As India’s apex vaccine testing laboratory clears a batch of oral tablet-based Covid-19 vaccine, American biotechnology company, Vaxart, moves a step closer to begin its phase II clinical trial in India soon.
India is a part of the company’s global trial, which was launched in the United States last October.
The country’s apex drug laboratory, Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, has cleared the samples of ‘VXA-CoV2 Enteric-coated tablets’ manufactured by Vaxart.
It is an oral recombinant vaccine that can be administered by popping the tablet rather than by injection.
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 drugmaker.
“We have cleared the tablet-based Covid vaccine and the trial is likely to begin soon. The vaccine, if proven successful, can be a gamechanger, as it is much easier to transport and administer,” a top government official told.
While CDL Kasauli had received tablets in February, the government lab had sought multiple clarifications from Vaxart to create a strong testing protocol.
“The lab has been testing injection-based vaccines for the past many decades. However, in this case, several points required clarification from the company headquarters. After the successful resolution, the tablets have been given clearances.”
The trial aims at determining the safety, immunogenicity and efficacy of an adenoviral-vector based vaccine against Covid-19.
The phase II will assess the efficacy of prophylactic vaccine candidate against confirmed Covid, occurring from seven days after the second dose, with a repeat-dose vaccination schedule in healthy adults compared to placebo.
The safety and immunogenicity of vaccine candidate will also be evaluated in this phase.
The participants will receive two doses of vaccine pill at Days 1 and 29 and they will be followed for six months for efficacy. 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.
