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American biotechnology company, Vaxart, will be starting phase II clinical trial of its oral tablet-based Covid-19 vaccine in India soon. According to a media report, Bengaluru-based Syngene International will conduct trials in India on behalf of the American drug maker on 96 participants. Vaxart had launched the global trail of its "VXA-CoV2 Enteric-coated tablets" in the United States last October with around 96 participants.
India's apex drug laboratory, Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, has received the samples of Covid-19 vaccine tablets manufactured by Vaxart. The pills have been imported by Syngene International, the contract research firm, the report said.
The vaccine pill samples will be tested and thereafter permission will be given to start dosing of Indian participants, a senior official from the health ministrytold a news channel.
During the trail, the participants will be given two doses of VXA-CoV2 Enteric-coated tablet at Day 1 and 29. Then they will be followed for six months to evaluate its efficacy. As it is an oral recombinant vaccine, it can be administered by popping the pill rather than by injection.
Vaxart believes that its oral tablet-based Covid-19 vaccine is ideal to protect against mucosal respiratory viruses such as SARS-CoV-2, the virus that causes Covid-19.
In a press release issued in October, the company said that the vaccine candidate produced "much higher serum antibody levels" in the non-human primate studies.
Premas Biotech developing oral Covid-19 vaccine in India
Indian biotech firm Premas Biotech is also developing an oral Covid-19 vaccine in partnership with Oramed Pharmaceuticals. Phase 1 of human clinical trials of the vaccine candidate started in South Africa in November.
Premas Biotech has designed a virus-like particle (VLP) vaccine technology, and Oramed is helping convert the product into an oral vaccine using its proprietary protein oral delivery technology.
With oral vaccines in tablet or capsule form the risks related to needle-stick injury will be gone, plus storage and shipping will become much easier. This will in turn help save crores of rupees spent on vaccination camps and enable better and faster coverage.