First batches of H1N1 vaccine ready

Meanwhile,the WHO has come out with a statement — following media reports expressing concern about the safety of vaccines for pandemic influenza — that elucidates that vaccines are among the most important medical interventions for reducing illness and deaths during a pandemic. However,to have the greatest impact,pandemic vaccines need to be available quickly and in large quantities,the statement added.

This may come as a relief to India,as the country is part of the WHO-collaborated vaccine manufacturing network. The ICMR and Union Health Ministry have also said that approvals are being given to vaccine manufacturing units in a fast-track manner.  

In WHO-collaborated centres,the process is likely to take five months,with stages of work including isolation and preparation of vaccine strain and optimising virus growth conditions,manufacturing bulk vaccines,as well as quality control and clinical trails by the manufacturers. The regulatory authorities in the countries are supposed to review data and release the vaccine later.

According to the WHO,pandemic vaccines are not regarded by regulatory authorities as entirely “new”,as they build on the technology used to produce vaccines for seasonal influenza,established procedures for testing and regulatory control,and an extensive body of safety data.

In such cases,approval procedures are similar to those applied to “strain changes” made each year,when seasonal vaccines are modified to match circulating viruses.

In the US,incidentally,less data is required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.

In the European Union,the European Medicines Agency uses a rolling review procedure whereby manufacturers can submit sets of data for regulatory review as they become available,without having to wait until all data is gathered in a single formal application.

Also in Europe,some manufacturers have conducted advance studies using a so-called “mock-up” vaccine. These contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advance studies can greatly expedite regulatory approval.

The current outbreak is the fastest ever pandemic and could affect up to two billion people,underscoring the need to get vaccines to the market as quickly as possible.

Leading flu vaccine makers include Sanofi-Aventis,GlaxoSmithKline,Novartis,Baxter,CSL and Solvay.

ANIMAL TRIALS BY MONTH-END IN PUNE

PUNE: With H1N1 cases in the city rising,the Serum Institute of India is all set to conduct swine flu vaccine trials on animals by August-end. With building pressure from the government to accelerate the process,the institute plans to conduct trials on humans by the year-end. It was in April that the WHO gave the company a contract to develop and manufacture the vaccine. “We will be conducting the trials on animals by the last week of August and test the efficacy of the vaccine in September. By October we would be testing the toxicity and by end of the year,we should be able to conduct the trials on humans,” said Dr Rajeev Dhere,director of the vaccine production unit at the Serum Institute. —ENS