The move paves the way for a cheap and easy-to-store injection that much of the world will depend on to help end the pandemic.
Today marks an important milestone in the fight against # COVID19. Provisional data shows that #OxfordVaccine is 70.4% effective… https://t.co/rz4SJmlDgt
– University of Oxford (@UniofOxford) 1606115164000
At home, the Pune-based Serum Institute of India (SII) has sought emergency approval for the vaccine that Covishield developed in conjunction with AstraZeneca and the University of Oxford.
Hyderabad-based Bharat Biotech, which is developing the country’s indigenous coronavirus vaccine in collaboration with the Indian Council for Medical Research, has also applied for emergency use authorization.
However, the committee of subject matter experts that met on Wednesday sought more data related to the immunogenicity of the vaccine, which will mean that approval for emergency use may take a few more days.
What is the emergency use authorization?
Regulatory authorities must approve vaccines, drugs, diagnostic tests, and medical devices before they can be used by the general public or medical professionals.
The US Food and Drug Administration (FDA) defines emergency use authorization as a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current pandemic. of Covid-19 “.
The FDA says it may allow the use of unapproved medical products or the unapproved uses of approved medical products in “an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain legal criteria are met, including no alternatives. appropriate, approved and available. ”
When can USA be granted?
The FDA says the development process may be atypical in public health emergencies, such as a pandemic. The EUA for a vaccine is issued after the FDA has determined that the known and potential benefits outweigh the known and potential risks of the vaccine.
The FDA has claimed that efforts to accelerate vaccine development to address the current 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 Drugs Standard Control Organization (CDSCO) has the power to grant USA. Unlike the US FDA or the UK regulator, there are no provisions for the US under Indian drug regulations and the process for receiving one is not clearly defined.
What India follows is the “accelerated approval process”.
Under this process, approval of the new drug can be based on data generated in a clinical trial. Expedited approval may also be granted for a new drug if it is intended to treat a serious or life-threatening condition or disease.
If remarkable efficacy is observed at a defined dose in the Phase II clinical trial of the new drug, the granting of marketing approval by the Central Licensing Authority based on the data from the Phase II clinical trial may be considered.
Government on Temporary Licensing of Covid-19 Vaccines in India
“Not all the regulatory frameworks in the countries mention the phrase emergency use authorization. That does not mean that the specific country does not have an enabling provision to grant such approval which is anticipated and which is distinct from regular market approval, ”said Union Health Secretary Rajesh Bhushan.
“India’s regulatory framework has a specific provision for granting emergency use authorization, although this phrase is not used,” he added.
Union Health Minister Harsh Vardhan has said that adequate safety and efficacy data are required for emergency use authorization and vaccine approval to ensure patient safety. The further course of action will depend on the data generated.
Full approval vs authorization?
According to the US FDA, people should know that the vaccine has only been granted an emergency use authorization and not a full approval. Final approval is granted only after completion of testing and complete data analysis; Until then, the US allows the public and health officials to use the drug or vaccine.
No country has made vaccination mandatory for its population.
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