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Foreign vax makers yet to chart India course

India may have to wait for a long time before foreign covid-19 vaccines are available in the country, as companies such as Pfizer, Moderna and Johnson and Johnson are yet to apply for emergency use licences that were allowed under the recently changed rules.

“It is up to them to apply. We are ready to give them the authorization if they apply,” a senior health ministry official said, seeking anonymity.

Three months into India’s vaccination campaign, touted as the world’s largest, far fewer people are being immunized against covid-19 than needed to contain surging infections that have overwhelmed the nation’s health infrastructure.

India has so far provided 122.6 million doses, including 16.2 million people who have got a second dose, covering about 8% of the population. At the current pace, India won’t have vaccinated the majority of adults until well into next year.

Shortages of medicines, oxygen and hospital beds and the slow pace of vaccination have evoked a mixture of resignation and anger among people as coronavirus infections sweep through broad swathes of the country. The vaccination process has been hobbled by shortages and delays in taking crucial decisions.

Last week, the government allowed foreign vaccine makers to seek emergency use authorization from the Central Drugs Standard Control Organisation for their respective covid-19 vaccines without having to conduct a local bridging trial prior to getting the licence, provided they had EUA from drug regulators in the US, UK, European Union, Japan or the World Health Organization. However, foreign vaccine makers will have to conduct a bridging study after the emergency approval licence and will need to monitor the first 100 vaccine recipients for safety outcomes before it is rolled out for mass immunization.

For Pfizer, it is not clear whether the company plans to conduct a local bridging study. It was the first to apply for an emergency import licence with DCGI for its mRNA vaccine, even before Serum Institute of India and Bharat Biotech International did for Covishield and Covaxin, respectively. The US drugmaker sought a waiver on conducting a local clinical trial, a request the subject expert panel of CDSCO declined due to lack of data on Indian population. Pfizer withdrew its application in February.

After the change in regulations last week, Pfizer said “we remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available”.

The company, however, did not comment on emailed queries sent by Mint on Thursday on whether it is open to conducting a bridging study after it gets an expedited import licence under the revised rules.

In the case of J&J, while the company on 9 April said it is in talks to start a bridging study, it has not commented on its plans after regulations were revised. Also, its contract manufacturing partner in India, Biological E, is yet to start production. Moderna, the third company eligible for EUA, did not reply to queries emailed on Thursday.

Even if the companies get authorization, there is a question of manufacturing capacity, pricing and logistics, an analyst with a foreign brokerage said on condition of anonymity. “Pfizer and J&J have commitments to the US and EU, which have provided financial support in return for doses. I doubt these companies will prioritize India,” the analyst said. Live Mint

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