FILE – This Saturday, March 6, 2021 file photo shows vials of Johnson & Johnson COVID-19 vaccine in the pharmacy of National Jewish Hospital for distribution in east Denver. The European Medicines Agency is meeting Thursday March 11, 2021, to discuss whether Johnson & Johnson’s one-dose coronavirus vaccine should be authorized, a move that would give the European Union a fourth licensed vaccine to try to curb the pandemic amid a stalled inoculation drive. (AP Photo/David Zalubowski, File)
An influential committee of the Centers for Disease Control and Prevention has endorsed the Johnson & Johnson vaccine that will likely clear the way for resumed one-shot inoculations.
On Friday, the group found that the benefits outweigh the rare risk of blood clots, but urged authorities to educate women under the age of 50 that they face a very small but increased risk of the syndrome and offered an alternative Pfizer and Moderna vaccines.
“This is a serious adverse event and we need to continue to be sure that awareness is raised,” said Dr. Grace Lee, a Stanford University pediatrics professor and member of the group, called the Advisory Committee on Immunization Practices.
Use of the vaccine was paused by the CDC and U.S. Food and Drug Administration after six cases of a rare health problem — severe stroke-like blood clots, accompanied by low platelet counts — among the 6.8 million people who have received the Johnson & Johnson vaccine.
Since then, authorities have found 15 cases of the syndrome in people vaccinated with the product. Of these, 13 were in women between 18-49 and two were in women over age 49. Three people have died. No cases were found in men.
The risk to this subgroup — women of child-bearing age — is 1 in 140,000, according to data presented at the Friday meeting. This group is among those who are at least risk of dying of COVID-19.
But loss of the vaccine threatens other groups: the homeless, incarcerated, migrant workers and people who are homebound and unable to travel to clinics for the two doses of the Moderna and Pfizer vaccines.
Explaining her support, Stanford’s Lee said that “What is striking to me is that there have been deaths and ICU admissions that would have been potentially preventable, had we not done the pause. At the same time, I recognize that the last 11 days have been reassuring and that we haven’t identified hundreds of more cases, despite enhanced awareness and case finding across the U.S.”
In a 10 to 4 vote, with one abstention, the vote was not unanimous. Those opposing the change sought to include an explicit warning in the proposed language change by the committee, which would have elevated awareness, they said.
Supporters said that such a warning is better placed in educational materials given to consumers during vaccine signup or administration.
With Friday’s vote, Johnson & Johnson’s revised “fact sheet,” in addition to including disclosure of possible arm soreness and other routine side effects, will now include this information: “Blood clots involving blood vessels in the brain, abdomen and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 vaccine.”
You should seek medical attention right away if you have any of the following symptoms after receiving the J&J vaccine:
• shortness of breath
• chest pain
• leg swelling
• persistent abdominal pain
• severe and persistent headaches or blurred vision
• easy bruising or tiny blood spots under the skin beyond the site of the injection.
