THE NEUTRAL ZONE
The Centers for Disease Control and Food and Drug Administration issued a joint statement Tuesday noting the organizations are reviewing data from Johnson & Johnson surrounding six cases of a rare but severe blood clotting disorder in individuals who received the company’s COVID-19 vaccine.
The patients experienced cerebral venous sinus thrombosis blood clots, a blood blockage in the brain channels, alongside low levels of blood platelets. All six cases were women between the ages of 18 and 48 who developed the clot within one to three weeks of the vaccination. One has died and another is hospitalized in severe condition.
The risk of blood clots in those who received the vaccine over a month ago is very low, according to a CDC official. The normal treatment for the clots can worsen the disorder, prompting officials to call for a closer look at the data. Nearly 7 million patients have already received the J&J vaccine in the U.S., with a majority experiencing mild or no side effects.
More than 40 states paused or made recommendations to pause administering the J&J vaccine. Some of the country’s largest pharmacy chains, including CVS, Walgreens and Rite Aid, stopped administering the vaccines and are working with customers to reschedule appointments for other available vaccines.
The pause will not have a “significant impact” on the country’s vaccination plan, according to the White House. More than 25 million doses of Pfizer and Moderna have been made available each week to the public. To date, the J&J vaccine makes up less than 5% of shots received in the U.S.
Although the acting FDA commissioner expected the pause to only last a matter of days, the decision led to other governments halting the vaccine’s use, prompting concern of a disruption in the global vaccination efforts. Johnson & Johnson delayed its rollout in Europe following initial deliveries this week. The European Union planned to boost its vaccination drive with the single-dose injection. South Africa suspended giving the shots as a “precautionary measure” after more than 289,000 doses were given to the country’s healthcare workers with no reports of blood clots. Australian health officials advised against the country buying any additional viral vector vaccines, including Johnson & Johnson, noting, “That’s not a reflection, that’s simply an observation.”
The pause comes less than a month after more than a dozen countries paused the use of AstraZeneca’s coronavirus vaccine following similar reports of blood clots. Despite recent developments, all three vaccines authorized in the U.S., including Johnson & Johnson, continue to be safe and effective. Infectious disease experts noted that the risk of severe but rare reactions to vaccines is outweighed by the risks associated with COVID-19.
While the U.S. administered 3.2 million daily vaccines over the past week, the fastest pace during the pandemic, cases continue to rise. Although more than one in five Americans are fully vaccinated, the U.S. reported a seven-day average of 69,000 daily new cases and roughly 960 deaths.
This section includes an aggregation of articles showing different viewpoints on the topic.
J&J COVID vaccine use paused due to one-in-a-million complication – Ars Technica – 4/13/2021
On Tuesday morning, the Food and Drug Administration and the Centers for Disease Control and Prevention issued a release acknowledging that an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot.
White House Downplays Johnson & Johnson Vaccine Pause, Predicts It Will Last ‘a Matter of Days’ – National Review – 4/13/2021
The White House downplayed the significance of a temporary halt in the distribution of the Johnson & Johnson coronavirus vaccines at federal vaccination sites Tuesday morning, just hours after the CDC and FDA announced the move. “This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” White House COVID-19 response coordinator Jeff Zients said in a statement.
What is cerebral venous sinus thrombosis? J&J COVID vaccine paused over blood clots – Newsweek – 4/13/2021
Officials from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) confirmed in a joint statement on Tuesday that the handful of known cases were linked to a condition called cerebral venous sinus thrombosis. The Baltimore, Maryland-based Johns Hopkins Medicine says the condition, also called CVST, is a rare type of stroke that typically affects about 5 in 1 million people every year, and occurs when a blood clot forms in the brain’s venous sinuses.
Did You Get The Johnson & Johnson Vaccine? Don’t Panic, Here’s What To Know – Refinery29 – 4/13/2021
“I know there are people who have gotten the vaccine who are probably very concerned,” Dr. Schuchat said in an FDA and CDC briefing Tuesday morning. “For people who got the vaccine over a month ago, the risk is very low at this time. For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms.” If you received the Johnson & Johnson vaccine, Dr. Pottinger says that there’s no need to panic. But if you have any issues within three weeks of vaccination, report them to your doctor.
In puzzle of rare blood clots and Covid vaccines, researchers see clues – STAT – 4/13/2021
The challenge for public health officials is that these deadly clots occur without vaccines. It’s possible that some people who developed clots after being vaccinated would have developed them even without being vaccinated. So officials have to compare the vaccines against each other, and to try and model the normal rate of clots with low levels of platelets.
This section includes an aggregation of tweets showing different viewpoints on the topic.