Over a week after Virginia ceased using the Johnson & Johnson vaccine, questions still remain.
RICHMOND – It’s been just over one week since Virginia halted the use of the Johnson & Johnson COVID-19 vaccine.
Over the course of those eight days, approximately 72,000 Virginians switched up their plans – and that number only accounts for those scheduled to receive the J&J vaccine. Countless other health clinics, pharmacies, staff and volunteers inoculating individuals also scrambled to change course.
Last week, Dr. Danny Avula, the state vaccination coordinator, laid out a plan. He expressed that wherever possible, vaccination sites using J&J would offer other COVID vaccines in their place.
Brookie Crawford, the Public Information Officer for the Central Region of the Virginia Department of Health, elaborated on the altered rollout.
“Virginia stopped using the Johnson & Johnson vaccine while the safety issues are being examined,” Crawford said. “We are using Pfizer and Modena as a substitute where we can, and we will cancel and reschedule any appointments where we can’t substitute vaccines.”
What Caused The Johnson & Johnson Pause?
So what happened to cause the pause?
The Centers for Disease Control and Prevention gave an in-depth overview of the potential issues surrounding the vaccine.
A small number of people who received the J&J vaccine suffered cases of cerebral venous sinus thrombosis with thrombocytopenia.
If that sentence gave you a headache, you’re not alone. So what does that mean, exactly?
Basically, six people developed blood clots in combination with low levels of blood platelets. The big problem is that those two things typically do not occur in unison. Also, a medicine commonly used in clot treatment and prevention, Heparin, seemingly makes this particular issue worse.
All six reported cases occurred in women and they ranged in age from 18 to 48 years old. One patient – as of April 13 – died from the complications.
Along with the 30-year age range, onset times of the blood clots varied from six days to 13 days.
Those within 30 days of their Johnson & Johnson shot may monitor themselves for adverse reactions. Complications indicative of a blood clot often include severe headaches, abdominal pain, leg pain and shortness of breath.
The Wait Continues
The CDC’s Advisory Committee on Immunization Practices met last Wednesday to discuss the recent J&J vaccine developments. However, the group did not reach a definitive conclusion concerning the rollout, citing the need for further information.
Vaccine advisers to the CDC plan to meet on Friday to continue the discussion.
Meanwhile the J&J rollout faced another hurdle. On Friday, the Food and Drug Administration concluded their investigation at the Emergent BioSolutions, Inc. facility in Baltimore, Maryland.
Weeks ago, the Emergent facility – not certified for COVID vaccine distribution – came under fire after mixing Johnson & Johnson and AstraZeneca COVID-19 vaccine ingredients. The mix-up botched 15 million J&J doses.
A report from the U.S. Securities and Exchange Commission released on Monday contained the following, in part: “On April 16, 2021, at the request of the FDA, Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility and to quarantine existing material manufactured at the Bayview facility pending completion of the inspection and remediation of any resulting findings.”
Johnson & Johnson Doses on Hold
Johnson & Johnson doses previously approved by other manufacturers are basically in quarantine. For vaccination sites with Johnson & Johnson doses on hand, direction on what to do with those vaccines remains in limbo.
“That will depend on the outcome of the CDC investigation,” Crawford said. “We will follow CDC guidance regarding our current stock.”
Jessica Baxter, communications and media relations manager with the Arlington County Public Health Division, expressed a similar plan for her area.
“The county will safely store the existing J & J doses until we receive further direction from the CDC and FDA,” Baxter said. “In regard to appointments, Arlington County intends to honor existing appointments utilizing Pfizer and Moderna in place of Johnson & Johnson over the next few days. We may need to reassess in a few days as supply is determined, but that is our current approach.”
Establishing Vaccine Trust
As far as vaccine trust goes, it’s hard to say how the J&J pause might impact that.
“I think we’ll have to see. I mean depending on what this additional time to solicit data and then any other information the Advisory Committee on Immunization Practice and FDA come up with, I think, you know, it will all have to do with what additional data is found and then what messaging accompanies that, right?” Avula aid. “I think it’s hard to speculate, but clearly pausing on the administration of vaccine certainly will raise question marks for the public and we’ve got to make sure that we have good answers and clarity on who this vaccine is safe for and who it should be used for if we’re going to restore that trust.”
Crawford expressed a positive take on the decision to pause the J&J rollout.
“This pause is reassuring in that it demonstrates that the systems that are in place to monitor vaccine safety are working,” Crawford said. “We look forward to a thorough review by federal health officials.”
Baxter also addressed the issue, alluding to the six cases out of over 6 million J&J vaccines administered.
“I think it is important to note that these adverse effects are extremely rare,” Baxter said. “We look forward to the thorough review by federal health officials. If individuals have medical concerns, they are advised to contact their health care provider.”
Amie Knowles reports for Dogwood. You can reach her at [email protected]