India has finally approved two made in India vaccines – Oxford-AstraZeneca’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ for emergency use authorisation.
On January 3, the Drug Controller General of India (DCGI), the country’s national drug regulator, announced that the Central Drugs Standard Control Organisation (CDSCO) has decided to accept the recommendations of its Subject Expert Committee (SEC).
Drugs Controller General of India VG Somani said the overall efficacy of the AstraZeneca/Oxford vaccine was found to be 70.42 per cent — well below vaccines from Pfizer and Moderna, but above the 50 per cent threshold set by many regulators.
“The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. Data of Phase-2/3 clinical trials on 1,000 participants within the country was also submitted and it was found comparable with the data from the overseas clinical studies,” Somani said.
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Here are the frequently asked questions:
What’s next?
The government will be procuring the vaccines – Serum Institute of India (SII), has manufactured Covishield, the Indian variant of the AZD1222 vaccine developed by Oxford University and AstraZeneca, and has managed to stockpile around 80 million doses. Covaxin, developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) is expected to take a few days or weeks to be available.
In the US and UK, the first shots were administered within 1-2 days of the Pfizer-BioNTech and Moderna vaccines receiving regulatory approval.
The government has not announced a timeline as of now, however, the process is likely to be very fast. It can be reasonably expected that the mass vaccination programme will begin within a week — perhaps by the coming weekend.
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Is it mandatory to take the vaccine?
No, taking the vaccine is voluntary.
Who will be the first recipient of the vaccine?
The government initially announced that first in line will be 30 million healthcare workers who have helped India in fighting the novel coronavirus. On January 2, Health Minister Dr Harsh Vardhan announced that the vaccine will be administered to them for free. Also receiving the vaccine in the first phase will be a third priority group – consisting of some 27 crore persons above age 50, and persons below age 50, but with associated comorbidities.
“In 1st phase of #COVID19Vaccination, free #vaccine shall be provided across the nation to most prioritised beneficiaries that incl[ude] 1 crore healthcare & 2 crore frontline workers. Details of how further 27 cr[ore] priority beneficiaries are to be vaccinated until July are being finalised,” Dr Harsh Vardhan tweeted.
What about others?
The government is planning to complete the first phase of vaccinations by August 2021. The rest of the population will have to wait until the first phase of vaccination is complete, however, a timeline for the rest of the population is not known as yet. Other groups will begin to be inoculated simultaneously after some weeks or months.
SII had mentioned that it is ramping up production at its facilities. Also, a whole lot of other vaccines — apart from Covishield and Covaxin — are likely to be approved for use in India in the coming weeks. These include the vaccines from Pfizer and Moderna, the Russian Sputnik-V, and Zydus-Cadila’s ZyCoV-D candidate.
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How is the government preparing for the vaccination?
Two rounds of vaccine dry run have already been held — the first in four states on December 28-29, and the second on January 2, covering 285 session sites in 125 districts in all states around the country.
On Saturday, Harsh Vardhan said that around 96,000 vaccinators have been trained and more than 75 lakh beneficiaries have been registered on the Co-WIN platform, which will provide real-time information on vaccine stocks, their storage temperature, and individual beneficiaries of the shots.
The country’s cold chain infrastructure has been sufficiently upgraded to ensure last-mile delivery, and adequate supplies of syringes and other logistics have been arranged, he said.
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If you have been tested positive once, will you be vaccinated?
Yes, it is advisable to receive a complete schedule of Covid vaccine irrespective of the past history of infection with coronavirus. “This will help in developing a strong immune response against the disease,” the centre had said.
How many doses will be administered?
According to the Health Ministry, two doses of vaccine, 28 days apart, need to be taken by an individual to complete the vaccination schedule.
When do we potentially develop immunity?
Protective levels of antibodies are generally developed two weeks after receiving the 2nd dose of Covid-19 vaccine, the health ministry has said.
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Can a person have one dose with one vaccine and a second dose with another?
No. According to the centre, the entire schedule of vaccination is completed by only one type of vaccine as different coronavirus vaccines are not interchangeable.
How do we register for Covid-19 vaccination?
As per reports, the COVID-19 Vaccine Intelligence Network (Co-WIN) system will be used to track the enlisted beneficiaries for vaccination and COVID-19 vaccines on a real-time basis.
Can it be done on spot?
No, only pre-registered beneficiaries will be vaccinated per the prioritization – there will be no provision for on-the-spot registrations.
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The registered mobile number will be used to inform the eligible beneficiaries.
What are the required documents for registration?
One of the following document will be required for registration – Driving licence, PAN card, bank passbook, passport, pension document, MGNERGA job card, voter ID, official IDs of MPs/ MLAs/ MLCs, government-issued service ID card and health insurance smartcard issued by Ministry of Labour.
Photo ID is a must for both registration and verification of beneficiary at the session site to ensure that the intended person is vaccinated, the guidelines state.
With PTI inputs
