Vaxzevria (formerly AstraZeneca COVID-19 vaccine)

The main articles are:

• Vaccines against coronavirus COVID-19
• Vaccines against coronavirus COVID-19 in Russia

2024: Stoppage of COVID-19 vaccine sales due to low demand and side effects

In May 2024, AstraZeneca halted sales of the COVID-19 vaccine due to low demand and side effects. The decision was announced after the company admitted in court that the drug could cause a rare thrombosis with thrombocytopenia syndrome.

AstraZeneca itself said in a statement that such a decision was made because "many new vaccines are available on the market, adapted to combat COVID-19 variants." This led to a decrease in demand for the AstraZeneca vaccine, which is no longer produced or supplied.

AstraZeneca halted sales of COVID-19 vaccine

We are incredibly proud of the role Vaxzevria has played in the fight against the global pandemic. According to independent estimates, 6.5 million lives were saved in the first year of its use alone, and over 3 billion doses were sent around the world, the company said in a statement. - Since vaccines have since been developed against numerous variants of COVID-19, there is an excess of updated vaccines. This led to a decrease in demand for Vaxzevria, which is no longer produced or sold, the pharmaceutical company said in a statement.

An application for the withdrawal of the Vaxzevria vaccine in the European Union was filed on March 5. It entered into force on May 7 after the publication of the relevant notification from the European Medicines Agency. In the near future, the vaccine is planned to be withdrawn in Britain and other countries, The Guardian newspaper writes in its May 8, 2024 issue.

The vaccine was authorized for use in individuals aged 18 and was administered as two injections, usually into the muscle of the upper arm, approximately three months apart.

AstraZeneca's market capital on the news of the vaccine recall increased by more than £3 billion ($3.75 billion), the newspaper notes. During trading on the stock exchange in the London company's securities on May 8, 2024, they jumped 1.6%.^[1]

2023

AstraZeneca has admitted a terrible side effect of its coronavirus vaccine

At the end of April 2024, the British-Swedish pharmaceutical company AstraZeneca for the first time admitted that its vaccine against the coronavirus COVID-19 could provoke a severe side effect. We are talking about thrombosis, which can cause death.

According to the newspaper The Telegraph, reports of the extremely negative consequences of the impact of the AstraZeneca vaccine on the body of some patients began to arrive in the spring of 2021. In very rare cases, an adverse reaction called vaccine-induced immune thrombocytopenia and thrombosis (VITT) was manifested. It is estimated that these complications in 20% of cases lead to the death of the patient. And survivors have health problems. For example, one of the patients after the introduction of the vaccine in April 2021 developed a blood clot and hemorrhage in the brain, which led to irreversible damage. As a result, the man completely lost his ability to work.

AstraZeneca admits for the first time that its COVID-19 coronavirus vaccine could provoke a severe side effect

A class action lawsuit has been filed against AstraZeneca alleging that a vaccine developed by the company in conjunction with Oxford University provoked a number of deaths or caused serious harm to the health of patients. The causal mechanism between the administration of the drug and the formation of thrombosis is unclear, court documents say.

In total, at least 158 people were affected by the AstraZeneca vaccine. As part of the British government program, compensation was paid in each case in the amount of £120 thousand (about $151 thousand at the exchange rate as of May 6, 2024). AstraZeneca will also compensate the victims and their relatives: the amount of payments is estimated at £100 million (approximately $125.86 million).

We sympathise with anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, says AstraZeneca.[2]

Danish government to pay $1.6 million to woman who lost performance due to AstraZeneca vaccine

In mid-December 2023, it became known that the Danish government would pay a record compensation to a local resident in connection with the loss of performance after undergoing vaccination against COVID-19. The woman is entitled to 11 million crowns, which is equivalent to $1.63 million at the exchange rate as of December 22, 2023.

According to the Danish trade union publication FOA, a 32-year-old medical student was vaccinated with AstraZeneca vaccine. However, the administration of the drug provoked serious side effects: incessant headaches, difficulty concentrating and chronic fatigue. As a result, the woman almost completely lost the opportunity to do the usual work. According to the conclusion of the organization "Economic Insurance of the Labor Market," it was recognized as having lost 90% of its performance.

It is emphasized that the victim received an injection of the vaccine 12 days before the drug introduced to her was withdrawn from circulation due to the identified side effects. Moreover, it is alleged that the woman was forced to agree to vaccination due to certain pressure: she belonged to a professional group for which the passage of the procedure was recommended by the municipality authorities. It is noted that the amount of compensation corresponds to the amount that a woman could have received by the time of retirement age, if she had not lost her performance.

In 2021, some countries of the European Union temporarily suspended the use of AstraZeneca's COVID-19 vaccine as a precautionary measure in connection with reports of rare cases of thrombosis in persons who received injections of this vaccine. Then the WHO said that the benefits of using the drug "outweigh the existing risks."^[3]

2022

In Spain, victims of the AstraZeneca vaccine complained that they were not treated

Workers of the vital services of Spain affected by the AstraZeneca vaccine in December 2022 ask the authorities to treat them for serious side effects, reports the Spanish newspaper El Periodico.

The Association of Essential Workers Affected by the AstraZeneca Vaccine said its members continue to suffer the serious adverse effects of vaccination.

In Spain, the AstraZeneca vaccine necessarily vaccinated vital workers, but after reports of thrombosis, its use was suspended for people under 60 years old, and then the vaccine was finally withdrawn from use.

A lack of knowledge about the side effects of this vaccine means many of the affected people suffer from delays in detecting diseases, according to association secretary Professor Bertha Giharro. Gijarro emphasizes that Spanish medicine does not recognize that the vaccine is a trigger for diseases suffered by members of the association, there is no therapeutic protocol for actions to treat side effects caused by vaccines. This means that specialists cannot receive advice on many cases.

Giharro herself has not been able to return to work for more than a year, since after vaccination against coronavirus she suffers from severe headaches due to thrombosis of the left venous sinus. The blood clot passed, but there were memory problems and severe headaches, she notes.

Confirmation of the safety of the combination with the Sputnik Light vaccine

On February 14, 2022, the R-Pharm Group of Companies, the Russian Direct Investment Fund (RDIF, the sovereign fund of the Russian Federation) and AstraZeneca announced interim results of phase II clinical trials to assess the safety of the combined use of AstraZeneca vaccine and the first component of the Sputnik V coronavirus vaccine (Sputnik Light drug based on human adenovirus 26 serotype). Read more here.

2021

Hungary: Sputnik V better protects against death from coronavirus than Pfizer, Moderna and AstraZeneca vaccines

At the end of November 2021, the Russian Direct Investment Fund (RDIF) published the results of an independent study of vaccines against the coronavirus COVID-19 in Hungary. According to the results of this work carried out by the National Center for Public Health of Hungary ( NPHC), Sputnik V shows higher protection against deaths (98%) compared to other drugs that are used in the country to vaccinate the population. The study was conducted based on an analysis of vaccination data from two components of Sputnik V vaccines, Moderna, Pfizer-BioNTech, Sinopharm and AstraZeneca of Hungarian residents between January 22 and June 10, 2021, ​Podrobneye here.

Canadian Health Ministry warns of risk of blood clots after J&J and AstraZeneca vaccinations

On November 9, 2021, Health Canada updated the labels of COVID-19 vaccines from AstraZeneca and Johnson & Johnson (J&J), adding the immune thrombocytopenia, an autoimmune disease, as a potential side effect. More than 224 thousand Canadians received two doses of AstraZeneca Vaxzevria vaccine from coronavirus (COVID-19) infection and more than 9 thousand received a single-use J&J vaccine.

Health Canada reported that very rare cases of immune thrombocytopenia (ITP) have been reported internationally after receiving COVID-19 vaccines from AstraZeneca and Johnson & Johnson. ITP is a disease that can cause mild or excessive bruising and bleeding resulting from unusually low blood platelet counts. Such cases usually occur within 28 days of vaccination, the agency said. Deaths resulting from post-vaccination ITP have also been reported outside of Canada. Some cases have occurred in people who have previously suffered from the condition.

Primary immune thrombocytopenia, formerly known as idiopathic thrombocytopenic purpura or Verlhof's disease, is an acquired autoimmune disease characterized by isolated thrombocytopenia. In the case of the disease, the number of platelets in the peripheral blood is less than 100 thousand/μl, in the absence of known causes that cause thrombocytopenia or disorders accompanied by thrombocytopenia.

Both AstraZeneca and J&J vaccines have been approved for use in Canada and are considered safe and effective. The Ministry of Health of Canada recommended that Canadians seek medical attention immediately if the following symptoms occur after AstraZeneca and J&J vaccinations:

• unexplained bleeding;
• unexplained bruising;
• small purple spots outside the vaccination site;
• shortness of breath;
• chest pain;
• leg pain or swelling;
• persistent abdominal pain.

Health Canada reported that if a person has a history of a thrombocytopenic disorder, such as immune thrombocytopenia, then the risk of low platelet counts should be considered before vaccine administration, and platelet monitoring is recommended after vaccination. In its label update, the Ministry of Health said there was also a rare risk of venous thromboembolism (VTE), a type of blood clot that forms in a vein, after being vaccinated with J&J vaccine.

In March 2021, Health Canada added a blood clot warning to the Oxford-AstraZeneca vaccine after several post-immunization reports. In June 2021, the Ministry of Health updated the label of Oxford-AstraZeneca and Covishield COVID-19 vaccines, adding capillary leakage syndrome as a potential side effect.^[4]

Argentine Ministry of Health: more serious side effects from Sputnik V than from AstraZeneca vaccine

At the end of October 2021 health care Argentina , the ministry published the results of a large-scale study of the side effects of vaccines against coronavirus, COVID-19 which the population is vaccinated with in the country. More. here

Britain apologized for fake about Russia's theft of AstraZeneca coronavirus vaccine formula

On October 12, 2021, the British newspaper Daily Express apologized for the publication, which stated that the developers of the Sputnik V coronavirus vaccine allegedly stole the AstraZeneca drug formula. Read more here.

The effectiveness of the AstraZeneca vaccine was much lower than that of Russian drugs

At the end of September 2021, AstraZeneca's COVID-19 coronavirus vaccine demonstrated 74% effectiveness in preventing symptomatic disease, which increased to 83.5% in people aged 65 and older. Such results were obtained from AstraZeneca's own large-scale analysis.

The overall vaccine effectiveness of 74% was lower than the interim figure of 79%, which the British drugmaker reported in March 2021 and which AstraZeneca revised a few days later to 76%, after a public rebuke from officials health care USA that this indicator was based on outdated information.

The study involved more than 26 thousand volunteers in the United States, Chile and Peru, who received two doses of the vaccine with an interval of about a month. The results of the study were published in the New England Journal of Medicine.

Among more than 17.6 thousand participants who received the COVID-19 vaccine by the end of September 2021, not a single case of severe or critical symptoms was registered, compared with 8 such cases among 8.5 thousand volunteers who received placebo. In addition, there were two deaths in the group, but none among those who received the vaccine.

I was pleasantly surprised. The AstraZeneca vaccine also provided a high degree of protection against severe illness and hospitalization, said Dr. Anna Durbin.

No cases have been recorded of a rare but serious side effect of blood clotting called thrombosis with thrombocytopenia, which has been linked to the AstraZeneca vaccine developed in conjunction with Oxford University researchers.

In late July 2021, AstraZeneca officials said they planned to apply for full approval with the U.S. Food and Drug Administration (FDA) rather than seek emergency use authorization. Chief Executive Officer Pascal Sorio told a media briefing that he hoped the vaccine could still play a role in the United States, even as the process takes longer than expected.

According to the UAE Ministry of Health, the effectiveness of Sputnik V during use in the country was 97.8%, the vaccine also provides complete (100%) protection against severe cases. Not a single case of serious side effects was recorded. EpiVacCorona and KoviVac were also more effective than AstraZeneca.

AstraZeneca is exploring the possibility of using booster doses for people who have already been vaccinated with two doses of their own vaccine or mRNA-based vaccines from Pfizer/BioNTech or. Moderna^[5]

Risk of Guillain-Barré syndrome nervous disorder after vaccine use

In September 2021, EMA released an important update: new side effects of the AstraZeneca vaccine are reported.

The European medicines regulator has added a rare nerve disorder, Guillain-Barré syndrome (GBS), as a possible side effect of the vaccine.

The regulator also noted some other less serious side effects of vaccines from Johnson & Johnson, Moderna and AstraZeneca.

Combination with first component of Sputnik V vaccine shows high immunogenicity profile

On August 20, 2021, the R-Pharm group of companies, the Russian Direct Investment Fund and AstraZeneca announced preliminary data on the immunogenicity of the combined use of AstraZeneca vaccine (developed jointly with Oxford University) and the first component of the Sputnik V coronavirus vaccine (Sputnik Light drug based on human adenovirus 26 serotype), obtained as part of a clinical study in the Republic of Azerbaijan.

In December 2020, the Gamaleya Center Russian direct investment fund, the R-Pharm group of companies and the AstraZenek company, in the presence of the President Russia Vladimir Putin , signed a memorandum suggesting joint clinical studies of the safety and immunogenicity of the combination of the AstraZenek vaccine and the first component of the Sputnik V vaccine.

Research in Azerbaijan, carried out at the initiative of the memorandum participants with the financial support of R-Pharm, began in February 2021. As of August 2021, 64 volunteers have been vaccinated, and recruitment to the clinical trial is ongoing.

According to preliminary data obtained from observations of the 20 first participants in the studies, 100% of volunteers had the production of antibodies to the spike protein (S-protein) of the SARS-CoV-2 virus.

An interim analysis of the data also previously demonstrated high safety indicators for combined use of drugs: there are no serious adverse events, as well as cases of coronavirus infection after vaccination.

A clinical trial of a combination of vaccines is being implemented within the framework of a global program in several countries at once. Volunteers are vaccinated in the United Arab Emirates and Argentina, regulatory approval for research in Russia and Belarus is obtained.

{{quote 'author = said Vasily Ignatiev, CEO of R-Pharm Group of Companies. |

Against the background of the spread of coronavirus mutations, the study of a combination of vaccines becomes more important. The obtained data on the high immunogenicity of such a combination look quite encouraging. We will continue to carefully analyze the preliminary results of the study and are already awaiting the receipt of data on the clinical effectiveness of this vaccination scheme.}}

Preliminary results of AstraZeneca and Sputnik Light vaccine combination study received in Azerbaijan

On July 30, 2021, preliminary results of a clinical study of the combined use of the AstraZenek vaccine (developed jointly with Oxford University) and the first component of the Sputnik V vaccine, conducted in the Republic of Azerbaijan, were obtained . Read more here.

Serbian Ministry of Health: Sputnik V caused the fewest side effects compared to Sinopharm, Pfizer and AstraZeneca vaccines

In July 2021, the Ministry of health care Serbia reported that "" Sputnik V caused the fewest side effects in comparison with other coronavirus vaccines COVID-19 used in the country. More. here

Immune response after first dose of vaccine allegedly persists for a year

The immune response after the introduction of the first dose of AstraZenek's COVID-19 vaccine persists allegedly for a year. This became known on July 1, 2021.

According to the results of clinical studies at the University of Oxford, the COV001 and COV002 administration of two doses of COVID-19 vaccine with a longer (up to 45 weeks) interval between doses, as well as the introduction of a third booster dose, contributes to an increased immune response.

Research data published by Oxford University as a preprint in the journal The Lancet showed that the high antibody titer remains for at least one year after the first dose of AstraZeneca's COVID-19 vaccine.

At the second dose, up to 45 weeks apart, the antibody titer was 18 times higher than after the first dose. In turn, at the interval between doses up to 12 weeks, the antibody titer increased by 4 times. The obtained results indicate that a longer interval between doses contributes to the enhancement of the immune response.

In addition, the results of the analysis showed that the introduction of the third dose of AstraZenek's COVID-19 vaccine 6 months after the second dose contributed to a six-fold increase in antibody titer and the maintenance of a T-cell immune response. The introduction of the third dose of AstraZeneca COVID-19 vaccine also contributed to an increase in the neutralizing activity of antibodies against the Alpha strains (B.1.1.7, Kent), Beta (B.1.351, South African) and Delta (B.1.617.2, Indian). The reactogenicity of the second dose of AstraZenek's COVID-19 vaccine administered with an increased interval, as well as the third dose of the vaccine, was lower than after the first dose.

This is encouraging news for countries with lower levels of access to COVID-19 vaccines, which are experiencing difficulties in supplying the second component. Even when two doses of vaccine are given 10 months apart, we observe a high level of immune response, said Professor Andrew John Pollard, leader of the Oxford University study.

Research data demonstrating that AstraZeneca's COVID-19 vaccine induces a persistent immune response gives confidence in long-term protection against coronavirus infection. We look forward to continuing to work with the University of Oxford and recommend that health regulatory organizations around the world continue to study the findings, noted Mene Pangalos, Executive Vice President, Biological Drug Research and Development, AstraZeneca.

The analysis included volunteers aged 18 to 55 years who participated in COV001 and COV002 studies and received either one or two doses of AstraZeneca's COVID-19 vaccine.

Georgian Health Minister infected with COVID-19 after vaccination with AstraZeneca

On June 1, 2021, it became known about the detection of coronavirus COVID-19 in. Ekaterina Tikaradze Prior to that, the minister health care Georgia was vaccinated with AstraZeneca. More. here

Identification of the cause of blood clots during vaccination with AstraZeneca

At the end of May 2021, a group of German scientists from Goethe University in Frankfurt established the cause of rare thrombosis when vaccinated with AstraZeneca and Johnson & Johnson. They suggest that the problem lies in the adenoviral vector used in vaccines to deliver instructions to the cell nucleus.

AstraZeneca and Johnson & Johnson's vaccines have been criticized in recent months for rare but serious cases of thrombosis. The first death in the EU associated with the Johnson & Johnson vaccine against COVID-19 was reported in Belgium, where a 37-year-old woman died. As a result, vaccination of people under 41 years old was suspended in the country. More than 140 cases of thrombosis have been reported among people who received the AstraZeneca vaccine in the European Economic Area. In the US, the Centers for Disease Control and Prevention found a "plausible causal relationship" between the Johnson & Johnson vaccine and 28 cases of blood clots.

Professor Rolf Marschalek and his team believe that some parts of the protein produced by the vaccine are cleaved and create "mutant" versions that cause blood clots. In the article, this phenomenon is called the syndrome "induced by the COVID-19 mimicry vaccine." The researchers suggest that vaccine manufacturers could alter the sequence of amino acids in the protein produced in a way that prevents unintended cleavage and "improves the safety of these drugs." The researchers also suggest that all mRNA-based vaccines, such as the Pfizer and Moderna vaccine, "should be safe" because they use a different technology.

It should be noted that the paper published on the preprint platform Research Square has not yet been peer-reviewed by journals.^[6]

Pfizer and AstraZeneca vaccine combination leads to more side effects - Lancet

In mid-May 2021, the international medical journal The Lancet published interim results of a study according to which when vaccinated against COVID-19 with a combination of drugs from Pfizer and AstraZeneca, the risks of side effects become higher than when the same drug is administered twice. Read more here.

The AstraZeneca vaccine produced in Russia was called "R-Covi"

On March 12, 2021, the name became known, coronavirus vaccines COVID-19 which, under the license of the British pharmaceutical company AstraZeneca Oxford University , will be produced by the Russian company "." R-Pharm More. here

After the introduction of the vaccine, AstraZeneca die 6 times more often than from Sputnik V

In April 2021, the Russian Direct Investment Fund (RDIF) published the results of a study of mortality after the introduction of vaccines against the coronavirus COVID-19 from different manufacturers. The report examined publicly available data from 13 medical regulators (USA, France, Germany, UK, Norway, Austria, Italy, India, Argentina, Brazil, Chile, Denmark and Russia).

According to statistics provided in the official Twitter account of Sputnik V (RDIF is promoting the vaccine), there are only 2 deaths per 1 million people vaccinated with this Russian drug. For comparison, the average mortality rates after vaccination with Pfizer/BioNTech and Moderna are 39.4 and 20.2, respectively. As for the AstraZeneca product, here we are talking about mortality of 12.8 (6 times more than Sputnik V). Johnson & Johnson has 7.5.

The reasons for such serious discrepancies in the number of deaths among various vaccines should become the subject of honest scientific and public discussion, the authors of the study noted, adding that at the time of publication of the work (April 2021), there was also no clear link between vaccination and deaths.

In April 2021, Roszdravnadzor said that the department is constantly monitoring the safety of vaccines and has not recorded a single fatal case resulting from vaccination against coronavirus.

The government of Hungary, which began to use Sputnik V, has published data on the safety and effectiveness of five vaccines. According to the report, the Russian drug showed the best indicators in the categories under consideration: for example, among 100,000 vaccinated, the average mortality was 7-32 times less, and the number of COVID-19 infections was 2-7 times lower.^[7]

Denmark is the first in the world to completely abandon the AstraZeneca vaccine

In mid-April 2021, Denmark was the first in the world to completely abandon the AstraZeneca vaccine against the COVID-19 coronavirus due to concerns about rare cases of thrombosis. It is assumed that this measure will delay the completion of the vaccination program in the country for several weeks. The country has completely abandoned the already purchased 2.4 million doses of the vaccine.

The European Medicines Surveillance Agency announced a possible link between vaccines and blood clots, but noted that the risk of death from COVID-19 is much higher. Several European countries previously briefly suspended vaccination, but soon resumed again, albeit with restrictions on older age groups.

In early April 2021, the United States, Canada and the European Union suspended vaccination with Johnson & Johnson for similar reasons due to suspected cases of thrombosis. South Africa also suspended the use of the Johnson & Johnson vaccine, although it was previously preferred, since this vaccine effectively prevented infection with the South African variant of the coronavirus.

The Danish Health Authority said studies have found a higher-than-expected incidence of blood clots after vaccine administration - with thrombosis developing in about one in 40,000 people. In Denmark itself, there were two cases of thrombosis suspected of being associated with vaccination. One case was fatal.

Health Director General Soren Brostrom noted that it was a "difficult decision," but Denmark has other vaccines, and the epidemic there is currently under control.

The World Health Organization (WHO) has criticised the EU for its low vaccination rates and there are concerns that the latest delays could lead to more problems.^[8]

Cause of blood clots after AstraZeneca vaccine administration

In April 2021, a study was published in the New England Journal of Medicine, in which a working group of immunologists and hematologists from, and Germany Canada Austria named the possible cause of formations blood clots after vaccination with a drug against coronavirus. COVID-19

Scientists studied the clinical and laboratory data of 11 patients from Germany and Austria who developed thrombosis or thrombocytopenia after administration of the AstraZeneca vaccine. In addition, the analysis includes blood samples of patients who are referred to assess the cause of thrombotic events after vaccination.

The researchers' conclusion is this: administration of the AstraZeneca vaccine can lead to the development of rare immune thrombocytopenia, which clinically mimics heparin-induced autoimmune thrombocytopenia. In vaccination, platelet mediated activation by anti- PF4 antibodies occurs.

Professor of Hematology from Norway Paul Andre Holm, who led the study of cases of the disease in vaccinated in the country, said that during the work an antibody was determined, which is formed after vaccination with AstraZeneca and can provoke an autoimmune reaction and subsequent thrombosis.

In March 2021, the director of the center. N.F. Gamaleya, who developed the Sputnik V vaccine, Alexander Gintsburg suggested that a possible cause of blood clots after the use of the coronavirus vaccine developed by AstraZeneca may be poor-quality cleaning of the drug. The degree of purification, which is carried out as a result of production operating time, is different - two to three stages.

Perhaps in this case, an incomplete degree of purification was used and some products that could remain in the final product could contribute to platelet aggregation in some of the patients who received this drug, - said Gunzburg.[9]

Death of vaccinated patients in India

As of the end of March 2021, 180 cases (29.2%) of patient deaths were reported in India after vaccination with Covishield for COVID-19, as well as AstraZeneca. A total of 617 cases of different severity of adverse reactions were recorded. This is reported by the National Committee on Side Effects after Immunization (AEFI). Read more here.

WHO recognizes association of AstraZeneca vaccine and blood clots

In April 2021, the World Health Organization (WHO) recognized the association of the AstraZeneca vaccine with the occurrence of blood clots in those vaccinated. After that, trials of the drug on children and adolescents were stopped in the UK, and the Haitian authorities completely refused to use it.

There is a clear connection between the use of the AstraZeneca vaccine from COVID-19 and a very rare emerging cerebral thrombosis, brain although the direct cause of this syndrome is still unknown, - WHO Director for Regulation and Pre-Qualification Rogeriu Pinto de Sa Gaspard, whose words are quoted. Reuters

At the same time, according to him, the advantages of the use of the AstraZeneca vaccine outweigh its disadvantages, so there is no reason to change the assessment of benefits and risks. WHO and the European Medicines Agency (EMA) continue to work by April 7, 2021, analyzing the risks and benefits of the vaccine.

We see rare examples of thrombocytopenia combined with thrombosis. However, it is necessary to understand that the vaccine significantly reduces mortality from coronavirus. This is not said much, but it must be taken into account... Now there are a number of committees and regulators that look at the data, and new data comes in every day, and evaluate this data, "said de Sa Gaspard.

According to Gaspard, WHO has contacted various national and regional expert committees that will decide on the regulatory status of the vaccine.

Oxford University said there were no problems in paediatric trials of the vaccine, however Oxford is awaiting more information from the Medicines and Healthcare products Regulatory Authority (MHRA) before continuing to vaccinate children and adolescents.^[10]

EU regulator confirms link between AstraZeneca vaccine and thrombosis

In early April 2021, the European Medicines Agency (EMA) confirmed the link between thrombosis and vaccination with the drug of the British-Swedish company AstraZeneca and the University of Oxford.

Now we can say that the association [of blood clots] with the vaccine is obvious. But we still do not know what causes such a reaction, "said Marco Cavalieri, head of the EMA health threats and vaccination strategy unit, in an interview with the Italian newspaper Il Messaggero.

According to him, young women, who are often susceptible to thrombosis, suffer less from the effects of COVID-19, so it will be necessary to assess the risk-benefit ratio for them.

Deputy Minister health care Italy Pierpaolo Sileri admitted that the EMA may recommend not using the AstraZeneca vaccine to certain age categories. At the same time, the minister noted that there are very few cases of thrombosis against the background of millions of vaccinations made.

There is no shadow of doubt that the risk-benefit ratio remains positive, "Sileri added.

The British Agency for the Control of Medicines and Medical Devices (MHRA) said that the medical authorities will "carefully and in detail study" information about "very rare and specific types of blood clots" in the case of the AstraZeneca vaccine. At the same time, MHRA chief June Raine urged Britons to "continue to vaccinate when given the opportunity."

On March 18, 2021, the EMA, the British Medical Regulator (MHRA) and the Dutch side effects center Lareb announced that they had not established a relationship between AstraZeneca vaccination and thromboembolic complications in those vaccinated. AstraZeneca denied the risks of blood clots in those who were vaccinated.

Cases of blood clots after the use of this vaccine were reported from different countries: for example, on April 3, 2021, it became known that seven people had died in the UK in recent days.^[11]

Renaming the vaccine to Vaxzevria

In March 2021, AstraZeneca changed the name of its controversial "scandalous" vaccine against the coronavirus "Covid-19 Vaccine AstraZeneca" to Vaxzevria.

Death of a serviceman in Ukraine after vaccination with AstraZeneca

On March 23, 2021, it became known about the death, Ukrainian serviceman which shortly before that passed coronavirus vaccination COVID-19 the drug. AstraZeneca More. here

Publication of data from a clinical study of vaccine efficacy in the United States

On March 22, 2021, AstraZeneca announced the publication of interim data from a clinical study of the effectiveness of the COVID-19 vaccine in the United States.

An interim analysis of a phase III study in the United States showed the effectiveness of a vaccine for the prevention of COVID-19:

• 79% in relation to the development of symptoms of COVID-19;
• 80% in persons aged 65 years and older;
• 100% with regard to the prevention of a severe course of the disease and hospitalizations.

An independent data monitoring committee involved in the study also confirmed the optimal safety profile of the vaccine, the company said.

The interim results of assessing the effectiveness of the vaccine are based on data from a study conducted in the United States with the participation of 32,449 volunteers, among which 141 cases of COVID-19 infection were detected. During the phase III study conducted by AstraZeneca in the USA, volunteers were administered two doses of vaccine or placebo with an interval of 4 weeks. All study participants were randomized to receive vaccine and placebo in a 2:1 ratio.

The results of the study in the United States add to the accumulated data indicating the effectiveness and optimal safety profile of the vaccine for the prevention of COVID-19 of all degrees of severity in different ethnic and age groups, the company noted.

AstraZeneca is preparing to submit the data to the Food and Drug Administration (FDA).

27-year-old nurse dies after being vaccinated with AstraZeneca vaccine in Georgia

On March 18, 2021 health care Georgia , the Ministry announced the death of a 27-year-old nurse who had previously been vaccinated against coronavirus COVID-19 with the drug. AstraZeneca According to the statement of the department, she died in the hospital from anaphylactic shock, which manifested itself in her immediately after vaccination. More. here

Chief Sanitary Doctor of Ukraine fell ill with coronavirus after AstraZeneca vaccination

On March 15, 2021, the chief sanitary doctor of Ukraine Viktor Lyashko reported infection with the COVID-19 coronavirus a few days after vaccination with AstraZeneca. Read more here.

16 countries stopped vaccination with AstraZeneca after dozens of cases of thrombosis in vaccinated

By mid-March 2021, 16 countries stopped vaccination against the coronavirus COVID-19 with AstraZeneca after a wave of thrombosis in vaccinated people. The manufacturer itself claims the safety of its development.

In particular, by March 15, 2021, the AstraZeneca vaccine is under a temporary ban in Austria,, Estonia,, To Lithuania, Latvia on Luxembourg, in,, Cyprus,,, Denmark, and Norway. Iceland Italy Bulgaria Romania Ireland Thailand

In addition, on March 14, the suspension of the use of the drug was announced in Holland. The Dutch government said it was waiting for the outcome of an investigation by the European Medicines Agency (EMA). Due to the decision to suspend the use of the drug, the authorities will have to cancel 43 thousand vaccination records. At the same time, in Holland itself, there were no cases of thrombosis in patients after vaccination with AstraZeneca.

By March 8, 15 cases of deep vein thrombosis and 22 cases of pulmonary embolism in vaccinated patients were detected in the EU and the UK. This is much less than one might expect, AstraZeneca explained.

The company noted that they studied in detail the health status of more than 17 million people in countries European Union and the UK who received doses of the drug. According to the pharmaceutical manufacturer, the analysis of the data did not show an increase in the risk of thrombosis and pulmonary embolism after vaccination.

On March 11, Minister health care France Olivier Veran assured the population that there was no reason to suspend vaccination with AstraZeneca, and statistically the benefit-risk ratio was "quite encouraging." According to him, the EMA said that vaccination with AstraZeneca's COVID-19 drug does not increase the risk of blood clots, the use of the vaccine can continue.^[12]

Suspension of vaccination in Denmark after blood clots in vaccinated

On March 11, 2021, the National Health Denmark Council announced the suspension of vaccination against coronavirus COVID-19 with the drug in the country. AstraZeneca This decision was made after reports of education blood clots appeared in people who were vaccinated.

Vaccination with a drug manufactured by AstraZeneca has been stopped for 14 days in Denmark. The decision on the further use of the vaccine will be made from March 29 to April 1.

Danish Health Minister Magnus Heunike noted that it has not yet been possible to accurately determine the connection between AstraZeneca vaccination and blood clots, but Denmark wants to prevent complications and considers it necessary to investigate.

We are in the process of the largest and most important vaccination in Danish history. We need all available vaccines, says the director of the Seren Brostrem National Health Council. - Therefore, it is not an easy decision to suspend vaccination with one of the drugs. But precisely because we vaccinate so many, we also need to respond in a timely manner to reports of possible serious side effects. We need to clarify the situation before we can continue using the vaccine from AstraZeneca.

Brostrem stressed that Denmark does not refuse the AstraZeneca vaccine, but only wants to make sure that it is safe and effective. The European Medicines Agency has begun a study of the AstraZeneca vaccine for its possible association with the development of blood clots in those who received this vaccination.

Earlier, the use of the vaccine from AstraZeneca was suspended in Latvia. The reason was also health problems, but it was indicated that we are talking about a certain series of the drug. It is noted that one person developed multiple thrombosis, he died 10 days after vaccination. Another patient was hospitalized with pulmonary embolism.^[13]

Stopping vaccination against COVID-19 in Austria after the death of the vaccinated

On March 7, 2021, the Federal Agency for Safety in the Field health care Austria (BASG) announced the suspension of vaccination of the population against coronavirus COVID-19 with the drug AstraZeneca after the death of the person to whom this vaccination was given.

The 49-year-old woman turned out to be dead. Death occurred as a result of severe bleeding disorder. The department also reported the development of pulmonary embolism in a 35-year-old woman who also underwent vaccination with AstraZeneca. She managed to avoid dangerous health consequences - the patient is recovering.

According to BASG, in both cases we are talking about vaccination with a drug from the same batch at a clinic in Tsvetl County (Lower Austria federal state). According to the Austrian publication Niederoesterreichische Nachrichten, both women worked as nurses at a clinic in Tsvetla.

The Austrian Federal Health Safety Agency is conducting an investigation to clarify the circumstances of the incident. They noted that there is no direct data on the connection of complications with vaccination. BASG clarified that blood clotting disorders are not indicated among the possible side effects after vaccine administration. The batch of drugs that were vaccinated in Austria will not be used.

As of March 8, 2021, almost 477 thousand cases of COVID-19 coronavirus infection were registered in Austria, including 1910 in the last day. 8732 people died from this infection, including 19 patients in the last 24 hours. More than 830 thousand vaccinations against COVID-19 were made in the country.

Earlier in Austria, 41 people died after vaccination with Pfizer, but the relationship between the introduction of the vaccine and the death of patients was also not established (at least by March 9, 2021).^[14]

AstraZeneca vaccine is the first most popular COVID-19 vaccine in the world

In early March 2021, it became known that Sputnik V"" became the second most popular coronavirus vaccine COVID-19 in the world. The Russian drug was ahead of the number of countries that approved it product Pfizer and is second only to the AstraZeneca vaccine, allowed in 49 states. More. here

Refusal of the vaccine in South Africa due to its inefficiency

South Africa has abandoned the COVID-19 coronavirus vaccine developed by AstraZeneca and Oxford University, declaring its inefficiency. According to the head of the country's Ministry of Health Zveli Mkhize, scientists at the University of Witwatersrand in Johannesburg concluded that the drug has "minimal protection against preventing the development of moderate disease" in the event of infection with the South African version of the virus. Now the authorities intend to wait for further recommendations from the manufacturer.

AstraZeneca, commenting on these data, noted that the study was selective, had a small scale, and its participants were predominantly young healthy people. In this regard, the company considered that it could not properly testify to the effectiveness of the vaccine against the strain from South Africa.

The lead researcher of the AstraZeneca vaccine trials in South Africa, Professor Shabir Madhi, said that it would be "somewhat reckless" to abandon the million doses of vaccine that the republic has already received. In his opinion, there is a chance that the drug will be able to protect the population from a severe course of the disease.

In December 2020, doctors in South Africa found a new type of coronavirus. Then Mkhize said that this variation of the virus is more infectious. It also affects young people more often.

South African President Cyril Ramaposa said that in early February 2021, the first batch of AstraZeneca vaccine in the amount of 1 million doses arrived in the country. states The head noted that South Africa will receive 12 million doses of vaccine in March through the COVAX mechanism, and another 9 million doses from the company Johnson & Johnson in the second quarter. Ramaposa also indicated that there is an agreement with the pharmaceutical group to Pfizer supply South Africa with 20 million doses of the vaccine it produces. It is noted that the contracts were concluded even before the publication of the results of clinical trials.^[15]

2020

AstraZeneca has begun testing its vaccine in conjunction with Sputnik V

On December 11, 2020 AstraZeneca , she announced the start of tests of her coronavirus vaccines COVID-19 own in conjunction with the Russian drug "," Satellite V which is also intended to fight this infection.

We are announcing the start of a clinical trial program to assess the safety and immunogenicity of the combined use of the AZD1222 vaccine and the Sputnik V vaccine, AstraZeneca said in a statement.

The company noted that studies of different vaccine regimens will help create more flexible vaccination schedules and provide doctors with a wide range of approaches for the prevention of coronavirus infection. The unification of the British and Russian vaccines is expected to lead to an increased immune response.

We welcome the start of a new stage of cooperation between vaccine manufacturers, intend to develop this partnership in the future and hope to start joint production after the new vaccine demonstrates its effectiveness in clinical trials, "said Kirill Dmitriyev, head of the Russian Direct Investment Fund (RDIF) (quoted by the press service).

After clinical trials of Sputnik V, which demonstrated more than 90 percent effectiveness of the drug, scientists from the N.F. Gamaleya National Research Center for Epidemiology and Microbiology proposed AstraZeneca to use one of the components of its vaccine to increase the effectiveness of AZD1222 due to the combined approach of Russian scientists.

The head of the Gamaleya Center, Alexander Gintsburg, explained to RIA Novosti that the AstraZeneca vaccine is not effective enough, and this can be corrected by the second component, which will be taken from Sputnik V.

AZD1222 and Sputnik V are based on adenoviral vectors in which the spike protein of the SARS-CoV-2 virus is embedded. At the same time, adenoviruses are deprived of the ability to replicate and are a system for delivering genetic material (antigen) to cells of the human body.^[16]

Manipulation of the results of trials of the coronavirus vaccine

The British pharmaceutical AstraZeneca the company manipulated the test results. COVID-19 coronavirus vaccines The group that showed 90% efficiency (it was this figure that many took to the headlines MEDIA) consisted of young people. The group, which showed less effectiveness, differed not only in dosage, but also included older patients, the agency wrote on November 24, 2020 Bloomberg , citing a representative of Operation Warp Speed ​ ​ - an American private state organization created as part of the development of vaccines against coronavirus.

Patients from the group of young people (under 55 years old) were given half the dose first, and after the full dose of the vaccine - with this method, the vaccine was 90% effective. But when two full doses were given in a group in which older people were present, efficacy was at only 62%. In its release, AstraZeneca did not mention the age of volunteers in different groups.

I don't think the FDA (U.S. Food and Drug Administration) will positively evaluate a trial in which a dose, age categories or any other variables were changed in the course of a study by accident or intent, said SVB Leerink analyst Jeffrey Porges.

Back in spring 2020, researchers were puzzled as volunteers experienced far less severe side effects than expected. After the test, it was found that the participants received only half of the required dose. Instead of starting the study anew, the scientists gave the original volunteers a second full dose of the vaccine. At the same time, patients registered for the trial later received two full doses.

On November 23, 2020, AstraZeneca announced that it would negotiate with the FDA to make adjustments to the study design to determine better vaccine dosing. Many American vaccine experts, including FDA representatives, require details of the studies published in AstraZeneca.

AstraZeneca shares fell in price for the third day in a row - from November 23 to 25, 2020 - due to uncertainty about the sufficient effectiveness of its vaccine. Since the beginning of the week, shares have lost 4.4% of their value, the newspaper notes.^[17]

First place in the ranking of the most popular vaccines against COVID-19

At the end of November 2020, Bloomberg published a rating of the most popular vaccines against the coronavirus COVID-19 according to the calculations of the London research firm Airfinity. Sputnik V is in 7th place, and the AstraZeneca vaccine tops the list, which most of the world counts on, with the exception of very rich countries like the United States. Read more here.

AstraZeneca vaccine against COVID-19 loses to Sputnik V in terms of effectiveness

The average effectiveness of the COVID-19 coronavirus vaccine, developed by AstraZeneca and Oxford University, showed an average effectiveness of 70%. The British-Swedish pharmaceutical company announced this on November 23, 2020.

According to the statement, the efficacy of one dosage variant of AZD1222 was 90%, the efficacy of the second variant was 62%. In the first case, volunteers were given half of the vaccine dose and after a month the full dose, in the second option, two full doses of the drug were administered with an interval of at least a month.

According to AstraZeneca, the vaccine shows protection against coronavirus 14 days or more after receiving two doses. The AZD1222 vaccine is well tolerated by patients in both dosing regimens, the manufacturer claims.

The size of the volunteer groups on the basis of which the preliminary results were obtained is not specified. The press release said clinical trials are also underway in the United States, Japan, Russia, South Africa, Kenya and Latin America. In the future, tests are also planned to be carried out in a number of European and Asian countries and increase the number of subjects to 60 thousand.

British Prime Minister Boris Johnson commented on the data on the trials of the coronavirus vaccine AZD1222 by AstraZeneca with the following statement:

Our brilliant scientists from Oxford and AstraZeneca are great, keep it up.

On his Twitter blog, he called the results of the British vaccine trials "fantastic." At the same time, some competing vaccines have already shown higher results.

The Russian National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya said earlier that the Sputnik V vaccine is 92% effective. Pfizer estimated the effectiveness of its vaccine at 90%, but after more detailed studies, the company raised its estimate to 95%.

Astrazeneca vaccine trial participant dies

On October 21, 2020, it became known about the death of one of the participants in clinical trials of the COVID-19 coronavirus vaccine, developed by AstraZeneca in conjunction with Oxford University.

Brazil's National Health Surveillance Agency reported the death of a 28-year-old test participant "as a result of complications of COVID-19."

An AstraZeneca spokesman declined to comment informatively on the volunteer data, citing "medical secrecy," CNBC reports. At the same time, the company said that "all significant medical incidents are carefully assessed," and "these assessments did not raise concerns about the continuation of the tests."

Clinical trials of AstraZeneca's coronavirus vaccine will continue after the death of a test participant, if it is proved that the death of a volunteer is not related to the introduction of the drug, RIA Novosti reported, citing Alexander Ginzburg, director of the Gamaleya Scientific Center.

If there is no causal relationship (between the death of the study participant and vaccination. - Vedomosti) and this is confirmed by some community of doctors who have the right to confirm this within the framework of the protocol of these studies, then, of course, it is necessary to continue. If there are any hints of a connection between these two phenomena - vaccination and death - then of course, it is necessary to stop according to any legislation, - said Gunzburg.

According to Bloomberg, the deceased young man received not a dose of vaccine in trials, but a placebo. The D'Or Institute, which is testing in Rio de Janeiro, said that in total in Brazil 8,000 people take part in AstraZeneca vaccine research, half of them received a dose of the vaccine, the rest - a placebo.

In Russia, the AZD1222 vaccine trial conducted by AstraZeneca remains suspended by October 22, 2020. This follows from the register of clinical trials of the Ministry of Health.^[18]

Two AstraZeneca vaccine testers develop spinal cord inflammation

At the end of September 2020, it became known that during a clinical trial of the AstraZeneca vaccine against the COVID-19 coronavirus, two volunteers from the UK developed serious neurological complications, possibly associated with vaccination. The second patient developed inflammation of the spinal cord, but, according to the developers, he has already been discharged from the hospital with a full recovery. However, while the authorities are checking, many experts express concerns and are outraged that the developers almost do not provide information about this incident, citing data privacy.

The incidents prompted AstraZeneca to stop testing twice, the second time in early September. After the patient was discharged, the study resumed in the UK, Brazil, India and South Africa, but is still on hold in the US.

By the end of September, about 18,000 people worldwide had received the AstraZeneca vaccine. One of the leading virologists of the National Institute of Neurological Disorders and Stroke, Dr. Avindra Nath, said that the leadership of the National Institutes is extremely concerned about the situation:

Everyone is counting on a vaccine, and if such a significant complication appears, the entire project may be closed.

AstraZeneca did not confirm that the patient developed transverse myelitis, but experts suspect this diagnosis from the available data. Transverse myelitis is a type of spinal cord inflammation that is accompanied by pain, muscle weakness, and can even lead to paralysis. According to Dr. Nat, AstraZeneca should be more open about "potential complications with the vaccine, which millions of people will ultimately receive."

However, the UK regulatory authorities examined this clinical case and allowed the study to continue. Experts note that it is very difficult to make such a decision, because it is not easy to determine the cause of a rare negative reaction to the new vaccine.^[19]

Suspension of clinical trials of a vaccine against COVID-19 in the Russian Federation

On September 11, 2020, it became known that AstraZeneca suspended clinical trials of a vaccine against the coronavirus COVID-19 in Russia after a volunteer's illness. This was told by Dmitry Lioznov, acting director of the Research Institute of Influenza named after A. A. Smorodintsev in St. Petersburg, on the basis of which it was planned to conduct tests.

Research has been stopped, in our country the drug has not been injected into anyone, everything has been stopped before the start, the agency quoted him as saying. TASS

According to Izvestia, testing of the AstraZeneca vaccine in Russia began on August 21, 2020 at four clinical bases, one of which is the A.A. Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation. There, the publication was informed that they only managed to select the participants.

Only 100 participants were planned in Russia. They are divided between four research centers approximately equally. All four centers in Russia have opened tests, Tatyana Zubkova, head of the consultative and diagnostic department of the Smorodintsev Influenza Research Institute, told Izvestia. According to her, at the Research Institute of A.A. Smorodintsev, the drug AstraZeneca has not yet been administered to anyone.

Earlier, Russian presidential spokesman Dmitry Peskov said that the Russian Sputnik V coronavirus vaccine is more reliable than the vaccine developed by the Anglo-Swedish company AstraZeneca. According to him, the Russian drug is built on human adenovirus, and the Anglo-Swedish vaccine is built on monkey adenovirus.

As a source in British scientific circles told Izvestia, the reaction of one of the volunteers to the vaccine caused panic in the circles of researchers. According to the interlocutor of the newspaper, the panic of scientists was also caused by the fact that not only this patient, but also many others had seizures after the administration of the drug.^[20][21]

Suspension of COVID-19 vaccine testing

On September 8, 2020, AstraZeneca announced the suspension of clinical trials of its COVID-19 coronavirus vaccine after one of the testing participants became seriously ill as a result of an adverse reaction from the drug.

The symptoms identified in the sick participant are not disclosed, and AstraZeneca is studying its possible causes. According to Bloomberg, he was diagnosed with transverse myelitis, an inflammation of the spinal cord, usually caused by infections.

The company itself emphasizes that the suspension of vaccination is a common procedure during any vaccine trials when there are signs of deterioration in well-being in participants. Such events are not uncommon, and in studies with a large number of participants, such cases often occur simply by chance. However, until the nature of the malaise is established, further vaccination has been postponed.

It is likely that the volunteer's disease is not at all related to his participation in the trials, suggested Erik Topol, a clinical trial expert at the Scripps Research Institute in San Diego.

The AstraZeneca vaccine uses the genetic material of the coronavirus with a modified monkey adenovirus designed so that it cannot reproduce. Pediatrician and vaccine expert at Children's Hospital of Philadelphia Paul Offit, quoted by Bloomberg, said that administering large doses of monkey adenovirus could cause a negative reaction.

According to the interlocutor of Stat, the suspension of injections has become reinsurance. But the second interlocutor of Stat noted that the detected side effects affect other trials of the AstraZeneca vaccine and even other manufacturers: they now check their data for similar cases.^[22]

Australia will spend $1.24 billion on 85 million doses of vaccine

In early September 2020, Australian Prime Minister Scott Morrison announced that Australia will receive the first batches of COVID-19 vaccine in January 2021. The Australian Department of Health and Nursing has struck a deal with CSL to produce two vaccines - one obtained by AstraZeneca and the University of Oxford, and the other developed in CSL's own laboratories in conjunction with the University of Queensland. In general, Australia is ready to pay $1.24 billion for 85 million doses of coronavirus drugs. Read more here.

Start of Phase 3 Clinical Trial

On September 2, 2020, it became known that AstraZeneca continues to develop the AZD1222 vaccine and is starting a phase III clinical trial to assess its safety, efficacy and immunogenicity in the United States.

The US clinical trial, called D8110C00001, is funded by the Office of Advanced Biomedical Research and Development (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at, and the U.S. Department of Health and Human Services (HHS) National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes health care , and is conducted by AstraZeneca. The study will also involve the Network Framework for Clinical Trials of Agents for Prevention (COVID-19 CoVPN) at NIAID.

We are pleased that the AZD1222 vaccine has demonstrated safety and immunogenicity in adult volunteers of different age groups, and we are proud to partner with BARDA and NIAID to accelerate the development process of this vaccine. If clinical studies show that the vaccine can protect against COVID-19, and if the vaccine is approved for use, we will make every effort to ensure and equal access to it around the world as soon as possible.

The study centers in the United States plan to recruit approximately 30,000 adult volunteers aged 18 years and older from various racial, ethnic and geographical groups, healthy or concomitant pathology in the stabilization stage, including those with HIV, and groups at increased risk of SARS-CoV-2 infection. In addition, the study will be conducted in other centers outside the United States based on the predicted transmission rate of the virus, including the recruitment of volunteers in Peru and Chile will begin soon.

Study participants randomly receive either two doses of AZD1222 vaccine four weeks apart, or, in the control group, 0.9% isotonic solution, with the size of the group that will receive the potential vaccine numerically twice the size of the control group. The study aims to assess the efficacy and safety of the vaccine in all participants, while local and systemic responses and immune responses will be evaluated in 3,000 participants.

Clinical development of the AZD1222 vaccine is ongoing around the world, with late-stage clinical trials for September 2, 2020 in the UK, Brazil and South Africa, and due to begin soon in Japan and Russia. These studies, together with phase III clinical trials in the US, will include up to 50,000 participants worldwide. The results of late-stage clinical trials are expected by the end of 2020, depending on the infection rate in the regions where the studies are being conducted.

In July 2020, the journal The Lancet published interim results from an ongoing phase I/II study of COV001, which showed the tolerability of the AZD1222 vaccine, as well as the development of a persistent immune response against the SARS-CoV-2 virus in all study participants.

AstraZeneca continues to work with governments, multilateral organizations and partners around the world to ensure equal access to the vaccine if clinical trials prove successful. Given the recent announcements about vaccine supplies to Russia, South Korea, Japan, China, Latin America and Brazil, global supply opportunities are approaching three billion doses of the vaccine.

The European Commission ordered 400 million doses of AstraZeneca vaccine

August 14, 2020 AstraZeneca announced the conclusion European Commission of a supply agreement. coronavirus vaccines COVID-19 The contract provides for up to 400 million doses of the drug, called AZD1222. More. here

Transfer to R-Pharm of antigen production and release of the final dosage form

On July 17, 2020, AstraZeneca and R-Pharm announced cooperation in the production of a recombinant adenovirus vaccine to prevent COVID-19 infection caused by the SARS-CoV-2 virus in Russia.

As part of the cooperation, it is planned to organize the production of the AZD1222 vaccine against COVID-19 if clinical trials are successful.

In accordance with the agreement, R-Pharm will use the technological capabilities for the implementation of the project. The cell line and adenoviral vector were transferred to Russia, here it is planned to produce antigen and produce a finished dosage form.

At the same time, Russia will be one of the hubs for the production and supply of vaccines to international markets. It is planned to organize exports to more than 30 countries of the world, including the Middle East, the Balkan region and the CIS countries.

AstraZeneca is confident that together with R-Farm it will be able to provide millions of people with the vaccine in the most effective way.

For July 2020, late-stage phase II/III studies are being conducted around the world to determine how well the vaccine will protect people from COVID-19, and to assess the safety and immune responses in people in different age ranges and at different doses. AstraZeneca recognizes that the vaccine may not work, but is set to accelerate the development of the clinical program and increase production in a risk environment.

AZD1222 was developed by the Jenner Institute of the University of Oxford in conjunction with the Oxford Vaccine Research Group. The vaccine uses a replication-defective vector based on a weakened adenovirus that causes infection in chimpanzees, which contains the genetic material of the spike protein SARS-CoV-2. After vaccination, surface spike protein synthesis occurs, which leads to the formation of an immune response to COVID-19 with a possible subsequent infection with this virus.

Italy, Germany, France and the Netherlands have signed a contract with AstraZeneca for the supply of vaccines against COVID-19

In mid-June 2020, it became known that, Italy, and Germany France Netherlands signed a contract with the company for AstraZeneca the supply of European citizens. COVID-19 coronavirus vaccines More. here

Agreement with CEPI and GAVI to support the production, purchase and distribution of 300 million doses of COVID-19 vaccine

On June 5, 2020, it became known that AstraZeneca took the following steps to ensure universal access to the COVID-19 vaccine developed by the University of Oxford, as part of historical agreements with the Coalition for Epidemic Preparedness Innovations (CEPI), the Global Alliance for Vaccines and Immunization (GAVI) and the Serum Institute of India (SII).

The company has reached an agreement with CEPI and GAVI to support the production, purchase and distribution of 300 million doses of the vaccine with the start of deliveries by the end of 2020 totaling US $750 million. In addition, AstraZeneca has entered into a licensing agreement with the Serum Institute of India for the supply of one billion doses to low- and middle-income countries, committing to provide 400 million doses by the end of 2020.

The agreements reflect the company's commitment to providing global access to the vaccine, including in low- and middle-income countries, in addition to the company's partnerships with the UK and US governments. At the same time, AstraZeneca is building several supply chains around the world to ensure global access to the vaccine on a non-profitable basis during a pandemic, and has prepared production facilities for the release of two billion doses of the vaccine.

The agreement with CEPI and GAVI is also the first increased commitment under the global Access to COVID-19 Tools (ACT) Accelerator initiative chaired by the Bill & Melinda Gates Foundation and the World Health Organization (WHO). The initiative aims to ensure equal access and distribution of the vaccine worldwide, including in low- and middle-income countries. The CEPI Coalition will develop and manufacture the vaccine, and GAVI will procure as part of this global initiative.

We are working tirelessly to deliver on our commitments to ensure access to the Oxford vaccine around the world on a non-profitable basis. We have taken an important step to help us provide a vaccine to hundreds of millions of people around the world, including in the poorest countries. I am deeply grateful to everyone for their commitment to this project and for their work, which made it possible to unite efforts in such a short time.

AstraZeneca and our other industry partners play a critical role in rapidly developing safe and effective vaccines and in producing the billions of doses needed to end the COVID-19 pandemic permanently. AstraZenek's commitment to ensuring equal global access to this vaccine and our partnership demonstrate how the Vaccine Global Access Facility brings together private, public and other sectors to make COVID-19 vaccines available to those who need them most in the interests of the world's population. "

Dr. Seth Berkley, Chief Executive Officer of GAVI, said:

We see the desire of donor governments to maintain equal access to the vaccine, especially for developing countries, and I am incredibly pleased to see the private sector joining this effort. We encourage other vaccine manufacturers to work with us to achieve a common global goal of finding solutions to ending this pandemic.

The Serum Institute of India is pleased to partner with AstraZeneca in delivering this vaccine to India and to low- and middle-income countries. Over the past fifty years, SII has increased significant potential in the production and supply of vaccines worldwide. We will work closely with AstraZeneca to ensure the fair and equitable distribution of the vaccine in these countries.

On the eve of AstraZeneca, it pledged to supply 400 million doses of vaccines to the United States and the United Kingdom after concluding a licensing agreement with Oxford University for a recombinant adenovirus vaccine, formerly known as ChAdOx1 nCoV-19, and for June 2020 the name AZD1222.

Earlier, the University of Oxford announced the start of phase II/III clinical studies of AZD1222 among about 10 thousand adult volunteers. Late-stage research will soon begin in several countries. AstraZeneca recognizes that the vaccine may not work, but is set to accelerate the development of the clinical program and increase production in a risk environment.

The company's comprehensive pandemic response also includes mobilizing AstraZenek's global research efforts to find antibodies that neutralize the coronavirus to prevent and treat the progression of COVID-19 disease in order to enter the clinical research stage in the next three to five months. Moreover, the company promptly began testing drugs for the treatment of infection, including the CALAVI and ACCORD studies of acalabrutinib and the DARE-19 study of dapagliflozin in patients with COVID-19 as of June 5, 2020.

The ChAdOx1 nCoV-19 vaccine, known as AZD1222, was developed by the University of Oxford's Jenner Institute in conjunction with the Oxford Vaccine Research Group. It uses a replication-defective chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infection in chimpanzees, and contains genetic material from the SARS-CoV-2 spike protein. After vaccination, surface spike protein synthesis occurs, which leads to the formation of an immune response to SARS-CoV-2 with a possible subsequent infection with this virus.

The recombinant adenovirus vector (ChAdOx1) was selected because of a strong immune response when administered in a single dose. In addition, it does not replicate, so it cannot lead to persistent infection after vaccination. At the beginning of June 2020, vaccines based on the ChAdOx1 virus were tested on a large group of people exceeding 320 people and showed that they are safe and well tolerated, although they can cause temporary side effects such as fever, flu-like symptoms, headache or pain in the hands.

US government issues $1 billion to AstraZeneca to develop coronavirus vaccine

At the end of May 2020, it became known that AstraZeneca received more than $1 billion from US government funding for the development of an experimental vaccine against the coronavirus COVID-19.

Investment is accelerating the race for vaccine supplies, which is seen as a key step towards restoring the global economy after the coronavirus crisis. AstraZeneca has received funds from the U.S. Office of Advanced Biomedicine Research and Development. The company claims that it will prepare the drug for widespread use as early as September, but the developed vaccine is still being tested in humans without any guarantees of success.

AstraZeneca's funding is part of Warp Speed's operation to provide safe vaccines for the U.S., according to a statement from the Department of Health and Human Services. Under the agreement, AstraZeneca can receive up to $1.2 billion for its work, and the US government expects 300 million doses to be available in October.

US Secretary of Health Alex Azar said that the United States "has repeatedly increased investments in the development and production of promising vaccines even before their approval, so that a successfully developed vaccine can be provided to the population immediately." In general, four promising candidates for the vaccine received support. The US government also provided funding to the French pharmaceutical company Sanofi, including $30 million for the development of a vaccine against Covid and $226 million for the development of a flu vaccine.

AstraZeneca said it was working with various organizations, including the World Health Organization, the Coalition for Epidemic Preparedness Innovation and the Gavi Vaccine Alliance, to ensure a fair distribution of the vaccine worldwide if successfully developed. The company said it has supply agreements for 400 million doses.^[23]

AstraZenek and Oxford University Agreement on Vaccine Development, Production and Distribution

On May 6, 2020, AstraZeneca and Oxford University announced an agreement on the global development and distribution of a potential recombinant adenovirus vaccine created by the university and designed to prevent the infectious disease COVID-19 caused by the SARS-CoV-2 virus.

The collaboration aims to develop a potentially effective ChAdOx1 nCoV-19 vaccine, which is being worked on by the Jenner Institute and the Oxford Vaccine Group at the University of Oxford. In accordance with the agreement, AstraZeneca will be responsible for the development, production, and distribution of the vaccine around the world.

"As COVID-19 continues to affect populations around the world, the need for a vaccine to fight the virus is very acute. This collaboration will bring together Oxford University's best practices in vaccinology and AstraZenek's global capabilities in drug development, production and distribution. We hope that by joint efforts we can accelerate the global development of a vaccine to fight the virus and protect people from the deadliest pandemic of our time, " noted' Pascal Soriot, Chief Executive Officer of AstraZeneca '

"Oxford University and AstraZeneca have a long-term relationship that contributes to the increase in basic research, and we are pleased with this cooperation in promoting a vaccine to prevent COVID-19 around the world. We look forward to working with Oxford University and innovative companies such as Vaccitech as part of our partnership, " noted Mene Pangalos, Executive Vice President, Biopharmaceutical Research & Development, AstraZenec

"This collaboration between Oxford University and AstraZeneca is a vital step that could help accelerate the production of a vaccine against coronavirus infection. If a vaccine is developed by the Jenner Institute at the University of Oxford, the agreement will also ensure its availability as soon as possible, helping to protect thousands of people from the disease, " noted Alok Sharma, UK Minister for Business, power and Industrial Strategy

"Our partnership with AstraZeneca will become the main force in the fight against the pandemic for many, many years. As soon as we receive an effective approved vaccine, we will jointly begin immunization against coronavirus. Unfortunately, the risk of new pandemics will always exist. The research center will increase the readiness of the world for this, as well as our reaction rate the next time we face a similar problem, " noted Sir John Bell, Professor, Department of Medicine, University of Oxford

Five trial centres in the south of the UK have launched phase I clinical trials of a potential vaccine among healthy volunteers aged 18 to 55 to examine its safety and efficacy. The results of the first phase of tests can be obtained in May 2020. The transition to subsequent phases of testing is planned by the middle of this year.

ChAdOx1 nCoV-19, developed by the University of Oxford's Jenner Institute in conjunction with the Oxford Vaccine Research Group, uses a viral vector based on a weakened version of a common cold (adenovirus) that contains the genetic material of the spike protein SARS-CoV-2. After vaccination, surface spike protein synthesis occurs, which leads to the formation of an immune response to COVID-19 with a possible subsequent infection with this virus.

The recombinant adenovirus vector (ChAdOx1) was selected because of a strong immune response when administered in a single dose. In addition, it does not replicate, so it cannot lead to persistent infection after vaccination. As of May 2020, vaccines based on the ChAdOx1 virus have been tested on a large group of people exceeding 320 people and have shown that they are safe and well tolerated, although they can cause temporary side effects such as fever, flu-like symptoms, headache or hand pain.

Notes