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CDC and FDA Recommend Pause On Johnson & Johnson Vaccinations

(CW44 News At 10) - UPDATE: Tuesday, the CDC and Food and Drug Administration announced they are recommending states and vaccine providers pause disbursement of the Johnson & Johnson vaccine.

On Tuesday, the CDC and FDA announced they identified six women between the ages of 18 and 48 who were diagnosed with a rare and serious blood clot called Cerebral Venous Sinus Thrombosis, paired with a blow blood platelet count. Unfortunately, of the six, one woman has died.

According to the CDC, over 6.8 million Johnson & Johnson vaccines have been administered in the United States to date, but with these six recipients showing blood clots, political leaders are asking healthcare providers to streamline the reporting of any side effects that patients experience after vaccination on a website called Vaccine Adverse Event Reporting System.

It's strange that side effects can be so severe for one group of people while others like Manatee County resident, Kelly Sedlak, who received the Johnson & Johnson vaccine says she experienced "no side effects that day. The following day I was achy a little bit tired and I've been fine since then." She says she received her vaccine three weeks ago to protect her family members, adding, "Everybody is a frontline worker, so they were exposed. So when they got [the vaccine], I felt relieved. And when I got it, I felt even more relieved."

The statement released by the CDC and FDA says the clotting symptoms in the women developed between 6 and 13 days after vaccination, and regular treatment of this type of blood clot could be dangerous. Experts say it could be an immune response causing the blood clots, similar to the European vaccine, AstraZeneca.

Dr. Peter Marks with the FDA says "The probable cause that we believe may be involved here that we can speculate is a similar mechanism that may be going on with the other adenoviral vector vaccine. That is that, this is an immune response that occurs very, very rarely."

The CDC says one of the six women has died and another is in critical condition. Now leaders are saying anyone who recently received the Johnson & Johnson vaccine should see a doctor for symptoms like severe headache, shortness of breath, and pain in the leg or abdomen. But despite all of this, both Sedlak and healthcare officials encourage people to still get vaccinated with Pfizer or Moderna.

"My message to everybody is to get any vaccine you can as soon as you can so we can all get back to normal," said Sedlak.

Leaders of the CDC and FDA say the pause on the Johnson & Johnson vaccine should only last a few days. They also say the CDC will be holding a meeting tomorrow with the Advisory Committee on Immunization Practices to go over the cases and investigation into the Johnson & Johnson vaccine side effects.

More Woes For Johnson & Johnson:

Florida was scheduled to see a large Johnson & Johnson vaccine decrease this week compared to last week's disbursement. This came after the company announced there were manufacturing issues with a batch of vaccines at the end of March.

According the CDC, last week, Johnson & Johnson shipped out almost five million vaccines last week across the country, but this week, that number is dropping to 700,000.

Manatee County resident Diana Higgins, who received the Johnson & Johnson vaccine in mid-March says, "I was sick the first night, the next day I felt fatigued, then I felt like I had a minor cold for a few days and then after that it was no issues whatsoever." She tells CW44 News At 10 that her decision to received the Johnson & Johnson vaccine was that of convenience as it is a single shot versus the staged doses with the Pfizer and Moderna vaccines.

According to the CDC, this week, Florida was scheduled to receive 37,000 Johnson & Johnson vaccines compared to last week's 313,000 vaccine shipment. Higgins shrugged off the news about the delay, adding, "I'm not surprised. I work in manufacturing. We get mix-ups."

Johnson & Johnson announced on March 31, 2021 that a quality control process "...identified a batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substances" for the company's COVID-19 vaccine.

On April 3, the company released this statement, saying "Johnson & Johnson is assuming full responsibility regarding the manufacturing of drug substance for it's COVID-19 vaccine at the Emergent Biosolutions Inc. Bayview facility." The company says it is now adding more quality, manufacturing and technical operations personnel to help avoid another problem.

Higgins says, "I do expect there to be issues. I've worked in manufacturing. I'm just glad quality control caught it and it didn't get out."

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