AZDHS Recommends Pause Of Johnson & Johnson COVID Vaccine

ARIZONA – The Arizona Department and Health Services has recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday because of blood-clot concerns. The state took action following the Food and Drug Administration and the Centers for Disease Control and Prevention's recommendation.

So far this week, Arizona has received 12,000 doses of Johnson & Johnson vaccines, less than a third of the 40,000 doses the state received on March 29, according to the CDC.

The department tweeted out its statement on Tuesday morning, falling in line with the CDC's guidance.

Based on recommendations from the @CDCgov and @US_FDA, ADHS recommends a pause in the use of the Johnson & Johnson COVID-19 vaccine. See full statement: https://t.co/aNngXFWkH9 pic.twitter.com/jKtrqfA8iZ
— AZ Dept of Health (@AZDHS) April" class="redactor-linkify-object">https://twitter.com/AZDHS/stat... 13, 2021

The department's statement said the following:

“While the occurrence of this rare blood clot are extremely rare compared to the number of doses of the Johnson & Johnson vaccine administered nationwide, we are following the guidance of the CDC and FDA out of an abundance of caution and we will continue to work with our federal and statewide partners about the status of the vaccine,” said Dr. Cara Christ, ADHS director. “The COVID-19 vaccine is safe and effective and is one of the best tools we have to reduce the spread of the disease in Arizona. I encourage everyone to get vaccinated against COVID-19.”

Maricopa County released a statement on Tuesday morning:

"The Centers for Disease Control and Food and Drug Administration have recommended a temporary pause on the use of Johnson and Johnson vaccine until they can review data involving six reported U.S. cases of an extremely rare type of blood clot in individuals after receiving the J&J vaccine.

"Until that review is complete, and the Advisory Committee on Immunization Practices provides further guidance, Maricopa County Department of Public Health recommends a pause in the use of Johnson and Johnson vaccine out of an abundance of caution.

"The primary goal is to understand all of the information available and to ensure that the health care provider community is aware of the potential for this rare adverse event and can recognize and manage this unique type of blood clot. It is important for the public to know that this rare blood clot has not been reported following receipt of the Pfizer or Moderna vaccines.

"Maricopa County is working closely with our partners to keep as many scheduled vaccine events running as possible by substituting another available vaccine. We thank you for your patience and flexibility as we await further guidance from the CDC, FDA and Arizona Department of Health Services and will communicate as soon as more information is available."

Related: Johnson & Johnson Vaccine Pause: 6 Things To Know

Pima County is also halting all J&J vaccine distributions, after giving out 24,600 doses of it since March 4.

In a statement, Pima County Health Department Director Dr. Theresa Cullen said the vaccine, while safe, will be pulled out of an abundance of caution.

“Vaccines available today are safe and effective,” Cullen said. “And although out of an abundance of caution we have paused the use of J&J, we urge unvaccinated to continue to keep getting vaccinated.”

Dr. Deepta Bhattacharya, associate professor of immunobiology at the University of Arizona, agreed.

“The estimated risk of a blood clot from the J&J vaccine is about 1 in a million,” Bhattacharya said. “The overall risk from dying if you get COVID-19 is about 1 in 100.
“Let’s say that there is a 10 percent chance that someone will catch COVID-19.

“Then the overall risk for an unvaccinated person catching and dying from COVID-19 is about 1 in 1,000, which is about 1,000 times more likely than having a complication from the J&J vaccine.”

The FDA reported that, as of Monday, more than 6.8 million doses of Johnson & Johnson's vaccine have been administered in the U.S. The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

"Right now, these adverse events appear to be extremely rare," the FDA said. "Treatment of this specific type of blood clot is different from the treatment that might typically be administered."

At least three pharmacies announced that they will pause the distribution of the vaccine.

Among those, CVS said it is "immediately implementing a pause in the use of the Johnson and Johnson's COVID-19 vaccine per the recommendation from federal health agencies."

The CDC reconvened a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance.

"Until that process is complete, we are recommending this pause," the FDA said. "This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."

White House COVID-19 Coordinator Jeff Zients issued a statement on the news, saying anyone that has a Johnson & Johnson vaccination appointment will be rescheduled for a Pfizer or Moderna vaccine instead.

"As FDA and CDC announced earlier today, out of an abundance of caution, they have recommended a pause in the use of the Johnson & Johnson vaccine as they review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the Johnson & Johnson vaccine. The FDA and CDC will be providing details at their briefing later this morning.

"This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date. Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines. This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office—and continue on to reach every adult who wants to be vaccinated. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine."

The CDC and FDA also issued a joint statement from the Johnson & Johnson COVID-19 vaccine from Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, and Anne Schuchat, principal deputy director of the CDC.

The statement said a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to the statement.

The pause is important, the statement said, "to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."

"COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously," the statement said. "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."

Johnson & Johnson released a statement on the matter:

"The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine.....

"In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe."

"We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public. The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot.

"The health authorities advise that people who have received our COVID-19 vaccine and develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."

Moderna released a statement saying that its vaccine has not had the same consequences.

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at CDC and FDA will provide additional information and answer questions later on Monday at a media briefing.

This is a developing story. Patch will have more information as it comes in.