Bharat Biotech, Pfizer in race for paediatric Covid-19 vax by December

Covaxin in trials already, Serum slated to start testing Novavax by July

Now, vaccine manufacturers are focusing on getting the paediatric Covid-19 jabs ready for use. If things go well, India could have at least two paediatric and adolescent vaccines by the end of this year.

Bharat Biotech’s Covaxin is in trials among children already; the intra-nasal candidate from Bharat Biotech, which is under trial now, has included children; Serum Institute of India will begin Novavax vaccine trials on children from July; Russian paediatric nasal vaccine is to be registered in that country by September; Pfizer vaccine has been approved for adolescents in the US; and Cadila Healthcare’s ZyCoV-D has done trials on 12 year-olds and above already.

Of the above options, at least two are expected to be available within this year — Covaxin may finish trials and seek approvals while the regulator may allow either Pfizer or Zydus vaccines for adolescents.

The Centre, too, has begun planning for this cohort. V K Paul, member, health, NITI Aayog, had said recently that for the 12-18 years age group, India is likely to need 250-260 million doses. He also pointed out that besides Covaxin, Zydus Cadila’s vaccine is also being tested on children; thereby indicating that these two are potential vaccines to immunise children.

Paul had said earlier this month that the decision on vaccinating children in India is being “continuously examined”.

Covaxin has started trials on children; it would be for children who are two years or older. Trials have started at the All India Institute of Medical Sciences (AIIMS), New Delhi, and some other centres. The company did not give timelines on when the trials could be over. However, a senior executive told Business Standard that this was a ‘safe bet’ as the vaccine was already approved for adults and the platform was ‘tried and tested’.

“The children’s trial for Covaxin is to check safety and immunogenicity, and this is a quicker process than our phase 3 efficacy study, which we started in November last year. We will have the phase 3 efficacy analysis by July. The study in children would not take that long, and a couple of sites have already begun enrolling kids,” the executive said.

He added, “I don’t want to give a timeline. We can expect a paediatric Covaxin soon. It is a safe bet as it is already approved for adults and the technology platform is tried and tested.”

Bharat Biotech is also betting on its intra-nasal candidate BB-154 as a paediatric candidate. The company has noted on its website that it is needle free, non-invasive, easy to administer (even without trained healthcare workers), and ideally suits children. The trials are on for this candidate too.

ZyCoV-D, the DNA plasmid vaccine from Ahmedabad’s Cadila Healthcare, has already done trials on adolescents who are 12 years and above. The candidate is likely to get approval soon from the Indian regulator as trials are over, and the company is expected to apply for approval any moment now.

If the regulator gives a nod, this vaccine can be approved for adolescents.

In an earlier interaction with Business Standard, Sharvil Patel, managing director (MD), Cadila Healthcare, had said, “We would have sufficient data on the safety and efficacy of the vaccine on children by the time we seek approval from the regulator. Moreover, this is a needle-free vaccine, which may make it more acceptable to children,” Patel had said then.

Cadila Healthcare’s ZyCoV-D would be administered through a needle-free injection system (NFIS). Typically, in an NFIS, a jet of fluid is accelerated at high speed, providing it significant penetrating power through a fine-diameter nozzle when placed against the skin. Patel felt the vaccine may have higher acceptance among children scared of needles. 

Serum Institute confirmed that it plans to start clinical trials on kids for Covovax, the Covid jab from Novavax, in July. Novavax has said this month that it got promising results from its PREVENT-19 phase 3 trials in the US and Mexico, with an overall efficacy of 90.4 per cent.

Meanwhile, Russia is also gearing up to approve a nasal Covid vaccine for children by September, said a Russian Direct Investment Fund (RDIF) spokesperson.

According to Russian news agency TASS, Alexander Gintsburg, director of the National Research Center for Epidemiology and Microbiology, has said that by mid-September a nasal vaccine for children may be registered in Russia. “Gunzburg said that the developers did not find any side effects when using the vaccine in the form of nasal drops among children aged 8-12 years,” TASS reported.

RDIF did not comment on when it plans to bring this vaccine to India or other countries.