H1N1 vaccine clinical trials get approval

H1N1 vaccine clinical trials get approval

New Delhi: Vaccines for H1N1 flu could be available in the country by the end of the month following approvals for human clinical trials by two multinational drug makers, GlaxoSmithKline Plc (GSK) and Baxter International Inc.

Among Indian vaccine makers, only Zydus Cadila has submitted the protocol to the Drug Controller General of India (DCGI), the country’s regulator, to conduct trials of its vaccine candidate.

However, others such as Novartis, one of the first to get the US drug regulator’s approval and Sanofi Pasteur have not yet applied, to the Indian regulator to test their H1N1 vaccines on the Indian population.

“India will get a minimum of four million doses in this season itself, so the vaccine should be available by the end of December," said Surinder Singh, DCGI. “Vaccine makers will conduct bridging studies in about 200-300 subjects to find out how the vaccine behaves in the Indian population."

Human clinical trials, or in this case bridging studies, are a prerequisite for any company wanting to sell drugs in India. A bridging study is a supplemental study performed in the new region to provide clinical data on efficacy, safety, dosage, and dose regimen. The Indian government has fast-tracked regulatory approvals for H1N1 vaccines to make them available to high-risk populations by the end of the year. Singh added that the main concern is that the vaccine should not have any adverse effects on the Indian population since any vaccine will provide some degree of protection.

Initially, the vaccine will be procured by the government for health workers who are at high risk of acquiring the H1N1 virus.

While Baxter declined to comment on the specifics of its vaccine, directing all questions to the national health authority, a spokesperson for the company confirmed that a bridging study would be conducted in India.

Responding to a query on the subject, a spokesperson from GSK India said: “GSK India along with other companies are in discussion with the government of India on the modalities of the introduction of the vaccine in India and procurement."

A Zydus Cadila spokesperson declined to comment, saying there was no information to share with the media.

There was no response from Novartis and Sanofi to questions seeking comments for this story at the time of going to press.

On 24 November, answering a question in the Rajya Sabha, health minister Ghulam Nabi Azad had said that three Indian manufacturers are being supported by the government to manufacture the H1N1 vaccine. These are Serum Institute of India, Bharat Biotech and Panacea Biotech.

Previously, the minister had said indigenous vaccines would be ready by March or April next year, leaving a large percentage of the population at a high risk of infection from the second wave of the H1N1 influenza expected in winter. Delhi has already seen a rise in the number of cases over the last 10 days. On 29 November, 60 cases of H1N1 reported in Delhi. Up till this date a total of 18,007 cases reported in India and 573 deaths. The Indian government has procured 40 million capsules and 400,000 bottles of antiviral oseltamivir to treat infections. The sale of the drug is also approved through restricted channels.