Covid-19 vaccine approval: why does it take so long? | India News

NEW DELHI: The UK on Wednesday became the first country to grant an emergency use license (EUA) to the Oxford University-AstraZeneca Covid-19 vaccine.
The move paves the way for a cheap and easy-to-store photo on which much of the world will rely to help end the pandemic.

Back home, the Pune Serum Institute of India (SII) in Pune applied for emergency approval for the Covishield vaccine developed in conjunction with AstraZeneca and Oxford University.
Bharat Biotech, based in Hyderabad, which is developing the country’s indigenous coronavirus vaccine, in collaboration with the Indian Medical Research Council, has also applied for the emergency use permit.

However, the subject matter committee that met on Wednesday sought more data on the immunogenicity of the vaccine, which will mean that emergency approval may take a few more days.
What is emergency use authorization?
Regulators must approve vaccines, medicines, diagnostic tests and medical devices before they can be used by the general public or used by medical professionals.
The US Food and Drug Administration (FDA) defines the authorization of emergency use as a “mechanism that facilitates the availability and use of medical countermeasures, including vaccines, in the event of a public health emergency, such as the current Covid-19 pandemic.”
The FDA says it may allow the use of unapproved or unapproved medical products in “emergency situations to diagnose, treat or prevent serious or life-threatening diseases or conditions when certain legal criteria have been met, including that there are there are no suitable, approved and available alternatives. ”
When can EUA be granted?
The FDA says the development process can be atypical in a public health emergency, such as a pandemic. EUA for a vaccine is released after the FDA has determined that the known and potential benefits outweigh the known and potential risks of the vaccine.
The FDA said efforts to accelerate vaccine development to address the ongoing Covid-19 pandemic have not sacrificed scientific standards, the integrity of the vaccine review process, or safety.

What is the process in India?
In India, the Central Drug Control Organization (CDSCO) has the power to grant EUA. Unlike US or UK FDA regulators, there are no provisions for EUAs under Indian drug regulations and the process for receiving them is not clearly defined.
What follows India is the “accelerated approval process.”
In this process, the approval of the new drug can be based on data generated in clinical trials. Accelerated approval may also be granted for a new medicinal product if it is intended to treat a serious or life-threatening illness or disease.
If the remarkable efficacy is observed with a dose defined in the phase II clinical trial of the new medicinal product, it may be considered for marketing authorization by the central licensing authority based on phase II clinical trial data.

Government to grant temporary licenses for Covid-19 vaccines in India
“Not all countries’ regulatory frameworks mention the term emergency use authorization. This does not mean that the specific country does not have a provision to allow such an approval that is early and that is distinct from a regular market approval “, said the Secretary of the Health Union Rajesh Bhushan.
“India’s regulatory framework has a specific provision for the granting of emergency use authorization, although this phrase is not used,” he added.

Union Health Minister Harsh Vardhan said adequate safety and efficacy data are needed to authorize emergency use, vaccine approval to ensure patient safety. An additional action will depend on the data generated.
Full approval vs authorization?
According to the US FDA, people should be aware that the vaccine has only been granted an emergency use authorization and not a full approval. Final approval is granted only after completion of the tests and analysis of the complete data; until then, EUA allows the drug or vaccine to be used by the public and health officials.
No country has made vaccination mandatory for its people.

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