Covaxin EUL by WHO possible by month-end
‘It will be an international recognition of safety and efficiency of the vaccine’
The possible Emergency Use Listing (EUL) by the World Health Organisation (WHO) of Bharat BioTech’s COVID-19 vaccine Covaxin by month-end “would bring in ease of international travel to Indians,’’ Dr. N.K. Arora, member, COVID-19 Task Force, told The Hindu on Tuesday.
If the approval comes, it would be an international recognition of safety and efficiency of the vaccine and this would help in terms of the host country not insisting on revaccination by a ‘WHO recognised COVID-19 vaccine’ or wanting an RT-PCR test or even quarantine period.
The WHO EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in-vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
The visa-related issues have emerged as one of the major consular challenges before the Modi government during the post-COVID-19 days. The main issue that has delayed the normalisation of visa procedures for Indian citizens is the fact that the “delta variant” of the virus was India-specific.
As a result, many countries delayed normalisation of visa procedures with India. The European Union (EU), which introduced a special “digital pass” called EUDCC (EU Digital Covid Certificate), has not eased the visa procedures for India till now though individual countries of Europe have recognised Serum Institute of India’s (SII) Covishield. The European Medicines Agency maintains that it has not received any application from the SII requesting recognition for Covishield.
The United Kingdom has, however, made a change in the visa status of India and moved India to the “amber” category, which now makes it possible for Indian travellers to skip the hotel quarantine for 10 days and opt for quarantine at home. The move also opened “Visit Visas” to the U.K. This development also coincided with the United States throwing open the visas for Indian students to its campuses after a year-long gap.
As of now, the student visas for Australia remain closed as despite promising a phased opening, Canberra is yet to indicate a clear timeline for the return of Indian students to Australian university campuses.
The Hyderabad-based company that makes Covaxin had applied for WHO EUL earlier this year. The vaccine will be granted EUL after a panel of the world body assesses the vaccine’s immunogenicity, safety and effectiveness.
“The EUL will also assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data,’’ the WHO states.
Besides ease of travel, the WHO EUL is a prerequisite for COVAX facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer vaccines. The EUL assesses the quality, safety, and efficacy of vaccines, as well as risk management plans and programmatic suitability such as cold chain requirements, said industry experts.
They noted that “currently RT-PCR negative certificate is much more valid than any “branded” Covid vaccine EUL.’’
So far, the WHO has approved COVID-19 vaccines from Pfizer-BioNTech, AstraZeneca-SK Bio or Serum Institute of India, Johnson & Johnson, Moderna, and Sinopharm.