After the Indian arm of US pharmaceutical giant Pfizer Inc, the Pune-based Serum Institute of India, on Sunday became the first indigenous company to apply for an emergency use authorization for the Oxford Covid-19 vaccine in the country.
The Pune-based company has collaborated with Great Britain’s Oxford University and pharmaceutical company Astra Zeneca to manufacture the vaccine and is conducting trials in India. “As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorization for the first vaccine made in India, Covishield,” SII CEO Adar Poonawala tweeted. “This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support,” he added.
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Pfizer India had said last week that it had applied to the Controller General of Drugs of India (DCGI), India’s drug regulator, for emergency use authorization for its Covid-19 vaccine, after the parent company of the company received authorization to treat from Great Britain and Bahrain.
What is the Emergency Use Authorization (EUA)?
Regulatory authorities must approve vaccines, drugs, diagnostic tests, and medical devices before they can be administered to people or used by medical professionals. These authorities give their go-ahead after evaluating the safety and efficacy of these vaccines, drugs, etc., based on trial data. Each and every phase of the trials must be approved by the regulator.
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The US Food and Drug Administration (FDA) says that an emergency use authorization is a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current one. COVID-19 pandemic “. 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, even there are no alternatives appropriate, approved and available “.
“Based on input from the FDA, manufacturers decide whether and when to submit a US application to the FDA. Once submitted, the FDA will evaluate a US application and determine if the relevant legal criteria are met, taking into account the totality of scientific evidence on the vaccine that is available to the FDA, ”the agency said on its website.
Emergency exceptions
The FDA has said that the development process may be atypical in public health emergencies, such as a pandemic. However, he said 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.”
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“Recognizing the urgent need for safe and effective vaccines, the FDA is using its diverse authorities and expertise to facilitate the expedited development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety and efficacy. At the beginning of a public health crisis, the FDA provides clear communication to the pharmaceutical industry regarding the scientific data and information necessary to ensure vaccine development and works quickly to provide advice on proposed development plans and evaluation. of the data that is generated, ”he said.
What is the process in India?
India’s pharmaceutical regulations do not have provisions for the US and the process for receiving one is not clearly defined or consistent. However, CDSCO granted emergency or restricted emergency approvals to Covid-19 drugs (remdesivir and favipiravir in June and itolizumab in July) during the current coronavirus pandemic.
How are volunteers kept informed?
The FDA says it must ensure that recipients of the vaccine under an EUA are informed “to the extent possible under the applicable circumstances,” that the agency has authorized the emergency use of the vaccine, “of the benefits and risks. known and potential, insofar as such benefits and risks are unknown, who have the option of accepting or rejecting the vaccine, and of any available alternative to the product “.
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