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.

UK approved Pfizer-BioNtech's COVID-19 vaccine, Vaccination starting from next week

 A vaccine is seen as the best chance for the planet to get back to some semblance of normality amid a worldwide pandemic which has killed nearly 1.5 million people and upended the worldwide economy.

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World News/Covid-19 Vaccine Tracker: Britain approved Pfizer's COVID-19 vaccine on Wednesday, jumping before the united states and Europe to become the West's first country to formally endorse a jab it said should reach the foremost vulnerable people early next week.

Prime Minister Boris Johnson touted the medicine authority's approval as a worldwide win and a ray of hope amid the gloom of the novel coronavirus which has killed nearly 1.5 million people globally, hammered the planet economy and upended normal life.

Britain's Medicines and Healthcare products regulatory agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, in record time - just 23 days since Pfizer published the first data from its final stage clinical trial.

"It's fantastic," Johnson said. "The vaccine will begin to be made available across the uk from next week. it's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again."

The world's big powers are racing for a vaccine for months in an attempt to be first to begin the long road to recovery.

The approval of a vaccine to be used almost exactly a year since the novel coronavirus emerged in Wuhan, China, may be a triumph for science, Pfizer boss Albert Bourla and his German biotechnology partner BioNTech.

China has already given emergency approval for 3 experimental vaccines and has inoculated around 1 million people since July. Russia has been vaccinating frontline workers after approving its Sputnik V shot in August before it had completed late-stage testing on safety and efficacy.

But the european Union's drug regulator said on Wednesday that its longer approval process for COVID-19 vaccines was safer, because it was supported more evidence and checks that the procedure chosen by Britain.

British leaders said that, while they would love to get a jab themselves, priority had to be given to those most in need - the elderly, those in care homes and health workers.

'HISTORIC MOMENT'

The U.S. drugmaker said Britain's emergency use authorization marks a historic moment within the fight against COVID-19. Pfizer announced its vaccine breakthrough on Nov. 9 with stage III clinical trial results.

"This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the uk," said CEO Bourla.

"As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world."

Britain's medicines regulator approved the vaccine in record time - partly by doing a "rolling" concurrent analysis of knowledge and therefore the manufacturing process while Pfizer raced to conclude trials.

"With 450 people dying of COVID-19 infection every day in the UK, the benefits of rapid vaccine approval outweigh the potential risks," said Andrew Hill, senior visiting research fellow within the Department of Pharmacology at the University of Liverpool.

"However, we need new independent clinical trials to monitor long-term safety and efficacy."

The U.S. Food and Drug Administration (FDA) is about to satisfy on Dec. 10 to debate whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and therefore the European Medicines Agency said it could give emergency approval for the shot by Dec. 29.

"The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development programme," said Ugur Sahin, chief executive and co-founder of BioNTech.

U.S. media reported on Tuesday that the White House had summoned FDA head Stephen Hahn to discuss why the U.S. agency hadn't moved faster to authorise Pfizer's vaccine.

FIRST IN LINE?

Britain said it might start vaccinating ordinary people early next week after it gets 800,000 doses from Pfizer's manufacturing centre in Belgium. The speed of the rollout depends on how fast Pfizer can manufacture and deliver the vaccine.

Johnson said last month that Britain had ordered 40 million doses of the Pfizer vaccine - enough for slightly below a third of the population as two shots of the jab are needed per person to gain immunity.

Health Secretary Matt Hancock said hospitals were ready to receive the shots and vaccination centres would be set up across the country but he admitted distribution would be a challenge as long as the vaccine must be shipped and stored at -70C (-94F), the sort of temperature typical of an Antarctic winter.

Pfizer has said the shots can be kept in thermal shipping boxes for up to 30 days, from up to fifteen days previously guided. Afterwards, the vaccine are often kept at fridge temperatures for up to five days.

Other frontrunners in the vaccine race include U.S. biotech firm Moderna, which has said its shot is 94% successful in late-stage clinical trials. Moderna and Pfizer have developed their shots using new messenger RNA (mRNA) technology.

AstraZeneca said last month its COVID-19 shot, which is based on traditional vaccine technology, was 70% effective in pivotal trials and could be up to 90% effective.

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