Covid-19 vaccination: Pfizer, Moderna deals hit roadblock

The Narendra Modi government is likely to inoculate 300 million Indians with made-in-India Covid-19 vaccines only as authorities are fast losing hope of inking deals with Pfizer or Moderna—the two companies to roll out vaccines so far.

While the negotiations with Moderna hit a roadblock a few months ago, Pfizer is yet to submit details asked for by the drug regulator.

According to officials involved in the vaccine administration plan, there are doubts if Pfizer has enough spare capacity to cater to Indian requirements after fulfilling its current commitments with the US, UK, EU, Bahrain, Canada, Mexico and Saudi Arabia. The drug major has a few plants including one in Lincoln, Nebraska . According to media reports, Pfizer has received orders for 1.1 billion doses of its vaccine.

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The subject expert committee of the Central Drugs Standard Control Organization or CDSCO—the body that scrutinizes applications for new vaccines— asked Pfizer to present its case two weeks ago but the company sought more time to formally submit its papers for an emergency authorization.

Interestingly, while Pfizer has delayed submission of its proposal to CDSCO, it is in touch with the government’s expert committee on vaccine administration (NAGVAC). “From our discussion, it seems Pfizer might not have the required capacity to address India’s demand,” said a senior official who asked not to be named.

Both Pfizer and Moderna, another top official claimed on condition of anonymity, have received several co-production offers from Indian companies. “But any co-production in India would also entail fresh round of trials in this country as per our drug laws. And that would mean additional costs,” this person said.

While Pfizer can still be tapped for supplying vaccines for the second half of 2021, India’s vaccine planners are keen to line up supplies for the 300 million people who are in its first four priority groups.

India has few logistics and cold storage chains that can support Pfizer’s requirement for keeping its vaccines at minus 70 degree Celsius, the price too, is a constraint. According to an official, the health ministry’s initial budget for vaccination is Rs 50,000 crore.

As many as seven Indian vaccines are at different stages of trials. Another two, SII’s Covishield and Bharat Biotech’s Covaxin have applied for emergency approval. SII is expected to be given the go-ahead for emergency rollout in the next few days. The company is manufacturing the AstraZeneca/Oxford vaccine in India.