Astrazeneca | Business Upturn

Aurobindo Pharma secures USFDA approval for diabetes drug with estimated market size of $514 million

Business Desk — Tue, 07 Apr 2026 12:48:27 +0000

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets in various strengths. This approval allows the company to produce tablets that are bioequivalent and therapeutically equivalent to the reference drug Xigduo XR, developed by AstraZeneca AB.

The approved tablets, which will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma, are set to be launched immediately. The product targets a significant market, with an estimated size of $514 million for the twelve months ending February 2026, according to IQVIA MAT.

Aurobindo Pharma has now secured a total of 579 Abbreviated New Drug Application (ANDA) approvals from the USFDA, comprising 554 final approvals and 25 tentative approvals as of 31 March 2026. The company is one of the first ANDA applicants to submit a substantially complete application with a paragraph IV certification for the Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, making it eligible for 180 days of shared generic drug exclusivity.

The tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India, with a presence in over 150 countries. The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals and active pharmaceutical ingredients. It operates more than 30 manufacturing and packaging facilities approved by leading regulatory agencies worldwide.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

Aurobindo Pharma receives USFDA approval for Dapagliflozin tablets with market size of $10.2 billion

Kinjal — Tue, 07 Apr 2026 12:44:26 +0000

Aurobindo Pharma has announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets, 5 mg and 10 mg. These tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Farxiga Tablets, 5 mg and 10 mg, produced by AstraZeneca AB.

The Dapagliflozin Tablets will be produced at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma. The company plans to launch the product immediately. According to IQVIA MAT, the approved product has an estimated market size of US$ 10.2 billion for the twelve months ending February 2026.

Aurobindo Pharma has a robust portfolio with a total of 579 ANDA approvals from the USFDA as of 31 March 2026, comprising 554 final approvals and 25 tentative approvals. The company is one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, making it eligible for 180 days of shared generic drug exclusivity.

Dapagliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus.

Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India, with operations in over 150 countries. The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

Alembic Pharmaceuticals receives USFDA approval for Dapagliflozin tablets with US$ 10.487 billion market size

Kinjal — Tue, 07 Apr 2026 06:54:28 +0000

Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, 5 mg and 10 mg. This approval marks a significant milestone for Alembic as it positions itself within a lucrative market segment.

The approved Dapagliflozin Tablets are therapeutically equivalent to the reference listed drug product, Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is indicated for reducing the risk of hospitalisation for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Additionally, it serves as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Alembic was among the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets. Consequently, with this approval, Alembic is eligible for 180 days of shared generic drug exclusivity, providing a competitive edge in the market.

The market size for Dapagliflozin tablets, 5 mg and 10 mg, is estimated at US$ 10,487 million for the twelve months ending December 2025, according to IQVIA. This substantial market size underscores the potential revenue opportunities for Alembic.

Alembic Pharmaceuticals has a cumulative total of 235 ANDA approvals from the USFDA, which includes 217 final approvals and 18 tentative approvals. This latest approval further strengthens Alembic’s position as a key player in the pharmaceutical industry.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

AstraZeneca Pharma gets CDSCO approval to import and sell Imfinzi for additional indication

Aman Shukla — Mon, 14 Jul 2025 11:31:00 +0000

AstraZeneca Pharma India Ltd. has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and sell Durvalumab Solution for Infusion (Imfinzi) for an additional indication in India.

The approval covers two dosage forms: 120 mg/2.4 ml and 500 mg/10 ml. As per the new indication, Imfinzi can be used in combination with gemcitabine and cisplatin as a neoadjuvant treatment, followed by single-agent Imfinzi as an adjuvant treatment after radical cystectomy. This is indicated for adult patients diagnosed with muscle invasive bladder cancer (MIBC).

With this clearance, AstraZeneca can proceed to market Imfinzi for this indication in India, pending any additional regulatory approvals that may be required.

In the meantime, AstraZeneca Pharma India shares closed at ₹9,194.50 on July 14. The stock opened at ₹9,200.00 and touched an intraday high of ₹9,303.00 and a low of ₹9,161.00. The company’s 52-week high stands at ₹10,691.00, while the 52-week low is ₹6,220.00.

AstraZeneca receives approval to import Lokelma for hyperkalaemia treatment in India

Aman Shukla — Thu, 06 Mar 2025 09:43:32 +0000

AstraZeneca Pharma India Limited has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import and distribute Sodium Zirconium Cyclosilicate powder for oral suspension, marketed as Lokelma.

This new drug approval, granted in Form CT-20, allows AstraZeneca to introduce Lokelma in 5 g and 10 g formulations for the treatment of hyperkalaemia in adult patients.

Hyperkalaemia, a condition characterized by elevated potassium levels in the blood, can be life-threatening if left untreated. Lokelma offers an effective treatment option by helping to regulate potassium levels safely and efficiently. With this approval, AstraZeneca is set to bring this advanced treatment to patients in India, subject to further statutory clearances.

The introduction of Sodium Zirconium Cyclosilicate in the Indian market marks a significant step in addressing hyperkalaemia, a condition often associated with chronic kidney disease and heart failure.

erkalaemia will soon have access to an effective, globally recognized treatment option.

AstraZeneca receives approval to import and distribute Eculizumab

Aditya Bhagchandani — Thu, 16 Jan 2025 11:52:59 +0000

AstraZeneca Pharma India Limited has announced that it has received regulatory approval to import and distribute Eculizumab concentrate for solution (300 mg, 10mg/ml) under the brand name SOLIRIS. This approval was granted by the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India.

Eculizumab is indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS), targeting complement-mediated thrombotic microangiopathy. With this approval, AstraZeneca is set to introduce this therapeutic solution in India, subject to additional statutory approvals if required.

This marks a significant step towards offering advanced treatment options for patients with these rare and severe disorders in the country.

The shares of AstraZeneca closed 0.76% higher at Rs 6782.95 on BSE.

Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information.

Stocks hitting 52-Week Highs: AstraZeneca, eClerx Services, and more

Aditya Bhagchandani — Mon, 07 Oct 2024 10:29:58 +0000

Several companies from the NIFTY 500 index have hit their 52-week highs today, signaling strong performance in the current market. Here’s a closer look at some of the top gainers hitting their peak prices over the last year.

Stocks Hitting 52-Week High:

AstraZeneca
- Day’s High: ₹8,139.00
- Current Price: ₹7,845.55
  AstraZeneca has reached its 52-week high at ₹8,139 today. The stock is currently trading at ₹7,845.55, indicating significant investor interest in this pharmaceutical major.
eClerx Services
- Day’s High: ₹3,217.00
- Current Price: ₹3,077.05
  eClerx Services, a prominent player in the business process outsourcing (BPO) and IT services sector, touched a 52-week high of ₹3,217 before moderating slightly to a current price of ₹3,077.05.
Coforge Ltd.
- Day’s High: ₹7,285.00
- Current Price: ₹7,208.05
  Coforge Ltd., another IT services company, has hit a 52-week high of ₹7,285 today and is currently trading at ₹7,208.05. The company has consistently delivered strong growth, reflecting positively in its stock price.
Vijaya Diagnostic
- Day’s High: ₹1,011.30
- Current Price: ₹982.55
  Vijaya Diagnostic reached a new high of ₹1,011.30, with its current price being ₹982.55. The healthcare diagnostics chain has been growing steadily, attracting investor attention.
Dr Lal PathLabs
- Day’s High: ₹3,558.45
- Current Price: ₹3,459.80
  Dr Lal PathLabs, one of the major diagnostic service providers in India, recorded a 52-week high of ₹3,558.45. The stock is presently trading at ₹3,459.80, maintaining its upward trend.

Market Overview:

These stocks reaching their 52-week highs indicate strong momentum and positive sentiment from investors.

The Nifty closed at around 24,800, and the Sensex shed around 580 points on October 7, ending the day on a weak note. The IT sector outperformed, standing as the only sector to close in the green, while all other sectoral indices faced losses.

AstraZeneca collaborates with Alveofit to improve lung disease diagnosis and treatment in India

Yakita Somani — Tue, 16 Aug 2022 10:22:35 +0000

AstraZeneca India has announced a collaboration with Alveofit, a SaaS-IoT enabled respiratory healthcare platform, to provide IoT-enabled handheld spirometers in hospitals across the country.

This collaboration wishes and commits to incorporating the most recent technological advances in diagnosing and managing lung disorders and associated noncommunicable diseases such as asthma, pulmonary fibrosis, and COPD.

AstraZeneca will provide Alveofit IoT-enabled handheld spirometers to clinics and last mile hospitals as part of this collaboration to enable point of care spirometry for optimised management of various lung-associated noncommunicable diseases, which will aid in tracking patients remotely and even conducting telespirometry with comprehensive care management solutions.

AstraZeneca’s A.Catalyst Network embodies the company’s commitment to using science to improve health for as many people, in as many countries, and in as many ways as possible.

AstraZeneca has installed spirometers in selected hospitals across the country as part of its collaboration with Alveofit. In cities such as Lucknow, Chennai, Nagpur, Delhi, Ahmedabad, and Kolkata, this includes ESIC hospitals for industrial employees, Command and Military Hospitals, General Hospitals, and last mile clinics. In a pilot project conducted prior to the launch of this initiative, 2800+ patients were tested, and 35-40% were diagnosed with lung issues ranging from 10-12 years old to 85-90 years old.

AstraZeneca has been developing new methods to assist people in managing their own health. Insights from patients and caregivers from various communities have assisted the company in developing new practises and technologies that enable people to take an active role in their own health by utilising tools such as digital sensors, integrated apps, connected devices, and artificial intelligence.

Combination of AstraZeneca and Sputnik V vaccines have no adverse side effects, says study

Diya S. — Fri, 30 Jul 2021 15:14:59 +0000

Russia’s sovereign wealth fund, the RDIF (Russian Direct Investment Fund) has announced initial safety results of the world’s first study on using a combination of AstraZeneca and Sputnik V vaccines. The first component of Sputnik V i.e. Sputnik Light was used.

For the study, fifty volunteers were vaccinated and new individuals have been invited to participate in the trail. It continued saying, “Interim analysis of the data demonstrates a high safety profile for the combined use of the vaccines with no serious adverse side events or cases of coronavirus after vaccination.”

In the month of August, the fund along with its partners will release initial data on the immunogenicity of the mixed use of AstraZeneca’s COVID-19 vaccine and Sputnik V’s first component in Azerbaijan.

Furthermore, the CEO of RDIF, Kirill Dmitriev has said that based on the high efficacy of the heterogeneous boosting i.e. vaccine cocktail approach, RDIF was first in the world to initiate partnerships with other markers of COVID-19 vaccines. He pointed out that the fund’s clinical trial with AstraZeneca was the first partnership of such kind.

Clinical trials of vaccine cocktails are being conducted in multiple countries including the United Arab Emirates (UAE), where the volunteers are being vaccinated.

AstraZeneca gains $1.2 billion, poor countries to benefit in future

Abhinay Talkhedkar — Thu, 29 Jul 2021 12:35:35 +0000

AstraZeneca is one of the most appreciated and, at the same time, criticised vaccines against Covid19. The first half of 2021 has proved to be influential against variants. Vaccine sales have hit $1.2 billion. The University of Oxford has contributed to the advancement of the jab.

The group has exported 319 million doses. Making a profit is not the prime motive but circulating it as much as possible is the objective.

Criticism faced by this was revolving around the blood clots. Several patients suffered from blood clotting after getting vaccinated. Safety doubts were lifted and suspensions occurred in some European nations. Vaccine sales tripled in the three months. The robust elevation was witnessed from 275 million US dollars to 894 million US dollars.

Chief Executive, Pascal Soriot asserted that “We have made dramatic progress with our Covid-19 vaccine Vaxzevria,” he further said, “As of today, AstraZeneca and our partners have released one billion doses to more than 170 countries.”

Winning the trust of these many countries and resolving the issue of rare clots has proved to be a success for Astrazeneca.

The development program did ensure authenticity included a phase three trial of 30000 partakers. Recently, 65.5 million pounds were declared openly by the British government as fresh funding for enhancing the quality of vaccines.

Nations are investing lots of money just to defend the third wave. But, due to various issues like production issues, data didagreements, etc. vaccine is struggling to prove its credibility.

The US has said ‘No’ to vaccines. On Thursday, Astrazeneca will approach the US for approval. The Philippines will get 4,15,000 doses of vaccine from the UK.

On Wednesday, UK Foreign Secretary Dominic Raab said, “This is part of the first batch of the 100 million doses we’ve pledged to get the poorest parts of the world vaccinated as a matter of urgency.”

Controversy is about to fade away like a night & The sunrise of a healthy world will take place.

No extra risk of blood clot after second shot of AstraZeneca’s COVID-19 vaccine, says Lancet study

Diya S. — Wed, 28 Jul 2021 15:27:14 +0000

According to a study led and funded by AstraZeneca plc, the UK-based drugmaker’s coronavirus vaccine is linked with a small risk of rare blood clots after the first shot but no extra risk after the second dose.

On July 27, the research published in The Lancet stated that after receiving both doses of the AstraZeneca COVID-19 vaccine, the rates of a very rare clotting disorder called thrombosis with thrombocytopenia syndrome (TTS), are comparable to those among people who are not yet inoculated. As per the authors, TTS’ estimated rate following a second shot of AstraZeneca COVID-19 vaccine was 2.3 per million vaccinated individuals. The rate stood at 8.1 million vaccinated people after the first dose.

After receiving the first shot of AstraZeneca’s vaccine, rare cases of the syndrome were reported in India, where Serum Institute of India (SII) is in charge of manufacturing the vaccine as Covishield. As a result, several countries across the world restricted or even stopped the usage of this vaccine.

The British-Swedish pharmaceutical company stated, “No specific risk factors or definitive cause for TTS following COVID-19 vaccination have been identified and AstraZeneca continues to perform and support ongoing investigations of potential mechanisms.” It continued saying that these “rare events” are avoidable if symptoms are identified and treated appropriately.

TTS is also referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT).

AIIMS Director says more data needed for mixing of COVID-19 vaccines

Aayushi Singh — Thu, 01 Jul 2021 10:56:29 +0000

Dr. Randeep Gulleria, AIIMS Director, said that if COVID-19 appropriate behavior is followed then everyone would be safe against any of the emerging variants. The Delta Plus variant of COVID-19 has been said to be a variant of concern by the central government and spread fear among the citizens of the country.

Mr. Gulleria said that that there was not much data on the Delta Plus variant to suggest it’s more infectious which causes more deaths and has developed a significant immune escape mechanism.

He added that more data was required on mixing of doses as the studies showed that it might be effective but he clarified that more data was needed before saying that the mixing of COVID-19 vaccine doses policy should be tried.

These remarks came after a recent study by the Oxford University which revealed that alternating doses of the Pfizer BioNTech and AstraZeneca vaccines produced robust immune responses against the SARs-CoV-2 causing COVID-19.

In the study, the researchers who were working to know the feasibility of using a different vaccine doss for the prime vaccination than the one used for the booster vaccination discovered that mixing the doses of two different vaccines could generate stronger immunity.

The Delta Plus variant was first identified on June 11, is a mutated form of the Delta variant, and had been detected in 12 countries so far.

Over 51 cases of the variant have been found in India from over 45,000 samples that were tested.

Dr. NK Arora, of the National Technical Advisory Group on Immunisation (NTAGI), said that the Deta Plus variant of COVID-19 had a greater affinity towards lung problems however it doesn’t mean that it could cause major diseases or had higher transmissibility.

Dr. Arora said the Delta Plus had a greater affinity to the mucosal lining in the lungs, higher compared to other variants but it was not clear yet that it causes damage or not.

The chance of the virus mutating rises as the virus circulated in a population causing infections said WHO.

AstraZeneca antibody cocktail fails to prevent COVID symptoms: Study

Himanjali Mahanta — Wed, 16 Jun 2021 06:29:02 +0000

AstraZeneca Plc’s antibody cocktail was only 33% effective at preventing Covid-19 symptoms in people who had been exposed to the virus, failing a study that was key to the drugmaker’s pandemic push.

The trial of 1,121 adult volunteers looked at whether the long-acting antibody combination could protect people who had recently been in contact with the SARS-CoV-2 virus in places like care homes. The company said it’s running other studies of the medicine that could help clarify the findings.

The outcomes are a blow an Astra for a drug that was hoped to be a bright spot in the company’s pandemic efforts following the mixed success of its vaccine with the University of Oxford Other drugmakers such as GlaxoSmithKline Plc have had some success in getting similar therapies through clinical tests and approved for people who are at risk of severing disease or can’t get vaccinated.

The study, conducted in the U.S. and U.K., showed 23 volunteers who got the AZD7442 cocktail developed symptomatic Covid-19 following exposure to the disease, compared with 17 cases in the placebo group. Twice as many participants got the antibody, but the difference between the two groups wasn’t considered statistically significant. The cocktail was well tolerated by participants.

Astra medicine attracted interest even before it could prove its efficacy. The U.S. has ordered up to 700,000 doses of the medicines for delivery in 2021, while the U.K was already reconsidering an earlier order for one million. Astra said Tuesday’s discussions with the U.S. government about the next steps were “ongoing”. Astra shares were little changed in London trading, rising 0.3%.

All the trial participants had been exposed to a person with Covid-19 in the past eight days. Further analysis showed the drug had some preventive effect.

COVID-19: Canada reports second case of blood clot from AstraZeneca jab

News Desk — Sun, 18 Apr 2021 10:33:16 +0000

A case was reported on Saturday, in the province of Alberta, in an unidentified man in his 60s. He had recently been vaccinated with AstraZeneca vaccine, which is manufactured by Pune-based Serum Institute of India (SII) under the brand name ‘Covishield‘.

Alberta’s chief medical officer, Deena Hinshaw, tweeted “The man was diagnosed, treated promptly, and is now recovering”.

Today, we announced a case of a rare blood clot disorder linked to the AZ vaccine. The patient was diagnosed, treated promptly and is recovering. Now that we know about this rare side effect we can watch for it and reduce the risk of serious harm or death even further. (1of5)

— Alberta Chief Medical Officer of Health (@CMOH_Alberta) April 17, 2021

Meanwhile, Canadian health authorities continue to urge people to get vaccinated and have backed the use of the AstraZeneca Vaccine. “I continue to recommend AstraZeneca Vaccine for anyone who is 55 and older, and recommend that Albertans get vaccinated as soon as they are able to,” Hinshaw said during her interaction with the media.

Further, she specified that it was only the second case in a country where more than 700,000 doses of AstraZeneca Vaccine had been served.

“The global rates of such clots has been estimated at only one in 100,000-250,000 doses. In contrast, those aged 55 and older, who get covid-19, have one in 200 chances of dying, and are also 1500 times more likely to be hospitalized due to COVID-19 than experiencing this disorder from the vaccine,” the medical officer added.

The case was confirmed by Health Canada. In a Tweet, the agency said that– ‘based on all the evidence available internationally, the organisation continues to consider that the benefits of AstraZeneca vaccine and Covishield vaccine to protect against Covid-19, far outweigh the potential risks.

5/5 Based on all of the evidence available internationally to-date, Health Canada continues to consider that the benefits of the #AstraZeneca and COVISHIELD vaccines to protect against #COVID19 outweigh the potential risks.

— Health Canada and PHAC (@GovCanHealth) April 17, 2021

The agency further added that it is continuing to monitor the adverse effects of the vaccine. “The report of this case shows that Canada’s vaccine safety monitoring system works,” it added. Hinshaw further clarified that with health authorities aware of the vaccine’s response, they could “watch for it and reduce the risk of serious harm or death even further”.

Canada’s first case of this particular kind of reaction to the vaccine was reported on April 14 in a patient. She was a Quebec-based woman, who is also said to be recovering. The country received 500,000 doses of Covishield on March 3 and the entire batch of the vaccine has been distributed across Canada.

COVID-19 Vaccine: Netherlands stays use of AstraZeneca for people under 60s

Nitin Anand — Sat, 03 Apr 2021 06:50:56 +0000

Ministry of Health, Welfare & Sport of Netherlands has temporarily halted the use of the AstraZeneca Covid-19 vaccine for people under the age of 60. The decision on Friday was prompted by possible blood clotting problems as a side effect of the vaccine, reports Xinhua news agency.

The Lareb side effects centre published report on Friday that after injecting some 400,000 doses of the AstraZeneca vaccine, five reports have been received concerning women aged 25-65 who developed thrombosis in combination with a reduced platelet count. One of these five women died after developing an extensive pulmonary embolism within 10 days of the vaccination.

Netherlands Health Minister Hugo de Jonge said there should be no doubt whatsoever about the safety of vaccines. “The crucial question is still whether it concerns complaints after vaccination or due to vaccination,” he said in a statement, adding that “it is wise to press the pause button now as a precaution”.

The European Medicines Agency said “the benefits of vaccination outweigh the risks, but it could not rule out a link between the shot and some unusual kinds of clots, and recommended adding a warning about possible rare side effects.” Most European Union countries, including Germany, resumed using the AstraZeneca vaccine on March 19.

Eight countries have so far fully suspended the AstraZeneca vaccine.

SII Chief Adar Poonawalla gets Covidshield vaccine shot

Ruchira Sonawat — Sat, 16 Jan 2021 08:50:35 +0000

Serum Institute of India (SII) CEO Adar Poonawalla shared a video on Twitter where he is seen taking a vaccine shot as India kicks off the biggest vaccination drive today.

The SII Chief received a shot of the Covishield vaccine which has been manufactured by his company.

Poonawalla, while wishing the country and Prime Minister Narendra Modi on taking a big step in fighting the pandemic wrote, “I wish India & Sri @narendramodi ji great success in launching the world’s largest COVID vaccination roll-out. It brings me great pride that #COVISHIELD is part of this historic effort & to endorse it’s safety & efficacy, I join our health workers in taking the vaccine myself.”

https://twitter.com/adarpoonawalla/status/1350338040321851392

Meanwhile, 1.11 crore doses of Covishield vaccine have been rolled out in India and there are plans to provide 5 to 6 crore more doses by February. Around 100 people will be vaccinated in each of the 3,006 centres across the country on the first day.

Co-developed by the University of Oxford and British-Swedish company AstraZeneca and known as Covishield in India, the vaccine was the first on which a scientific study was published based on Phase 3 clinical trials.

Emergency use authorization is given in the UK, Argentina, Mexico and India.

The Prime Minister, today, launched India’s COVID-19 vaccination drive and asserted that the made-in-India vaccines which are rolled out will ensure a “decisive victory” for the country over the Coronavirus pandemic.

Launch of the #LargestVaccineDrive. Let us defeat COVID-19. https://t.co/FE0TBn4P8I

— Narendra Modi (@narendramodi) January 16, 2021

India’s abrupt Covaxin approval draws questions over its efficacy

Ruchira Sonawat — Wed, 06 Jan 2021 10:13:31 +0000

India’s approval of Bharat Biotech’s Covaxin, without proof of its efficacy, grew certain criticism on Wednesday after a regulatory panel approved the shot just one day after asking the vaccine maker for more evidence it would work.

The drugs regulator’s panel asked Bharat Biotech to present more efficacy data for its COVID-19 shot before it could consider approving the treatment. The very next day, the committee recommended approving Bharat Biotech’s vaccine for “restricted use in an emergency situation” in the public interest as an abundant precaution.

The SEC also separately recommended emergency use authorisation for the Oxford University’s AstraZeneca COVID-19 vaccine, being produced by Serum Institute of India.

Health experts questioned why the SEC abruptly recommended approval one day after asking Bharat Biotech for more analysis.

“The SEC appears to have been pressured overnight into reconsidering its decision and giving approval the next day, albeit hedged in by many conditions,” the All India People’s Science Network, a network of science advocacy groups, said in a statement.

Regulators also granted approval to Bharat Biotech’s vaccine only “in clinical trial mode”, an unusually cryptic language that left some experts baffled.

“They’ve introduced terminologies that are confusing. The phrase ‘in clinical trial mode’ is not generally a term you will see in approvals. Any confusion around vaccines could harm immunisation programmes by causing distrust. It takes decades of work to build confidence in vaccines,” said Giridhar Babu, a professor of epidemiology at the Public Health Foundation of India. “

Private clinics of Brazil sign deal with India to get alternative COVID-19 vaccine

Ruchira Sonawat — Tue, 05 Jan 2021 07:55:26 +0000

A deal has been signed by Brazil’s private clinics for an alternative Coronavirus vaccine made by India’s Bharat Biotech. This comes as a result of a diplomatic push to ensure Indian-made shipment of AstraZeneca’s COVID-19 vaccine, Al Jazeera reported. Brazil has signed the deal despite “a lack of public results from late-stage trials” of the Indian vaccine.

This came a day after India’s health regulator gave its vaccine, Covaxin, a nod for emergency use. An association of private Brazilian clinics declared their intention to secure five million doses of Indian company Coronavirus vaccine. A memorandum of understanding has already been signed by Brazil with Bharat Biotech.

“Brazil will be able to secure only one million doses of AstraZeneca’s vaccine by the second week of February,” the head of Brazil’s Fiocruz Institute told Reuters last week.

Geraldo Barbosa, head of the Brazilian Association of Vaccine Clinics (ABCVAC) said that this should be the first vaccine available on the private market in Brazil and the doses should arrive by mid-March, to be sold by private clinics after regulators there approve the vaccine.

Meanwhile, Bharat Biotech is yet to publish efficacy data of its COVID-19 vaccine.

SII in anticipation of DCGI approval for emergency use of Covidshield

Shlok Arya — Mon, 07 Dec 2020 05:41:23 +0000

On December 6, the Serum Institute of India applied for emergency use authorization of the Oxford-Astrazeneca COVID-19 vaccine. SII is the primary to apply for authorization for coronavirus vaccine in the country through the Drug Controller General of India.

The phase–three clinical trials of the Oxford COVID-19 vaccine, Covidshield is underway by the Pune-based Serum Institute of India and it is backed by the India Council of Medical Researcher (ICMR). The clinical trial is being carried out in various parts of countries.

SII informed that four clinical studies are currently undergoing in the UK, Brazil, and India. Moreover, Covidshield is highly effective against symptomatic and severe COVID-19 infections. The results are in line with other anti-coronavirus vaccines and because of the huge disease burden, Covidshield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm told DGCI.

A source said to PTI, “In terms of safety, Covidshield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covidshield is safe and well-tolerated and can be used effectively for the prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covidshield.”

As per ICMR, the SII has manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license is obtained from the DCGI.

Japan government to cover cost of COVID-19 vaccine for all citizens

Sarthak Yadav — Wed, 02 Dec 2020 10:52:39 +0000

Japan will give free coronavirus vaccines to all of its residents under a bill passed Wednesday, as the nation battles record numbers of daily cases. The bill, which says the government will cover all vaccine costs for Japan’s 126 million residents, was approved by the upper house.

The country has secured COVID-19 vaccines for 60 million people from pharmaceutical giant Pfizer, and for a further 25 million people from biotech firm Moderna. It has also confirmed it will receive 120 million doses of AstraZeneca’s vaccine.

The bill’s passage comes two weeks after Japan’s newly appointed Prime Minister Yoshihide Suga said that the country was on “maximum alert” over the virus and medics have warned that hospitals are on the brink of collapse. Japan witnessed comparatively small COVID-19 outbreak overall, with around 2,100 deaths, 150,000 cases and has not imposed the strict lockdowns seen elsewhere.

The country is now experiencing a third wave of the disease, reporting an increased number of daily infections nationwide. The governor has urged residents to avoid non-essential outings and asked businesses serving alcohol to shut early, although there is no enforcement mechanism for these recommendations.

AstraZeneca meets threshold for approval despite dosing error

Divya Joyce — Thu, 26 Nov 2020 06:00:29 +0000

A top executive at AstraZeneca PLC on Wednesday rejected criticism that the company failed to disclose enough data from a clinical trial of its COVID-19 vaccine, and acknowledged scepticism about the vaccine’s 90% effectiveness in a group of patients who were accidentally given a lower dose than intended.

“I’m not going to pretend it’s not an interesting result, because it is—but I definitely don’t understand it and I don’t think any of us do,” said Mene Pangalos, AstraZeneca’s executive vice president for biopharmaceuticals research and development. “It was surprising to us.”

AstraZeneca on Monday said in interviews with news media that the half-dose regimen was the result of a manufacturing error, which neither the company nor Oxford initially mentioned in their press releases announcing the results. The dosing error was identified after a trial investigator noticed that volunteers weren’t having as much of an inflammatory response to the shot, prompting the researchers to analyze their vaccine supply and find that they had miscalculated the dose, Dr Pangalos said.

AstraZeneca and Oxford informed regulators in the U.K., U.S., and European Union and amended the study design to include the half-dose group in their analysis.

“The mistake is actually irrelevant,” said Dr Pangalos. “Whichever way you cut the data—even if you only believe the full-dose, full-dose data….We still have efficacy that meets the thresholds for approval with a vaccine that’s over 60% effective.”

Oxford researchers said on Monday that the lower dose may have been more effective because it more accurately reflects the natural immune response to viruses, but that they would have to investigate the findings further to know for sure.

Other factors could also be at play. The half-dose was only given to volunteers 55 and younger, whereas the full-dose group also included older patients, said Dr Moncef Slaoui, chief scientific adviser to the U.S. government’s Operation Warp Speed initiative, on a call with reporters on Tuesday, the first disclosure of the lack of older participants in the half-dose group. It is also possible that the difference between the groups was a statistical fluke and the result of chance, he said.

“There are a number of variables that we need to understand,” said Dr Slaoui. “It’s unlikely but it’s still possible that it’s a random difference.”

The U.K. company said on Monday that the vaccine it is codeveloping with the University of Oxford was on average about 90% effective in preventing Covid-19 when volunteers were given a half-dose shot followed by a full dose a month or more later, but only 62% effective when two full doses were given. The data pooled trial results from the U.K. and Brazil.

U.S. regulators have set the bar for authorizing vaccines at 50% effectiveness, but vaccines in development by Moderna Inc. and partners Pfizer Inc. and Germany’s BioNTech SE have made the study results greater than 90% effectiveness. Those vaccines use a new gene-based technology that, despite its impressive clinical results thus far, requires the shots to be stored at subzero temperatures. AstraZeneca’s vaccine can be stored in a more standard refrigerator, which could make it attractive to low- and middle-income nations.

Independent scientists and U.S. government officials said the data is further proof that vaccines can prevent COVID-19, but they also cautioned that the 90% effectiveness rate might not hold up under further analysis.

AstraZeneca plans to test the half-dose regimen in a large, ongoing U.S. study expected to enrol more than 30,000 volunteers, Dr Pangalos said. The study has enrolled more than 11,000 volunteers and could have results soon given the progression of the pandemic, Dr Slaoui said.

Dr Pangalos said there is a theoretical rationale for why a lower first dose might work, but that he wouldn’t speculate until the researchers investigate the data further. “I’m not going to handwave with the immunologists,” he said. “Until I see some data that gives me some science behind it, I’m going to say ‘I don’t know.’”

Some scientists have criticized AstraZeneca for not revealing key data from the trial results, such as how the number of infections that occurred across patient groups and broken down by age and severity of disease—though the company did say that no patients receiving the vaccine developed severe disease or required hospitalization.

“AstraZeneca provided very little real information for one to independently assess how their vaccine trials are doing,” said Shane Crotty, a vaccine and infectious diseases researcher at La Jolla Institute for Immunology. “It’s quite reasonable for people to be sceptical.”

Dr Pangalos said the researchers only received the data last weekend and are working to quickly release the full data in a peer-reviewed journal. “The right way of publishing and documenting the results is in a scientific journal, and these data will all be published within the next week or so,” he said.

University of Oxford developed 90% effectiveness of COVID-19 vaccine by accident

Divya Joyce — Tue, 24 Nov 2020 09:16:41 +0000

The COVID-19 vaccine developed by the University of Oxford and AstraZeneca could be 90 percent effective after receiving half-dose due to error, giving public health officials hope that they may soon have an effective and cheaper vaccine which will be easier to distribute.

Today marks an important milestone in the fight against #COVID19. Interim data show the #OxfordVaccine is 70.4% effective, & tests on two dose regimens show that it could be 90%, moving us one step closer to supplying it at low cost around the world>> https://t.co/fnHnKSqftT pic.twitter.com/2KYXPxFNz1

— University of Oxford (@UniofOxford) November 23, 2020

The participants were given two high doses, which showed 62 percent efficiency, but it rose to 90 percent when they were given a half dose, followed by a high one.

“The reason we had the half dose is serendipity,” said Mene Pangalos, executive vice-president of biopharmaceuticals research and development at AstraZeneca.

When university researchers were distributing the vaccine at the end of April, around the start of Oxford and AstraZeneca’s partnership, they noticed expected side effects such as fatigue, headaches or arm aches were milder than expected. “So we went back and checked and we found out that they had underpredicted the dose of the vaccine by half,” said Pangalos. Instead of restarting the trial researchers decided to continue with the half dose and administer the full dose booster shot at the scheduled time, he said.

Scientists said they still could not fully explain why the half dose gave better protection but said that it may have triggered the immune system differently. Prof Sarah Gilbert from Oxford University, who led the research, said, “It could be that by giving a small amount of the vaccine to start with and following up with a big amount, that’s a better way of kicking the immune system into action and giving us the strongest immune response and the most effective immune response.”

Prof Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the trial added, “What we don’t know at this moment is whether that difference is in the quality or the quantity of immune response. And that’s something we’re going to be digging into over the next weeks.”

The vaccine still needs to be approved by the Medicines and Healthcare products Regulatory Agency but could be made available in the coming weeks if given the go-ahead.

The UK government has already pre-ordered 100 million doses of the Oxford vaccine, reported BBC.

COVID-19 vaccine is ‘highly effective’ prevention, claims AstraZeneca

Shlok Arya — Mon, 23 Nov 2020 08:46:01 +0000

AstraZeneca says late-stage trials of its COVID-19 were “highly effective” in preventing disease.
A vaccine developed in partnership between AstraZeneca and the University of Oxford prevented 70% of people from developing the coronavirus in late-stage trials, the team reported.

AstraZeneca CEO Pascal Soriot said, “This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency.

Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment on broad, equitable and timely access mean it will be affordable and globally available, supplying hundreds of millions of doses on approval.”

Key researcher Dr. Andrew pollard said scientists were pleased with the results and researchers to have found that if people were given a half dose followed by a full dose, rather than two full doses, protection rose to about 90%.

He said, “These findings show that we have an effective vaccine that will save many lives.”
Two competitors, Pfizer and Moderna, last week reported preliminary results from late-stage trials showing that their COVID-19 vaccines were almost 95% effective.

Government planning to procure Oxford-AstraZeneca vaccine (COVID) on half the price from MRP

Sarthak Yadav — Mon, 23 Nov 2020 07:09:35 +0000

India is planning to get hands on the first lot of anti-Covid shots in late January-early February which will be distributed among frontline workers like doctors, nurses and municipal staff.

India is planning to give Serum Institute of India (SII) emergency use approval for the Oxford-AstraZeneca vaccine candidate soon after it gets similar approval in the UK. SII is expected to apply for emergency use in December. The government will be making bulk purchases, has also negotiated a better price almost half that of the expected MRP Rs 500-600 for the two-shot vaccine.

According to an official ” if everything goes as per plan and the company (SII) manages to secure emergency authorization in December, we are expecting the first lot of vaccines by January-February and the first set of beneficiaries has been identified.”

The priority population of 25-30 crores is categorised into four different groups which will require around 50-60 crore doses according to the estimate. The limited stocks are expected to arrive by January-end which will be provided to 70 lakh healthcare professionals and over 2 crore frontline workers including police, municipal workers and armed forces.

Bharat Biotech’s Covaxin can be considered for emergency approval after the results of phase I and phase II trials.

“If Serum Institute submits its efficacy data from UK and applies for emergency authorization here, it can easily be granted But even in case of Bharat Biotech, if the company applies for emergency use approval after its data from phase I and phase II are published, the regulator can consider the same,” remarked by the officials .

The SII has almost completed its phase 3 trials in India and the follow up is expected to start soon.

National Technical Advisory Group initiating Immunisation and The Central Drug Standards and Control Organistaion to focus on grant of emergency authoristaion will be the two major bodies dealing with vaccine introduction.

India to get 100 million shots of AstraZeneca COVID-19 vaccine ‘AZD1222’ by next month

News Desk — Sat, 14 Nov 2020 05:13:33 +0000

Serum Institute of India (SII) is speeding up production of AstraZeneca’s COVID-19 vaccine (AZD1222), aiming to produce 100 million doses by December for vaccination of the entire country after approval by New Delhi.

SII is waiting for final-stage trial data, if AstraZeneca’s vaccine candidate is giving effective protection from the virus, the Serum Institute of India, which is partnered to produce at least one billion doses might get an emergency authorization from New Delhi by December, said Adar Poonawalla, Chief Executive Officer, SII.

AstraZeneca trial has been put on hold two times after a vaccinated person died and a woman in the UK experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis. The trial resumed on 23 October 2020, in the US, UK, Brazil, South Africa, and Japan confirming that it was safe to do so.

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

India to get 200 million doses of AstraZeneca vaccine by January

Shalmali Bhagwat — Fri, 13 Nov 2020 07:55:47 +0000

The world’s largest vaccine maker, is speeding up production of AstraZeneca Plc’s COVID-19 shot, aiming to have 100 million doses ready by December for an inoculation drive that could commence in India that same month. If final-stage trial data show AstraZeneca’s candidate offers effective protection from the virus, the Serum Institute of India Ltd. — which is partnered to produce at least one billion doses — may get emergency authorization from New Delhi by December, said Adar Poonawalla, chief executive officer of the family-owned firm based in the western city of Pune.

That initial amount will be diverted to India and full approval early next year will allow distribution on a 50-50 basis with the South Asian nation and Covax, the World Health Organization-backed body that’s purchasing shots for poor nations. Serum, which has collaborated with five developers, has so far made 40 million doses of AstraZeneca’s vaccine in the past two months and aims to start production of Novavax Inc.’s contender soon.

Poonawalla said AstraZeneca has a significant edge over a rival candidate from Pfizer Inc. and BioNTech SE, which this week grabbed headlines after declaring it was more than 90% effective in stopping Covid-19 infections. Expensive cold-chain infrastructure is needed to transport and store that vaccine at -70 degrees Celsius. Poonawalla said it was “just impossible” for most of the world to use at scale, compared to those his company will produce that can be stored at fridge temperatures.

Drugmakers are just now receiving data that will show the effectiveness of their vaccine on candidates , but there are plenty of hurdles remaining as the global race to find an effective shot against the pathogen reaches its final stages.

Astra and co-developer University of Oxford still need to evaluate testing results. And even if their vaccine proves effective and gets a nod from regulators, there are uncertainty over the speed of distribution and availability. Poonawalla reiterated that it will take until 2024 to vaccinate the entire world and two years to see a real reduction in infections, due to affordability and manufacturing hurdles.