FDA Clears Rotavirus Vaccine Despite Pig Virus
The Food and Drug Administration (FDA) yesterday said in a statement that Rotavirus vaccines made by GlaxoSmithKline Plc and Merck & Co Inc are safe to protect infants despite being contaminated with a pig virus.
In its statement, the FDA said clearly that doctors could resume giving Glaxo's Rotarix and Merck's Rotateq to patients.
The health regulators added that no evidence has been linking the contamination to any kind of harm and the vaccines were important in preventing hospitalizations and death, though pieces of DNA from porcine circovirus (PCV) have been found in both the vaccines.
Earlier on May 7, a FDA advisory panel had recommended the use of these vaccines saying the risk to humans from the pig virus was theoretical at best. The panel said that the benefits of these vaccines are far greater than any potential risk.
Meanwhile, Glaxo officials said their are no manufacturing or safety issues with its vaccine and Merck has also stressed that its products are safe for human use. Neither vaccine is very popular in the market. Sales of Merck's vaccine totaled $522 million last year, while sale of Glaxo's vaccine were $440 million globally last year.
