A medic sorts vials of COVID-19 vaccines at a government vaccination centre in Bengaluru, November 30, 2021. Photo: PTI/Shailendra Bhojak
- India has approved nine vaccines for use against COVID-19 – but this doesn’t mean India’s vaccination driven avails all of them.
- A vaccine’s approval only means the government has approved it for use. It doesn’t mean the vaccine is also available for use.
- A crucial step after a vaccine has been approved is if a body called NTAGI includes it in the government’s vaccination drive.
New Delhi: India’s drug regulator approved the country’s ninth vaccine against COVID-19 on February 6, 2022.
The Central Drug Standards Control Organisation (CDSCO) green-lit the Sputnik Light shot. It is a single-dose vaccine.
Now, if nine vaccines have been approved, why have only two formed the bulk of India’s COVID-19 vaccination drive?
According to Co-WIN, India has administered 172 crore doses of COVID-19 thus far. Covishield and Covaxin have together contributed more than 99% of them.
In truth, the euphoria over India’s approval for nine vaccines is unwarranted. Specifically, approval for vaccines is not the same as availability of vaccines.
Union health minister Mansukh Mandaviya tweeted on February 6, 2022, celebrating the approval for Sputnik Light. “This will further strengthen the nation’s collective fight against the pandemic,” he said.
DCGI has granted emergency use permission to Single-dose Sputnik Light COVID-19 vaccine in India.
This is the 9th #COVID19 vaccine in the country.
This will further strengthen the nation’s collective fight against the pandemic.
— Dr Mansukh Mandaviya (@mansukhmandviya) February 6, 2022
Sputnik Light is another version of the Sputnik V vaccine developed by Russia. The latter is a two-dose jab. Its share in India’s COVID-19 vaccination drive is only 0.07% (more on that later).
Before we discuss other vaccines, it’s important to understand how vaccines enter government programmes.
First, a vaccine’s manufacturer shares its clinical trial data with the subject expert committee (SEC) of the CDSCO. If the SEC is satisfied with the data, it recommends that the Drug Controller General of India (DCGI) approve the vaccine.
Second, the DCGI approves or rejects the vaccine based on the scrutiny of its own office.
The vaccine’s approval only means the government has approved it for use. It doesn’t mean the vaccine is also available for use.
Next, the National Technical Advisory Group on Immunisation (NTAGI) decides which vaccine should be used and in which age group. It accounts for the evidence from India and elsewhere, if available. Crucially, the NTAGI is not influenced by how many vaccines have been approved.
After deliberations, the NTAGI submits its recommendation to the Union health ministry.
The ministry has a special group for COVID-19 vaccines called the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). It is chaired by national COVID taskforce chairman V.K. Paul, with health ministry secretary Rajesh Bhushan as co-chair.
Finally, based on NEGVAC’s recommendation, vaccine manufacturers prepare for rollout into the market.
Now, back to India’s nine vaccines. (For the record, the government has not yet indicated whether it is going to use Sputnik Light and for which age group.)
Corbevax and Covovax
In late December 2021, the CDSCO had approved two COVID-19 vaccines named Corbevax and Covovax.
Congratulations India 🇮🇳
Further strengthening the fight against COVID-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day for:
– CORBEVAX vaccine
– COVOVAX vaccine
– Anti-viral drug MolnupiravirFor restricted use in emergency situation. (1/5)
— Dr Mansukh Mandaviya (@mansukhmandviya) December 28, 2021
The Texas Children’s Hospital Centre for Vaccine Development and the Baylor College of Medicine in Houston developed Corbevax – and Hyderabad-based Biological E manufactures it. Novavax, a US firm, and the Coalition for Epidemic Preparedness Innovations have developed Covovax, with Serum Institute as the manufacturer.
The DCGI had approved Corbevax and Covovax in December. But the NTAGI hasn’t yet decided how to use them. Media reports on February 5 said the government had ordered five crore doses of Corbevax and quoted unnamed sources to say it could be handy as boosters. The same report also said the NTAGI would take a call on expanding the vaccination drive to children below 15 years.
ZyCoV-D
Just last week, the Indian government received its first tranche of Zydus Cadila’s vaccine, ZyCoV-D.
The drug regulator had approved it in August last year. The government has hailed it as the country’s first DNA-based vaccine and that people older than 12 years could receive it. These claims made big headlines, with a section of the media impressing upon parents that a COVID-19 vaccine for their children was just one step away.
But five months after the DCGI’s approval, the health ministry said ZyCoV-D would be available only for adults, and only in seven states. The ministry’s aim was to inoculate those who hadn’t yet received their first dose until then. But even then the ministry did not say children were going to get it.
The first tranche that the government received last week was only then forwarded to Bihar.
Moderna and J&J
In mid-2021, two more vaccines created a buzz: Moderna’s vaccine, a.k.a. Spikevax, and the Johnson and Johnson’s vaccine.
“This is the first internationally developed vaccine for which now such permission exists today, and this potentially opens up a clear possibility of this vaccine being imported into India in the near future,” V.K. Paul had said in a press conference on June 30, 2021.
“Let’s see how this opportunity will be used for accessing the vaccine in the country. There must be other formalities that they will have to follow but a very important [licence] has been given.”
The Indian government was also reportedly in talks with Pfizer. This generated a lot of excitement.
But not a single dose of any of these vaccines has landed in India thus far. The government hasn’t come on record to say what failed and when.
The three companies were demanding immunity from claims of wrongdoing or compensation in the event of severe adverse effects. And there were rumours that the Indian government didn’t wish to provide this request, so the deals collapsed.
Yet the 2021 Economic Survey hailed India’s decision to allow the import of the Moderna and the Johnson & Johnson vaccines. It didn’t bother to clarify that India had not received any doses of either.
Sputnik V
The first international vaccine approved for use in India and which landed in India was the two-dose Sputnik V. The DCGI authorised it in April 2021.
However, to date, it has contributed less than 1% to India’s vaccination programme. Initially, the vaccine’s commercial rollout had been delayed. Then, there was a shortage of second doses (Sputnik V uses distinct first and second doses).
Next, seven pharmaceutical firms in India had decided to produce Sputnik V in India. But all of them struggled to produce the second dose.
As a result, Sputnik V has remained a minor player in India’s COVID-19 vaccination drive.
Now, India has approved another version of the vaccine, called Sputnik Light. Only time will tell if the government will decide to actually administer it.