
Photo by Charly SHELTON
By Mary O’KEEFE
The pause of the administration of the Johnson & Johnson/Janssen COVID-19 vaccine continues as more Southern Californians become eligible to be vaccinated.
The Centers for Disease Control and Prevention (CDC) suspended use of the J&J vaccine due to safety concerns.
The decision was made because, according to the CDC, “The safety systems that make sure vaccines are safe received a small number of reports of people who got this vaccine experiencing a rare and severe type of blood clot with low platelets.”
The European Medicines Agency [EMA] announced on Tuesday it had found possible risks for rare blood clots but the benefits of the vaccine outweighed these risks. The EMA’s safety committee [PRAC] reviewed the cases and concluded that a warning about the unusual blood clots with low blood platelets should be added to the medication information.
“The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine,” stated Johnson and Johnson in a release on Tuesday.
The company will update the vaccine’s warning to include “important information of the diagnosis and management of this very rare adverse event. Healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, as well as the appropriate course of treatment,” the statement continued.
Research found that there were eight reports in the U.S. of serious cases of unusual blood clots; one of those cases was fatal. The eight cases are among 7.4 million people who have received the vaccine as of April 7.
Although the decision to hold off use of the Johnson & Johnson vaccine has caused concern, Dr. David Tashman, director of the USC Verdugo Hills Hospital Emergency Services, points out that the decision to pause is due to the extensive monitoring of the vaccines. It is evident that these vaccines, including Pfizer, Moderna and the AstraZeneca that was being used in Europe and other countries, are all being monitored closely by the CDC, Food and Drug Administration and EMA.
AstraZeneca has also been linked to blood clots and is not used in the U.S.
“[Medical monitors] would rather be safe and pause Johnson & Johnson,” Tashman said.
The Advisory Committee on Immunization Practices, convened by the CDC, reviewed the reported cases on April 14 and will reconvene on April 23 for further discussions.
Tashman said there is a slightly higher risk of blood clots happening to women younger than 50 years old, with the main concern centering on blood clots in the brain.
“But what concerns me more is COVID,” Tashman said. “It is so much more dangerous and more than one in a million will get complications from COVID.”
Tashman added that it is good that the vaccine is being additionally researched and that people who are concerned about getting the Johnson & Johnson vaccine should call their doctor. Severe headaches can be a sign of a problem and neurological symptoms, including vision issues, can be a symptom of a brain blood clot. The CDC has also included abdominal and leg pain and/or shortness of breath as adverse reactions and advises those experiencing these symptoms to seek medical care right away.
The CDC and FDA are continuing their reviews of the Johnson & Johnson vaccine. As of April 16, Los Angeles County has administered a total of 6,319,798 first doses of the COVID-19 vaccine, which includes Pfizer, Moderna and Johnson & Johnson until the pause. There have been 2,239,672 second doses administered. These numbers do not include providers in the Cities of Long Beach and Pasadena; both have their own public health departments.
Tashman said he has definitely noticed a difference since mass vaccinations have begun in LA County.
“I have seen a huge drop in the [number of people in the Emergency Department]. I’ve seen one case of COVID in the last two weeks compared to 80% [of patients] COVID-related in January,” he said.