A Chinese Covid-19 vaccine developer whose product has been approved for general use on adults is seeking to expand its use to children as young as three years old.
Zhang Yuntao, vice-president of China National Biotec Group (CNBG), told China National Radio that the company was testing how well the vaccine could induce immune response among the younger population and hoped to make it suitable for minors aged three to 17.
The vaccine was last month approved to be used on 18-to-60-year-olds after interim analysis found it offered 79 per cent protection in its phase 3 trial, conducted on the same age group. It has also been approved for emergency or general use in several other countries, including Egypt, Jordan and the United Arab Emirates.
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Vaccines by Moderna and AstraZeneca-Oxford have been approved for emergency use on those aged 18 and over in the United States, European Union and Britain, while the one made by Pfizer-BioNTech is approved to be used on people 16 years old and above.
Zhang said CNBG, a subsidiary of Sinopharm, had completed phase 1 and 2 trials on three younger age groups – ages 12 to 17, five to 12, and three to five – to establish whether the vaccine was safe and could trigger an immune response.
“The safety data is excellent but the data for immunogenicity is still being tested,” he said.
With that data and earlier trial results, Zhang said the company would file applications for use covering a broader range of ages.
“In future we will be in talks with the National Medical Products Administration and continuously apply with the safety data, immunogenicity data and levels of neutralising antibodies to expand the vaccine from 18 years old and above to be eligible for three years old and above,” he said.
CNBG started human trials in April, meaning enough time had since passed to say that the vaccine offered six months’ protection, but 14 to 15 months was needed from those April trials to determine whether it offered immunity for a year, Zhang said.
He also suggested that a third dose might be added to the two-dose regimen to maintain immunity, an option that will be assessed when immunity data is available to evaluate the immunisation already given.
“From our experience, most inactivated vaccines [the method used to develop CNBG’s vaccine] need a third shot as a booster,” he said. “I personally don’t feel a fourth dose will be necessary – not until we get the scientific data on how long-lasting the immunity is, like whether the level of antibodies falls in one or two years. Then a fourth dose could be a booster.”
CNBG’s vaccine was one of three approved by China’s drug regulator for emergency use in July, and after being approved for general use is part of a national effort to vaccinate 50 million people by early next month. More than 9 million doses have been injected so far.
Zhang said the company had scaled up production and expected to produce enough doses this year for 500 million people. It is upgrading its facilities in Beijing and Wuhan to boost production capacity, a process it expects to complete in a month or two, he said.
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