The TLDR: In a sudden flurry of action, the government approved Sputnik V—and opened the nation’s door to a wide range of vaccines. But the actual number of vaccines we Indians can choose from remains to be determined. Here’s a short explainer why.

First, the numbers

The case numbers: We recorded our highest single-day spike on Tuesday, adding 185,190 cases. The number of deaths—1,026—was the highest in six months. The #1 state was Maharashtra, which reported 60,212 infections (accounting for about 32% of the new cases). 

The vaccine numbers: According to an IndiaSpend analysis, our current stocks will only last until April 15:

“[Health Minister] Harsh Vardhan said that India has 24 million vaccine doses in stock and 19 million doses in the pipeline. At the rate of 3.5 million doses per day that India has averaged in April, the doses in stock would not last more than a week from April 8 and those in the pipeline would help sustain for another five days.”

The crunch could come faster if we factor in our average vaccine wastage rate of 6.5%.

For more: read our explainer on the shortages.

Ok, what vaccines did they greenlight?

The government specifically approved the Russian vaccine Sputnik V for emergency use. For the others, it announced a new policy that opens the door to fast-track approvals. 

• Until now, India required any vaccine—even if it has been approved for use in other parts of the world—to conduct phase 2 and 3 ‘bridge trials’ in India. 
• These are small human trials with around 1000 participants that test the safety of the vaccine in the local population—and confirms its ability to trigger an immune response. 
• But the new rule removes that requirement. Companies can now first get the approval, and conduct the bridging trial while the vaccine is in use.
• And any vaccine approved for use in the US, EU, UK, Japan or by the WHO can directly apply for approval in India. This means any of the other vaccine manufacturers can apply for authorisation asap! 
• For example, Pfizer had shelved its request to enter the Indian market because of the bridging trial requirement. It now plans to ask for emergency use authorization.
• Also: Johnson & Johnson was gearing up for a bridging trial. But it now may apply directly for approval.
• Serum Institute of India—which is manufacturing the local version of the US vaccine Novavax—could also fast-forward its plans for a September rollout.

So what’s the problem?

While in theory, we could be flooded with an array of new vaccines, there are a number of stumbling blocks. 

Private sales: The government has loosened its grip on the approval process, but it still tightly controls the purchase and distribution of all vaccines. In other words, you will not be able to walk into your doctor’s office and buy a vaccine of your choice. As NDTV notes: 

“At the moment, however, the government has firmly rejected the roll-out of any vaccine at commercial rates, repeatedly stressing the vaccines needed to be made available to priority groups identified by the Centre and at prices which it has set.”

Pricing: If the government sets the purchase price, then there will be a lot of haggling ahead. All of these vaccines are far more expensive than either Covishield or Covaxin which cost Rs. 150 + GST or $2.02 for both. And it’s already an issue with Sputnik V—which costs $10 a dose in other markets. And its financier—the Russian Direct Investment Fund—has already said, “I'm not sure that we can get exactly to that [Covishield] pricing given our production process.”

Point to note: In most cases, governments that came to the table early—and invested money while the vaccines were still in development—got a price break. For example: The EU pays only $14.70 per dose for the Pfizer vaccine compared to the US which shells out $19.50. And there is little reason to believe that the Indian government will be an exception to the rule with these vaccines. And many may choose to stay out of the Indian market if the price isn’t right.

Cold storage: mRNA vaccines like Moderna and Pfizer require sub-zero storage containers—which are very expensive and scarce. And those kinds of requirements also push up the price—and create room for other disagreements. For example, its manufacturer claims the vaccine can now be stored and transported in standard refrigerators at 2 to 8 degree Celsius. But the Indian government wants them kept at minus 18 degrees Celsius—which was the original requirement for the vaccine. 

Safety concerns: Finally, there are always ongoing concerns about safety. For example, the US has now suspended the use of the Johnson & Johnson vaccine due to the emergence of blood clots in six women. Now consider what might happen if the new fast-track system was already in place: If J&J had got its approval in India based on the US authorisation, would it then have to be suspended in India as well? 

A related Sputnik worry: Within 24 hours of getting the nod in India, there are troubling reports about the vaccine out of Slovakia. The country’s drug regulators claim that the doses they received does “not have the same characteristics and properties” as the Sputnik V vaccine whose data was published in the Lancet—establishing a whopping 91.6% efficacy:

“Noting that about 40 countries are using or scheduled to use the Russian vaccine, the Slovak regulatory agency asserted that ‘these vaccines are only associated by the name.’ That raised questions about deviations from the formula reviewed in The Lancet.

 

‘The comparability and consistency of different batches produced at different locations has not been demonstrated,’ the Slovak regulator said. ‘In several cases, they appear to be vaccines with different properties (lyophilisate versus solution, single-dose ampoules versus multi-dose vials, different storage conditions, composition and method of manufacture).’”

Meanwhile, RDIF has demanded Slovakia return all doses asap due to “multiple contract violations.” Also: It casts a whole new light on RDIF’s revised claims about refrigeration requirements of its new “formulation.”

The bottomline: The government needs to take the next logical step and open up the private market for vaccines. Let companies directly import and/or manufacture these vaccines and sell them to the Indian consumer—while the government reserves its vaccines for those who need it most.

Reading list

Indian Express has detailed explainers on the new approval policy and on pricing strategy. NDTV looks at all the potential sticking points around Sputnik V. New York Times has the Slovakia story. The Guardian has the latest issues surrounding the Johnson & Johnson vaccine. The Hindu has a detailed analysis of the second wave. We did an explainer last year on Sputnik’s shady trials—before it redeemed itself in The Lancet.