The whole world is suffering from COVID-19 and waiting for the vaccine to end the pandemic. Various companies are conducting trial regarding the COVID-19 vaccine including Pfizer, AstraZeneca, and Moderna which have showcased hopeful results and hoping that it will successfully end the pandemic. After receiving positive results, the companies have begun seeking emergency approval in order to roll out their vaccine for people usage as soon as possible.
The first company to seek an emergency approval from India is Pfizer on 4 December, 2020 and is also followed by the Serum Institute of India (SII) on 7 December, 2020.
Pfizer India has become the first pharmaceutical firm to seek an emergency use of authorisation for its COVID-19 vaccine from the Drugs Controller General of India (DCGI) after its parent company secured such type of clearance in the UK and Bahrain.
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About Pfizer India and Vaccine
Pfizer India has been developing its vaccine candidate in collaboration with BioNtech. It has been reported that the company has submitted its application to the Drugs Controller General of India on 4 December. Also, the company has received emergency clearance for the mass distribution of the vaccine in the UK and Bahrain. It is said that the vaccine should be stored at a temperature of -70°C which is equivalent to an Antarctic winter. As this can be a biggest challenge for India as the country will have to completely revamp its cold storage facilities. It is also said that without an extremely cold storage system, the vaccine may become ineffective within two days.
About Serum Institute of India
The Serum Institute of India on 6 December applied to the Drugs and Controller General of India (DCGI) for emergency use of authorisation for its Oxford COVID-19 vaccine in the country. Here to inform is that the vaccine which is developed by SII with Oxford and AstraZeneca is the first candidate that is being tested in India to seek emergency approval.
Official sources said about SII application that the firm stated the data from four clinical studies i.e. two in the UK and one each in Brazil and India shows that Covishield is very efficacious against symptomatic and most significantly against severe COVID-19 infections.
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The phase-3 clinical trial of the Oxford COVID-19 vaccine namely Covishield is being conducted by the Pune-based SII which is co-sponsored by the Indian Council of Medical Research (ICMR) in several parts of the country additionally to clinical studies that are being administered by Oxford-AstraZeneca within the UK and Brazil.
According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
As per the source “Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield,â€.
Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at SII said that “In line with our philosophy, we assure you that for COVID-19 vaccines also, we are committed to make our country ‘aatmanirbhar’ (self-reliant) and fulfil our Prime Minister’s clarion call of ‘vocal for local’ and ‘making in India’ for the world”.
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Points to remember
Therefore we can say that the UK became the first country to grant temporary authorisation for the emergency use of Pfizer’s mRNA vaccine (BNT162b2) against COVID-19.
In its application, the Pfizer has sought permission to import its vaccine and also to start out a clinical trial on the population of India under relevant provisions of the New Drugs and Clinical trial Rules, 209. As per the sources, the waiver sought by the firm will be scrutinised by the SEC.
On 6 December, 2020, UK’s National Health Service said that people aged 80 and above, as well as care home workers, will be the first to receive vaccine along with NHS workers.
According to the Pfizer, the final efficacy analysis of their ongoing Phase 3 clinical trial indicates that an efficacy rate of 95% in volunteers without prior SARS-CoV-2 infection. Further, the company told that “efficacy was consistent across age, gender, race, and ethnicity demographics. The observed efficacy in adults over 65 years of aged was over 94%”.
Further for SII, for the emergency approvals, the interim data has been shared by the SII of four clinical trials that is one each from India and Brazil, and two trials from the UK with the DCGI. One of the major advantages of this vaccine is that it can be easily stored at a temperature between 2 and 8°C.
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PM Narendra Modi for COVID-19 Vaccine
Also, the PM of India Narendra Modi said that the COVID-19 vaccine is expected to be ready in few weeks and then India will launch the programme of vaccine soon after the nod from the experts.
Also, the government has stated that the frontline COVID-19 warriors and health workers will be the first to get vaccinated. And the country is also gearing up the cold storage facilities and cols chain points across the country are re-modelling themselves to support the storage of the upcoming vaccine.
As per the officials of the Rajiv Gandhi Super Speciality Hospital, the first vaccine storage facility in Delhi said that the national capital may even receive its first batch of vaccines by the end of December 2020.
Background
Related to the vaccine efficacy the big news first came from Pfizer. They announced on 9 November, 2020 that their candidate was 90% effective in late-stage human trials. Just a couple of days later, Modern too announced its vaccine candidate to be 94.5% effective. Also, Russia’s Sputnik V also reported 92% efficacy in its trial. And soon Oxford University and AstraZeneca announced their vaccine to be 70.4% effective.
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