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The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted 10-4 with one abstention to recommend the Janssen Johnson & Johnson vaccine for persons age 18 and over, under the Food and Drug Administration's Emergency Use Authorization.
This means that the one-shot J&J vaccine is reaffirmed as the third vaccine in the U.S. arsenal to vaccinate all Americans.
Dr. Beth Bell, chair of the committee's working group, said she feared the vote would mean women would not be adequately informed of the risks posed by J&J vaccination. Others expressed a similar view.
Most of the reported cases of blood clots have been in women under the age of 50 who received the Johnson & Johnson vaccine. Risk factors include use of oral contraceptives and obesity.
The committee had also considered, but did not vote on, recommending the use of the Johnson & Johnson vaccine with the caveat that women age 50 and younger be aware of the increased risks of thrombosis with thrombocytopenia syndrome, or TTS, and be able to choose another COVID-19 vaccine.
Thrombosis with thrombocytopenia syndrome is a rare and new syndrome of blood clotting which has been reported in individuals who have received the AstraZeneca vaccine, and in those who received the Johnson & Johnson vaccine.
It's a "a platelet storm" leading to clotting, said Dr. Michael Streiff, medical director of Johns Hopkins University School of Medicine, who spoke on Friday.
The condition can be fatal if it causes bleeding into the brain.
The committee did not definitively link a causal relationship to getting the J&J vaccine.
Committee members and J&J Chief Medical Officer Dr. Joanne Waldstreicher said there were 15 cases of thrombosis with thrombocytopenia. All of these involved women, with a cluster of seven in the age group of mid-to-late 30s. Two patients were using oral contraceptives, and obesity was prevalent in this group.
Just because there were zero cases in males does not mean there is no risk for men getting the vaccine, members said.
Whether there is a biological basis to the age component or whether there is more prevalence now among younger populations as older adults have already been vaccinated is unclear, Streiff said.
Symptoms, such as headache, develop about six days after vaccination, not a day later as is a common vaccination side effect. Individuals may also have abdominal pain and these symptoms warrant seeing a doctor.
WHY THIS MATTERS
Committee members weighed whether the benefits of having a third COVID-19 vaccine for use in the United States outweighed the risks of the rare TTS syndrome.
J&J's Dr. Mathai Mammen, global Head of Janssen Research and Development, said the benefits of lowering mortality and hospitalization did outweigh the risks, as coronavirus variants are making containment more challenging globally.
The J&J vaccine requires one dose and needs to be stored at regular refrigerator temperatures, as compared to the two doses needed and the colder temperatures required for the Moderna and Pfizer vaccines, which have received FDA emergency use authorization.
As of April 17, 2.7 million doses of Pfizer and 2.5 million doses of Moderna have been administered.
Committee members said the vaccine is needed in rural areas and to get vulnerable populations vaccinated. These include: the homeless, homebound populations, incarcerated individuals and migrant populations.
Other recommendation options weighed by the committee included one against use for all persons and a recommendation for vaccination only in adults aged 50 and over.
THE LARGER TREND
This issue first gained attention following reports of blood clots that developed in individuals who had received the AstraZeneca vaccine.
The CDC reported six cases observed in women ages 18-48 who received the J&J vaccine. In clinical trials, one 25-year-old male developed TTS.
On April 13, the advisory committee recommended a pause in use of the J&J vaccine, which had received EAU.
The CDC's average daily of new cases this week is 62,596, a decrease of 10.1% compared with the previous seven-day moving average of 69,614. A total of 31,666,546 COVID-19 cases were reported as of April 21.
The highest peak was on January 8 with 249,436 cases.
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