E-Paper
WHO nod likely by September: Bharat Biotech
Bharat Biotech on Tuesday announced that it applied to WHO (World Health Organisation) for emergency use listing of its Coronavirus disease (Covid-19) vaccine, Covaxin, and expected approvals anytime between July and September, amidst rising concerns that the lack of such recognition could come in the way of international travel by those who received this vaccine
Bharat Biotech on Tuesday announced that it applied to WHO (World Health Organisation) for emergency use listing of its Coronavirus disease (Covid-19) vaccine, Covaxin, and expected approvals anytime between July and September, amidst rising concerns that the lack of such recognition could come in the way of international travel by those who received this vaccine.
“Application for emergency use listing (EUL) has been submitted to WHO-Geneva, regulatory approvals are expected Jul-Sept 2021,” the Hyderabad-based company said in a statement about its inactivated whole virion Covid-19 vaccine.
As the world opens up after the pandemic, it is likely that countries will put in place restrictions on incoming travellers. In some cases, this may mean mandating vaccination, by a vaccine recognised either by that country or WHO.
According to Bharat Biotech, regulatory approvals for Covaxin are currently in process in at least 60 countries, including the US, Brazil, and Hungary.
So far, the company has obtained emergency use authorisations in 13 countries including Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, and Zimbabwe.
In the second interim analysis of the phase 3 clinical trial results that the company released last month, Covaxin has been found to have an efficacy of about 78%.
The company’s vaccine has also been found to be effective against mutant strains of the virus.
“This is something where we’re still gaining data on a daily basis. But the most recent data, was looking at convalescent Sera of Covid-19 cases and people who received the vaccine used in India, the Covaxin. It was found to neutralise the 617 variants,” Dr Anthony Fauci, prominent American infectious disease expert, had earlier said.
The company is yet to publish the final results of its trial.
“Most countries recommend vaccinations against Covid-19. Unvaccinated travellers can travel with negative RT-PCR tests prior to travel, in the absence of any other country specific travel restrictions,” the company added in its statement.
Bharat Biotech announced last week that it would scale up Covaxin production to up to 1 billion doses a year by the last quarter of this year.
Covaxin was developed with seed strains received from the National Institute of Virology, and the phase 3 clinical trial was co-funded by the Indian Council of Medical Research (ICMR).
Bharat Biotech is selling a vaccine dose for ₹400 to state governments, and ₹1200 to private hospitals. Pricing for international markets and supplies to government’s under emergency use authorizations have been established between $15 and $ 20 per vaccine dose. Like many others, Covaxin is a two-dose vaccine.
