Texas directs providers to halt Johnson & Johnson vaccine after CDC and FDA's guidance

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Tuesday, April 13, 2021
US recommends 'pause' for Johnson & Johnson COVID-19 vaccine
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The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson's Covid-19 vaccine.

HARRIS COUNTY, Texas (KTRK) -- Following a call by the Centers for Disease Control and Prevention and the Food and Drug Administration Tuesday morning, Harris County announced it will pause administration of the Johnson & Johnson vaccine at county distribution sites.

According to a tweet from the office of Harris County Judge Lina Hidalgo, residents who were scheduled to get the Johnson & Johnson vaccine today at NRG Park will be offered the Pfizer vaccine instead.

The pause will not affect residents scheduled to receive their vaccine at mobile sites, which are administering the Moderna vaccine.

The Houston Health Department made a similar announcement Tuesday morning, saying it will pause the distribution of the Johnson & Johnson vaccine.

It was unclear if the distribution pause would affect any scheduled appointments.

In a joint statement Tuesday, the CDC and the FDA said they were investigating clots in six women that occurred in the days after vaccination. The clots were observed along with reduced platelet counts - making the usual treatment for blood clots, the blood thinner heparin, potentially "dangerous."

The Texas Department of State Health Services noted that none of the six blood clot cases occurred in Texas, where more than 500,000 doses of the Johnson & Johnson vaccine have been administered.

Texas DSHS released the following statement regarding pausing distribution:

"The Texas Department of State Health Services is asking vaccine providers in Texas to pause all administration of the Johnson & Johnson/Janssen COVID-19 vaccine following today's recommendation from the Centers for Disease Control and Prevention and the Food and Drug Administration.

The pause is recommended following reports of blood clots in six individuals 6 to 13 days after receiving the Johnson & Johnson vaccine. Right now, these adverse events appear to be extremely rare and are being further evaluated to ensure vaccine safety. People who have received the Johnson & Johnson vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider.

None of the cases of blood clots reported at this time have occurred in Texas, where more than 500,000 doses of the Johnson & Johnson vaccine have been administered.

DSHS has not been notified of any change in vaccine distribution. Providers that have or receive the Johnson & Johnson vaccine should continue to store it in the proper conditions. Providers should report all adverse events following any vaccination to the Vaccine Adverse Events Reporting System at vaers.hhs.gov. DSHS will provide updates as they become available."

More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.

Now, U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot. The other two authorized vaccines, from Moderna and Pfizer, are not affected by the pause.

READ MORE: FDA and CDC call for 'pause' on Johnson & Johnson COVID-19 vaccine after blood clot reports

CDC's Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.

They are recommending that people who were given the J&J vaccine and who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot to contact their health care provider.

The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the U.S. as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.

Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the U.S. government of providing about 100 million doses by the end of May.

Johnson & Johnson released the following statement:

"The safety and well-being of the people who use our products is our number one priority. We share all adverse event reports about individuals receiving our COVID-19 vaccine, along with our assessment of these reports, with health authorities in compliance with regulatory standards.

We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.

We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public."