Health Dept. pauses J&J COVID-19 vaccine use following FDA-CDC recommendation
By Pedro Correa Henry
Special to The Star
After the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended pausing the use of the Johnson & Johnson-Janssen (J&J) COVID-19 vaccine in response to at least six reported cases in the mainland U.S. of women presenting a “rare and severe” blood clot, Puerto Rico Health Secretary-designate Carlos Mellado López followed suit Tuesday with the announcement that the island Health Department would pause its administration of the single-shot vaccine until further notice.
“It is important to clarify that in Puerto Rico we do not have any case related to the adverse event, specifically about blood clots,” Mellado said. “We are concerned and will be vigilant.”
The Health secretary-designate added that the agency and other providers will continue to administer its major vaccine source, which is the Moderna and Pfizer vaccines, as the island continues receiving more than 100,000 doses weekly.
As for the vaccine campaign being further delayed amid the FDA- and CDC-recommended pause, Dr. Iris Cardona Gerena, who directs the Health Department Vaccination Program, told the STAR that the pause would delay the vaccination against the coronavirus in Puerto Rico “to the extent that no more vaccines were assigned.”
“It’s not that it will bring delays -- we have made some projections initially counting on the two vaccines we have had available since December,” Cardona said. “The Johnson and Johnson-Janssen vaccine promised to bring us forward, but certainly, if the pause is prolonged or, at the end of the day, if it can’t be used again, it presents us with a delay within that lead time.”
Cardona said it was not possible to predict how long it would take for the FDA and CDC to make a final determination on the J&J vaccine given that “these cases are looked at very seriously.” She said both agencies will be holding a meeting today.
“This type of meeting is usually lengthy, sometimes lasting more than a day,” Cardona said. “They look at the issue, these six cases, but they’re going to look at it in detail.”
“Whether that’s going to happen tomorrow, in three days or in a week, we don’t know,” she added.
Cardona pointed out that the reported cases are few in number given that they occurred among 6.8 million vaccines administered, but that they occurred in a particular population, women between the ages of 18 and 48, “from two entities that came together, which is cerebral venous sinus thrombosis (CVST), which is a thromboembolic event associated with thrombocytopenia.”
“This is a very rare occurrence, but in an entity with AIDS, which is said to occur in five cases per million people annually in the United States,” Cardona said. “It’s very rare and very serious.”
The Vaccine Program chief told the STAR that the cases reported low numbers in white platelets, leading the two federal agencies to be particularly alert to their seriousness.
“They are calling for a pause, for health professionals to be prepared and educated on this issue, how to recognize the symptoms, what the treatment alternatives are, and what things to watch out for,” Cardona said.
Meanwhile, she said, the federal agencies called on people who have received the J&J vaccine to be vigilant for three weeks following their inoculation to identify specific symptoms.
Dr. Brenda Mariola Rivera Reyes, who is a pediatric pulmonologist, said the decision the FDA and CDC made, although unfortunate, was correct as “no vaccine, medication or treatment is perfect.”
“Ensuring people have confidence in the vaccination process is key to a successful vaccination campaign,” Rivera Reyes said via Twitter.
As for further scenarios with the J&J COVID-19 vaccine, she said the most common would be that any causal relationship with the vaccine is ruled out at the end of the investigation and it is determined in time that it was only a coincidence and vaccination would carry on.
She said the only consequence in this scenario would be “the delay in the vaccination campaign and the damage that may have been done to the population’s trust in the vaccine.”
On the other hand, she said, if a relationship between the vaccine and the adverse effect is confirmed, such a result would have an effect “on the severity, frequency, and identification of possible risk factors or predisposing conditions.”
“If the frequency is very low, you include this information in the insert and in vaccination alerts and continue to use it if the risk-benefit balance is still on the side of vaccination,” she said. “If any specific predisposing factor to this event is identified, this contraindication is included in the insert.”
“If, on the other hand, it is very frequent, or very severe, and not preventable, the risk-benefit balance may limit the use of the vaccine,” she added.
Rivera Reyes also told the STAR that a delay in the vaccination process during the J&J pause would depend on how media outlets report the aforementioned issue.
“Headlines with panicked, apocalyptic overtones have been our enemies throughout the pandemic,” she said. “They have been a problem that has reduced efficiency in the efforts to return to ‘normality.’ It’s vital to always mention the pros and cons.”