Vaccination plans still hazy in India

Two fundamental questions remain unanswered: Which vaccine/vaccines will India be using? How will the rollout happen? 
Vaccination plans still hazy in India

India's COVID vaccination programme is all set to begin. Except for one small problem: there’s no vaccine to give! Plans have been made, dry runs conducted in some states and targets have been given, but there is as yet no vaccine. Not only is there no locally made vaccine, the government has failed to even place orders for ones that are already in commercial use in many countries around the world.

As country after country starts vaccinating its citizens against COVID, Indians anxiously await information on when one of the world’s largest immunisation programmes to vaccinate a country of 1.3 billion people would begin. While China and Russia have been vaccinating their citizens since September-October or perhaps even earlier, the UK became the first Western country to launch its programme with the Pfizer vaccine.

Within days, the US followed suit. Earlier, the UAE and Bahrain approved the Chinese vaccines and started their programme. This week, the EU launched its own drive with the aim of giving a billion doses of Covid vaccines by the end of 2021.

Countries like Canada and Singapore have also commenced attempts to protect their residents. In India though, the plans are still hazy. Two fundamental questions remain unanswered: Which vaccine/vaccines will India be using? How will the rollout happen?

The answer to the first question still does not seem clear. At this point, it appears that the Covishield vaccine of Oxford University-Serum Institute and Covaxin by Bharat Biotech-ICMR (BBV152B) may be the only two that are chosen.

Covaxin, in phase 3 clinical trials, was to be tested on 25,900 volunteers. Media reports say that until last week, only half that number of volunteers had been recruited. Also, the approval for the phase 3 trials was given only on November 11.

Even assuming the trial started from November 15, the second dose of the vaccine would have been given only 28 days after the first. So it would only have been in mid-December that the first volunteers could have received the second dose.

The end point measurement was to start 42 days after the first dose and this would mean that December 27 would be the earliest that outcome measurement can even start. So it is impossible for us to expect the trial to be completed anytime before mid- or end-February if indeed the initial plan of recruiting 25,900 people still holds.

How Bharat Biotech applied for emergency use authorisation without phase 3 trials is a mystery. Thankfully, it was turned down and the firm was asked to submit phase 3 data. Even less is known about Covishield except what is claimed by those doing the trial.

Unlike Covaxin, even the phase 2 clinical trial data (combined with phase 3 under a special approval) of Covishield has not been made available in the public domain. While it is believed to be only a version of the Oxford University-AstraZeneca vaccine, the approvals that need to be obtained are country-specific.

Also, this vaccine has been developed using the master seed of the AZD1222 Oxford University-AstraZeneca vaccine and its efficacy needs to be confirmed, on whether it is on par with the original. The Oxford University vaccine was approved in the UK on December 30 and so it is expected that approvals in India will be obtained soon. But as yet, the government has not placed any firm orders for this vaccine either.

The reluctance in putting out and/or the delays in publishing the data and having it peer reviewed - both absolutely essential steps for scientists to determine the efficacy and safety of the vaccines - is deeply troubling. But India has put all its COVID vaccine eggs in these two baskets.

Unlike many countries that have spread their risks by placing orders for multiple vaccines, India has not placed orders for the Pfizer or Moderna vaccines or even the Sinovac Chinese vaccine (that has put out at least its phase 2 data). Incredibly, India even allowed Dr Reddy’s Laboratories to carry out phase 3 trials on the Russian Sputnik V vaccine, about which precious little is known.

While it is believed that DRL has the option of manufacturing 100 million doses of Sputnik V if it is approved for the Indian market, the government has been largely silent about this. This strategy of focusing only on vaccine development, something India has never done until 2018, needs to be urgently corrected.

The need of the hour is to immediately start the vaccination programme and provide hope to people that there is light at the end of the tunnel. Had the Centre pre-booked the Pfizer or Moderna vaccines as so many countries have done, at least healthcare workers and at-risk persons would have started receiving the vaccine by now.

While the higher cost and the storage requirement of –70 degrees (for the Pfizer vaccine—it can be taken out from this temperature, stored in a fridge and administered within five days) were dampeners, the economic spin-offs of seeing a way out of the crisis may well have made at least a part of the investment worthwhile. The EU has placed orders for 300 million doses of the Pfizer vaccine, the US 100 million, Japan 120 million, Canada 26 million and Israel 8 million.

Peru, Costa Rica, Ecuador, New Zealand, Australia, Singapore, Kuwait, Lebanon, Saudi Arabia and Switzerland are among other countries that have booked the Pfizer vaccine. Here’s the clincher: China, which was the first off the blocks with its own Sinopharm and Sinovac vaccines, has placed an order for 100 million doses of the Pfizer vaccine.

The Moderna vaccine, though predominantly (for now) for use in the US, has also found orders coming in from the EU, Japan and Qatar. India needs to urgently place orders for the vaccines already in commercial use like the Pfizer/Moderna vaccines, at least as a short-term measure.

The rollout process also needs clarity. Health in India is predominantly a state subject and attempts by the Centre to issue diktats have met with limited success over the years. Early in the Covid crisis, the Centre tried to impose its way on procurement of test kits, but fortunately good sense prevailed and state governments were allowed to do their own procurement.

It will be wise if the Centre follows the same practice and allows states to do their own vaccine procurement and plan their vaccination programme. State health authorities know their populations far better than those in the Union health ministry or ICMR and unless the Centre wants to hog the credit for saving the people from Covid, it will be well advised to avoid the landmine that such a massive rollout could turn out to be.

The credibility of any vaccine being used extensively in the Western countries will be much higher than homemade vaccines. If indeed there are side effects in a few, the vaccine programme will not be derailed with a Western vaccine unlike with Indian vaccines, where it will be easier for anti-vaxxers to cast aspersions on their safety and efficacy.

The government needs to ensure that both Bharat Biotech and Serum Institute put out the phase 3 clinical trial data and have them peer reviewed at the earliest. In parallel, an Information, Education and Communication (IEC) campaign must be started, and the public must be made aware of how the rollout is going to be operationalised.The challenge is massive but experience with COVID has shown that many state governments are up to the task. They must be empowered to deliver.

(The writer is a political analyst, doctor and healthcare IT professional and tweets at @sumanthraman)

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