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AstraZeneca’s COVID-19 vaccine authorized for emergency supply in the UK

 COVID-19 vaccine(AstraZeneca COVID-19 vaccine)in collaboration with the University of Oxford said it has developed a formula that protects citizens 100% against severe coronary heart disease, which leads to hospitalization. Pfizer and modern vaccines are equal.

British authorities are expected to approve the “Astra Zenka” coronavirus vaccine this week. Meanwhile, the head of the pharmaceutical company says that their vaccine will be as effective as the “Pfizer-BioNek” and “Moderna” vaccines against the coronavirus.“Their company has found the winning formula and how it works,” Pascal Sourio, chief executive of Astra Zenka, told The Sunday Times.He added that he believes their company’s vaccine is also effective against the new and more contagious strain of the coronavirus, which has caused concern around the world.

VOA English Service –

AstraZeneca COVID-19 vaccine
FILE PHOTO: Vials with a sticker reading, “COVID-19 / Coronavirus vaccine / Injection only” and a medical syringe are seen in front of a displayed AstraZeneca logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

According to Imena, initial tests of this vaccine have yielded different results in terms of its effectiveness. Initially, its effectiveness was about 70%, but with the change in dose of the vaccine, its effectiveness increased to 90%.

In clinical trials of the vaccine on a large scale by volunteers in English and Brazil, the vaccine for two-dose completely received about 60 percent efficiency, but people first half of the dose and one month after a dose of full received, showed 90% efficiency. The lack of clarity and clarity in the different results obtained from these experiments led to strong criticism of these results.

The UK government announced on December 23 that suppliers of the Oxford-AstraZeneca vaccine had provided information about the vaccine to the Medicines and Health Regulatory Agency. This information is under review and is expected to be made public after the Agency has issued its opinion.

Europe Union member states yesterday to the official population of 450 million EU vaccination plan against the epidemic,  “COVID-19” began. Vaccination programs in EU member states began while cases of the coronavirus mutation, which had previously spread to Britain, were also reported in France and Spain.

The leaders of the 27-nation European Union have worked to ensure that the vaccine is made available to all of them fairly, and each country began its own corona vaccination program yesterday with vaccines from Pfizer and Bayonne Tech.

Over the past few weeks, three new strains of the coronavirus have been identified that are prevalent in at least 13 countries around the world. Among these viruses, the strain that was identified in the UK on December 14 and is called VUI-202012 is up to 70% more contagious than other strains of the virus.

Last week, South Africa announced the discovery of a new strain of the coronavirus called 501.V2, which has mutated even more than the British strain and is now the dominant virus in South Africa.

A third strain of the virus, identified as P681H, has been identified in Nigeria. The mutation type of this virus is different from the previous two species, and apparently, its spread rate is slower than the other two new species.
However, none of the new species are more lethal than the previous species and are not vaccine-resistant.

This announcement contains inside information

30 December 2020 07:00 GMT


Working with the UK government, first vaccinations to begin early in the New Year

Regulatory interactions continue around the world for next approvals

AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorisation for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunisation of individuals 18 years or older. The authorisation recommends  two doses administered with an interval of between four and 12 weeks. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.

AstraZeneca is working with Public Health England and National Health Service England to support the deployment and roll out of the vaccine in the UK, in line with the MHRA and the UK’s Joint Committee on Vaccination and Immunisation dosing recommendation. The Company aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total.

Pascal Soriot, Chief Executive Officer, said: “Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”

Matt Hancock, UK Secretary of State for Health and Social Care, said: “This is a moment to celebrate British innovation – not only are we responsible for discovering the first treatment to reduce mortality for Covid-19, this vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease. It is a tribute to the incredible UK scientists at Oxford University and AstraZeneca whose breakthrough will help to save lives around the world. I want to thank every single person who has been part of this British success story. While it is a time to be hopeful, it is so vital everyone continues to play their part to drive down infections.”

Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants. Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.”

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. This is the first authorisation for this vaccine.

The MHRA’s decision was based on independent advice from its Commission on Human Medicines following a rolling review of trial data that included an interim analysis of the Phase III programme led by the University of Oxford. The data were also published in The Lancet on 8 December 2020.

Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials. AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional marketing authorisation during the health crisis. AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries.

AstraZeneca is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. The vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.

AZD1222
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.

The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the UK and Brazil Phase III trials conducted by Oxford University. As announced on 23 November 2020, the primary efficacy endpoint based on a pooled analysis showed that the vaccine was 70.4% (confidence interval: 54.8% to 80.6%) effective at preventing symptomatic COVID-19 occurring more than 14 days after receiving two doses of the vaccine. A secondary efficacy endpoint of prevention of severe disease demonstrated no cases of severe infections or hospitalisations in the vaccine group.

The safety data published so far is from over 20,000 participants enrolled across four clinical trials in the UK and Brazil and South Africa. The Lancet publication confirmed that AZD1222 was well tolerated and that there were no serious safety events confirmed related to the vaccine. The participants were from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. This analysis provides safety data on 74,341 person-months of follow-up after first dose (median 3.4 months) and 29,060 person-months of follow-up after two doses (median 2.0 months). The overall reported rates of serious adverse events were 0.7% in the vaccine group and 0.8% in the control group.

In addition to the programme led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enrol up to 60,000 participants globally.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation 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. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

source: AstraZeneca

But only one day after the announcement of AstraZeneca, The European Medicines Agency is demanding more data from AstraZeneca and the University of Oxford on its Covid-19 vaccine before authorizing it.

AstraZeneca / Oxford vaccine will not get the green light from the EU in January

The European Medicines Agency is demanding more data from AstraZeneca and the University of Oxford on its Covid-19 vaccine before authorizing it.

The EU will not give the green light in January for the AstraZeneca / Oxford vaccine (image
AstraZeneca COVID-19 vaccine
IMAGES BY TANG MING TUNG VIA GETTY IMAGES
EU will not give green light in January for AstraZeneca / Oxford vaccine (illustrative image)

CORONAVIRUS – An authorization from January within the European Union of the anti-Covid vaccine developed by the AstraZeneca group with the University of Oxford, which has just been approved in the United Kingdom, seems unlikely, estimated the European Medicines Agency (EMA).

“Additional scientific information on issues related to the quality, safety and efficacy of the vaccine is deemed necessary to strengthen the rigor required for a conditional marketing authorization and this has been requested of the company” the EMA said in a statement on Wednesday.

“Aucune autorisation de mise sur le marché formelle n’a encore été soumise à l’EMA” pour ce vaccin, signifiant qu’un calendrier n’a pas pu être établi pour le moment, avait indiqué mardi soir à l’AFP l’agence basée à Amsterdam.

EMA deputy executive director Noël Wathion told Belgian daily Het Nieuwsblad on Tuesday that a possible authorization within the next month was “unlikely”, remarks later confirmed by the agency.

“Further information on ongoing clinical trials is also expected from January,” the EMA added on Wednesday.

The agency says it is “well aware” that the MHRA, the UK regulator , has approved the vaccine “for emergency use, which is separate from a marketing authorization” in the EU .

“We are able to confirm that we have submitted a complete dossier to the European Medicines Agency, in order to support an application for conditional marketing authorization for the AstraZeneca vaccine against Covid-19”, affirmed Wednesday a spokesperson for AstraZeneca with AFP.

“AstraZeneca has provided data on an ongoing basis and will continue to work closely with the EMA to support the start of a formal process for applying for conditional marketing authorization,” he said.

The AstraZeneca / Oxford vaccine is currently undergoing a “continuous review”, a fast-track procedure that allows the EMA to review vaccine safety and efficacy data as they become available, even before they are released. a formal request for authorization is submitted by the manufacturer.

The EMA authorized the Pfizer / BioNTech Covid-19 vaccine on December 21 , for which the European Commission immediately gave the green light, and must decide on January 6 on that of Moderna.

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