Pfizer seeks govt nod for bringing vaccine to India via fast track

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US pharmaceuticals giant Pfizer is seeking an "expedited approval” for its COVID-19 vaccine, the company’s CEO Albert Bourla said on LinkedIn on Monday.</p>
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He also announced a donation of medicines worth more than $70 million to fight the pandemic.</p>
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"Unfortunately, our vaccine is not registered in India although our application was submitted months ago," Bourla said.</p>
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"We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country,” he disclosed.</p>
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India has now introduced a fast-track approval for foreign-made COVID-19 vaccines. The move exempts companies from carrying out long-drawn  "bridging" trials for their vaccines which could stretch over several months. </p>
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Pfizer had earlier refused to carry out the bridge trials.</p>
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However, according to the new rules Vaccines for Covid-19, which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use the US, UK, Europe and Japan or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India.</p>
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The new rules state that the first 100 beneficiaries of a foreign vaccine shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.</p>
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US drugs major Johnson & Johnson has already applied for approval for its single-shot vaccine under the new fast-track rules.</p>