India’s Bharat Biotech has been submitting data on the emergency use listing (EUL) of Covaxin “regularly and very quickly” to a technical committee which hopes to have a final recommendation to the WHO next week, a top official of the global health agency said on October 28, stressing that the United Nations body “trusts” the Indian industry that manufactures high-quality vaccines.
Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the World Health Organization (WHO) on April 19 for the vaccine’s EUL.
A technical advisory group of the UN health agency which met on October 26 has sought “additional clarifications” from Bharat Biotech for Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine. The technical advisory group will now meet on November 3 for a final assessment.
“Bharat Biotech has been submitting data regularly and very quickly, but they submitted the last batch of data on October 18,” Dr Mariangela Simao, Assistant Director-General, Access to Medicines and Health Products at WHO, said at a press briefing in Geneva.
She was responding to a question on the delay in granting the Emergency Use Listing to Covaxin while Chinese vaccines Sinopharm and Sinovac were given approval even “with lack of data”.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Simao said that when the technical advisory group met on October 26 to discuss the EUL for Covaxin, they asked Bharat Biotech for additional clarifications.
She said WHO is in touch with Bharat Biotech and has “daily conversations” and calls and meetings “clarifying what additional data needs” to be submitted to the technical expert group.
“Let me just clarify and without wanting to mention any specific manufacturer but saying that we have assessed an Indian manufacturer earlier in the year and it took 30 days,” she said, a reference to the Serum Institute of India which manufactures the AstraZeneca Covishield vaccine.
“So, this is not about moving quicker with one or another vaccine…We really trust the Indian industry. India produces a majority of vaccines in the world, high-quality vaccines. We are right now at the last stage of the assessment by this external advisory group, and we hope to have a final recommendation to the WHO next week. I hope that is well understood.”
Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.
The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.
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