CDC And FDA Call For States To ‘Pause’ J&J Vaccinations
As the Food and Drug Administration investigates very rare reports of blood clots in six people who had the Johnson & Johnson covid-19 vaccine, federal health agencies are recommending that states halt its usage. More than 7 million doses of the vaccine have been administered.
CNBC:
FDA Temporarily Halts Use Of Johnson & Johnson Vaccine Due To Rare Blood Clotting Issues
The Food and Drug Administration said Tuesday it is asking states to temporarily halt using Johnson & Johnson’s Covid-19 vaccine after six people in the U.S. developed a rare blood clotting disorder. The FDA said the recommendation is “out of an abundance of caution.” “Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.” (Lovelace Jr., 4/13)
Stat:
U.S. Calls For Pause On Use Of Johnson & Johnson Covid-19 Vaccine
The clotting issue is similar to the one reported after use of AstraZeneca’s Covid-19 vaccine, which has not been authorized for use in the United States to date. And it is similar to an event that occurred during Johnson & Johnson’s U.S.-based clinical trial, an event that led to a temporary pause in that trial. The Centers for Disease Control and Prevention and the Food and Drug Administration jointly announced the recommendation, which falls short of an order not to use the vaccine. The statement said a special meeting of CDC’s Advisory Committee on Immunization Practices will be held Wednesday to review the data around the issue. (Branswell, 4/13)
AP:
US Recommends 'Pause' For J&J Vaccine Over Clot Reports
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women that occurred in the days after vaccination. The clots were observed along with reduced platelet counts — making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.” More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects. (Miller, 4/13)
In other vaccine safety and efficacy news —
Reuters:
AstraZeneca Shot Is Good If Safety Issues Can Be Overcome, U.S. Official Fauci Says
U.S. infectious disease official Anthony Fauci said AstraZeneca’s COVID-19 vaccine had good efficacy, but safety concerns needed to be straightened out and it might not be needed for Americans because of supplies of other shots. “I think that the AstraZeneca vaccine from a standpoint of efficacy is a good vaccine, and if the safety issue gets straightened out in the European Union ... the efficacy of that vaccine is really quite good,” he told BBC radio on Tuesday. (4/13)
USA Today:
No Evidence Of Surge In Miscarriages Since Vaccine Rollout
While vaccines are generally considered safe for pregnant women and new mothers, this group's exclusion from COVID-19 vaccine trials has left health care professionals with no clear data to guide their patients. But a new study released by the American Journal of Obstetrics and Gynecology in late March found that the vaccines based on messenger RNA, or mRNA, conferred good protection against the virus to both pregnant and lactating women, and likely their newborns. (Fauzia, 4/12)
CNBC:
Can You Mix And Match Covid Vaccines? Here's What We Know So Far
With new guidance following reports of rare blood clots, the global medical community is considering whether it’s possible, and safe, to administer two different vaccine candidates to the same person. This week the European Medicines Agency and the U.K.’s Medicines and Healthcare products Regulatory Agency both determined that there is a possible link between the AstraZeneca-University of Oxford vaccine and very rare cases of unusual blood clots with low blood platelets. (Tatelbaum, 4/9)
NPR:
CDC Studies 'Breakthrough' COVID Cases Among People Already Vaccinated
Ginger Eatman thought she was safe after getting her second COVID-19 vaccination in February. But she kept wearing her mask, using hand sanitizer and wiping down the carts at the grocery store anyway. A few weeks later, she noticed a scratchy throat. "By Wednesday morning, St. Patrick's Day, I was sick. I had congestion — a lot of congestion — and some coughing," says Eatman, 73, of Dallas, Ga. Her doctor thought her symptoms might be allergies. But Eatman started feeling sicker. And then she suddenly lost her sense of smell. She even tried her strong perfume. Nothing. (4/13)
