Thursday 21 February 2019 ,
Thursday 21 February 2019 ,
Latest News
  • Newly elected women MPs sworn in
  • PM returns home
  • 5 killed in Lalmonirhat road crash
  • DIP asks authorities to get its clearance
  • Young Turks work on floating new party
  • Untreated wastes enter Bangladesh through Agartala border
  • UK pledges support on repatriation
21 January, 2019 00:00 00 AM

FDA approves expanded use of Adacel (Tdap) vaccine for repeat vaccination

drugs.com
FDA approves expanded use of Adacel (Tdap) vaccine for repeat vaccination

The U.S. Food and Drug Administration has approved the expanded use of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria and pertussis. It is now the first and only Tdap vaccine in the U.S. approved for a repeat dose in people 10 through 64 years of age 8 years or more after the first vaccination. Adacel is also the only Tdap vaccine available in a syringe made without natural rubber latex, which may help reduce risk to patients with an allergy.

"While strong vaccination programs are in place for young adolescents, a single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity," said David P. Greenberg, M.D., Regional Medical Head North America at Sanofi Pasteur. "The licensure of Adacel as the first Tdap vaccine in the U.S. for repeat vaccination is an important step for eligible patients and offers flexibility for health care providers to help manage their immunization schedules."

The FDA licensure was based on clinical data from a study of the safety and effectiveness of repeat Adacel vaccination in adults. In the study of more than 1,300 adults (aged 18 through 64 years), participants received either Adacel vaccine or a tetanus-diphtheria (Td) vaccine 8-12 years after a previous dose of Adacel vaccine. The results of the study published in the Journal of the Pediatric Infectious Diseases Society showed a second dose of Adacel vaccine in adults administered 8-12 years after a previous dose found no significant differences in adverse events between vaccine groups.1 A total of 87.7% of Tdap vaccine recipients (n=999) and 88.0% of Td vaccine recipients (n=328) reported at least 1 injection-site reaction.

Sanofi Pasteur has provided the results of the study to the CDC's Advisory Committee on Immunization Practices for their consideration in future recommendations.

The U.S. Centers for Disease Control and Prevention (CDC) currently recommends a single dose of Tdap vaccine for adolescents and adults, and for pregnant women during every pregnancy. Tdap helps protect adolescents and adults and may prevent the spread of the infection to babies and young children who are still building immunity. Despite the CDC-recommendation, nearly three of four adults have not received the Tdap vaccine.

Indication for Adacel Vaccine

Adacel vaccine is given to people 10 through 64 years of age to help prevent tetanus (lockjaw), diphtheria, and pertussis (whooping cough).

Important Safety Information for Adacel Vaccine

Adacel vaccine should not be given to anyone who has had a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine. Some signs of severe allergic reactions are hives, swelling of the throat, low blood pressure, shock, and difficulty breathing. If you begin to experience any of these signs seek treatment right away. These reactions are rare and usually occur before leaving the doctor's office.

For one presentation of Adacel, the tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex‐sensitive individuals. The vial stopper is not made with natural rubber latex.

Tell your doctor if you have ever experienced a severe brain disorder, such as encephalopathy (altered consciousness), Guillain‐Barré syndrome (severe muscle weakness), brachial neuritis (inflammation of nerves in the arms), or an Arthus‐type reaction (severe, exaggerated swelling involving an injection site) after a previous dose of a tetanus toxoid‐ or pertussis antigen‐containing vaccine.

Fainting can occur shortly after injecting vaccines, including Adacel.

If you notice any other problems or symptoms following vaccination, please contact your health care professional promptly.

After the first and second dose of Adacel, the most frequently reported side effects were pain, swelling, and redness at the injection site; headache, body ache or muscle weakness, tiredness, muscle aches, and general discomfort.

 

Comments

Most Viewed
Digital Edition
More story
From the Editor

From the Editor

Our cover story this week is on Dental Disorders. Teeth are a very important part of the human body. They are the body's hardest and most durable…
Cancer’s long-term prognosis: As an oncologist I’ve never been so hopeful

Cancer’s long-term prognosis: As an oncologist I’ve never been so hopeful

“You’re an oncologist, isn’t that depressing?” Answering this question, posed with equal parts dread and fascination, is an occupational…
What are the most common dental problems?

What are the most common dental problems?

Tammy Davenport    Dental problems are never any fun, but the good news is that most of them can be easily prevented. Brushing twice a day,…
Tooth, cavities and root canal

Tooth, cavities and root canal

Our dental surgeons now a days talk about re-construction of a broken tooth with a chemical compound they call 'miracle mix' or magic mix'…
What can you do about sensitive teeth?

What can you do about sensitive teeth?

If you pass on hot or cold drinks because you know they’ll make your teeth hurt, it may be time to talk to your dentist about the possibility that…
Everything you need to know about bad breath

Everything you need to know about bad breath

Tim Newman Bad breath affects an estimated 25 percent of people. There are a number of possible causes of halitosis, but the vast majority come down to…
7 Daily ways to protect your teeth

7 Daily ways to protect your teeth

Some say the eyes are the window to the soul. But if you really want to know what someone’s about, check their smile. A welcoming show of pearly…
Surprise rheumatoid arthritis discovery points to new treatment for joint inflammation

Surprise rheumatoid arthritis discovery points to new treatment for joint inflammation

Researchers at the University of Virginia School of Medicine have identified an unexpected contributor to rheumatoid arthritis that may help explain the…
Enhance social emotional learning along with cognitive capacity of the children with NDDs

Enhance social emotional learning along with cognitive capacity of the children with NDDs

Neurodevelopmental disorders (NDDs) are indicated by developmental deficits which usually appear at the early age of a child’s development and can…
icddr,b explores sustainable ways to improve WASH and menstrual hygiene management in RMG factories

icddr,b explores sustainable ways to improve WASH and menstrual hygiene management in RMG factories

icddr,b in partnership with The Waterloo Foundation, UK have undertaken a new study to explore water, sanitation and hygiene (collectively known as WASH)…
Researchers find clues that depression may speed brain aging

Researchers find clues that depression may speed brain aging

Memory and thinking skills naturally slow with age but now scientists are peeking inside living brains to tell if depression might worsen that decline—and…
FDA approves Spravato (esketamine) nasal spray for adults with treatment-resistant depression

FDA approves Spravato (esketamine) nasal spray for adults with treatment-resistant depression

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic…
FDA approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), first generic of advair diskus

FDA approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), first generic of advair diskus

Mylan N.V. recently announced the U.S. Food and Drug Administration (FDA) approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder,…

Copyright © All right reserved.

Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Disclaimer & Privacy Policy
....................................................
About Us
....................................................
Contact Us
....................................................
Advertisement
....................................................
Subscription

Powered by : Frog Hosting