CDC, FDA Lift Pause Of Johnson & Johnson Coronavirus Vaccine


The Center for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended that the United States can begin administering the Johnson & Johnson coronavirus vaccine again.

The government halted the distribution of the vaccine over concerns that it may be linked to rare but serious blood clots last week.

Shortly after the panel made their recommendation, the FDA and CDC lifted the pause, allowing states to begin administering the vaccine.

"We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older," acting FDA Commissioner Dr. Janet Woodcock said in a statement.

"We are confident that this vaccine continues to meet our standards for safety, effectiveness, and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider."

The vaccine will come with a warning that says women under the age of 50 should be aware of the risk of developing a rare blood clotting disease.

The CDC committee reviewed an additional nine confirmed cases of the disorder, bringing the total to 15. All of the cases were in women, with 13 reported in women between 18 and 49 years old. Three of the women died, and seven remained hospitalized.

Johnson & Johnson told the panel that the benefits of the vaccine far outweigh the risks. The company said that if vaccinations were restarted for all adults, they would expect to see between 26 and 45 cases of the rare blood clotting disorder.

"We could expect that if 1 million people in the United States were vaccinated with the J&J single-dose vaccine, there would be over 2,000 fewer deaths and 6,000 fewer Covid-related hospitalizations," said Dr. Joanne Waldstreicher, Johnson & Johnson's chief medical officer.

Following the committee's recommendation, which was approved by a 10-4 vote, the FDA is expected to lift the pause as early as this weekend.

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