Washington — US regulators on Thursday severely restricted who could be vaccinated with Johnson & Johnson’s COVID-19 vaccine due to the rare but serious risk of blood clotting.
The Food and Drug Administration said the shot should only be given to adults who cannot be vaccinated with another vaccine, or specifically request J & J.
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vaccination.For months, U.S. officials have recommended that Americans starting COVID-19 vaccination use Pfizer.
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Or modern
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Shot instead.
Dr. Peter Markes, FDA’s head of vaccines, reviewed data on the risk of life-threatening blood clots and concluded that it was limited to J & J vaccines before authorities decided to limit the vaccine. Said.
“If there is an alternative that seems equally effective in preventing serious consequences from COVID-19, we would rather see people who choose it,” Marks said. “But I’ve been cautiously saying that this is still a good option compared to not vaccinated.”
This problem occurs in the first two weeks after vaccination. “Therefore, if you were vaccinated six months ago, you can sleep soundly tonight, knowing that this is not a problem.”
The FDA approved J & J shots for adults over the age of 18 in February last year.
Vaccines were initially considered an important tool for combating pandemics because they require only one vaccination. However, the single dose option proved to be less effective than the double dose of the Pfizer and Moderna vaccines.
During December Recommended by Centers for Disease Control and Prevention Moderna and Pfizer attacked J & J due to safety issues.
As of mid-March, federal scientists have identified 60 side effects, including 9 fatal cases. This corresponds to 3.23 cases of thrombosis per 1 million J & J shots. According to Marks, this problem was common in women under the age of 50, with a mortality rate of approximately once in a million shots.
According to Marks, the FDA has spent extra time analyzing the problem and has confirmed that it is not related to other problems, such as women taking contraceptives that increase the risk of coagulation.
The J & J vaccine provides harsh warnings about the potential “long-term and debilitating health effects” of side effects.
Under the new FDA’s instructions, the J & J vaccine can continue to be given to people who have a severe allergic reaction to one of the other vaccines and cannot receive additional vaccinations. J & J’s shots could also be an option for those who refuse to be vaccinated with mRNA from Pfizer and Moderna, otherwise they will remain unvaccinated, the agency said.
A J & J spokesman said in an email statement:
The coagulation problem first occurred last spring with J & J Shot in the United States and a similar vaccine made by AstraZeneca used in other countries. At that time, U.S. regulators have determined that the benefits of J & J’s one-off vaccine outweigh what was considered a very rare ri. sk — As long as the recipient is warned.
COVID-19 also causes a deadly blood clot.However, the vaccine-related varieties are different and are thought to be formed due to an improper immune response to J & J and AstraZeneca.
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Vaccines because of how they are made. Coagulation is also formed in abnormal locations, such as veins that drain blood from the brain, and in patients with abnormally low levels of platelets that form coagulation. Symptoms of abnormal blood clots include severe headache (not immediately), abdominal pain, and nausea 1-2 weeks after J & J vaccination.
The company, based in New Brunswick, NJ, announced last month that it was not expecting any profit from this year’s vaccine and was suspending sales forecasts.
The company’s vaccine deployment was hit by a series of problems, including manufacturing issues at the Baltimore plant, which forced J & J to import millions of doses from abroad.
In addition, regulators have added warnings about blood clots and a rare neural reaction called Guillain-Barré syndrome.
Pfizer and Moderna provide the majority of COVID-19 vaccines in the United States. Over 200 million Americans have been fully vaccinated with two company vaccinations, and less than 17 million Americans have been vaccinated with the J & J vaccine.
