J&J vaccine set to resume in US after temporary hold

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Suporna Das

Distribution of the Johnson & Johnson COVID-19 vaccine is set to resume in the United States after the Centers for Disease Control and Prevention and the Food and Drug Administration released a joint statement on April 23, in support of ending the previous pause that was placed on the administration of the shot.

The CDC and FDA called for a hold on the rollout of the J&J shot on April 13, in relation to six reported cases of a severe type of blood clot condition one-to-three weeks after receiving the vaccine. This came after more than 6.8 million doses of the J&J vaccine were already distributed throughout the United States.

All cases of the rare blood clot were observed in women between the ages of 18 and 48, leading people to wonder how the vaccines might be affecting women differently than men, if at all.

However, since the hold, nine additional cases of the blood clotting condition in women were confirmed. So far, three women have died from the condition while seven remain hospitalized.

In a statement released by Johnson & Johnson addressing the hold, the company warned anyone who develops “severe headache, abdominal pain, leg pain or shortness of breath” within three weeks of receiving their vaccine should seek assistance from their health advisor.

Advisers with the CDC met on April 23 to discuss next steps for the J&J vaccine. Shortly after, the CDC and FDA lifted their hold on the vaccines and advised the United States to continue the administration of the doses.

As the rollout of the vaccine resumes, experts expect up to 45 more cases of blood clots over the upcoming months, in comparison to 1,400 fewer coronavirus-related deaths.

As a precautionary measure, J&J will now be adding a label warning of the clotting condition. However, with the hold tarnishing J&J’s public image, it is questionable whether the new labels will be enough to restore faith in the vaccine.

“These cases are not just numbers to any of us, and we take them very seriously,” Dr. Joanne Waldstreicher, the chief medical officer of J&J, said. “These are people.”

Although only 15 cases of the rare blood clot have emerged out of the more than 8 million vaccines administered, the experts attending the meeting seemed to take all COVID-19 vaccine symptoms and risks seriously.

Women appear to be at greater risk for developing conditions from vaccinations in general. Consequently, experts are especially advising women with a history of breast cancer and women who are scheduled for fertility treatments to take several precautions before receiving any type of COVID-19 vaccine.

Despite the potential risks of receiving the vaccines, vaccinations remain crucially important in mitigating the deathly effects of the COVID-19.