Exclusive: The UK drugs regulator has asked Novartis to recall two batches of flu vaccine after the company reported ‘quality defects’.
The move follows a halt on use of Agrippal vaccine by several EU countries including Italy, France and Germany.
A spokesman for the Medicines and Healthcare Products Regulatory Agency (MHRA) told Pulse there were no current safety concerns for anyone who had already received the vaccine but they would continue to monitor the situation.
It means the removal of around 160,000 doses from the supply chain, which the MHRA said would have minimal impact on flu vaccine supplies in the UK, but was a ‘worrying’ development according to GP experts.
An MHRA spokesperson told Pulse: ‘We have asked Novartis to issue a precautionary recall of two batches of Agrippal vaccine.
‘The decision was made after the company reported quality defects with the vaccine which do not currently indicate a safety issue for those who received the vaccine.
‘Patients should not be unduly concerned. The recall is being taken as a precautionary measure.’
In October GPs warned of vaccine shortages after pharmaceutical company Crucell withdrew its vaccines after problematic test results were found with two batches.
The Department of Health came under criticism from GPs for lacking any emergency supplies to help practices who were relying on vaccine supplied from Crucell.
A DH review of flu vaccine procurement carried out last year recommended a central stockpile was needed, but as in previous years, reserves will be built up at the end of the season, the DH said.
Dr George Kassianos, RCGP immunisation lead and a GP in Bracknell, Berkshire, said the recall was ‘worrying’ and it was key to ensure supplies from other manufacturers could fill the gap.
He said: ‘Any reduction in flu vaccine available is a problem in the UK as the various vaccine manufacturers have tried hard to supply the Crucell practices with enough vaccine to carry out the Government influenza immunisation programme.
‘The Novartis withdrawal is worrying, but it may not significantly affect our immunisation programme if the other vaccine manufacturers can make up the numbers.
‘More worrying is the fact that the DH has not come forward with offer of vaccines to Practices from its reserves, if they indeed exist.’
Derbyshire LMC secretary, Dr John Grenville, said that the recall showed the importance of not relying on one manufacturer.
‘If a practice has ordered its stocks entirely from Novartis, then it could find itself in trouble.’
Several practices in Derbyshire found themselves short of supplies of flu vaccine after the Crucell vials were pulled.
He said: ‘They are coping now on the whole but they are still a little bit behind with their campaigns,’ he said.
A spokesperson from Novartis said: ‘Following discussions with the MHRA, Novartis is conducting a recall of two batches of its seasonal influenza vaccine Agrippal in the UK.
The recall is a precautionary measure following Novartis identification of visible protein aggregates in one batch of Agrippal manufactured in Italy, which was not released for distribution.
‘We remain focused on working with authorities to release all other batches and resuming distribution as soon as possible. This will help ensure adequate supply to protect against seasonal influenza, which is an important public health concern.’