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Emergency use authorisation sought by SII, Pfizer

Covid-19. Red liquid vaccine in glass tubes.. Cases of COVID-19 illustration. Image credit: Ivan Uralsky. vaccine hesitancy concept. Also to illustrate article re: emergency use authorisation
Image credit: Ivan Uralsky / 123rf

The Serum Institute of India (SII) is seeking emergency use authorisation for Covishield, also known as the ‘Oxford Vaccine’. Pfizer has done the same for its vaccine candidate.

Phase-III trials of Covishield – made by the University of Oxford in collaboration with AstraZeneca – are underway in various parts of the country, conducted by the SII with the co-sponsorship of the Indian Council of Medical Research (ICMR). The SII is appealing to the Drug Controller General of India (DCGI) for emergency use authorisation of the vaccine. This came on the heels of a similar requests by drugmaker Pfizer for emergency use authorisation for its vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – or, simply, coronavirus – which is the virus that causes the disease COVID-19.

Professor Andrew Pollard (director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial) said in November “we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around ninety percent effective and if this dosing regimen is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world.”

In its application to the DCGI for emergency use authorisation, the SII cited data from four clinical studies of Covishield which it claims to have shown strong efficacy against symptomatic cases of COVID-19, especially those that are severe in nature. Of the clinical studies in question, one was conducted in India whilst one came from Brazil and two from the United Kingdom. The ICMR has said that forty million doses of the vaccine have already been made. 

In Pfizer’s case, the application for emergency use authorisation is likely to be heard this week according to official sources quoted in The Economic Times. “The matter has been referred to the Subject Expert Committee (SEC), the panel that advises the Drug Controller General of India on new drugs and vaccine approvals,” said the senior government official cited.

As explained by The New Indian Express, “for vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials. In fact, approval from the regulator is required at every stage of these trials. This is a long process, designed to ensure that a medicine or vaccine is absolutely safe and effective. The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed. 

“In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals if there is sufficient evidence to suggest a medical product is safe and effective. Final approval is granted only after completion of the trials and analysis of full data; until then, emergency use authorisation…allows the medicine or the vaccine to be used on the public.”

Many view a vaccine against the novel coronavirus as a pancaea in the fight against the global pandemic that has claimed more than 1.5 million lives to date. In India, one of the countries hardest-hit by COVID-19, provisions are underway to ensure the gargantuan logistical challenge of administering a vaccine to a population of more than 1.3 billion people is met. The Union Government has demarcated US$7 billion for rollout, with as many as 300 million prioritised for receipt. 

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