A coronavirus inoculation for children is likely to be approved by September, according to two officials involved in the development of the vaccines, including Bharat Biotech’s managing director Krishna Ella, who said the trial phase of the clinical studies in volunteers in the 2-18 age group has been completed.
There are two vaccine candidates that have been tested among children in India: Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D. The Covaxin trial includes 525 volunteers while ZyCov-D’s trials – as part of the phase II/III clinical studies – includes 1,000 volunteers in the 12-18 age group.
“Our clinical trial final phase is over. We are hoping that by either by month end or by next month we should get the license for vaccine in children. This is the only vaccine in the world that can be given to children between 2 and 18 years,” Ella said in an interview to DD News on Wednesday.
A senior official from Indian Council of Medical Research’s National Institute of Virology (NIV) in Pune, which collaborated with Bharat Biotech for Covaxin, said she expected the results from the studies to be out soon and an approval to follow shortly after.
“Hopefully, the results (of the trials) are going to be available very soon. These will be presented to the regulators. So, by September or just after it, we may have Covid-19 vaccines for children,” said Priya Abraham, director of NIV, Pune, in an interview to India Science, a web channel of the government’s Department of Science and Technology.
“…Zydus Cadila’s vaccine trial is also going on. This can also be applied for children and will be made available,” added Abraham.
Experts at India’s drug regulator are assessing ZyCov-D’s data for approval. The company has said its assessment of the clinical trials showed an efficacy rate of 66.6%.
An expert aware of the process said early data has shown some promise. “There are a few promising data sets that the experts are examining that includes the vaccine candidate of Zydus Cadila, which has been tried in around 1,000 children. Then there is data from Bharat Biotech’s Covaxin trial in children that people are anticipating,” this person said, asking not to be named.
The expert, who works with the central government, indicated the assessment of Covaxin may be easier since it is already in use and has established efficacy rates. “There are high hopes because Covaxin has already received the necessary approval for adults, so it will be examined for safety and immunogenicity in children.”
Ella and Abraham also spoke on booster doses, which they both said will eventually become necessary.
According to Abraham, studies on booster doses have been going on overseas and at least seven vaccines have been tried for it. “Now, WHO (World Health Organization) has put a stop to it till more countries catch up with vaccination. This is because there is an alarming vaccine [supply] gap between high-income and low-income countries. But, in future, recommendations for boosters will definitely come,” she said.
Ella took a similar position. “It is a fact; I can’t lie about it that booster dose will be required. However, our priority will be to vaccinate all adults first. We are also doing trials for our nasal vaccine candidate against Covid-19, and instead of a booster dose of Covaxin we may even have the option of taking one dose of Covaxin and second dose of the nasal vaccine. It is too early to say anything conclusively at the moment; research is on,” he said.
The NIV Pune director said there were no safety concerns in mixing different Covid-19 vaccines and the institute was carrying out further studies that will lead to more details in the coming days.
Abraham reiterated that vaccination is a must and the studies at NIV show the vaccines in use work against variants of the coronavirus, citing the levels of antibodies produced in the bodies of vaccinated people.
She said that while levels were reduced in case of some variants, “yet, the vaccines are still protective against the variants. They may show a little less efficacy, but vaccines are very important to prevent serious forms of disease due to which patients may get hospitalised and even die. So, whatever the variant, vaccine is till now protective against all, including the Delta variant. So, there should not be any hesitancy at all.”