CDC recommends ‘pause’ in single-dose Johnson & Johnson vaccine due to blood clot investigation

Coronavirus

WASHINGTON (KETK/AP) – The Centers for Disease Control are recommending a “pause” in using the Johnson & Johnson COVID-19 vaccine while reports of potentially dangerous blood clots are investigated.

In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said it was investigating clots in six women in the days after vaccination, in combination with reduced platelet counts.

Currently, more than 6.8 million doses of the J&J vaccine have been administered throughout the country.

U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.

The Texas Department of State Health Services released a statement shortly after the announcement adhering to the federal government’s recommendation.

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 a 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.

TEXAS DEPARTMENT OF STATE HEALTH SERVICES

CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation of the cases.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a joint statement.

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

Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.

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.

Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorization in the U.S. Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.

The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.

But the J&J and AstraZeneca vaccines are made with the same technology. Leading COVID-19 vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.

The announcement hit U.S. stock markets immediately, with Dow futures falling almost 200 points just over two hours before the opening bell. Shares of Johnson & Johnson dropped almost 3%

This is a developing story and KETK News will update it once more information becomes available.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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