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. Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.
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. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research said in a joint statement. Anne Schuchat, Principal Deputy Director of the CDC and Dr. “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. 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. The other two authorised vaccines, from Moderna and Pfizer, are not affected by the pause. US 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 clots were observed along with reduced platelet counts - making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.” More than 6.8 million doses of the J&J vaccine have been administered in the US, the vast majority with no or mild side effects. In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women that occurred in the days after vaccination. European regulators emphasized similar rarity with the AstraZeneca vaccine, with one number putting a risk at one in 250,000.WASHINGTON: The US is recommending a “pause” in administration of the single-dose Johnson & Johnson Covid-19 vaccine to investigate reports of potentially dangerous blood clots. The agencies emphasized how “extremely rare” the adverse events appear to be, with six reported cases from nearly 7 million doses administered. TangentĪustralia has said it would not be purchasing Johnson & Johnson’s vaccine due to similarities between it and the AstraZeneca shot. vaccination campaign under the Biden administration, which has made more substantial use of Covid-19 vaccines from Moderna and Pfizer. It is unclear how the pause will impact the U.S. The drug regulator has stressed that there is no clear causal link between vaccine and blood clots at present. The European Medicines Regulator also opened an investigation into the Johnson & Johnson vaccine this week, though it is under the name of the company’s European subsidiary, Janssen. The inconsistent and, at times, contradictory handling of the issue by regulators has been criticized for damaging already fragile confidence in the vaccines and many of the regulators restricting its use continue to emphasize the benefits outweigh the possible risks. echo those of AstraZeneca in Europe, where many countries have restricted shots to older people. The concerns about the Johnson & Johnson vaccine in the U.S.
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