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Serum Institute likely to supply Covid vaccine at Rs 250 a dose to the government: Media reports

BENGALURU: Serum Institute of India, the world’s largest vaccine producer by volume, is close to signing a supply contract with the country’s Central government and likely to fix prices at 250 rupees ($3.39) per dose of the vaccine, Business Standard reported on Tuesday, citing people familiar with the matter.

The government is pinning its hopes for mass supply on Serum Institute, which lodged the first formal application for emergency-use approval of AstraZeneca’s shot on Monday.

Chief Executive Officer Adar Poonawalla had earlier said the vaccine would be priced at 1,000 rupees ($13.55) per dose in India’s private market, but governments signing large supply deals would likely buy it at lower prices.

Poonawalla had said Serum will first focus on supplying the vaccine to Indians before distributing it to other countries.

With 9.70 million COVID-19 cases recorded so far, India is second only to the United States and is accelerating its review of vaccines developed by Pfizer Inc and AstraZeneca to authorize for emergency use, a senior official said on Monday.

While the state-run Indian Council of Medical Research and Indian Ministry of Health did not respond to Reuters request for comments, Serum Institute declined to offer one.

Serum Institute of India says will ship AstraZeneca Covid-19 vaccine to Canada in ‘less than a month’

Pune-based Serum Institute of India (SII) is awaiting approval from Canada’s regulatory authority to export Covishield, its vaccine against Covid-19.

“As we await regulatory approvals from Canada, I assure you, SII will fly out Covishield to Canada in less than a month. I’m on it,” Adar Poonawalla, CEO and owner SII tweeted on Monday.

In an official statement to ET, Serum said that they have applied for registration with Health Canada with the help of Toronto-based Verity Pharmaceuticals.

SII has been authorised by Oxford-AstraZeneca to make supplies in certain territories including Canada.

The government has authorised supply of 24 million doses of Covid-19 vaccines to 25 countries on a commercial basis this month.

The Ministry of External Affairs (MEA) would oversee the export of the vaccine on a commercial basis to foreign countries and international organisations.

India has so far supplied 16.7 million doses of the Oxford-AstraZeneca vaccine manufactured by SII to 20 countries.

This includes approximately 6.3 million doses that were supplied free to 13 countries — Bangladesh, Myanmar, Bhutan, Nepal, Afghanistan, Sri Lanka, Bahrain Oman and in the Caribbean. About 10 million more doses were exported on a commercial basis to Brazil, Morocco, South Africa, Algeria and Egypt among others. Commercial supplies in February will include Saudi Arabia, Myanmar, Nepal, Nicaragua, Mauritius, Serbia, UAE and Qatar.

The Trudeau government plans vaccination of all residents by September 2021 but has faltered in its goal. Cases have been on the rise in Toronto, the largest city in Canada. Canada has recorded over 800000 cases so far.

Canada though has advance purchase agreements with all vaccine makers the country has been slow in its vaccine roll out because of supply delay by companies such as Pfizer and Moderna.

Spokesperson for Health Canada said the regulator been reviewing

AstraZeneca

’s vaccine since it was submitted on October 1, 2020, and is expediting the review of all COVID-19 vaccines. This is being done through rolling submissions, where data is being reviewed as it becomes available from the manufacturer.

The approval it said is being done under the interim order pathway for COVID-19-related drugs and vaccines.
“An interim order is one of the fastest mechanisms available to the federal government for putting in place temporary regulations to help make health products available to address large-scale public health emergencies.

This interim order facilitates timely access for Canadians to drugs and vaccines that have demonstrated the ability to diagnose, prevent, treat or cure COVID-19. The interim order introduces temporary regulations to expedite the authorization for importing, selling and advertising COVID-19-related drugs without compromising patient safety.”, said André Gagnon Media Relations Advisor, Health Canada in an email response to ET.

( Originally published on Feb 15, 2021 )

Six-week sprint got Indian-made AstraZeneca vaccine approved in Canada

Problems at AstraZeneca Plc‘s European production site in January kicked off a six-week push to get a version of its COVID-19 vaccine made at an Indian facility approved by Canada’s drug regulator, according to the Canadian pharmaceutical company that filed the application.

Last week, when Health Canada approved AstraZeneca’s COVID-19 vaccine, it also cleared a version of the shot made by the Serum Institute of India (SII). SII filed the application with a Canadian partner, Verity Pharmaceuticals.

Some 500,000 doses made by SII, the world’s largest vaccine producer, are set to arrive in Canada on Wednesday, a surprise boost for Canada’s lagging vaccination drive.

Health Canada’s relatively fast approval was underpinned by SII and Verity’s four years of working to bring a cancer treatment to Canada.

“It’s been a lightning six weeks,” said Verity’s Chief Executive Howard Glase in an interview. “The health regulators have really outdone each other … They’ve really put in 24- hour days.”

After Friday’s approval, Canada said it agreed to buy 2 million vaccine doses from Verity and Serum by mid-May, enough to vaccinate as much as 2.7% of its population. Only about 3.6% of Canadians have received at least one vaccine dose in Canada, according to volunteer-run data project COVID-19 Tracker Canada.

With no local COVID-19 vaccine production, Canada trails many developed nations in inoculations as the world works toward vaccinating enough people to halt the pandemic that has claimed more than 2.5 million lives globally.

The SII shipment comes weeks after Indian Prime Minister Narendra Modi assured Canadian counterpart Justin Trudeau that India would do its best to supply Canada with vaccines, a sign of improving diplomatic relations that soured after Trudeau expressed concern over India’s farmer protests late last year.

ALL-NIGHTER
In January, AstraZeneca warned European customers it would fall short of its first-quarter vaccine supply commitments because of production issues.

It was after this that the British drugmaker called on Serum to make doses for Canada, and AstraZeneca and Canadian government officials approached Verity, Glase said.

Verity had been working with SII on a product called BCG, a tuberculosis vaccine that can also treat some bladder cancers. Canadian patients had endured years of shortages, so Verity applied to import a supply made by SII. That application was approved with conditions in December 2020, regulatory records show.

As part of that process, Verity brought Health Canada inspectors to SII more than a year ago, Glase said. That meant it did not have to visit again to approve the vaccine manufacturing site.

Separately, Britain’s drug regulator inspected SII’s manufacturing operations last month. The UK and Canadian regulators have a mutual recognition agreement that makes their manufacturing site approvals equivalent.

Health Canada and Verity’s staff put in long hours to get the approval done, working through the night to get the document describing the vaccine’s properties and intended uses, known as a product monograph, translated, proofed and approved in the early hours of Friday morning, said Glase. Health Canada confirmed that staff worked through the night.

SII, whose CEO recently publicly assured Canada it would soon receive vaccine supplies, did not immediately respond to a request for comment on when it secured export permit approvals from the government to ship to Canada.

So far, Canada has received about 2.4 million doses of the vaccines from Pfizer Inc/BioNTech SE and Moderna Inc. The government has said shipments should increase sharply in the second quarter.

India AstraZeneca shot delay could be ‘catastrophic’ for Africa: Health official

India’s temporary hold on major exports of

AstraZeneca

‘s COVID-19 shot will undermine Africa‘s vaccination plans, and could have a “catastrophic” impact if extended, the head of the continent’s disease control body said on Thursday.

India decided to delay big exports of the shots made in its territory by the Serum Institute of India (SII) to make sure it could meet local demand, two sources told Reuters last week.

The hold “will definitely impact our ability to continuously vaccinate people,” the director of the Africa Centers for Disease Control and Prevention, John Nkengasong, told a news conference in Addis Ababa.

The African Union had planned to vaccinate 30-35% of the continent’s population by the end of the year he said. “If the vaccines are delayed we are unlikely to meet our target,” he added.

That AU target primarily relies on supplies from the global COVAX vaccine-sharing facility, through which 64 poorer countries including many in Africa are supposed to get doses from the SII. COVAX aims to provide enough shots for African countries to inoculate at least 20% of their populations.

“If the delay continues, I hope it’s a delay and not a ban, that would be catastrophic for meeting our vaccinations schedule,” Nkengasong said.

African countries have reported 4.25 million coronavirus infections and 112,000 related deaths, though experts have said the actual numbers could be higher.

The AU has also been negotiating with manufacturers to help member states secure the additional doses they will need to achieve 60% coverage.

On Monday, Johnson & Johnson announced it would supply the AU with up to 400 million doses of its COVID-19 vaccine. Delivery of those doses is due to begin in the third quarter of this year and will continue through 2022.

Those doses are separate from the GAVI/WHO-backed global COVAX facility.

Nkengasong said on Thursday the AU has “pivoted” towards the J&J shot in part as a result of the delay in the delivery of AstraZeneca shots, and also because it is a single-dose shot.

The J&J doses will begin to arrive in June or July, which will ease any shortage caused by the delay in the AstraZeneca doses, Nkengasong said. The gap until the arrival of the J&J doses is a concern, he added.

AstraZeneca vaccine less effective against S.African strain: study

LONDON: The Oxford/AstraZeneca vaccine fails to prevent mild and moderate cases of the South African coronavirus strain, researchers said Sunday.

The University of Witwatersrand, Johannesburg, which conducted the trial, said in a statement that the vaccine “provides minimal protection against mild-moderate Covid-19 infection” from the variant.

But in a full paper due to be published on Monday, AstraZeneca said that none of the 2,000 participants developed serious symptoms.

That could mean it will still have an effect on severe disease, although there is not yet enough data to make a definitive judgement.

The data, which has not yet undergone peer review, “appear to confirm the theoretical observation that mutations in the virus seen in South Africa will allow ongoing transmission of the virus in vaccinated populations,” it said.

“Protection against moderate-severe disease, hospitalisation or death could not be assessed in this study as the target population were at low risk.”

But the vaccine developers in Britain said informally the results offered some hope that the vaccine could prevent deaths from the variant.

“We may not be reducing the total number of cases but there is still protection against deaths, hospitalisations and severe disease,” said Sarah Gilbert, who led the development of the vaccine with the Oxford Vaccine Group.

It could also be “some time” before they determine its effectiveness for older people in fighting the strain, which is a growing presence in Britain, she told BBC television.

“We might have to put it together from a number of studies,” she said.

Researchers are currently working to update the vaccine, and “have a version with the South African spike sequence in the works” that they would “very much like” to be ready for the autumn, she added.

UK vaccines minister Nadhim Zahawi said the government’s strategy to combat the spread of the strain was to continue with its mass vaccination programme “as rapidly as possible” as well as “hyper-local surge testing” where it is detected.

Britain is in the midst of a massive vaccination drive, which it sees as its way out of one of the worst outbreaks in the world that has seen more than 112,000 fatalities among those testing positive for the virus.

It has so far vaccinated more than 11 million people using either the Pfizer/BioNTech or Oxford/AstraZeneca shots.

The AstraZeneca vaccine has been the source of an ugly row with the European Union, which is angry that the Anglo-Swedish firm was unable to meet the delivery target agreed with Brussels.

France, Germany and Switzerland are also among countries to recommend the vaccine not be used for the elderly due to a lack of data.

One in four people experience mild side effects from Covishield COVID-19 vaccine: Lancet study

One in four people experience mild, short lived systemic side effects after receiving either the COVID-19 preventive by Pfizer or AstraZeneca vaccine — known as Covishield in India — with headache, fatigue and tenderness the most common symptoms, according to a study published in the Lancet Infectious Diseases journal. The researchers from King’s College London in the UK also found that most systemic side effects — meaning side effects excluding where the injection took place — peaked within the first 24 hours following vaccination and usually lasted 1-2 days.

The analysis of data from the ZOE COVID Symptom Study app found much fewer side effects in the general population with both the Pfizer and

AstraZeneca

vaccines than reported in trials.

The study also reports a significant decrease of infection rates from 12 to 21 days after the first dose of the Pfizer (58 per cent reduction) and AstraZeneca (39 per cent reduction) vaccines compared to a control group.

The drop in infection at least 21 days after the first dose for Pfizer is 69 per cent and for AstraZeneca 60 per cent, according to the study.

Systemic effects included headache, fatigue, chills and shiver, diarrhoea, fever, arthralgia, myalgia, and nausea.

Local side effects — meaning side effects where the injection took place in the arm — included pain at the site of injection, swelling, tenderness, redness, itch, warmth and swollen armpit glands.

“The data should reassure many people that in the real world, after effects of the vaccine are usually mild and short-lived, especially in the over 50’s who are most at risk of the infection,” said Professor Tim Spector, lead scientist on the ZOE COVID Symptom Study app and Professor at King’s College London.

The data comes from 627,383 users of the ZOE COVID Symptom Study app who self-reported systemic and local effects within eight days of receiving one or two doses of the Pfizer vaccine or one dose of the AstraZeneca vaccine between December 8 and March 10.

The study also found that side effects were more common among people under 55 years of age and among women.

Participants who had a confirmed case of prior COVID-19 were three times more likely to have side effects that affect the whole body after receiving doses of the Pfizer vaccine than those without known infection.

Those with a confirmed case of prior COVID-19 number were almost twice more likely to have side effects that affect the whole body after the first dose of the AstraZeneca vaccine.

People with prior known COVID-19 infection were also more likely to experience local side effects, the researchers said.

The researchers noted that in Phase III clinical trials of the Pfizer vaccine, the most common side effects were pain at the injection site (71-83 per cent), fatigue (34-47 per cent) and headache (25-42 per cent).

However, the real-world analysis found less than 30 per cent of users complained of injection site pain and less than 10 per cent of fatigue and headache after the first dose, they said.

Similarly, in Phase III trials for the AstraZeneca vaccine, systemic side effects were found in 88 per cent of younger participants (18-55 years) after the first dose but the study found a significantly lower rate of 46.2 per cent after the first dose.

“Our results support the after effects safety of both vaccines with fewer side effects in the general population than reported in the Pfizer and AstraZeneca experimental trials and should help allay safety concerns of people willing to get vaccinated,” Spector added.

Oxford study indicates AstraZeneca effective against Brazil variant, source says

Preliminary data from a study conducted at the University of Oxford indicates that the COVID-19 vaccine developed by AstraZeneca PLC is effective against the P1, or Brazilian, variant, a source with knowledge of the study told Reuters on Friday.

The data indicates that the vaccine will not need to be modified in order to protect against the variant, which is believed to have originated in the Amazonian city of Manaus, said the source, who requested anonymity as the results have not yet been made public.

The source did not provide the exact efficacy of the vaccine against the variant. They said the full results of the study should be released soon, possibly in March.

Early results indicated the AstraZeneca vaccine was less effective against the South African variant, which is similar to P1. South Africa subsequently paused the use of the vaccine in the country.

The information comes as a small-sample study suggested the COVID-19 vaccine developed by China’s Sinovac may not work effectively against the Brazilian variant.

Responding to a request for comment, Fiocruz, which sent the samples that formed the basis of the study, told Reuters it did not have any information on the study, as it was being led by AstraZeneca and the University of Oxford.

Representatives for AstraZeneca and the University of Oxford did not immediately respond to requests for comment.

Brazil is currently confronting a brutal and long-lasting second wave of the coronavirus, hitting a daily record of 1,910 deaths on Wednesday.

The P1 variant is among the factors that epidemiologists believe is contributing to a rise in cases and deaths, and there has been concern in the scientific community about the variant’s resistance to vaccines.

Supply of COVID-19 vaccines may meet, even outstrip demand in India by Q3: AstraZeneca chief

New Delhi: The supply of vaccines for COVID-19 may meet up or even outstrip the demand in India by the third quarter of this year, given the number of vaccines being developed in the country and its capacity,

AstraZeneca

Pharma India Country President and MD Gagan Singh said on Friday.

The pandemic has shown how resilient healthcare is, and how important pillar biopharmaceutical industry is as part of the healthcare ecosystem. Therefore, support for academic research, a vibrant healthcare system that embraces innovation is going to be very critical, he added.

“I am very hopeful given our enterprise, given the number of vaccines India is developing and the capacity available, hopefully in my own personal read, by quarter 3, we may actually have a situation where supply will meet up the demand or even outstrip,” Singh said.

We must compliment our government also in its efforts towards getting the country in putting the plan for vaccination together and now in the rollout, he added.

For any vaccine to be meaningful in the current pandemic, it has to be made available broadly, equitably and timely. That is why AstraZeneca globally went around having supply agreements in place towards 3 billion doses covering 160 countries and more importantly at no profit during the pandemic, Singh said.

AstraZeneca’s partnership in India with Serum Institute is a sub-licensing agreement of its molecule and they (Serum Institute) bring in close to 1 billion doses which are extremely important not only for India but also for low and middle income countries, he added.

Talking about the safety and efficacy of the company’s vaccine, Singh said that in the month of December, Lancet enabled us to share a full disclosure of the Oxford programme interim analysis.

The results clearly showed that the vaccine is effective against COVID-19, and in particular with no severe infection and no hospitalisations in the vaccine group, he said, adding that this data was for over 11,000 plus volunteers across multiple countries.

He was speaking in a session on healthcare at a virtual event organised by TiE Delhi-NCR.

At the session, Apollo Hospitals Joint MD Sangita Reddy said that the vaccine is an incredible validation of the capability of India’s manufacturing sector, it is a huge referendum on the global cooperation of sciences and manufacturers to bring something to humanity.

Sweden plans to donate 1 million doses of AstraZeneca vaccines to India

Sweden plans to donate 1 million doses of AstraZeneca vaccines to India via the U.N.-backed COVAX, an initiative devised to give countries access to coronavirus vaccines regardless of their wealth.

The Scandinavian country’s International Development Cooperation Minister Per Olsson Fridh announced it Monday on Swedish broadcaster SVT, adding “we see how the pandemic is raging around the world. People are dying, poverty is spreading, and children are still not back at school.”

“We need to do everything we can to face this pandemic and fight it across the world.”

The donation will have no impact on the rollout in Sweden which has decided to only administer the

AstraZeneca

shots to people 65 and over.

The country’s vaccine coordinator Richard Bergstrom said there are enough spare vaccines that Swedes can give away, adding “This is just a million … we actually have another 4 or 5 million more of Astra Zeneca’s vaccine that we can share later.”

AstraZeneca says US trial data shows vaccine 79% effective

AstraZeneca

says advanced trial data from a U.S. study on its COVID vaccine shows it is 79% effective.

The U.S. study comprised 30,000 volunteers, 20,000 of whom were given the vaccine while the rest got dummy shots. The results were announed Monday.

The early findings from the U.S. study are just one set of information AstraZeneca must submit to the Food and Drug Administration. An FDA advisory committee will publicly debate the evidence behind the shots before the agency decides whether to allow emergency use of the vaccine.

While the AstraZeneca vaccine has been authorized in more than 50 countries worldwide, scientists have been awaiting results of the U.S. study in hopes it will clear up some of the confusion about just how well the shots really work.

( Originally published on Mar 22, 2021 )

In Video: Covid-19: AstraZeneca’s vaccine found to be 79% effective in US study; Fauci says ‘good news’