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The Hindu
The Hindu
National
Bindu Shajan Perappadan

CorbeVax cleared as precaution dose vaccine, awaits WHO’s emergency use listing

Still awaiting World Health Organisation’s emergency use listing (EUL) the Central Government on August 10 approved Biological E’s CorbeVax as a precaution dose for those above 18 years fully vaccinated with either Covishield or Covaxin.

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 products to people affected by a public health emergency. Also international travel in many countries requires people to get a vaccine that’s on the WHO’s approved list.

That pending, the latest approval by the Central Government makes this the first time that a booster dose that is different from the one used for primary vaccination has been allowed in the country.

This will be in addition to the existing guidelines for homologous precaution dose administration of Covaxin and Covishield vaccine. Also all necessary changes in regard to the administration of precaution dose of CorbeVax vaccine are being made on the Co-WIN portal.

The approval is based on the recommendations made recently by the Covid-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI). CorbeVax is to be considered as a precaution dose after completion of six months or 26 weeks from the date of administration of the second dose of either Covaxin or Covishield vaccines for those aged above 18 years enabling use of CorbeVax as a heterologous Covid-19 vaccine for precaution dose administration in this age group.

Biological E announced on February 21, 2022, that the CorbeVax vaccine received emergency use authorisation from India’s Drugs Controller General of India (DCGI) for the 12 to 18-year age group. And for the 12-14 age group on March 17, 2022. In addition, the Subject Expert Committee (SEC) recommended granting emergency use authorisation to Corbevax for children aged five to 11 years with certain conditions on April 21, 2022.

The DCGI approved CorbeVax for restricted use in emergencies among adults on December 28, 2021. On June 4, 2022, the DCGI approved CorbeVax as a heterologous COVID-19 booster dose for adults.

India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10. The country began inoculating children aged 12-14 from March 16 and also removed the comorbidity clause making all people aged above 60 eligible for the precaution dose of Covid vaccine. India on April 10 began administering precaution doses of Covid-19 vaccines to all aged above 18 years.

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