U.S.A Lifts Pause on Johnson & Johnson Covid Vaccine Use

Image Credit – CNBC


Health regulators from the U.S. lifted a recommended pause on the use of the Johnson & Johnson Covid-19 vaccine on Friday. This gives states and local officials to distribute the doses across hard-to-reach communities.

The announcement was made by the Centers for Disease Control and Prevention. The Food and Drug Administration stepped in after CDC’s Advisory Community on Immunization practices known as ACIP. It recommends the continued use of the aforementioned vaccine. It is estimated that the benefits of the shot will outweigh the risk. The committee is an outside panel of experts that advises the CDC.

Members of the advisory panel did not recommend U.S. regulators restrict the use of the J&J vaccine based on age or gender, but they did propose that the Food and Drug Administration consider adding a warning label for women under the age of 50.

In a statement late Friday, the FDA and CDC said they were confident that the vaccine is safe and effective in preventing Covid-19, adding the risk of the blood clots is “very low.”

“Safety is our top priority,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases.”

“We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices,” Woodcock said. “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.”

The announcement took place at a press conference where Woodcock said healthcare providers should review revised fact sheets from the FDA about the vaccine, which includes details about rare blood clots. People who have questions about the vaccine should discuss it with a healthcare provider.

Prior to Friday’s vote, the committee debated whether to recommend against the use of J&J’s vaccine or endorse it with U.S. regulators enforcing a warning label. The committee also considered limiting the vaccine’s use based on age or other risk factors.

CDC official Dr. Tom Shimabukuro said there have been no reports of the condition in those who received the Pfizer-BioNTech mRNA vaccine. There were three reports of CVST in patients who received the Moderna vaccine, he said, though the patients didn’t have the low level of blood platelets seen in the J&J recipients.

Dr. Michael Streiff, a hematologist at Johns Hopkins University School of Medicine, said the condition, in normal circumstances, is very rare. “I can tell you from my experience, treating these patients, I’ve just never seen it,” he told the committee during a presentation Friday.

The rollout of the vaccines will begin soon. The single-shot vaccine was recommended to have a warning added to its label. Research is at full peal including reports from the U.S.


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