Feds: Pause Johnson & Johnson COVID Vaccine In Texas, Elsewhere

Austin TX

13 April, 2021

10:15 AM

Description

TEXAS — The Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday because of blood-clot concerns. The pause would impact many Texas vaccination sites. Texas was expected to receive 46,300 doses of the J&J vaccine this week at many of its state allocated sites. In Central Texas, only 6,400 doses of the Johnson & Johnson vaccine were distributed this week. Of those doses, Hays County got the most with 3,200 doses. Travis County got 2,300 doses, Gillespie County got 600 doses, and Williamson County got 200 doses. The Texas Department of State Health Services announced Tuesday it is asking vaccine providers in the state to pause all administration of the Johnson & Johnson/Janssen COVID-19 vaccine following the federal health authorities recommendations. More on this: Johnson & Johnson Vaccine Pause: 6 Things To Know "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," the health agency said. 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 said. Before the decision to pause the one-dose vaccine, the state health agency said Friday it expected to receive less vaccine this week due to a reduction of approximately 350,000 doses of the Johnson & Johnson vaccine. The Centers for Disease Control and Prevention told states to expect smaller weekly allocations of the J&J vaccine until a plant in Baltimore was authorized to participate in vaccine production, DSHS said. The FDA and CDC addressed the issue during a 10 a.m. media call. Watch the clip here: The FDA reported that, as of Monday, more than 6.8 million doses of New Brunswick-based company'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 two pharmacies announced that they will pause the distribution of the vaccine. 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 news comes after reports of a New Jersey man who became very sick with COVID-19 weeks after getting the Johnson & Johnson vaccine. The case, however, appears to have no connection to the federal government's actions on Tuesday. Read more: Edison Man Hospitalized With COVID-19 After J&J Vaccine: Reports The CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. The FDA will review that analysis as it also investigates these cases. "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." 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). Moderna's statement on CVST or thrombotic events. pic.twitter.com/yPjASmzmCC— Moderna (@moderna_tx) April 13, 2021 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." 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. A recording of that media call will be available on the FDA's YouTube channel. RELATED CORONAVIRUS VACCINE COVERAGE: Travis County: Where To Get Vaccinated For Week Of April 12 Williamson County: Where To Get Vaccinated For Week Of April 12 As States Expand Vaccine Eligibility, Many People In Prison Still Wait For Shots