Pennsylvania has resumed use of Johnson & Johnson’s COVID-19 vaccine, following a thorough federal review which reaffirmed the vaccine’s safety and effectiveness against the virus, according to the Harrisburg-based Hospital and Health System Association of Pennsylvania.
Last week, the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration recommended lifting the a temporary pause imposed after a rare blood-clotting issue was reported in 15 cases among the 8 million people who received the one-dose vaccine.
During a meeting on April 23, the CDC’s Advisory Committee on Immunization Practices recommended updating Johnson & Johnson’s emergency use authorization to include information about the risk for the rare blood-clotting issue, but reaffirmed the vaccine’s overall safety and effectiveness.
The ACIP reported that serious blood-clotting complications occurred in 15 women and no men since the vaccine’s approval in February. The FDA updated its vaccine fact sheets to include a warning about the rare complications involving blood clots and low platelet counts that have been reported.
“We are confident that this vaccine continues to meet our standards for safety, effectiveness, and quality,” said Dr. Janet Woodcock, acting FDA commissioner in a statement. “We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”
To date, the Johnson and Johnson vaccine was administered to 300,000 people in Pennsylvania, according to HAP. Roughly 9.1 million vaccines doses in total were administered in the commonwealth, this includes all vaccines brands, including Johnson & Johnson, Moderna and Pfizer.
Attorney General Josh Shapiro announced on Oct. 21 that he and Attorneys General Josh Stein (NC), Herbert Slatery (TN), and Ken Paxton (TX) secured a $48 billion agreement in principle with pharmaceutical companies Cardinal Health, McKesson, AmerisourceBergen, Johnson & Johnson, and Teva for their roles in fueling the opioid epidemic, according to Shapiro’s office.
The framework agreed upon includes having the companies pay $22.25 billion in cash and $26 billion in medication-assisted treatment drug provision and distribution to each of the four states over 10 years. In addition, the three major distributors have also agreed to change their policies to prevent over-distribution in the future.
“The opioid, heroin and fentanyl epidemic claims the lives of 12 Pennsylvanians per day, and this public health and public safety crisis was engineered by opioid manufacturers and distributors,” said Shapiro. “Today’s agreement holds three of those distributors and two manufacturers accountable for their roles in perpetuating this epidemic.”
The agreement announced today is an agreement in principle. Each state and its local governments will receive a share of the $22.25 billion in cash to take action to abate the crisis, including providing addiction treatment, community paramedic services, and telehealth treatment, among other activities. The formula for distributing this cash is being finalized.
This agreement is the result of an investigation led by Shapiro with 40 other Attorneys General into six manufacturers and three distributors for their roles in the opioid epidemic.
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