CDC, FDA deregulates Johnson & Johnson covid vaccine with blood clot warning

US lifts ban on the J&J vaccine with a warning on the bottle

The US Centers for Disease Control and Prevention and Food and Drug Administration lifted their recommended pause on the use of Johnson & Johnson's coronavirus vaccine Friday and said the label will be updated to warn of blood clot risks.

Vaccinations could resume as soon as Saturday, the FDA said

The agencies acted quickly after a vote by the CDC's Advisory Committee for Immunization Practices recommended lifting the pause.
"We have concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older," acting FDA Commissioner Dr. Janet Woodcock said in a statement.
"We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider."


US has more than 9 million Johnson & Johnson doses ready to go if pause lifts

"I support the ACIP's recommendation that the Johnson and Johnson COVID-19 vaccine be used for persons 18 years of age or older in the United States population under the FDA emergency use authorization, and I have signed this recommendation," CDC Director Dr. Rochelle Walensky said Friday.
"With these actions, the administration of Johnson and Johnson's COVID-19 vaccine can resume immediately."
ACIP members worried that taking one of only three vaccines out of the mix available to Americans would slow efforts to immunize the population against a virus that has killed more than half a million people in the United States. Plus, they agreed that having a one-shot vaccine that doesn't need to be stored in freezers was valuable and would be preferred by many people who do not want to come back for a second dose, or who would struggle to make two vaccination appointments.
Walensky said a CDC risk-benefit analysis made the decision an easy one. The agency searched and found 15 likely cases of a rare blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS), with three deaths among people who got the vaccine.
Blood clots versus Covid deaths
"Based on an in-depth analysis, there is likely an association but the risk is very low. 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," Walensky told a news conference. Among women over 50, the rate is 0.9 cases per million. No cases were seen among men.
Walensky noted that Covid-19 is deadly. It's killed more than half a million Americans. The analysis looked at what would happen with and without the vaccine available across the country.
"For every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women aged 18 to 49, and this vaccine could prevent over 4,700 hospitalizations and nearly 600 deaths among women over 50," Walensky said. "These are significant numbers and show the important impact of this vaccine in our country." she added.
The ACIP agreed, voting 10 in favor of lifting the pause, four opposed, with one abstention.
"This is a very rare event -- a very rare event," Dr. Jose Romero, who chairs ACIP and who is also the top health official for Arkansas, told the meeting.

Story Courtesy

https://edition.cnn.com/2021/04/23/health/johnson-vaccine-acip-recommendation/index.html

Tags : #CDC #FDA #JohnsonandJohnson #JohnsonCovidVaccine #CovidVaccine #USCovidNews #USNews

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Serum Institute of India Partners with Oxford University to Develop Meningitis-B VaccineApril 18, 2024
Ethical Concerns Arise: Nestlé Accused of Adding Sugar and Honey to Infant Formula and Breakfast Cereals in Low-Income CountriesApril 18, 2024
Empowering India's Youth: IG Drones & AASSC Launch Drone Skill Program, to Upskill 10M YouthApril 17, 2024
Autonomix Medical Inc. Covered in Benzinga Article Highlighting Innovative Nerve Treatment TechnologyApril 17, 2024
Top 5 online learning platform for learnersApril 17, 2024
Broad-Spectrum RNA Vaccine Breakthrough for Enhanced Virus ProtectionApril 17, 2024
The Impact of Excessive Internet Usage on School Absence: Finnish Study Reveals Key FindingsApril 17, 2024
Uncovering Delhi's Illegal Fertility Centre Operations: Insights from Recent Child Trafficking CasesApril 17, 2024
CarDekho's CSR Arm Girnar Foundation Hosts Health Check-up Camps for Underprivileged Children in Jaipur and GurugramApril 16, 2024
Atal Incubation Centre – Centre for Cellular and Molecular Biology (AIC-CCMB) signs agreement for placement of equipment with Thermo Fisher Scientific to help advance innovation in India April 16, 2024
AVEKSHA, four-day care centres, for the kids of industrial workers inauguratedApril 16, 2024
Nearly a third of the constituencies have zero women candidates in Phase 1 and 2 of LS Elections; reveals The Quantum Hub’s Factsheet April 16, 2024
Emergency Healthcare Provider Medulance Secures $3 Million Series A Funding Led by Alkemi Growth CapitalApril 16, 2024
The Healing Power of Natural Diversity: How Nature Boosts Mental HealthApril 16, 2024
Unveiling Cellular Recycling: How Nutrient-Starved Cells Adapt to Stressful ConditionsApril 16, 2024
Advancing Cancer Care: AIIMS Bhopal’s Workshop on Biomarker Interpretation in Breast CancerApril 15, 2024
10 Powerful Benefits to Diversify Healthcare Advertising ChannelsApril 15, 2024
Understanding Hospital Sink Contamination: Challenges in Fighting Multidrug-Resistant BacteriaApril 15, 2024
Rajasthan’s Swine Flu Situation: Health Department Observes DeclineApril 15, 2024
Is Your Doctor’s Prescription Incomplete ? Insights from Recent ICMR Study Suggests So!April 13, 2024