Pfizer wants approval for emergency use in India after UK

 Pfizer Inc submitted application to DCGI seeking emergency use authorisation on Dec 4; also seeks permission to import vaccine for sale and distribution in India.

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World News/Covid-19 Vaccine Tracker: Pfizer has become the primary company to seek emergency use approval of its vaccine candidate in India after getting clearance within the UK and Bahrain. Pfizer Inc and BioNTech SE vaccine candidate, BNT162b2, has shown 95 per cent efficacy against coronavirus during a preliminary clinical trial data analysis. It's sought approval from the Drugs Controller General of India for emergency use authorisation. the development is significant since Prime Minister Narendra Modi, during an all-party meet on Friday, cited experts to mention that India could have the first coronavirus vaccine in weeks and that eight vaccines are going to be manufactured in India.

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Pfizer, in its application submitted on December 4, has sought permission to import the vaccine for sale and distribution in India. It also sought the waiver of clinical trials on Indian population as per the special provisions under the New Drugs and Clinical Trials Rules, 2019, to urge instant approval for emergency use, a PTI report said.

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"Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorisation (EUA) for its COVID-19 vaccine in India," an official source told the press agency .

AIIMS Delhi Director Dr Randeep Guleria had earlier said that India was in talks with Pfizer-BioNTech regarding its COVID-19 vaccine candidate. He said no such communication had been initiated with Moderna for its experimental COVID-19 vaccine.

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The UK became the first country within the world to approve Pfizer and BioNTech coronavirus candidate on December 2 after the Medicines and Healthcare Products regulatory agency (MHRA) found the jab safe. The country has already ordered 40 million doses of the Pfizer vaccine to vaccinate its 20 million population. After the united kingdom , Bahrain has also approved the vaccine for 'emergency use'. Bahrain's drug regulatory body said the approval was granted after a radical analysis and review of all available data.

The approval for Pfizer's vaccine candidate came in just 10 months since it started developing it, which is that the fastest within the history of vaccines. Other countries just like the US and the European Union also are vetting the Pfizer and BioNTech candidate and the one developed by Moderna Inc. 

Notably, Pfizer, BioNTech, Moderna, and Russia's Sputnik V are the sole vaccines that have claimed over 90 per cent efficacy of their respective candidates so far. While Russia had already rolled out Sputnik V for the masses in August, the recently announced data results on the efficacy of Moderna, Pfizer, and BioNTech's vaccines have also raised high hopes. Besides, Swedish drugmaker AstraZeneca and therefore the University of Oxford's vaccine candidate, being developed along side India's Serum Institute, has also achieved 70 per cent efficacy during the preliminary analysis of its Covid-19 trial participants.

India’s Serum says produced 40 million doses of AstraZeneca COVID-19 vaccine

 India’s Serum Institute has said it's made 40 million doses of AstraZeneca's potential Covid-19 vaccine. The ICMR will pursue "early availability" of the shot in India, it added.

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Latest News/Covid-19 Vaccine/Corona Virus Vaccine Update: Serum Institute of India, the world's largest vaccine producer, has said it's made 40 million doses of AstraZeneca's potential Covid-19 vaccine, and can soon begin making Novavax's rival shot, as they both seek regulatory approval.

Serum on Thursday said it had enrolled 1,600 participants in India for late-stage trials of AstraZeneca's candidate, and also plans to seek regulatory approval to run late-stage trials for the Novavax vaccine.

The AstraZeneca vaccine, co-developed by Oxford University , is that the most advanced in human testing in India, Serum said, adding that the company and therefore the Indian Council of Medical Research (ICMR) will pursue "early availability" of the shot in India.

Representatives for both Serum and therefore the ICMR declined to comment on whether the 40 million doses of the AstraZeneca vaccine were meant for supply only in India. 

The ICMR, a federal government body, had funded the clinical trial site fees for the AstraZeneca vaccine, Serum said. The company and therefore the ICMR are currently conducting mid-stage clinical trials of the shot at 15 centres across India.

The news came as coronavirus infections in India, the world's second-worst hit country, reached 8.68 million on Thursday and therefore the death toll increased to over 128,000.

India also has at least two home-grown Covid-19 vaccine candidates in development, while local drugmaker Dr Reddy's Labs is carrying out a trial within the country for Russia's vaccine candidate.

Earlier in the week , Pfizer and its partner BioNTech said their vaccine candidate had proven over 90% effective based on initial trial results. Pfizer said it had been committed to advancing its engagement with India's government to supply its potential vaccine within the country.

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Unlock 5.0 : Re-opening guidelines of India out,cinemas to reopen on October 15

October are going to be crucial due to Durga Puja and therefore the first phase of Bihar Assembly Election 2020. The Centre’s focus would be more on reopening adhering to social-distancing norms

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India News: The ministry of home affairs has announced a detailed guideline for Unlock 5.0, or for reopening to be effective from October 1, shortly. Despite a steep rise in the number of Covid-19 cases in the country, the home ministry has made it clear that there would be more relaxations and fewer restrictions, though local administrations in some states are heavily counting on voluntary curfew, local lockdowns etc.

Here are the guidelines:

* Cinemas/ theatres/ multiplexes are going to be permitted to open with upto 50% of their seating capacity, for which, SOP are going to be issued by Ministry of information & Broadcasting.

* Business to Business (B2B) Exhibitions are going to be permitted to open, for which, SOP are going to be issued by the Department of Commerce.

* Swimming pools being used for training of sportspersons are going to be permitted to open, for which the standard operating procedure (SOP) are going to be issued by Ministry of Youth Affairs & Sports (MoYA&S).

* Entertainment parks and similar places are going to be permitted to open, for which the SOP are going to be issued by Ministry of Health & Family Welfare (MoHFW).

Opening of schools, colleges, education institutions and coaching institutions

* For re-opening of schools and coaching institutions, State/ UT Governments have been given the flexibility to take a decision after October 15, 2020, in a graded manner. the decision shall be taken in consultation with the respective school/ institution management, based on their assessment of the situation, and subject to the subsequent conditions:

* Online/ distance learning shall still be the preferred mode of teaching and shall be encouraged.

* Where schools are conducting online classes, and some students prefer to attend online classes instead of physically attend school, they'll be permitted to do so.

* Students may attend schools/ institutions only with the written consent of parents.

* Attendance must not be enforced, and must depend entirely on parental consent.

* States /UTs will prepare their own SOP regarding health and safety precautions for reopening of schools/ institutions based on the SOP to be issued by Department of school Education and Literacy (DoSEL), Ministry of Education, Government of India, keeping local requirements in view.

* Schools, which are allowed to open, will need to mandatorily follow the SOP to be issued by Education Departments of States/ UTs.

* Department of higher Education (DHE), Ministry of Education may take a decision on the timing of the opening of Colleges/ higher education Institutions, in consultation with Ministry of Home Affairs (MHA), based on the assessment of the situation. Online/ distance learning shall still be the preferred mode of teaching and shall be encouraged.

Unlock 5.0 is probably going to become the most crucial as a number of religious festivals are scheduled in October, including Durga Puja. the first phase of Bihar Assembly Election 2020 is scheduled on October 28. The Centre is probably going to revise its order concerning the maximum number of individuals who can gather at an area .

The phase-wise unlocking began in June with only some essential activities beginning outside the containment zones. Over the last four months, offices, public transport including metro, domestic flights, religious places, restaurants, hotels, gyms, schools and colleges are allowed to resume activities, though the state governments concerned are the ultimate authorities.

Tamil Nadu and Maharashtra have extended lockdown till October 31.

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