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How are vaccines approved: All you need to know – health

The United Kingdom became the first country to approve the Covid-19 vaccine created by Pfizer and BioNTech for emergency usage, after its Medicines and Healthcare products Regulatory Agency (MHRA) gave its nod on Wednesday.

With the first bunch of Pfizer vaccines expected to roll out in the UK by next week, as confirmed by Health Secretary Matt Hancock, here is a look at how countries around the world are approving vaccines-

What is EUA ?

The History of Vaccines website says that vaccine development often takes around 10 to 15 years of time and is a long and complex process. To counter such long timelines, FDA defines EUA as the power to use unapproved medical products or unapproved uses of approved medical products to treat serious or life threatening diseases.


Independent regulator MHRA in the UK cleared Pfizer’s Covid-19 vaccine after a “rolling review” process. With Britain formally out of the European Union, Hancock said that they were able to approve the Pfizer vaccine quicker than the european neighbours.

MHRA’s chief executive June Raine had said that “no corners were cut” in the process of giving emergency authorisation to the vaccine.

European Union

The European Union too has a rolling review process, under which it is currently observing all vaccine candidates at advanced stages of development.

European Medicines Agency (EMA) is the regulatory body for all 27 EU countries and it defines rolling review as a tool to “speed up the assessment of a promising medicine or vaccine during a public health emergency.”


Food and Drug Administration (FDA) is the regulatory body in the United States assisted by an independent advisory committee. Both the FDA and the committee analyses the vaccine candidates before an EUA is provided.


Russian health ministry’s scientific centre for evaluation of medicines is responsible for medical tests in the country and uses “system of state testing, using comparable medications, a double-blind study and other control tests independent of the developers” as mentioned in their website.

President Vladimir Putin has ordered large scale vaccination in the country with Sputnik V, Russia’s own vaccine candidate.


China has already started administering experimental Covid-19 vaccination from Sinopharm to nearly a million people, the company said.

With a few candidates in phase III trials, China’s regulator expects companies to perform three stages of clinical trials and also share their production process.


Central Drugs Standard Control Organisation (CDSCO) is India’s regulator for pharmaceutical and medical devices.

AstraZeneca has partnered with Serum Institute of India (SII) in Pune, who’s CEO Adar Poonawalla on 28 November said that the Institute is in the process of submitting an application to seek EUA for their Covishield vaccine. Also Bharat Biotech has been progressing in the development of their candidate Covaxin.

(With agency inputs)

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