Decision to put J&J vaccine on hold stunning for trial participant

TSD freelance contributor Dr. Sybil C. Mitchell is participating in the ongoing Johnson & Johnson COVID-19 vaccine trial. This week she learned the J&J one-shot option is on hold pending a review of concerns that have surfaced about blood clotting in a small number of women. (Courtesy photo)

 

For the longest time, I had no words. I sat staring at my laptop, a blank page staring back at me.

On Monday (April 12) evening, I was at The Healing Center, watching a smoothly running COVID-vaccination operation. Johnson & Johnson’s vaccine, which only requires one shot – unlike the Moderna and Pfizer that require two shots — was being used. 

Nearly 100 people had received their shot. 

Tuesday morning (April 13), news broke that six serious cases of blood clotting resulted in women, who had received the J&J vaccine. One died as a result of the clotting complication.

Despite the fact that the J&J vaccine has been delivered to more than 6.8 million Americans without serious side effects, further use of the vaccine was halted by federal authorities “out of an abundance of caution.”

I took the vaccine on Dec. 14 when I entered a trial study of the J&J vaccine because I wanted to help; to be a part of a grand experiment to test a substance Janssen Pharmaceuticals had developed to combat a virus that was hitting the African-American community harder in so many places.

More African Americans were needed for the study. Signing up seemed a good idea at the time.

I still think it was the right decision.

A first-hand, inside look at a trial study would be useful in quelling fears about vaxing, I thought. Sure, there are risks. But serious illness from blood clots and death? 

For that, I am sorry. I never imagined that.

The public acknowledgment of an investigation into the clotting cases has sparked fears that more cases of clotting could be forthcoming.

The vaccine was shipped in record numbers last week. However, prior to that time J&J reported that a quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site representatives said had not yet been authorized to manufacture drug substance for the J&J COVID-19 vaccine. The batch never was advanced to the filling and finishing stage of the manufacturing process.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID), said the millions already vaccinated without complications attests that the issue is not the vaccine’s efficacy. Also, he said clinical trials prove it is highly efficacious. 

“What we’re talking about now has nothing to do with the efficacy of the vaccine,” Fauci said.

Officials are still looking for answers. Is there a bad batch mixed in with the increased production and shipment that went out last week? All six clotting victims were women. Is that significant? But how?

If more cases surface, they are expected to most probably be women between the ages of 18-18, vaccinated between 6-13 days ago.

Fauci called the clotting effect “rare – only one in more than a million.”

But it occurs to me that for the family who lost a loved one, the complication’s rarity is irrelevant. What is the cause? An “aberrant immune response,” officials said.

I am so sorry these precious women suffered. And a fatality…perhaps someone’s mother or sister.

What a consequence from a medical treatment that is supposed to protect us. Really, hard to speak of it.

It seems that we’re all in the same human family and our choices globally are to not be vaccinated and chance catching COVID-19 with severe illness or death. 

Or, we can trust the science, although imperfect, to devise the best solutions for our consumption.

I pray there are no more casualties, no more deaths from a vaccine. 

I pray for herd immunity by Labor Day. I pray for hugs from our children and kisses from our elderly parents.

I pray for the joy of some former things, pre-COVID – like trips to a water park, traveling to see sorely missed loved ones and eating freely inside our favorite restaurants. 

I pray for businesses that have lost financial footing; that they may find new life. 

I pray for our children returning to school and enjoying all the games and activities that make their experiences growing up so memorable. 

I pray for families who had to leave a loved one in the cemetery for any reason during this pandemic.

Most of all, I pray for hope and I pray for more love. And, I give thanks every day for a God who hears us.

https://tri-statedefender.com/decision-to-put-jj-vaccine-on-hold-stunning-for-trial-participant/04/15/

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