FDA, CDC Urge US to Pause J&J Vaccine Over Rare Blood Clot Concern

The FDA has found that the single-shot COVID-19 vaccine by Johnson & Johnson is safe and effective.  

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The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have recommended the Unites States to pause the use of Johnson & Johnson’s COVID vaccine over six reported cases of severe and rare blood clots in the country.

Around 6.8 million doses of the Johnson & Johnson’s vaccine have been administered in the United States so far, including the six rare cases.

According to a joint statement on Tuesday, from Dr Anne Schuchat, principal deputy director of the CDC and Dr Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, all six cases occurred within 6 to 13 days of being vaccinated, among women between the ages of 18 and 48.

Why It’s Better to Pause the Vaccine Now

The CDC will convene a meeting of the Advisory Committee on Immunisation Practices (ACIP) on Wednesday, to further review these cases and assess their significance.

The statement further stressed, “The move is important to ensure that the healthcare provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

Federal Health Channels to Stop J&J Vaccine Use Immediately

According to a federal health official, all federal health channels, including mass vaccination sites, community health centres and the likes, will stop administering the J&J vaccine for now.

The same was recommended for the states as well. However, since the states have their own allocation of the vaccine, pausing the vaccine will be at their discretion.

The pause is being initiated as the rare blood clot is not listed as a potential adverse side-effect in the emergency use authorisation of the drug.

Studies have shown that the Johnson & Johnson vaccine is 66 percent effective in preventing cases of moderate to severe illness and 85 percent effective against severe cases of COVID.