An American biotechnology company, Vaxart, is set to begin its phase II clinical trial of its oral tablet-based Covid-19 vaccine in India soon, News18.com has learnt.
India is a part of the company’s global trial, which was launched in the United States last October with giving doses to around 96 participants.
The country’s apex drug laboratory, Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, has received the samples of “VXA-CoV2 Enteric-coated tablets†manufactured by Vaxart.
These tablets have been imported by Bengaluru-based Syngene International, the contract research firm which will conduct trials in India on behalf of the American drug maker.
“The samples of Covid vaccine pill have been received for testing and thereafter they will be given to start dosing of Indian participants,†a senior official from the health ministry told News18.com.
The participants will receive two doses of vaccine pill at Days 1 and 29 and they will be followed for six months for efficacy.
It is an oral recombinant vaccine that can be administered by popping the tablet rather than by injection.
Vaxart believes that its vaccine candidate is ideal to protect against mucosal respiratory viruses such as SARS-CoV-2, the virus that causes Covid-19.
According to the company’s press release issued in October, the company’s chief scientific officer, Dr Sean Tucker, announced that the vaccine candidate has produced “much higher serum antibody levels†in the non-human primate studies.
INDIAN ORAL VACCINE IN THE MAKING
Another Indian developer of novel biotherapeutic and vaccine candidates, Premas Biotech, has started Phase 1 of human clinical trials in South Africa, for its oral Covid-19 vaccine in November.
The company is developing the oral vaccine in partnership with Oramed Pharmaceuticals. While the Indian biotech firm has designed a virus-like particle (VLP) vaccine technology, Oramed will use its proprietary protein oral delivery technology for converting the product into an oral vaccine.
If successful, oral vaccines – in tablet or capsule form – will be a gamechanger as they will be easier to store and shipped out without refrigeration.
It also removes the risks related to needle-stick injury. It will save crores of rupees spent on vaccination camps and will lead to much better and faster coverage.
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