INDIANAPOLIS — The Federal Government is taking a step back after the Centers for Disease Control and Prevention and the Food and Drug Administration began evaluating a possible side effect of the “Johnson and Johnson” COVID-19 vaccine.
They’re asking health departments to suspend the use of the shot. Over the news that 6 patients out of nearly 7 million doses administered have experienced dangerous blood clots.
“Due to reports of 6 cases of a rare and severe type of blood clot following vaccine administration. We’re recommending this pause while we work together to fully understand these events,” said FDA, Acting Commissioner, Dr. Janet Woodcock.
That rare type of blood clot according to the CDC and the FDA is ‘Cerebral Venous Sinus Thrombosis’ in combination with a low level of platelets in women ages 18-48.
“Of the clots seen in the united states one case was fatal and one patient is in critical condition,” said FDA, Director for Center of Biologics Evaluation and Research, Dr. Peter Marks, MD, PhD.
Officials say this combination is different from a typical blood clot and is also treated differently. Which is why they’re investigating.
“Healthcare providers who see people presenting to them either low blood platelet counts, or blood clots should establish whether or not the individual has been recently vaccinated,” said Dr. Marks.
They are also providing healthcare providers with a revised fact sheet to include this information.
Our local health experts say this could increase vaccine hesitancy but also, it’s science regardless of if the vaccine is fully approved or under emergency use.
“I think what we’re seeing playout in real time is a normal scientific process where we find a blip of data and we investigate it to see if it’s real or not,” said Regenstrief, Director of Public Health and Informatics, Dr. Brian Dixon.
Which is why they are advising you to be on the lookout. If you got the shot more than a month ago, you’re technically in the clear. If it was in the last few days or weeks, you should look out for severe headaches, abdominal and leg pain or shortness of breath.
“There are 3 vaccines available. And we are not seeing these clotting events with low platelet counts with the other two vaccines. People who have vaccine appt with the other two vaccines should continue with their appointments,” said CDC Principal Deputy Director, Dr. Anne Schuchat.
And if you have concerns about moving forward.
“Call their doctor and get some advice. Because physicians are monitoring this very closely and will be able to assess your situation and tell you yes go ahead with the vaccine or maybe wait one more week Until we know a little bit more about these isolated cases,” said Dr. Dixon.
On Wednesday the CDC’s advisory committee on immunization practices will review the data of these cases and consider the next steps. Those at the federal level say the timeline of the pause will depend on what they learn. But they expect it to be a matter of days not weeks.