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Further expanding its Covid-19 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 for all those above 60 years of age, thereby removing the precondition of co-morbidity.
In a tweet, Union Health Minister Mansukh Mandaviya said on Monday, “I am happy to inform that from March 16, Covid vaccination of children in the age group of 12 to 13 and 13 to 14 will start. Also, everyone aged 60+ will now be able to get precaution doses. I urge the families of children and people in the age group of 60-plus that they must get the vaccine”
The health ministry said that after ‘due deliberations’ with scientific bodies, it has decided to start Covid19 vaccination for 12-14 year old children (those born in 2008,2009 and 2010) from March 16.
There are 71.1 mn children in India falling in this age group, according to the health ministry.
Therefore, around 142 mn 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 to 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 authorization was done to compare the immune responses between Corbevax and Covishield.”
She added that previous vaccines were approved based on clinical efficacy in up to about 30000 or 40,000 people, but this was not possible because when the trials were done, there were hardly any Covid19 naive 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, now the aim should be to collect effectiveness data in all the children who will be administered Corbevax—and this should be done in several lakh children at least.
This can easily be done by linking CoWin with the Covid19 testing data,” Kang told Business Standard.
She added that ideally, the aim should be to collect effectiveness data in all the children who will be administered Corbevax, and this can be done by linking CoWin with the Covid19 testing data.
Already a handful of vaccines are approved by the Drugs Controller General of India (DCGI) 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 (RBD) protein sub-unit vaccine Corbevax.
Vaccine industry sources feel that the decision may be triggered by the huge inventory of Corbevax that the Centre now has. “The Centre had placed orders for about 300 mn doses last year, and the supplies too had begun in February. Therefore, the government is sitting on a huge stockpile of this vaccine, and 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 trial 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 2-8 degrees Celsius temperature.
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 Dwarka said: “The government will decide on the success rate of children’s Covid vaccination and how future Covid waves behave for children under the age of twelve. This decision will be totally based on facts.”
Meanwhile, the government has also decided that the condition of co-morbidity for Covid-19 booster dose for those over 60 years of age will be removed forthwith. From March 16 onwards, the entire population in this group will be eligible for the booster jab.
The move is likely to spur the demand for the booster shot among seniors. Some 35-40 per cent of the eligible population above 60 years (about 27 million people) has taken boosters 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 also no need for a doctor’s prescription, regarding the presence of co-morbidities, and all those wanting and eligible for a booster dose would have got it by now.”
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