UPDATE: APRIL 26, 2021 – On Friday, a CDC advisory committee recommended that the Johnson & Johnson COVID-19 vaccine be put back into distribution, following a brief pause to investigate a possible link between the shot and a rare blot clotting disorder.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” CDC director Rochelle Walensky said. “What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 49 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million.”
While officials believe the J&J shot is likely safe for most patients, the CDC did recommend that it be accompanied by new warning language, yet to be finalized, acknowledging that there may be some elevated chance of blood clots, particularly among women between 16 and 50, and those at increased risk of thrombosis with thrombocytopenia.
“To end this pandemic, we need to use every dose we have, and the Johnson & Johnson vaccine is a critical piece of that strategy,” L.A. Mayor Eric Garcetti said at a briefing on Sunday, announcing that local vaccination sites would resume giving out the J&J shot this week.
The City of Los Angeles currently has 29,000 doses of the single-shot vaccine on hand, with more scheduled to arrive. Los Angeles County has another 13,000 doses, and public health officials estimate that other providers within the county, including private pharmacies and health clinics hold another 25,000.
APRIL 13, 2021 – After reports of blood clots were reported among individuals who received the Johnson & Johnson COVID-19 vaccine, regulators have decided to temporarily pause the distribution of that particular shot. The cases–which have not yet been confirmed to be linked to the vaccine–appear to have occurred in six people out of the nearly 7 million who have received the Johnson & Johnson vaccine so far.
The six individuals who developed blood clots were all women between the ages of 18 and 48, in locations across the United States, and all reported the clots one to three weeks after being injected with the J&J vaccine. Each year, some 300,000 to 600,000 Americans develop blood clots, though The New York Times reports that the specific clotting disorder these six individuals exhibited, cerebral venous sinus thrombosis, is considered “extremely rare.”
Some doctors are worried that there could be a connection between the immune system response brought on by the vaccine and the development of the clotting disorder, and have suggested the hold on J&J distribution for at least a few days while they look into the situation. This type of an investigation into what experts term a “safety signal” for a new drug or therapy is common–and often result in the determination that there is no significant risk associated with the drug.
“Out of an abundance in caution, we’re recommending a pause in the use of the Johnson & Johnson COVID-19 vaccine,” acting FDA commissioner Dr. Janet Woodcock told reporters at a briefing Tuesday morning. “We’re recommending this pause while we work together to fully understand these events and also so we can get information out to healthcare providers and vaccine recipients.”
The review is likely to take only “a matter of days,” Woodcock added.
California and Los Angeles public health officials have announced they will be following the federal guidance and putting a hold on the J&J shot for the time being. In a tweet, Governor Gavin Newsom noted that the company’s vaccine accounts for only around four percent of the total vaccine supply arriving in the state, and thus the pause is expected to cause minimal disruption.
Out of an abundance of caution CA will follow the CDC & FDA & temporarily pause use of J&J.
J&J is just 4% of CA’s supply from the feds right now.
Vaccines are still overwhelmingly safe.
We’re vaccinating 3+ million people a week and are still on track to fully reopen 6/15.
— Gavin Newsom (@GavinNewsom) April 13, 2021
In the UK and Europe, there were concerns last month of a possible link between AstraZeneca’s COVID-19 vaccine and blood clots, with most of those cases also occurring in younger women. After analyzing the cases, European regulators determined that blood clots should be listed as a “very rare side effect” of the AstraZeneca vaccine, but that it was not concerning enough to stop distributing the vaccine. In the UK, they also resumed distribution of the AstraZeneca shot, though offered an advisory that young patients consider using an alternative brand.
The type of vaccine technology in the AstraZeneca and J&J vaccines are similar, but very different from the mRNA technology used in the Moderna and Pfizer vaccines. There have been no reports of a connection between clotting and either mRNA shot.
Individuals who have already received the Johnson & Johnson vaccine are encouraged to self-monitor, particularly around seven to 14 days following their shot. Flu-like symptoms within the first 24 to 36 hours are completely normal and so reason for concern. However, if different, serious symptoms of headache, shortness of breath, leg pain, or abdomen pain develop starting about a week after injection, it may be wise to contact a doctor and have them determine if the individual has an unusually low platelet count.
“I am a woman between the ages of 18 and 48 who got the Johnson & Johnson vaccine eight days ago, and I recommend that people do what I’m doing, which is not panic,” Georgetown University virologist Angela Rasmussen told The Washington Post. “First of all, we don’t know if these six cases are actually associated with the vaccine. We don’t know if those six cases had some other conditions that would have predisposed them to having blood clots like this. We don’t know a lot about it, which is why there’s a pause”
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