India may approve AstraZeneca vaccine by next week

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Covid-19 Vaccine Tracker/India News:  India is probably going to approve Oxford/AstraZeneca’s coronavirus vaccine for emergency use by next week after its local manufacturer submitted additional data sought by authorities, two sources with knowledge of the matter told Reuters on Tuesday.

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This could be the first country to give the regulatory green light for British drugmaker’s vaccine because the British medicine regulator continues to look at data from the trials.

India, the world’s biggest vaccine-making country, wants to start out inoculating its citizens next month and is additionally considering emergency use authorisation applications for vaccines made by Pfizer Inc and native company Bharat Biotech.

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Getting vaccines to the world’s second-most populous country with one among the very best infection rates also will be an enormous step within the battle against the pandemic.

The AstraZeneca-Oxford shot is taken into account vital for lower-income countries and people in hot climates because it's cheaper, easier to move and may be stored for long periods at normal fridge temperatures.

India's Central Drugs Standard Control Organization (CDSCO) first reviewed the three applications on Dec. 9 here and sought more information from all the businesses , including from Serum Institute of India (SII), which is making the AstraZeneca shots.

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SII, the world's biggest vaccine manufacturer, has now provided all the info , the 2 sources said. The authorities were still expecting more details from Pfizer, a government health adviser told here a news briefing on Tuesday, while one among the sources said additional information was expected from Bharat Biotech.

Both sources said Indian health officials were in direct contact with their British counterparts over the AstraZeneca shot which there have been “strong indications” an approval would come by next week.

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The expected approval comes after data from AstraZeneca’s late-stage trials within the UK and Brazil released earlier this month showed the vaccine had efficacy of 62% for trial participants given two full doses, but 90% for a smaller sub-group given a half, then a full dose.

The Indian regulator is merely considering the 2 full-dose regimen of the shot despite it showing a lower success rate, the sources said.

“Serum is ready,” said one of the sources. “Initially, we may get around 50 million to 60 million doses.”

The sources declined to be named as deliberations were ongoing and therefore the timeline could change.

CDSCO chief V.G. Somani didn't immediately respond to a request for comment. Bharat Biotech and Pfizer declined to comment, while SII didn't immediately answer an email seeking comment.

India has not yet signed a vaccine supply affect any company, but SII has already stockpiled quite 50 million doses of the AstraZeneca shot and plans to form a complete of 400 million doses by July.

India says may not need to vaccinate entire population to control COVID-19

 India News/Covid-19 Vaccine Tracker: India may not need to vaccinate all of its 1.3 billion people if it manages to inoculate a critical mass and break the transmission of the coronavirus, senior government officials said on Tuesday.

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Indian Prime Minister Narendra Modi, who toured the facilities of three vaccine makers over the weekend, has emphasized the importance of a vaccine to rein in COVID-19.

India says may not need to vaccinate entire population to control COVID-19

In October, he said that the government was preparing to reach every single citizen as soon as a vaccine was ready.

World Health Organization experts have pointed to a 65%-70% vaccine coverage rate as sufficient to reach population immunity.

“The government has never spoken about vaccinating the entire country,” Rajesh Bhushan, the top bureaucrat in India’s federal health ministry, told a news conference on Tuesday without reference to Modi.

India says may not need to vaccinate entire population to control COVID-19

India currently has the world’s second-highest number of coronavirus infections, behind only the United States, with 9.46 million cases and 137,621 deaths.

India recorded 31,118 new coronavirus cases on Tuesday, the lowest daily tally since Nov. 17, data from the health ministry showed.

“...If we are able to vaccinate a critical mass of people, and break that virus transmission, then we may not have to vaccinate the entire population,” Balram Bhargava, Director General of the state-run Indian Council Of Medical Research, said at the press briefing.

India’s plan to roll out a COVID-19 shot in the first few months of 2021 wouldn’t be impacted by an alleged adverse reaction during AstraZeneca’s COVID-19 vaccine trial, Bhushan said.

India says may not need to vaccinate entire population to control COVID-19

A 40-year-old Indian man said in a complaint over the weekend that he had suffered serious “neurological and psychological” symptoms after receiving the vaccine in a trial being run by the British drugmaker’s partner, Serum Institute of India.

The incident is currently under investigation.

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Pfizer wants emergency use of its COVID-19 vaccine in US

 The action comes days after Pfizer Inc and its German partner BioNTech announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease during a large, ongoing study.

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World News/Covid-19 Vaccine: Pfizer said Friday it's asking US regulators to permit emergency use of its COVID-19 vaccine, starting the clock on a process that might bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter. The action comes days after Pfizer Inc and its German partner BioNTech announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the ultimate testing is fully complete.

In addition to Friday's FDA submission, they have already started "rolling" applications in Europe and therefore the UK and intend to submit similar information soon.

With the coronavirus surging round the US and therefore the world, the pressure is on for regulators to make a speedy decision.

"Help is on the way," Dr Anthony Fauci, the top US infectious disease expert said on the eve of Pfizer's announcement, adding that it's too early to abandon masks and other protective measures. "We need to actually double down on the public health measures as we're waiting for that help to come."

Friday's filing triggers a sequence of events because the FDA and its independent advisers debate if the shots are ready. If so, still another government group will need to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.

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How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed.

About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of medicine this week. Recipients will need two doses, three weeks apart.

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When covid vaccines will be ready? Govt reviews progress of trials

 

Prime Minister Narendra Modi in his Independence Day speech on Saturday said India has prepared a roadmap to make sure that a COVID-19 vaccine reaches everyone within the shortest possible time

The Indian government on Monday reviewed the progress of the covid vaccines undergoing clinical trials within the country. The domestic pharma giants presented the present status of varied candidate vaccines for COVID-19 to the central government. The National Expert Group on Covid-19 Vaccine Administration on Monday met leading domestic vaccine manufacturers: Serum Institute of India, Pune; Bharat Biotech, Hyderabad; Zydus Cadila, Ahmedabad; Gennova Biopharmaceuticals, Pune; and Biological E, Hyderabad.

The meeting was mutually beneficial and productive, the health ministry said.

"It provided the National Expert Group with inputs about the present stage of various candidate vaccines being developed by the indigenous manufacturers as well as their expectations from the Union government."

Three Covid vaccine candidates in India are in several phases of clinical study.

The first is that the inactivated virus vaccine which is that the Bharat Biotech Vaccine being developed together with Indian Council of Medical Research (ICMR).

Similarly, the second is that the DNA vaccine of pharma giant Zydus Cadila.

The third, may be a recombinant Oxford University vaccine manufactured by Serum Institute of India (SII) which got approval from DCGI to conduct phase 2, 3 clinical study within the nation.

The central government has constituted a committee under the chairmanship of Dr VK Paul, member (health) at Niti Aayog, on covid vaccine administration.

The terms of reference of this expert committee are to streamline suitable vaccine selection, how procurement of vaccine are going to be done, how vaccine would be delivered, prioritising groups to whom vaccine has got to be administered.

Prime Minister Narendra Modi in his Independence Day speech on Saturday said India has prepared a roadmap to make sure that a COVID-19 vaccine reaches everyone within the shortest possible time.

He said three vaccine candidates are in several stages of trials within the country.

The prime minister said whenever there's talk about COVID-19, the question that involves everyone's mind is - when will a vaccine be ready.

"I want to tell people, the talent of our scientists is like that of 'rishi munis' and they are working very hard in laboratories. Three vaccines are in various stages of testing. When scientists will give us the green signal, it will be produced on a mass scale and all preparations have been made for it," PM Modi said in address.

Keyword : Coronavirus Vaccine Tracker

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