US Again Using Johnson & Johnson Vaccines
UMMATIMES - US health regulators have lifted the 11-day lag on the Johnson & Johnson (J&J) Covid-19 vaccine. However, the US will add a warning label about the potential for very rare blood clots.
The US Centers for Disease Control and Prevention (CDC) panel previously agreed to restart the US vaccination rollout. Fifteen vaccine recipients suffered from dangerous blood clots from the nearly eight million given the vaccine shot. This week, European drug regulators also ended J&J vaccine restrictions.
European regulators this month also linked a similar and very unusual blood clot to the AstraZeneca Covid-19 injection, but found that the benefits of the drug outweigh the risks. On Friday afternoon, the CDC and the US Food and Drug Administration (FDA) quickly followed the recommendations of the CDC advisory panel after voting by a 10-4 vote to continue rolling out vaccines for people 18 years and over according to its original authorization.
The decision means at least 10 million doses of the J&J vaccine, sent from the company's factory in the Netherlands, could be immediately used across the US.
Health officials identified nine more cases of blood clots, adding to the six cases identified since regulators first approved the vaccine as safe and effective in February. All cases occurred in women, mostly under the age of 50. Three died and seven remain in hospital. About twelve cases were experienced by women aged 30-39 years. Seven of the women were obese, two had high blood pressure, and two were using oral contraceptives, according to health officials.
CDC officials who presented the data on Friday said several cases of blood clots in men were also being reviewed. US health regulators said on Friday that it is important for women to be informed of the potential risks of the vaccine so they can decide whether to look for alternatives.
Dr Sarah Long, from Drexel University College of Medicine, was among the panel members who rejected the proposal because she said it was not enough to warn women. "It is the age group most at risk (from blood clots) who are getting vaccines primarily to save the lives and pain of other people, not themselves," he said.
"And I think we have a responsibility to make sure they know this," he added.
Symptoms can appear within three weeks of vaccination and include acute headaches, shortness of breath, and leg and stomach pain. US health officials warned doctors that heparin, a common treatment for blood clots, could worsen vaccine-related conditions.
The US stopped using single-dose injections earlier this month because of multiple reports of post-vaccine brain blood clots among US women. Following that advice, all federal websites in the US stopped using the vaccine.
It is not J&J's first setback in launching a US coronavirus vaccine. Last month, ingredients of up to 15 million doses of the pharmaceutical giant's vaccine were destroyed at a Baltimore facility. Federal inspectors this week identified a range of problems at BioSolutions' plants, including hygiene and safety issues.