No Choice Between Covishield & Covaxin: Is that Problematic?

People will not have a choice between the two COVID vaccines that will be rolled out on 16th January across India. Speaking at a press conference on January 12, the Union Health Secretary Rajesh Bhushan gave examples of how vaccines have been rolled out around the world.

"In no country is there an option available regarding choice of vaccines. We would be staggering our supply orders," he said.

Even as over 45 countries have started the process of inoculating its populations against the novel coronavirus, many have run into problems linked to supply and sluggish distribution.

Elaborating on this, Dr VK Paul, member (health),Niti Ayog, said, "All the vaccines in the world used currently against COVID-19 have been cleared under the emergency-use framework. As we go ahead, we will have more options. India has also been able to get these vaccines at very competitive prices.’’

But experts and even HCWs who are first in line to get the vaccine, raise questions on efficacy, transparency, and lack of data.

Covaxin No Longer a 'Back Up?'

On January 13, Covaxin doses, manufactured by Bharat Biotech, reached 10 cities across the country. The government has inked a deal with the pharma major for nearly 55 lakh doses, at a cost of Rs 295/dose. Of these nearly 17.5 lakh doses will be provided for free.

At the time of the approvals given to the two vaccines, various experts, including Dr Bhargava and Dr Randeep Guleria of AIIMS had said that Covaxin will remain a 'back up' till its efficacy data from the ongoing phase 3 trials is made available.

Covaxin was given a restricted approval by the Drugs Controller General of India, coded in a complicated language: “Grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.”

Speaking with FIT at the time, Dr Guleria had said, "If one reads what’s been shared, the vaccine has been approved for ‘emergency situation out of abundance of precaution.’ I think because of what is happening in the US, UK and Europe, if India has a surge in cases, and an emergency situation arises, we will need more doses and there is no drug available, then this vaccine may be made available. Otherwise it will be Covishield that will be used."

With the vaccine roll-out starting on January 16, and both Covaxin and Covishield already dispatched, it's clear that for the government, Covaxin is no 'back up,' a term that had at the time irked Dr Krishna Ella, CEO of Bharat Biotech.

The government has defended its stance, with Dr Paul saying the vaccine has been tested on "1000s of people and it is safe."

Safety and Immunogenicity Does Not Equal Efficacy

But some Healthcare Workers, first in line to receive the jab, told FIT that lack of transparency around the vaccines is giving rise to hesitancy among HCWs.

"Both vaccines are publicly funded and both have issues with lack of data. For Covaxin, phase 3 trials are still ongoing and no raw data is available. For both Covishield and Covaxin, information around adverse events remains opaque. There is concern among doctor groups regarding the roll-out, specially around adverse events involving neurological symptoms," says Dr Sumit Ray, Critical Care specialist at Delhi's Holy Family Hospital.

Malini Aisola, co-convenor of the All India Drug Action Network, tweeted about lack data on the 4-week dosing schedule that has been approved by the government for Covishield. The Indian bridge trials for the Oxford AstraZeneca vaccine, being manufactured in India by Serum Institute are still ongoing.

For Covaxin, phase 3 trials finished recruitment less than a week ago, so the government's claim that the vaccine has been tested on '1000s of people' doesn't paint the full picture.

Speaking with FIT, Dr Gangandeep Kang, virologist from CMC Vellore, had said, "The question is at what point do you give approval, even a restricted approval. To me it is very important that we have both safety and efficacy data. I have worked with vaccines long enough to know that immunogenicity does not equate to efficacy. So I would really like to see some clinical efficacy data for Bharat Biotech before it is widely used."

How Will the Govt Carry Out Vaccination in 'Clinical Trial Mode'?

With nearly 55 lakh doses of Covaxin procured, it will very much be part of the first inoculation drive on January 16. How will the government track and trace these lakhs of people who will receive the jab?

Prof K Srinath Reddy, Chairperson, Public Health Foundation of India, in an editorial in The Quint had said, "Will the Phase 3 trial continue as a blinded two-arm trial, even as others receive the vaccine with monitoring of efficacy and safety? If so, the latter will not have a comparison group. Will Phase 3 and Phase 4 (post-licensure surveillance) data be gathered simultaneously but analysed separately?"

These are complicated questions. Dr JVR Prasad Rao, Former Union Health Secretary, in a conversation with The Quint's podcast team, acknowledges these challenges.

"Everyone who is getting the vaccine will be in the government records. But for those who get Covaxin, if they are observed under clinical trial mode, they will have to be closely monitored for adverse events."

Dr N K Ganguly, former director-general of ICMR, said the choice between vaccines will have to wait till they reach the private market.

"When vaccines are given via a government programme, there can't be choices. The vaccines will be deployed across districts, and it's possible the districts that get Covishield will not get Covaxin. But by June, when vaccines reach the market, and if Pfizer, Johnson & Johnson and other mRNA vaccines are also available in the private market, then you can have a choice. By then you will also have more data on how various vaccines have performed."

Questions remain on how despite the wording of the two approvals for Covaxin and Covishield, the roll out seems to be no different. And while countries like the US, UK, and European Union have also not offered this 'choice between vaccines' to its people, their regulatory processes have ensured there is no opacity in granting EUAs to lifesaving COVID vaccines.