JOIN USVaccine for 12-14-year-olds: Paediatrics ask parents to wait for some more time
Many paediatricians in Bengaluru say they will ask parents to not immediately vaccinate their children aged 12-14 against Covid-19.
On Wednesday, authorities rolled out the Corbevax vaccination programme for children belonging to the age group. The vaccine has been developed by Hyderabad-based Biological E Limited.
But paediatricians say parents should wait because data on the vaccine's clinical trials have not been published yet.
According to them, they have no clue about the sample size of Corbevax’s clinical trials. This is in contrast to Covaxin, the Covid vaccine for the 15-18-year-olds, where doctors knew that the jab was evaluated in 175 subjects aged 12-18 and in 350 subjects below 12 years of age in clinical trials.
They said data for this protein sub-unit vaccine was not publicly available, except in adults where the study population was of the 18-65 age group. Three hundred and sixty people were studied in phase 1/2 trial and 100 in phase 2. In all, 460 were vaccinated.
In a paper posted on pre-print server Medrxiv, on March 9, the findings read: “Low incidence of adverse events was reported post-vaccination of different Corbevax formulations and majority were mild in nature and no Grade-3 or serious adverse events were observed.”
The interpretations read: “Corbevax was well tolerated with no observed safety concerns. Neutralising antibody titers were suggestive of high vaccine effectiveness compared with human convalescent plasma or protective thresholds observed during vaccine efficacy trials of other Covid-19 vaccines.”
The Phase-1/2 and Phase-2 studies were carried out in five and seven centres across India, respectively, between November 11, 2020, to August 20, 2021.
Epidemiologist Dr Jayaprakash Muliyel, who is also a member of the National Technical Advisory Group on Immunisation, said: "I'm not sure of the protection it offers post-Omicron, maybe it offered protection pre-Omicron. We did not discuss any recommendation for its use in 12 to 14-year-old children. The Centre may have consulted other bodies."
Paediatrician Dr Shrikanta J T, a member of the state high-level expert committee for the prevention and management of the Covid third wave, said: "I will ask parents to wait for data as a parent I cannot vaccinate my kid without looking at some data. In the US, Pfizer was administered to 50,000 children as a part of a study before it was rolled out to 12-18-year-olds. We have no comparable paediatric data with Corbevax that is in the public domain."
Dr Senthil K, a paediatrician at Manipal Hospitals, Whitefield, said: "We have to wait and watch. I am not sure whether to recommend it or not. Unless the safety profile in children is made publicly available, I can't ask parents of kids to go ahead."
Clinical trials had 176 kids aged 12-14: Biological E
Biological E says 176 kids in this age group were part of the paediatric clinical trial.
"We started clinical trials for 5-18-year-olds which are still ongoing. A part of the trial for 12-18-year-olds has been completed and following the submission of the data to the government, we received the approval on February 21. For the 5-12 age group, our trials are almost over and we have submitted the interim report," said Vikram Paradkar, Executive Vice President, Biological E.
"We expect additional reviews from vaccinology experts at Government of India, the Subject Expert Committee as well as the Central Drug Standard Control Organisation at the Drug Controller General of India's office. Post this review, we're confident of getting approval for that age group as well in the near future," he added.
Narender Dev Mantena, head, global strategy and CEO of speciality generic injectables and synthetic biology, BE, pointed out that they plan to test this vaccine on children as young as six months of age eventually, whenever the safety data is available.
As far as the publication of data in a scientific journal is concerned, the company said their partners are still reviewing the adult data and that paediatric data can be published only after that.
As per the company's package insert, "In Phase II/III clinical study, conducted in 624 subjects aged ≥ 5 to < 18 years in two age cohorts (≥ 5 to < 12 and ≥ 12 to < 18 years) to prove the safety, tolerability and immunogenicity, the interim results from ≥ 12 to < 18 years age group showed significant increase in IgG and nAb titers post-vaccination (at Day-42) against Wuhan and Delta variants, which indicates excellent immune response generated by CORBEVAX™ and is in line with IgG and nAb titers observed in earlier clinical trials in adults."
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