Medical Disorders
Resources
Basic InformationLookupsLatest News
Obesity More Deadly for Men Than Women When COVID StrikesReal-World Studies Show Pfizer Vaccine Shields Against COVID Variants1 in 4 U.S. Teens Has Had a Concussion: StudyWhat's the Right Amount of Sleep for a Healthy Heart?U.S. COVID Outlook Shows Big Improvement by July'Prediabetes' Raises Odds for Heart Attack, StrokeA Vitamin Could Be Key to Women's Pain After Knee ReplacementBiden Sets New Goal of Vaccinating 70% of Americans by July 4Wildfires Are Changing the Seasonal Air Quality of the U.S. WestMany Americans Wrong About Sun's Skin Cancer Dangers: PollNot Just About Antibodies: Why mRNA COVID Vaccines May Shield From VariantsYou Got Your COVID Shot: What to Do With That Vaccine CardFDA Plans to OK Pfizer Vaccine for Those Aged 12 and UpAHA News: As Pre-Pandemic Activities Return, So Does AnxietyCOVID Anxieties Still High for Americans: PollCOVID Vaccination in Pregnancy May Pass Helpful Antibodies to BabyWhy U.S. Hispanics Got COVID at Higher Rates: Their JobsHerd Immunity for Americans May Be an Elusive Goal, Experts SayUrgent Care or the ER? Which Should You Choose?Needle Anxiety Behind J&J COVID Vaccine Reaction Clusters: Study1 in 5 Patients on Kidney Dialysis Say No to COVID-19 Vaccine: StudyYoung, Immune-Compromised Patients Are Hotspots for Coronavirus Mutations: StudyCOVID Deaths Continue to Decline in U.S.Researchers Seek Antiviral Pill That Would Ease COVID SeverityAHA News: Take Stock of Your Health With This Post-Lockdown ChecklistPoll Reveals Who's Most Vaccine-Hesitant in America and WhyGood Stroke Recovery May Depend on Your ZIP Code: StudyNew Advice for Blood Pressure That's a Bit Too HighMany U.S. Colleges Will Mandate Vaccines on Campus Next Fall: SurveyPfizer/Moderna Vaccine Protection: 64% at First Dose, 94% at SecondAbout 1 in 7 Who Get Pfizer Vaccine Will Have Any 'Systemic' Side Effect: StudyPolls Find Most U.S. Young People Take COVID Threat SeriouslyAHA News: Experts Remain Confident About Vaccine Safety MonitoringNothing to Sniff at: Depression Common for People With COVID-Linked Smell LossHead Injury, Alzheimer's Appear to Affect Brain in Similar WaysCDC Says Vaccinated Can Shed Masks Outside, Except in CrowdsCOVID-19 Could Raise Odds for Heart Failure, Even in Those With No Prior Heart RiskU.S. to Share Up to 60 Million Doses of AstraZeneca Vaccine With Other CountriesLow Risk of Mom Passing COVID to NewbornThese Factors Could Lead to a Real Pain in the NeckWhy COVID Infection Raises Risks in PregnancyNew Drug May Be Better Psoriasis TreatmentMillions of Americans Have Missed Their Second COVID Vaccine Dose: CDCIs a Cheap 'Universal' Coronavirus Vaccine on the Way?Vertigo: A Common Symptom With Many Different CausesFDA Moves to Resume Use of J&J COVID Vaccine'Garage Lab' Vape Products May Be Driving Lung Injury in Rural AppalachiaNBA Study Shows Post-COVID Viral Transmission Rare, Even With Positive TestCDC Decision on Johnson & Johnson Vaccine Pause Expected FridayAHA News: How to Make Sure Everyone Gets a Fair Shot at the COVID-19 Vaccine
Questions and AnswersVideosLinksBook Reviews
Related Topics

Cancer
Men's Health
Women's Health

FDA Moves to Resume Use of J&J COVID Vaccine

HealthDay News
by By Dennis Thompson HealthDay Reporter
Updated: Apr 23rd 2021

new article illustration

FRIDAY, April 23, 2021 (HealthDay News) -- The U.S. Food and Drug Administration on Friday lifted the temporary pause it had placed on the Johnson & Johnson COVID-19 vaccine and said it will add a note to the shot's labeling warning of the potential for rare blood clots.

The move came just hours after recommendations from a special panel of experts at the Centers for Disease Control and Prevention, which supported resuming use of the vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) determined that the benefits of the vaccine in preventing deaths and hospitalizations far outweigh the risks of rare blood clots, risks that are mainly borne by young women.

The J&J vaccine has certain advantages over the Pfizer-BioNTech and Moderna shots also approved for use in the United States, because unlike those vaccines it requires only one dose and does not require super-cold storage.

The panel vote was 10 in favor, 4 opposed and one abstention. The opposing votes favored a stronger warning for women younger than 50 that would give them the option of choosing another vaccine.

The panel's recommendation comes more than a week after the CDC pressed "pause" on the rollout of the J&J vaccine. It now goes to CDC Director Rochelle Walensky for final approval.

Just how much do the benefits of the J&J shot outweigh its risks?

In coming to its decision, ACIP considered a risk/benefit analysis that estimates that, for every one million doses of the Johnson & Johnson vaccine administered:

  • 13 cases of blood clots will occur in women 18 to 49, but at the same time 12 COVID-related deaths, 127 ICU admissions for COVID and 657 related hospitalizations will be prevented.
  • 2 cases of blood clots will occur in women 50 and older, but 593 deaths, 1,292 ICU admissions and 4,794 hospitalizations will be prevented.
  • 2 cases of blood clots will occur in men 18 to 49, but 11 COVID deaths, 114 ICU admissions and 601 hospitalizations will be prevented.
  • No cases of blood clots will occur in men 50 and older, but 708 deaths, 1,485 ICU admissions and 5,513 hospitalizations will be prevented.

The pause in use of the one-dose vaccine came after six U.S. reports, one fatal, of a rare but severe form of blood clot tied to use of the J&J shot, all occurring in women.

At Friday's meeting, a CDC scientist presented nine new confirmed cases of the disorder, bringing the total to 15, The New York Times reported. All the cases have been in women, and 13 have been in women between 18 and 49 years old.

Three women have died from the rare clots and seven remain hospitalized, four of whom are in the intensive care unit, the CDC scientist said.

At the time of the pause, more than 7 million doses of the J&J vaccine had been administered so far in the United States.

Dr. Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, said the company has agreed with the U.S. Food and Drug Administration to add a warning label to the vaccine, which notes that "most cases" of the clotting disorder have occurred in women between 18 and 49 years old.

ACIP is calling the rare clots thrombosis with thrombocytopenia syndrome (TTS). TTS is characterized by a rare form of clot in the brain (and possibly elsewhere in the body) that occur in tandem with a low level of blood clotting cells called platelets.

According to CNN, some blood specialists believe the clots could stem from an unusual immune reaction targeting platelets, which causes the platelets to clump together to form a clot.

One of the most worrying things about the clots is that they are atypical and require different treatment. They occur in unusual places, such as in veins that drain blood from the brain, the Associated Press reported. The six cases first announced last week raised an alarm bell because that number is at least three times more than experts would have expected to see of more typical clots, said the CDC's Dr. Tom Shimabukuro.

"What we have here is a picture of clots forming in large vessels where we have low platelets," Shimabukuro explained to the AP. "This usually doesn't happen," but it is similar to European reports of clotting with the AstraZeneca vaccine.

According to CNN, Johns Hopkins University blood specialist Dr. Michael Streiff will brief the ACIP panel on treatments for TTS. Blood thinners -- with the notable exception of heparin -- can typically be used to dissolve the clots, and an immune product called IVIG can also help dampen the erroneous immune response.

In Europe, most but not all cases following AstraZeneca vaccinations have been among women under 60, leading different countries to deploy that vaccine in more limited ways.

More information

The U.S. Centers for Disease Control and Prevention has more about COVID-19 vaccines.

SOURCES: Advisory Committee on Immunization Practices meeting, April 23, 2021; The New York Times; CNN




Facebook

Amazon Smile

 

Children and Adult services are available now with no wait time.  

Please contact HBH at 860-548-0101, option 2.

 


powered by centersite dot net