Explanation: India’s new vaccine policy

India will dramatically expand its vaccination coverage from May 1, to include everyone aged 18 and over. The fourth phase of the mass vaccination program incorporates several changes in vaccine policy.

What are the changes in procurement?

In the first three stages, when healthcare workers, frontline workers, and the over-45s were vaccinated, the Center received the entire number of vaccines from the manufacturers, the Indian Serum Institute (Covishield) and Bharat Biotech (Covaxin) , and distributed to states. The provinces distributed the stock to government vaccination centers, which administered the vaccine free of cost, and to private hospitals that charged recipients Rs 250 per dose.

From May 1, supply will be split into two baskets: 50 percent for the Center, and 50 percent for the open market. Through the second – with the exception of the Government of India – channels, state governments, private hospitals, and industries with facilities to administer the vaccine, will be able to procure doses directly from manufacturers.

What changes in distribution?

First, the 50 percent basket of vaccine doses earmarked for provinces and private hospitals in the open market will be used to vaccinate the over-18s.

Secondly, free vaccination would be available at all vaccination centers receiving doses from the Government of India – with those doses, healthcare workers, frontline workers, and the over 45s will be vaccinated.

Will private vaccination centers still administer the vaccine at Rs 250?

As no doses will be available to the private sector, private hospitals will have their own rates.

So, how much will a shot at a private mall cost?

In the first three stages, out of the Rs 250 charged for vaccination, private hospitals received Rs 100 for administering the injection. As they will now acquire the vaccine at a higher price, the cost of injection is expected to be much higher than in the first three stages.

The Center said Monday that the prices charged by private hospitals would be monitored. A mechanism will be put in place, and vaccine stocks and prices will be held on the Winning Platform.

States receive doses from the Center and also acquire additional from the open market – so how will they plan vaccination sessions?

This is not yet final. However, the Center has said it will be able to prescribe vaccines for 15 days – which means states will know in advance that they will receive a certain number of doses for the next 15 days. Therefore, they will have a big picture as well as a granular of availability on a date and for the next two weeks.

How will the Center determine which state gets the dose?

The Center will allocate its 50 percent share to states based on size of infection (active cases) and performance (speed of administration). Currently, states receive vaccine doses on demand (number of registrations and walk-in vaccinations). Now, low waste will be incentivized.

Will imported vaccines also be shared among the Center, provinces and private hospitals?

The Center will allow the fully ready-to-use imported vaccines to be used exclusively in the channel other than the Government of India. Therefore, if and when a foreign pharma giant brings its vaccine to India, it will be free to sell the entire stock directly in the open market at a competitive price.

Will those who have received the first dose – and whose second dose is due – be prioritized?

Yes. The Center said that the second dose of all existing priority groups, “wherever it has become due, would take precedence, that a focused and focused strategy would be communicated to all stakeholders”.

On what basis will vaccine makers decide who to sell – and at what price?

There are no guidelines as yet. The Center has only said that private vaccination providers will state self-imposed vaccination prices transparently. States have not had freedom to negotiate prices.

The Serum Institute of India (SII) on Wednesday announced the prices for its vaccine – Rs 400 per dose to states, and Rs 600 per dose to hospitals. Bharat Biotech and Dr Reddy (who will distribute Sputnik V Russian shot) have not made an announcement yet.

SII’s CEO, Poonawalla Birds, has been vocal about delivering to hospitals, rather than to states. He believes that hospitals are better placed to carry out the vaccination exercise; besides, states are expected to get some free supplies from the Center anyway. Buying is an “option” for states and not compulsory, he said.

“We want to sell to the private hospitals, which will look after all these provinces and corporations. I don’t know why so many hullabaloo about every state complain about this price because, look, it’s their choice, not their compulsion, ”Poonawalla said in an interview with CNBC TV-18 on Wednesday.

And how will manufacturers apportion their quota for states? Which provinces will get first, and more?

Again, there is little clarity on the mechanism that manufacturers will use to determine among order-placing states. And in the absence of a formula or guidelines, transferring control to private vaccine producers will mean that there will be no social basis for allocating vaccines to states, according to Professor R Ramakumar of TISS.

“Only commercial considerations are likely to prevail. States will compete for a fixed number of vaccines, which will continue to be in excess demand, ”he said.

“Private companies would prioritize selling at Rs 600 per dose and not Rs 400 per dose. This means that selling to states will be less of a priority for vaccine producers than for private hospitals. States are likely to be crushed as a result, ”he said.

That said, however, manufacturers are likely to follow the Centre’s lead in prioritizing – and provinces with a high caseload will be put on the queue.

Could it be first come, first served?

It would depend on how many provinces commit to manufacturing, and on the availability of doses. Wealthier states, capable of procuring large quantities, and states with large networks of private hospitals, are expected to receive a higher share of doses from the open market.

Which other countries in the world have allowed the sale of vaccines on the open market?

Not yet. The main reason is that the vaccines used worldwide have only received Emergency Use Authorization (EUA) – none have yet presented sufficient evidence on their safety and effectiveness to receive full regulatory authorization .

Under normal circumstances, it may take 8-10 years to develop, test and receive approval for a vaccine. But in this remarkable pandemic scenario, the development, clinical trials and approvals have been accelerated to ensure that people have the opportunity to escape serious disease or death.

“No other country is doing this (open market sale) as yet, because all of these vaccines are still under a restricted or urgent use authorization and are not yet fully licensed in their countries of origin , except, perhaps, in Russia, ”a vaccine expert. and Christian Medical College professor Dr Gagandeep Kang said.

Given the public health priority of vaccinating a large part of their populations, several countries, including the United States, the UK, Japan, France and China, provide free vaccines to citizens.

Once an estimated 600 million new recipients become eligible on May 1, when and where will the required vaccine stocks be procured?

About 130 million shots have been given in India so far, and over 111 million people are yet to receive their second dose. Depending on how many people in the priority groups are still left to receive their second shot by the time May 1 comes around, the country may need over 1.2 billion doses of vaccines. Given the country’s current production capacity and the delay in bringing in foreign vaccines, supply will almost certainly fall short of demand.

SII is going to prioritize doses of Covishield for India “at least” for the next two months, which means there will be a potential supply of around 120 million to 140 million doses for the country between May and June . However, the company expects to start delivering for the open market only from the third or fourth week in May.

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Sputnik V is expected to start arriving in the country by the end of May. Dr Reddy Laboratories has an agreement to distribute 250 million doses of the Russian vaccine, but it is unclear how many of these doses may be available to India. The company is still in discussions with the government about the price and number of doses required.

It is unclear whether Bharat Biotech will be able to supply for the open market from May 1. If so, the company could supply an estimated 29 million doses across provinces over the entire month. The company has announced an extended capacity of about 700 million doses per year (about 58 million doses per month).

It is also unclear how many doses J&J, which plans to conduct transition studies in the country, can supply to India. This process in itself can take a few months.

Pfizer has said it intends to supply to the government only, but it is not known when an agreement can be reached, and how many doses it can provide.