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Coronavirus News Updates: COVID-19 expert panel recommends emergency use authorisation for Bharat Biotech's COVAXIN

Coronavirus News LIVE Updates: Covaxin has been indigenously developed by Bharat Biotech in collaboration with the ICMR

FP Staff|Jan 02, 2021, 22:45:49 IST

Coronavirus News LATEST Updates: An expert panel of India's central drug authority on Saturday recommended granting permission for restricted emergency use of the indigenously developed COVID-19 vaccine Covaxin with certain conditions, a day after giving similar direction for the Oxford COVID-19 vaccine, reports said.Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday's review meeting, a source said.The School and Mass Education department of the Odisha government on Saturday said that lectures for Class 10 and 12 will reopen from 8 January. Schools will be strictly following the COVID-19 protocol SOP.Nearly 75 health workers underwent dummy vaccination at Bhopal in Madhya Pradesh on Saturday as part of the first dry run of COVID-19 vaccine programme in the state. The mock vaccination programme was conducted at three health centres in the state capital — Gandhi Nagar community health centre (CHC), Govindpura CHC and L N Hospital.As part of the process, SMSs were sent to the health workers, in which they were asked to come to these health facilities. "After the dummy vaccination shots were given to them, these health workers were asked to wait for 30 minutes at the centres so that they are kept under observation, like in the actual vaccination plan," PTI quoted an official as saying.Four people who recently returned to Gujarat from the United Kingdom (UK) have tested positive for the new strain of coronavirus, a top state health department official said on Saturday. Results of the 15 samples that had tested positive for coronavirus on arrival in Ahmedabad from the UK are currently pending with the National Institute of Virology (NIV) in Pune."All the passengers who had reached Ahmedabad from the UK were screened, and the samples of those who had tested positive for coronavirus were sent to the NIV. We have received intimation that the UK strain of coronavirus has been detected in four such cases," Principal Secretary (Health), Jayanti Ravi told reporters.Union aviation minister Hardeep Singh Puri said on Saturday that flights from India to UK will resume from 6 January, while services from that country to India will resume from 8 January onwards. "Resumption of flights between India & UK: India to UK from 6 Jan 2021. UK to India from 8 Jan 2021. 30 flights will operate every week. 15 each by Indian & UK carriers," Puri said on Twitter."This schedule is valid till 23 Jan 2021. Further frequency will be determined after review," he added. Earlier, Puri had announced on Friday that only 30 flights per week will operate between India and the UK when services resume from 8 January and that this arrangement will continue till 23 January.The government will give priority to 1 crore healthcare workers and 2 crore frontline workers when India begins the rollout of the COVID-19 vaccine.Each passenger arriving from the UK would have to bring his or her COVID-19 negative report from a test done 72 hours prior to the journey, the health ministry said.While reviewing preparations for the exercise, the health minister also appealed to everyone to not believe in rumours and emphasised that the COVID-19 vaccine was safe.The total confirmed coronavirus cases in India have risen to 1,03,05,788 on Saturday after 19,079 fresh infections were registered in a day, said the Union health ministry.With the death of 224 more COVID-19 patients in the past 24 hours, the toll due to the novel coronavirus in India reached 1,49,218, the Union health ministry said on Saturday.The COVID-19 dry run is being conducted in 116 districts across 259 sites. Some 96,000 vaccinators have been trained for this, the health ministry had said.An expert panel on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended grant of permission for restricted emergency use of Oxford COVID-19 vaccine Covishield in India, subject to certain regulatory provisions, official sources said.As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from SII and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter.While granting emergency use approval for the Oxford COVID-19 vaccine, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks.Further, the SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest. Also, the Pune-based firm should submit the safety data including the data on adverse event following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country.The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.While considering Bharat Biotech's application, the SEC noted that the ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated."After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval," an official source said.Pfizer's application was not deliberated, sources said.The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday had approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use."In terms of safety, Covishield was well tolerated with respect to solicited adverse events. Majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield is safe 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," the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated.SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on 6 December, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on 7 December.Pfizer had applied for regulatory approval for its vaccine on 4 December.

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