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astrazeneca

AstraZeneca seeks US emergency approval for Covid-19 antibody cocktail

by Medically Speaking Team October 5, 2021

As treatment options for the pandemic expand beyond vaccination, AstraZeneca Plc has proposed an antibody cocktail for emergency permission in the United States to prevent Covid-19 infection.

It’s the first regulatory submission for the drug, which was found to be 77 percent effective in avoiding symptomatic Covid in a clinical trial including patients with significant infection risk factors.

The mixture can be used to augment immunizations for those who haven’t responded well to vaccinations or to protect those who haven’t been able to get them. The announcement comes only days after Merck & Co. expressed hope that the first Covid tablet will be available shortly. Both therapies have the potential to provide a straightforward approach to treat a large number of patients before they reach the hospital.

“We are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines,” Mene Pangalos, Astra’s executive vice president for biopharmaceuticals research, said in a statement.

Supply arrangements for the drug, known as AZD7442, are currently being discussed with the US government and others across the world. Antibody medicines are more difficult to manufacture in large quantities.

The United States has placed an order for up to 700,000 doses to be delivered in 2021, with the contract’s worth depending on the results of a prior experiment that failed to prove it worked in persons who had been directly exposed to Covid.

In London trade, Astra shares were barely moved.

October 5, 2021 0 comment

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Australia approves Indian Astra-Zeneca vax for Covid-19

by Medically Speaking Team October 1, 2021

written by Medically Speaking Team

Sinovac Biotech Ltd. of China has been recognised by Australia. Covid-19 shot and AstraZeneca Plc jabs produced in India, allowing outside visitors and fee-paying foreign students who have got those vaccines to enter the country.

The nation’s top drugs regulator, the Therapeutic Goods Administration, said the shots should be “recognized vaccines” in determining incoming travelers as being inoculated, Prime Minister Scott Morrison said Friday.

As vaccination rates throughout the country reach the crucial threshold of 80 percent, Australia is beginning to relax some of the world’s most stringent pandemic border restrictions. The World Health Organization has authorised Beijing-based Sinovac’s injection for emergency usage, in contrast to the United Kingdom and neighbouring New Zealand, which have yet to ratify it.

A number of European nations have said that they will accept the Coronavac vaccination as part of their vaccinated entrance programmes. The United States hinted something similar when it revealed intentions to allow most vaccinated visitors to enter the country last week.

The announcement on Friday may open the door to thousands of international students who have been barred from entering Australia due to the pandemic. International education is a valuable source of money for the country, with the state of New South Wales alone earning A$14.6 billion ($11 billion) in 2019.

“Very soon, we’ll be able to open those international borders again,” Morrison told reporters. “This will start happening from next month.”

Vaccines produced by Sinovac and the state-owned Sinopharm are among the most widely used in China, with effectiveness rates ranging from 50 to 80 percent in avoiding symptomatic Covid, which is lower than that of mRNA vaccines created in the United States. Sinovac is also one of the most widely used Covid injections in the world, with deployments ranging from Indonesia to Brazil and Turkey. Chile said earlier this week that it will begin giving it to youngsters aged six to eleven.

Covishield, which was also acknowledged on Friday, is the name of the AstraZeneca Plc shot manufactured by India’s Serum Institute, the world’s largest vaccine manufacturer.
According to the New South Wales government, more than 57,000 students are projected to be studying abroad. According to the Australian Trade Department, Chinese people are the largest source of foreign students in Australia, followed by those from India, Nepal, and Vietnam.

The decision on Friday may also be interpreted as an olive branch from Australia, which has faced criticism and trade restrictions from China since requesting a worldwide investigation into the origins of the coronavirus.

October 1, 2021 0 comment

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New Brand Names for 3 Covid-19 Vaccines Authorized by Health Canada, Details

by Medically Speaking Team September 18, 2021

written by Medically Speaking Team

Pfizer-BioNTech, Moderna, and AstraZeneca’s authorised Covid-19 vaccines will now be known as Comirnaty, SpikeVax, and Vaxzevria, respectively. The Canadian pharmaceuticals regulator, Health Canada, has approved brand name modifications for the three vaccines.

In light of the aforementioned developments, Health Canada and PHAC tweeted, “Health Canada has authorized brand name changes for the Pfizer-BioNTech, Moderna, and AstraZeneca COVID-19 vaccines. The Pfizer-BioNTech vaccine will now be named Comirnaty, the Moderna vaccinewill be named SpikeVax, and the AstraZeneca vaccine will be named Vaxzevria.

These are only name changes.There are no changes to the vaccines themselves.All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality”, the tweet further added.

As per a recent release by the company, the Pfizer-BioNTech vaccine has been named Comirnaty, which is a combination of the terms COVID-19, mRNA, community, and immunity.The vaccine was initially authorized for use in Canada under an Interim Order Authorization on December 9, 2020.

On September 16, the Health Canada granted full approval for COMIRNATY to prevent COVID-19 in individuals 12 years of age and older.The authorization permitted the essential rollout of vaccine doses across Canada to help provide protection during the COVID-19 pandemic, based on preclinical and clinical data, including initial data from the Phase 3 clinical trial.

“Today’s full approval is a testament to the vaccine’s efficacy and safety profile,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Our companies have shipped more than 1.4 billion doses worldwide, and we will continue to work tirelessly to broaden access to our vaccine and to be prepared for potential emerging escape variants,” he added.

Despite the fact that the vaccine’s brand name will now be COMIRNATY, Canada will continue to receive vials labelled as Pfizer-BioNTech COVID-19 Vaccine. Pfizer-BioNTech COVID-19 Vaccine has the same formulation as COMIRNATY, and Health Canada considers the two vaccines interchangeable for the COVID-19 immunisation series. Due to the current pandemic, a gradual transfer to new labelling with the COMIRNATY brand name will take place at a later period.

Fabien Paquette, Vaccines Lead, Pfizer Canada said in a release, “Based on the longer-term follow-up data that we submitted, today’s decision by Health Canada affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,”

Meanwhile, Health Canada has accepted the New Drug Submission for SPIKEVAX, formerly known as COVID-19 Vaccine Moderna, for active immunisation against COVID-19 in people aged 12 and above.
The SPIKEVAX vaccine from Moderna is an mRNA vaccine against COVID-19, which encodes for a prefusion stabilised version of the Spike (S) protein.

“Health Canada’s approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax. I would like to thank Health Canada for their hard work throughout the process, “said Stéphane Bancel, Chief Executive Officer of Moderna.

I would also like to thank the Government of Canada for the partnership they have built with us and for their confidence in our mRNA platform in addressing the COVID-19 pandemic,” he said.

Health Canada approved the New Drug Submission for SPIKEVAX based on clinical data from the Phase 3 COVE study of the Moderna COVID-19 vaccine, which enrolled more than 30,000 participants in the US In final analysis of Phase 3 COVE study data, SPIKEVAX showed 93%efficacy, with the efficacy remaining durable through six months after administration of the second dose.The safety profile based on extended safety follow-up was consistent with the Phase 3 COVE study primary results.

However, in the case of AstraZeneca’s COVID-19 vaccine, the Canadian drug regulator, Health Canada, said that the AstraZeneca Vaxzevria COVID-19 vaccine is authorized for use in Canada under the Interim Order respecting the importation, sale and advertising of drugs for usein relation to COVID-19.Canadians will continue to have access to AstraZeneca Vaxzevria after September 16, 2021 while the submission is under review for transition to the Food and Drug Regulations.

September 18, 2021 0 comment

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Covid-19 is prevented in high-risk populations by an antibody medication from AstraZeneca, according to a study

by Medically Speaking August 20, 2021

written by Medically Speaking

In a pivotal trial, AstraZeneca’s Covid-19 antibody cocktail was found to be 77 percent effective in avoiding symptomatic Covid-19 in high-risk patients, suggesting that the spectrum of medicines accessible to vulnerable groups might be expanded.

According to Astra’s findings, no one in the experiment who got the combination acquired severe Covid-19 or died as a result of the condition, according to the company’s statement on Friday. The 5,197-person study began in November and was conducted in the United States, the United Kingdom, Belgium, France, and Spain to see if the medication might prevent infection in at-risk populations.

The outcome will be a big relief for Astra after another study testing whether the cocktail could prevent symptomatic Covid-19 in people explicitly exposed to the virus failed in June. The findings may also salvage a deal with the US to purchase the drug. The US had ordered as many as 700,000 do doses for delivery in 2021, the value of which was partly co ntingent on the failed trial.

Astra said in June it was in “ongoing” discussions with the US government and awaiting results of this latest study – named Provent — before deciding how to proceed. The trial accrued 25 symptomatic Covid-19 infections for the primary accrued 25 symptomatic Covid-19 infections for the primary a nalysis. Volunteers were given the AZD7442 cocktail on a 2:1 randomized drug-to-placebo ratio.

“We need additional approaches for individuals who are not adequately protected by Covid-19 vaccines,” Mene Pangalos, executive vice president of biopharmaceuticals research and development, said in a statement. “We are very encouraged by these efficacy and safety data in high-risk people.”

August 20, 2021 0 comment

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Combination of Sputnik V component with AstraZeneca, Sinopharm and Moderna shows high safety: RDIF study

by Medically Speaking Team August 5, 2021

written by Medically Speaking Team

In a finding that could provide a boost to the global fight against COVID-19, Russian researchers have discovered that a combination of variants of Sputnik V with vaccines of AstraZeneca, Sinopharm, and Moderna could provide immunity against COVID-19. A study by the Russian Direct Investment Fund (RDIF) has said that the approach could provide a longer and more durable immunity against the deadly virus.

“A study was conducted in Argentina, in which, the heterogeneous boosting approach (‘vaccine cocktail’ using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component) was at the core of Sputnik V, the world’s first registered vaccine against coronavirus. With this approach proving successful in creating a longer and more durable immunity against the coronavirus,” RDIF said in a statement.

According to news agency ANI, 121 volunteers were analysed in the regimens – Sputnik Light/AstraZeneca, Sputnik Light/Moderna, Sputnik Light/Sinopharm, Sputnik Light/Sputnik Light compared to control group Sputnik V 1 Comp./Sputnik V 2 Comp.

Sputnik V is effective against the Delta variant of COVID-19: Study

“RDIF is the first country to offer vaccine cooperation to other producers to conduct joint mix and match studies. This approach is the most promising one to fight the pandemic and new strains of coronavirus emerging around the world,” Kirill Dmitriev, CEO of RDIF said.

The outcome of the study may be important given that it could strengthen the ongoing global fight against the deadly virus. In India, Sputnik is being produced in partnership with the Serum Institute of India, the largest vaccine producer in the world. A recent study has shown that it is one of the most effective vaccines against COVID-19, including its Delta variant.

August 5, 2021 0 comment

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Sputnik V, AstraZeneca booster dose trial result expected this week: Report

by Medically Speaking Team August 5, 2021

written by Medically Speaking Team

The Russian Direct Investment Fund (RDIF) has recently issued a statement regarding the trials conducted about the booster dose of Sputnik V and Astrazeneca trials which has not shown any adverse effects. According to news agency ANI more trials are still underway and it is expected to announce more results this week.

The government has also given its view on mixing of two vaccines for Covid-19. Minister of state for health Bharati Pravin Pawar in a written reply in the Rajya Sabha said,”Covid-19 vaccines have been developed recently. Therefore, scientific evidence about mix and match studies of different vaccines is still evolving.”

Meanwhile, Dr Reddy’s Laboratories issued a statement on 2 August regarding the availability of ‘Made in India’ Sputnik V COVID-19 doses from September /October, the Sputnik V team confirmed it was scaling up its vaccine production capacity.

Sputnik V team said in a statement,”Sputnik V team confirms that owing to a major scale-up in vaccine production capacity temporary second component delivery delays that occurred due to this production scale-up will be fully resolved in August.”

“Sputnik V has built production partnership with producers in 14 countries and will additionally double its capacity in September thanks to our partnership with top producers including Serum Institute of India, the world’s largest vaccine producer,” reads the statement.

“Sputnik V will also continue to play a leading role in vaccine combinations (mix and match approach). Sputnik V, which pioneered the heterogeneous boosting (vaccine cocktail) approach by using two different adenoviral vectors (Ad5 and Ad26) for two different shots, was first to offer a joint mix and match trial to another producer when it made an offer to AstraZeneca on November 23, 2020. Joint Sputnik V and AstraZeneca trials have been ongoing in the United Arab Emirates, Azerbaijan, and Argentina since February 2021. The early positive results were announced on July 30. More positive results on immunogenicity are expected this week,” it added.

August 5, 2021 0 comment

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AstraZeneca and Sputnik V combination show no adverse events: RFID

by Medically Speaking Team July 30, 2021

written by Medically Speaking Team

The Russian Direct Investment Fund (RDIF) has announced initial safety results of the world’s first study of a combination between the AstraZeneca vaccine and the first component of the Sputnik V vaccine in the Republic of Azerbaijan.

In a statement, RDIF said that the heterogeneous boosting approach (“vaccine cocktail” using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component) was at the core of Sputnik V. With this approach proving successful in creating a longer and more durable immunity against the coronavirus, RDIF took the lead in initiating partnerships with other vaccine producers to conduct joint studies of a combination of the first component of Sputnik V with foreign vaccines.

The statement also notified that the first partnership of this kind was concluded in December 2020 in the presence of Vladimir Putin, President, Russia. RDIF, The Gamaleya Center, AstraZeneca and R-Pharm signed a Memorandum of Intent aimed at cooperation in vaccine development.

Studies on the safety and immunogenicity of the combination of the AstraZeneca vaccine and the first component of the Sputnik V vaccine in Azerbaijan began in February 2021. Till date, 50 volunteers have been vaccinated and new participants are invited to join the trial. The interim analysis of the data demonstrates a high safety profile for the combined use of the vaccines with no serious adverse events or cases of coronavirus after vaccination, said the statement.

It further notified that RDIF and partners will publish the initial data on the immunogenicity of the combined use of the AstraZeneca vaccine and the first component of the Sputnik V vaccine in Azerbaijan next month.

Kirill Dmitriev, CEO, RDIF, said, “As new strains of coronavirus emerge, partnerships between vaccine manufacturers and combining different vaccines are key to successfully fight the pandemic. Based on the high efficacy of the heterogeneous boosting (“vaccine cocktail”) approach, RDIF was the first in the world to initiate partnerships with other coronavirus vaccine manufacturers. The first partnership of this kind was a joint clinical trial with AstraZeneca. We look forward to its success in Azerbaijan and other countries, which will allow a more effective implementation of vaccination programmes and protect people around the world. We consider it important to conduct joint research on combining the first component of Sputnik V with vaccines from other manufacturers for a more effective fight against emerging new strains of coronavirus.”

The statement added that the clinical trials of a combination of vaccines are being carried out in several countries as part of a global programme. Volunteers are being vaccinated in the UAE, and regulatory approval to conduct trials has been granted in Russia and Belarus.

Irina Panarina, General Manager, AstraZeneca Russia and Eurasia, said, “A heterogeneous prime-boosting involving administering components of different vaccines to a patient is one of the most promising vaccination regimens to study. It is becoming especially relevant now, when the issue of preventing the spread of new strains of coronavirus infection is acute, and the need for revaccination of the population is also coming to a head. That is why the results of the study can be of great importance for those countries where both, the vaccine by AstraZeneca and the University of Oxford, and the Sputnik V vaccine are registered.”

Adding to it, Vasily Ignatiev, CEO, R-Pharm Group, commented, “The initial results obtained at times when the delta strain is spreading are important for assessing the safety and early efficacy of the vaccine combination. We will continue researching and analysing the data with the prospect of a publication in an international journal.”

July 30, 2021 0 comment

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Antibody levels to Pfizer and AstraZeneca vaccines may fall after 2-3 months, according to a Lancet study

by Medically Speaking July 27, 2021

written by Medically Speaking

According to a study published in The Lancet journal, total antibody levels begin to decline six weeks following complete vaccination with Pfizer NSE 4.16 percent and AstraZeneca NSE -0.49 percent vaccines, and can drop by more than 50% in ten weeks.

If antibody levels continue to fall at this rate, researchers at University College London (UCL) in the United Kingdom are concerned that the vaccines’ protective properties will begin to wear off, especially against new strains. However, they said, how soon that might happen cannot be predicted yet.

The UCL Virus Watch study also found that antibody levels are substantially higher following two doses of the Pfizer vaccine than after two shots of the AstraZeneca preventive, known as Covishield in India. Antibody levels were also much higher in vaccinated people than those with prior SARS-CoV-2 infection, they said.

“Antibody levels following both doses of either the AstraZeneca or Pfizer vaccination were initially quite high, which is likely to be an important component of why they are highly protective against severe COVID-19,” said Madhumita Shrotri of the University College London Institute of Health Informatics.

“However, we found these levels dropped substantially over the course of two to three months,” Shrotri said in a statement. The findings based on data from over 600 people aged 18 and above were consistent across all groups of people regardless of age, chronic illnesses or sex, according to the researchers.

The authors highlight that although the clinical implications of waning antibody levels are not yet clear, some decline was expected and current research shows that vaccines remain effective against severe disease. For Pfizer, antibody levels reduced from a median of 7506 Units per millilitre (U/mL) at 21–41 days, to 3320 U/mL at 70 or more days. For AstraZeneca vaccine, antibody levels reduced from a median of 1201 U/mL at 0–20 days to 190 U/mL at 70 or more days, over five-fold reduction.

July 27, 2021 0 comment

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EU regulator backs AstraZeneca drug for rare blood disorder in children

by Medically Speaking Team July 27, 2021

written by Medically Speaking Team

AstraZeneca said on Monday the European Medicines Agency (EMA) recommended approving a medicine from its U.S.-based Alexion unit for treating a rare, deadly blood disorder in children and adolescents aged up to 18 years.

The drugmaker recently completed its $39-billion acquisition of Alexion, which it had agreed to buy as a bet on rare-disease immunology and to boost its business that includes a fast-growing cancer medicines unit and a major COVID-19 vaccine.

AstraZeneca said the drug Ultomiris had been given a positive opinion for paroxysmal nocturnal haemoglobinuria (PNH) by the human medicines committee of the EMA, and it follows a U.S. approval in June.

The EMA endorsement is to include children with a body weight of 10 kg or above, and those patients who are clinically stable after having been treated with another Alexion drug, Soliris, for at least the past six months.

“The potential approval of Ultomiris, which offers the efficacy and safety already established with Soliris (eculizumab) and requires fewer treatments each year, would have a meaningful impact for children with PNH and their families,” said Austin Kulasekararaj, MD at King’s College Hospital in London.

Ultomiris is an improved version of Alexion’s best-selling drug Soliris, which is used against a range of rare immune-disorders including PNH where the body’s immune system attacks its own red blood cells causing anaemia and blood clots.

July 27, 2021 0 comment

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Study suggests AstraZeneca followed by Pfizer, 4 weeks apart, gives strong immunity

by Medically Speaking Team June 29, 2021

written by Medically Speaking Team

According to the results of a study recently conducted by a University of Oxford, mixing doses of Covid-19 vaccines from Pfizer Inc. and AstraZeneca Plc creates a strong immune response against Covid-19.

A mixed schedule of the Pfizer shot followed by the Astra vaccine, and vice versa, resulted in high concentrations of antibodies against Covid-19 when given four weeks apart, researchers reported Monday in the Lancet medical journal.

The order in which people got the vaccines affected the results. Astra followed by Pfizer produced higher levels of immune antibodies and T-cells than Pfizer followed by Astra.

Doctors and public health officials have been analyzing various ways to extend vaccine supplies — by delaying the time between first and second doses, for example — as many low- and middle-income nations try to figure out how to cope with vaccine scarcity. The ability to mix doses might help countries with supplies of different vaccines assist one another.

June 29, 2021 0 comment

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