Georgia DPH pauses J&J vaccines according to CDC, FDA guidance
ATLANTA - The U.S. is recommending a "pause" in the administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots. In Georgia, the Department of Public Health announced Tuesday morning it would follow federal agencies' guidance.
The department released a statement after the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women that occurred 6 to 13 days after vaccination.
"Following the guidance and recommendations of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), the Georgia Department of Public Health (DPH) is pausing J&J (Janssen) vaccinations in Georgia until further notice. The FDA and CDC are reviewing data involving six reported cases of a rare and severe type of blood clot occurring 6-13 days after vaccination. Additional information, including information about appointments and rescheduling to come."
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. Georgia DPH said more than 124,000 doses of the J&J vaccine have been safely administered in Georgia.
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Adults ages 16 and older are eligible for the vaccine in Georgia.
The CDC and FDA statement said the clots were observed in the sinuses of the brain along with reduced platelet counts — making the usual treatment for blood clots, the blood thinner heparin, potentially "dangerous." Georgia DPH said it made the decision to pause "out of an abundance of caution."
The Georgia Department of Public Health acknowledged the condition appears to be extremely rare but said individuals who have received the J&J vaccine and develop a severe headache, abdominal pain leg pain or shortness of breath within three weeks after vaccination should contact their health care providers.
The Georgia DPH said the six cases being studied by federal agencies are not related to reactions reported at Cumming Fairgrounds last week.
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Georgia DPH and district health departments are coordinating Pfizer or Moderna vaccines for people previously scheduled appointments for the J&J vaccine. The process may require appointments to be rescheduled.
The Georgia DPH echoed sentiments from state leaders, that vaccination remains one of the best tools for stopping the spread of COVID-19, along with basic prevention measures: wearing a mask, distancing from others, avoiding large gatherings and frequent hand washing.
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 other two authorized vaccines, from Moderna and Pfizer, make up the vast share of COVID-19 shots administered in the U.S. and are not affected by the pause.
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.
"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.
Johnson & Johnson said it was aware of the reports of "thromboembolic events," or blood clots, but that no link to its vaccine had been established.
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"We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines," said Johnson & Johnson in a statement. "At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine."
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.
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. 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%.
The Associated Press contributed to this report.
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