India Vaccine Plan: Pulling a Chain When Train's Left the Station

India rolls out the red carpet for foreign vaccine makers. But is it  case of too little, too late? 

(Photo: iStock) 

It's ironic that the government's top drug regulator gave Russia's Sputnik V vaccine, that's already approved and in use in over 60 countries, emergency use approval (EUA) on the same day it turned its vaccine approval process on its head.

In collaboration with Dr Reddy's Laboratories, Sputnik V had undergone phase 2-3 trials in the country. The approval process, overseen by Drugs Controller General of India's Subject Expert Committee, had seen weeks of back and forth with stress on immunogenicity and safety data from these trials.

Well, gone is the need for these pre-approval trials on the local population. Any vaccine, that has received approvals from more stringent regulators like those in the US, UK, European Union and Japan or those that have been cleared by the World Health Organisation, will be eligible for use in India.

Remember how Pfizer eventually withdrew its application for emergency use approval in India in February 2021, when the regulators insisted on bridging trials?

They could walk in now - but the bigger question is, will they?

Also what happens to vaccines like Johnson & Johnson's game-changer 'one and done' shot, that has been stalled post rollout by the US Food and Drug Administration (US FDA)?

India's COVID Vaccine Programme is on Oxygen Support

• In a report filed by The Quint on Monday we highlighted how India's vaccine programme was on oxygen support. While India is producing approximately 4 million doses of vaccines in a day, it is vaccinating over 3 million people in a day.

• At the current pace, as this piece points out, India will run out of vaccines in a span of days.

• 90 percent of India's vaccine capacity comes from ONE vaccine manufacturer. Serum Institute of India is manufacturing 65-70 million vaccines a month, it needs cash infusion from the government to ramp it to 100 million doses a month.

• Bharat Biotech's Covaxin, launched with much fanfare, is barely making a dent in India's vast vaccine requirement with 12.5 million doses a month.

• Sputnik V, newly approved and already in deals with five vaccine manufacturers in India to build up a capacity of 850 million doses, has said its local production will kick off by summer and they'll be able to produce 50 million vaccines a month to begin with. What chunk of this comes to India? We don't know. According to some reports, India is negotiating prices with RDIF.

Laying Out the Red Carpet, but Stars Are Reticent to Walk

According this is report in The Economic Times, Pfizer representatives have welcomed the government's move and is committed to providing vaccines to the world.

There are no reports on whether pricing negotiations have started, or if Pfizer even has the stocks India needs NOW to deliver. According to the same paper, they have pre-purchased orders from 12 countries with a bulk of it going to the US and EU to the tune of 700 million doses which need to be delivered by mid to end 2021. They've been either already paid by these governments in billions, or pricing has been fixed. It's a different market than January 2021, and competition is high.

We know that a bulk of Moderna stock is blocked for the US till end of 2021. We also know from this report that Tata Medical and Diagnostics was keen to bring Moderna into India. Not much seems to have moved on that front.

J&J, the Star Vaccine, Put on Hold: How Does it Impact India?

Johnson and Johnson's single shot 'game-changer' vaccine's latest woes are going to impact the already sluggish supplies. Put on pause by the US FDA over reports of rare but serious blood clots in women in the age group of 18-48, will India roll back its red carpet from J&J?

Also, will it have an impact on J&J's contract with Biological E?

We wrote in our earlier story on how Biological E is contracted to deliver 600 million doses of J&J vaccine. But as Leena Menghaney, a vaccine access activist with MSF, told The Quint, that contract is so shrouded in secrecy, we don't even know if production has started or if any of these doses are meant for India.

J&J's own supplies have been hit by problems with a manufacturing plant in the US that led to millions of doses being junked.

Price negotiations, lack of supplies, reticent pharmaceutical companies and bizarre policy paralysis on India's side has led to India facing acute vaccine shortage at a time it needs to push the pedal on its vaccination programme. India's best bet to meet its immediate requirements is to infuse funds into Serum Institute and Bharat Biotech to help ramp up their production capacity, help Sputnik scale up its production with some negotiations to keep atleast a part of those vaccines in India. Till then, the new 'Welcome to India' policy is pure optics.