effective. Therefore, on Friday, 30th April, the US lifted the pause on Johnson & Johnson’s COVID vaccine.

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

Janet Woodcock, acting FDA Commissioner

Although the committee does not call for any restrictions on the vaccine, it did propose changes to the vaccine’s label to include a warning for blood clot risks.

Vaccine Side-Effects are ‘Non-serious’

During March-April 2021, approximately 8 million people received Johnson & Johnson’s COVID vaccine. AICP’s report reviewed all adverse events reported among these vaccine recipients; including the cases of blood clots and thrombocytopenia. A total of 13,725 incidents of vaccine adverse events came forward during the review.

The report identified 97% of the adverse events as nonserious and only 3% as serious. It found a total of 17 cases of blood clots with low platelet count among the vaccine recipients. 13 of these cases occurred in women less than 50 years of age. Moreover, researchers also noted the presence of 88 vaccine-associated deaths; three of which occurred in patients with CVST.

A rare but serious adverse event occurring primarily in women, blood clots in large vessels accompanied by a low platelet count, was rapidly detected by the U.S. vaccine safety monitoring system

AICP’s Report

The overall risk of blood clot was an estimated 1.9 cases per million. However, among women aged 18-49 years, this risk went up to 7 cases per million. Due to the increased risk among women younger than 50, FDA recommends that women are made aware of this risk before getting the vaccine.

COVID-19 infection not only carries with it a risk of hospitalization, but also a significantly higher risk of blood clots. Therefore, US officials chose to lift the pause, as the benefits of the vaccine outweigh the risk of infection. As a result, the country is expected to receive access to some 10 million vaccine doses.

Reference:

Shay DK, Gee J, Su JR, et al. Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine — United States, March–April 2021. MMWR Morb Mortal Wkly Rep. ePub: 30 April 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7018e2

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