Thursday, July 7, 2022

Virginia puts Johnson & Johnson vaccine on hold per CDC and FDA advice

One step closer: Pfizer Inc. and BioNTech SE have applied for a FDA emergency use authorization for their coronavirus vaccine. (WYDaily/ Courtesy of Unsplash)
The Johnson & Johnson vaccine was approved for an emergency use authorization on Feb. 27, but this morning, the CDC and FDA advised a pause on further administration after six reports of a rare possible side effect. (WYDaily/ Courtesy of Unsplash)

STATEWIDE — Virginia is putting a hold on administering the Johnson & Johnson (J&J) COVID-19 vaccine after the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) advised on Tuesday (April 13) that state agencies  should pause the vaccine’s rollout. 

“We are closely monitoring the actions by the federal government to pause all Johnson & Johnson vaccinations while it investigates an extremely rare possible side effect,” Dr. Danny Avula, state vaccination coordinator for the Virginia Department of Health, said in a statement on Tuesday. “In Virginia, we will cease all Johnson & Johnson vaccines until this investigation is complete.” 

Dr. Avula added that Virginia will continue administering the vaccines manufactured by Pfizer and Moderna. 

The hold on the J&J vaccine is due to reports that six women developed a rare blood clot called cerebral venous sinus thrombosis (CVST). The blood clots were found in conjunction with low levels of blood platelets (thrombocytopenia) after receiving the J&J vaccine. What makes this specific clot dangerous is that it cannot be treated like normal blood clots with use of the conventional drug, heparin. Instead, the drug could exacerbate these type of blood clots. 

Dr. Janet Woodcock, acting FDA commissioner, said that the decision to pause administration of the J&J vaccine was to ensure health professionals were aware that blood clots potentially associated with a vaccine should not be treated with heparin. 

According to a joint statement released by the CDC and FDA, all six cases occurred in women between the ages of 18 and 48, and that the symptoms occurred 6 to 13 days after vaccination.

The J&J vaccine was originally approved for emergency use by the FDA on Feb. 27, Clinical trials showed that the vaccine is 66.3% effective (efficacy rate) at preventing laboratory-confirmed COVID-19 illness in people who had no evidence of prior infection two weeks after receiving the single-dose vaccine.

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According to the CDC and FDA, Since April 12, more than 6.8 million doses of the J&J vaccine have been administered in the U.S. since April 12.

How many of those doses were administered in Virginia is unknown at the moment.

“Right now, these adverse events appear to be extremely rare,” the joint statement noted. “People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.”

The CDC also advises health care providers to report adverse events to the Vaccine Adverse Event Reporting System here. 

Dr. Woodcock said that the amount of time in which the agency is recommending pausing the administration of the J&J vaccine depends upon what is learned about the possible side effects in the next few days.

The hold on administrating this vaccine will not only have a national impact, but a local one as well.

According to a Facebook post from the City of Williamsburg, the Greater Williamsburg Clinic was scheduled to hold its largest vaccination clinic tomorrow (April 14), in which the clinic planned on administering the Johnson & Johnson vaccine. 

“Until guidance has been changed, we will no longer be offering the Johnson & Johnson vaccine at our clinics,” the post stated.

Those who are scheduled to receive a vaccine at tomorrow’s Greater Williamsburg Clinic will now receive the Moderna vaccine. The post also stated that no new appointments are being scheduled for that day.

Anyone who has any questions concerning their upcoming vaccine appointments can call 877-724-1954. Those who need to cancel an appointment, are advised to email WJCCCOVIDVaccineclinic@jamescitycountyva.gov.

Should we add something about how it not clear what will happen to the other/excess J&J doses? 

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