India has 2 vaccines, Covishield of the AstraZeneca-Oxford University, and Covaxin, manufactured by Bharat Biotech of Hyderabad with ICMR, on the verge of being okayed for use in emergency conditions.

Both vaccines now need the final go-ahead from the Drugs Controller General of India (DCGI) before being put out after a committee of experts recommended it.

Though there are some misgivings on its efficacy data, Covaxin has completed two of the three phases of clinical trials. A report said some 10 million Covaxin doses are ready.

The country seems to be gearing up for the approval. Uttar Pradesh CM Yogi Adityanath said vaccine delivery could be less than 15 days away. On Saturday, all states and union territories conducted a dry run to figure out the challenges in logistics and ensure smooth vaccination once the vaccine is rolled out in the country. Co-WIN application which has been developed specifically for Covid-19 vaccine drive will also be tested during the dry run. This was the second dry run. Earlier on December 28, a dry run was conducted in four states – Assam, Andhra Pradesh, Punjab and Gujarat.

Under the exercise, 25 health workers got dummy vaccines at each centre. The dry run was conducted in 116 districts across 259 sites. The exercise is meant at figuring out the possible loopholes ahead of the actual vaccination drive. According to the health ministry, an important focus during the dry run will be management of any possible adverse events following immunization. Health minister Harsh Vardhan said the government has done extensive preparation for the dry run, just like elections. He has asked officials in all states to ensure that the checklist and Standard Operating Protocol are followed during the dry run.

Earlier on Friday, the Covishield vaccine being manufactured by Serum Institute of India in collaboration with Oxford University and drugmaker AstraZeneca was recommended by an expert panel to DCGI for emergency use authorisation. There are conditions along with the recommendation. Every recipient will be given a factsheet about the vaccine prior to vaccination. The company may also be asked to report side-effects every 15 days. SEC has recommended EUA for 2 full doses of Covishield to be given with a gap of 4-6 weeks. The final approval for the vaccine by DCGI is likely to take place in a day or two. 

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India might be getting its first Covid-19 vaccine soon as Central Drugs Standard Control Organisation’s Subject Expert Committee (SEC) will be taking a call on emergency use authorisation of Oxford University-Astrazeneca Covid-19 vaccine Covishield being developed by Serum Institute of India (SII) later in the day today.

Earlier, the vaccine was approved by the UK government following recommendation by the Medicines and Healthcare Regulatory Agency (MHRA). Expressing his delight at the development AstraZeneca CEO Pascal Soriot said it was significant in fight against Covid-19. Last week, Serum Institute of India had submitted additional data on the safety and efficacy of the vaccine following Drug Controller General of India’s demand early this month.

The approval to Covishield was granted in the UK following rigorous clinical trials and a thorough analysis of the data. MHRA has said the vaccine has been able to adhere to the standards set up by it for safety, quality and effectiveness.

UK has already begun vaccination drive in the country with Pfizer vaccine. Over 6 lakh people in the country have been vaccinated in the country since emergency use approval was granted to the Pfizer vaccine.

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Although Pfizer has also applied for emergency use authorization in India, big questions remain about the price, storage facility and transport feasibility of the vaccine. Covishield seems to be better alternative for India as it will be affordable and can be stored at normal fridge temperature. There are also concerns regarding the safety of Pfizer vaccine as many people who have been administered with it have reported allergic reactions. An official of US Food and Drug Administration (FDA) has said that the reaction might be a result of  polyethylene glycol, which has been used in the manufacturing of the Covid-19 vaccine by the drugmaker.  

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As India awaits Covid-19 vaccine, CEO of Serum Institute of India, Adar Poonawalla has said the vaccination drive in the country might begin from January 2021 as Oxford-Astrazeneca vaccine being produced by his institute might get emergency use approval by the end of December. He said everyone in India is expected to get vaccinated by October 2020 following which life can return to normal.

While speaking at the The Economic Times Global Business Summit, Poonawalla said that the confidence and sentiments will be coming back once 20% population of India is vaccinated. He said he was hopeful that the emergency licence for the vaccine will soon be granted kicking off the immunisation process in the country.

A days ago, an expert committee of the Central Drugs Standard Control Organisation (CDSCO) has asked Serum Institute and Bharat biotech to submit more data about safety and efficacy of their vaccine candidates.

Earlier, the US Food and Drug Administration on Friday granted emergency use authorisation to Pfizer-BioNTech Covid-19 vaccine. President Donald Trump shared the news on social media with a video hailing it as medical miracle. He added that process of vaccination would begin within 24 hours. US is the worst affected country due to the pandemic with 292,000 confirmed deaths.

The FDA has said that vaccine can be administered to people aged 16 or older. the country is likely to give priority to healthcare workers and elderly during the vaccination drive.

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An expert committee formed by US drug and administration had recommended the Pfizer Covid vaccine for emergency use approval. The committee was asked to vote in favour if they believed that the benefits of the vaccine outweigh its risk for individuals aged 16 and above. 17 members of the committee voted in favour of emergency use approval of the vaccine, while four members voted against it. There was one abstention as well.

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