In 2011 this blog was listed as one of the top 10 blog in pharma technical information it is popular amongst the pharmacists and pharma industry professionals. We have published very important and very useful information for pharma industry professionals.

Friday, May 21, 2010

Rotavirus Vaccines Rotarix RotaTeq are safe US FDA advice

US FDA Revises Recommendations for Rotavirus Vaccines (Brands Rotarix and RotaTeq)

The U.S. Food and Drug Administration on May 14, 2010 revised its recommendations for use of rotavirus vaccines for the prevention of the disease in infants and has found that Rotavirus Vaccines Rotarix of GlaxoSmithKline and Rotarix of Merck and Co., Inc are suitable for use in prevention of rotavirus infection,clinicians and health care professionals are advised to resume the use of Rotarix or RotaTeq Vaccines.

The US FDA said in its news release that, they reached this decision after a careful evaluation of information from laboratory results obtained from the manufacturers and the US FDA’s own laboratories, and a thorough review of the scientific literature was done , and also they gathered input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines.

The US FDA considered the following points in its decision:

1.Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.

2.The US FDA said they have no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.

The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is just hypothetical and there are no evidences for risk available so far.

Pre- and postmarket studies have shown both vaccines to be highly effective at preventing serious gastrointestinal disease caused by rotavirus. No serious or unexpected safety concerns have been identified in postmarket surveillance of either Rotarix or RotaTeq.

Rotavirus infects the bowels and causes severe diarrhea among infants and children’s about 600,000 children deaths reported are due to rotavirus infection worldwide annually

Why US FDA had suspend the use of Rotarix

On March 22, 20101, US FDA provided an early communication regarding Rotarix, manufactured by GlaxoSmithKline Biologicals (GSK) , it was found to contain DNA from porcine circovirus type 1 (PCV1) in the vaccine. Both FDA and GSK have confirmed the presence of PCV1 in the vaccine. and US FDA recommended that clinicians and public health professionals in the United States to suspend temporarily the use of Rotarix .

Also on May 6, 20102, US FDA provided information about RotaTeq, manufactured by Merck & Co, Inc.and preliminary studies conducted by Merck identified presence of fragments of DNA from PCV1 and from a related porcine circovirus type 2 (PCV2) in RotaTeq. FDA noted that it would seek input from its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and provide updates in the near future.

What are Rotarix and RotaTeq?

Rotarix / RotaTeq are live-attenuated (weakened) Rotavirus Vaccines used to prevent rotavirus infection and disease Rotavirus causes severe diarrhea and dehydration in young infants.

The active ingredient in Rotarix is a live-attenuated human rotavirus. It causes a slight infection that typically produces no symptoms, but is able to trigger immune response which confers or creates immunity against rotavirus as antibodies against rotavirus are produced in body of vaccinated individual.

Rotarix vaccine was licensed by US FDA after evaluating data from extensive clinical and non-clinical tests, to GlaxoSmithKline in April 2008 and Merck’s RotaTeq in February 2006.

What is PCV
Porcine circovirus types 1 and 2 (PCV1 and PCV2) are both small viruses composed of a single strand of circular DNA. Both viruses are common in pigs. Neither PCV1 nor PCV2 are known to infect or cause illness in humans, however PCV2 may cause illness in pigs.

PCV1 and PCV2 should not be confused with “PCV7” and “PCV13,” which are common abbreviations for two licensed pneumococcal conjugate vaccines, Prevnar and Prevnar 13. These vaccines are not related to circoviruses.

Is PCV a pig material?
No. PCV is a virus. It is not an animal material.

We also advise you to visit US FDA'S website for further information on this topic.

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

No comments:

What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.

What is a Site Master file of a pharmaceutical company

What is Generic Drug

What is Reference Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents

What are Post Market studies

Why a drug is bound to protein, What is protein binding?  What is drug absorption , distribution ?

Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions

Antibiotic Definition and classification

Antibiotic Resistance and Antibiotic resistance mechanism

Antioxidants food supplements

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D

What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production


Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Clean Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials




Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs


Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates