Covid-19 vaccination drive: 12-14-year-olds to get Corbevax shots

Union Health Ministry also opened up vaccination for all those above 60 years, removes the precondition of co-morbidity

Further expanding its Covid vaccination drive, India will start vaccinating children aged 12-14 years from this week with two doses of Biological E-manufactured Corbevax vaccine. The Union health ministry also opened up vaccination to all those aged 60-plus, thereby removing the clause of comorbidity.

In a tweet, Union Health Minister Mansukh Mandaviya said on Monday: “I am happy to inform you that from March 16, Covid vaccination of children in the age group of 12-14 will start. Also, everyone aged 60-plus will now be able to get precaution doses. I urge families of children and people in the age group of 60 and beyond to get the vaccine.”

The health ministry said after ‘due deliberations’ with scientific bodies, it has decided to start Covid vaccination for 12-14 year olds (those born in 2008, 2009, and 2010) from March 16.

Stirring up a controversy,  JP Muliyil, epidemiologist at CMC Vellore and member of the working group of National Technical Advisory Group (NTAGI) said that the NTAGI had not yet recommended to go for vaccinating children below the age of 15 years yet.

"There is no scientific evidence to suggest that children who have been already infected with Omicron will be better protected if they are given a vaccine now. The NTAGI has not recommended such usage. Typically, the NTAGI recommends the vaccine and also the strategy for vaccinations for all public vaccination drives in the country. This time the government has gone ahead with their decision," Muliyil told Business Standard.

His peer T Jacob John, senior virologist and former head of the departments of clinical virology and microbiology at Christian Medical College, Vellore said that it is better to go ahead with vaccinations, collect evidence and then if evidence shows that vaccination is not necessary, then do away with it. 

"But deciding to not vaccinate because of lack of scientific evidence may prove to be risky. Even if there is a single child's death in that case, it would be on our conscience," John said. 

There are 71.1 million children in India falling in this age group, according to the health ministry.

Therefore, around 142 million doses of Corbevax would be required to cover the entire population in this age group.

The Centre has not given any specific reason behind the decision to use only Corbevax for this age group. Already children aged 15-17 years are being administered only Covaxin, the inactivated virus-based vaccine manufactured by Bharat Biotech.
 

Experts like Gagandeep Kang, microbiologist and professor at Christian Medical College, Vellore, said that while Corbevax is understood to be safe, “we do not know whether it is effective yet”.

“We know that Corbevax is a safe vaccine to be administered in children. It uses an adjuvant, which is not used in vaccines in our country so far, but this vaccine is understood to be safe. Here we do not have clinical efficacy data as the trial that resulted in emergency-use authorisation was done to compare the immune responses between Corbevax and Covishield,” said Kang.

She added that previous vaccines were approved, based on clinical efficacy in up to 30,000-40,000 people, but this was not possible because when the trials were done, there was hardly any Covid-naïve population available for the study. 

“We know that this vaccine induces antibody response in children, but whether that response is effective, we do not know yet but we have the expectation that will be the case. However, in order to understand how well the vaccine really prevents disease in children, the aim now should be to collect the effectiveness data in all the children who will be administered Corbevax — and this should be done in several hundred thousand children at least. This can easily be done by linking CoWIN with the Covid-testing data,” Kang told Business Standard. 

Already a handful of vaccines are approved by the Drugs Controller General of India for use in children above 12 years — Covovax (the Novavax vaccine manufactured by Serum Institute of India), ZyCoV-D (Zydus Lifesciences), and Covaxin (Bharat Biotech), apart from Biological E’s receptor-binding domain protein sub-unit vaccine Corbevax.

Vaccine industry sources feel that the decision may be triggered by a huge inventory of Corbevax that the Centre now has.

“The Centre had placed orders for 300 million doses last year, and the supplies too had begun in February. Therefore, the government is sitting on a huge stockpile of this vaccine. This may be one of the reasons behind using only Corbevax for this age group. As more population segments are opened up, more vaccine candidates may be used,” said a senior executive of a vaccine manufacturing firm.

Last September, Biological E received approval to conduct a Phase II/III clinical trials on Corbevax in children and adolescents aged 5 to 18 years. Based on the no-objection certificate, Biological E initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing Phase II/III study, which indicated that the vaccine is safe and immunogenic.

The Corbevax vaccine is administered through an intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees’ Celsius.

Doctors felt that the success rate of vaccination in this age will determine whether or not vaccination is opened up for children below 12.

Meena J, senior consultant, paediatrician and neonatology, Aakash Healthcare in Dwarka, said: “The government will decide on the success rate of children’s Covid vaccination and how future Covid-19 waves behave for children under the age of 12. This decision will be totally based on facts.”

Meanwhile, the government has also decided that the condition of comorbidity for Covid precaution dose for population over 60 will be removed forthwith. Hence, from March 16 onwards, the entire population above 60 years of age will be eligible for precautionary dose of Covid vaccine.

The move is expected to boost demand for the booster shot among senior citizens. Around 35-40 per cent of the eligible population above 60 years (27 million) has taken precaution shots so far. The total population above 60 years is 111 million.

Harsh Mahajan, president, NATHEALTH, said “Removal of this requirement will not lead to a dramatic rise in those above 60 years of age coming for vaccination. There was previously no need for a doctor’s prescription, regarding the presence of comorbidities, and all those wanting and eligible for a booster dose would have got it by now.”