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Public outcry over swine flu tests on Romanian children
LAURA TOMA AND DAN ALEXE
Today @ 09:00 CET
Growing concern in Romania about the opaque circumstances in which a vaccine against swine flu is being tested on children has forced health authorities to postpone the launch of the vaccination campaign by at least one month.
The controversy started last week when Romania Libera, a daily newspaper, revealed that hundreds of children between six and 16 in the Romanian cities of Arad and Timisoara had been tested for a new vaccine against swine flu.
Their families - most of them low-income - are being paid up to ?600 for allowing their children to be inoculated. The vaccine, called Cantgrip, is produced by the Cantacuzino Institute, a private company with minority state ownership.
Cantgrip is "not among the H1N1 pandemic vaccines authorised by the European Medicines Agency," says Monika Benstetter, a spokeswoman for the London-based agency.
Formally, the tests are not covered by EU legislation. The Romanian authorities argue that as long as Cantgrip is used only inside the country, EU approval is not needed. This is confirmed by Ton van Lierop, a spokesman for the outgoing EU Industry Commissioner Guenter Verheugen, who is also in charge of vaccine marketing in Europe: "If the product is commercialised only inside Romania, we cannot speak of a breach of EU law."
However, Cantacuzino seems to have sidestepped established procedures of testing and introducing new drugs. Usually, companies that want to test medicines on children present a Paediatric Investigation Plan (PIP), ensuring that the specific risk profile of children is taken into account. No such plan has been presented by the Cantacuzino Institute.
The tests were not carried out by the Cantacuzino Institute itself but by a small private company, IFE Human Pharmacology, now operating under the name Pierrel Research HP-RO. It appears that Human Pharmacology was the only participant in the public tender for the testing of the vaccine. The vaccine was administered only two days after the public tender.
Until now, the European Medicines Agency has recommended only four swine flu vaccines, all manufactured in Switzerland and Great Britain.
They are Focetria, manufactured by Novartis of Switzerland, Celvapan, by Baxter, also of Switzerland, Pandemrix, coming from the GlaxoSmithKline (GSK) labs in the UK, and more recently Arepanrix produced also by GSK. The latter is still awaiting approval by the European Commission, necessary before it can be marketed.
The Romanian Medicines Agency claims that companies such as Novartis or GSK were also free to bypass EU controls by releasing a vaccine country-by-country, obtaining approval from national authorities only.
LAURA TOMA AND DAN ALEXE
Today @ 09:00 CET
Growing concern in Romania about the opaque circumstances in which a vaccine against swine flu is being tested on children has forced health authorities to postpone the launch of the vaccination campaign by at least one month.
The controversy started last week when Romania Libera, a daily newspaper, revealed that hundreds of children between six and 16 in the Romanian cities of Arad and Timisoara had been tested for a new vaccine against swine flu.
Their families - most of them low-income - are being paid up to ?600 for allowing their children to be inoculated. The vaccine, called Cantgrip, is produced by the Cantacuzino Institute, a private company with minority state ownership.
Cantgrip is "not among the H1N1 pandemic vaccines authorised by the European Medicines Agency," says Monika Benstetter, a spokeswoman for the London-based agency.
Formally, the tests are not covered by EU legislation. The Romanian authorities argue that as long as Cantgrip is used only inside the country, EU approval is not needed. This is confirmed by Ton van Lierop, a spokesman for the outgoing EU Industry Commissioner Guenter Verheugen, who is also in charge of vaccine marketing in Europe: "If the product is commercialised only inside Romania, we cannot speak of a breach of EU law."
However, Cantacuzino seems to have sidestepped established procedures of testing and introducing new drugs. Usually, companies that want to test medicines on children present a Paediatric Investigation Plan (PIP), ensuring that the specific risk profile of children is taken into account. No such plan has been presented by the Cantacuzino Institute.
The tests were not carried out by the Cantacuzino Institute itself but by a small private company, IFE Human Pharmacology, now operating under the name Pierrel Research HP-RO. It appears that Human Pharmacology was the only participant in the public tender for the testing of the vaccine. The vaccine was administered only two days after the public tender.
Until now, the European Medicines Agency has recommended only four swine flu vaccines, all manufactured in Switzerland and Great Britain.
They are Focetria, manufactured by Novartis of Switzerland, Celvapan, by Baxter, also of Switzerland, Pandemrix, coming from the GlaxoSmithKline (GSK) labs in the UK, and more recently Arepanrix produced also by GSK. The latter is still awaiting approval by the European Commission, necessary before it can be marketed.
The Romanian Medicines Agency claims that companies such as Novartis or GSK were also free to bypass EU controls by releasing a vaccine country-by-country, obtaining approval from national authorities only.
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