On the day it was announced that a 14-year old girl died in the UK after receiving Cervarix, GlaxoSmithKline has been told by US regulators that a decision to approve the cervical cancer vaccine has once again been put back.

The US Food and Drug Administration has told the firm that it has not yet completed a review of the Biologics License Application for Cervarix, the recombinant vaccine which protects against the two strains of human papillomavirus (types 16 and 18) that are the most common cause of cervical cancer. As a result, the review will continue beyond yesterday’s action date.

There is no reason to believe the delay has anything to do with the death of Natalie Morton in Coventry, nor indeed if there are any safety issues causing concern for the FDA. The agency has regularly put back action dates in recent times, as a result of its growing workload.

The delay is particularly frustrating for GSK seeing as how earlier this month the FDA’s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix (12-1 and 11-1, respectively). That was after GSK had satisfied requests contained in a complete response letter issued in 2007 requesting more data.

So once again, the prospect of Cervarix competing soon with Merck & Co’s well-established jab Gardasil has again been put off. The latter has been on the market in the USA since 2006.

Approval recommendation in Japan
Better news for Cervarix came from Japan where an advisory panel to the country’s Health Ministry backed the jab. Full approval is expecting within a month, making it the first cervical cancer vaccine to be available in the world's second-biggest market. However Gardasil has also been filed in Japan and a decision on its approvability is expected soon.

DoH calls for calm
As for the situation in the UK, the Department of Health said that “as a purely precautionary measure”, it has asked the National Health Service to quarantine all stocks of Cervarix from the batch related to the Natalie case, adding that “no link can be made between the death and the vaccine until all the facts are known”.

Results of tests on the batch of vaccine will be announced as soon as they are known, the DoH said, and “there is no reason” for the HPV vaccination campaign to be suspended or interrupted, though “minor delays” may occur in the next day or so in some areas. The UK government added that more than 1.4 million doses have now been given in the country and Cervarix has a strong safety record.

“It is important that we get all the facts before we draw conclusions on the cause of this tragic event,” the DoH concluded.