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AstraZeneca COVID-19 vaccine not approved by EU
AstraZeneca COVID-19 vaccine not approved by EU. Major data breaches? AstraZeneca vaccine approved for emergency use in the UK, but not approved by the EU.
On December 30, the third COVID-19 vaccine in Europe and America received new developments. AstraZeneca announced on its official website that its COVID-19 vaccine has been approved for emergency use in the UK, for use in people 18 years and older. This is the first time the vaccine has been approved for use, and it is also the third COVID-19 vaccine approved for emergency use in European and American countries. According to the previously announced Phase III clinical data, the incidence of symptomatic COVID-19 14 days after two doses of the vaccine was 70.4%.
As soon as the news came out, AstraZeneca’s stock rose nearly 2% at one time, and as of the close, it fell back, rising 0.56%.
However, it is worth noting that this controversial vaccine has not been approved by the European Union. The European Medicines Agency (EMA) stated that in order to further determine the safety and prevention capabilities of the vaccine, more data is needed to make an approval decision.
01 AstraZeneca’s COVID-19 vaccine was approved for emergency use in the UK
According to 21st Century Business Herald, the British Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized the emergency use of AstraZeneca’s COVID-19 vaccine AZD1222 for active immunization of people aged 18 and over. It is recommended that the vaccine be injected twice with an interval of 4 to 12 weeks. Clinical trials have shown that this program can effectively prevent the infection of symptomatic COVID-19. There were no serious cases or hospitalized cases more than 14 days after the second administration.
This vaccine was jointly developed by Oxford University and its derivative company Vaccitech. It uses a replication-deficient chimpanzee virus vector based on a weakened version of the common cold virus (adenovirus), which causes infection in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, a surface spike protein will be produced. If it later infects the human body, it will stimulate the immune system to attack the SARS-CoV-2 virus.
AstraZeneca is working with the MHRA and the UK Joint Committee on Vaccination and Immunization, and the Department of Public Health and the UK National Health Service to deploy and promote the vaccine in the UK. The company plans to provide millions of doses in the first quarter of 2021 as part of an agreement reached with the government. According to the agreement, AstraZeneca will provide a total of 100 million doses of vaccine to the UK.
The British government stated that the AZD1222 vaccine will be given priority to susceptible people, and the injection will start next Monday.
Pascal Soriot, CEO of AstraZeneca, said, “Today is an important day for the millions of people in the UK who can use this new vaccine. It has been proven to be effective, well tolerated, and easy to administer. Sleeca is free. We would like to thank many colleagues from AstraZeneca, Oxford University, the British government, and thousands of clinical trial participants.”
The MHRA’s approval decision is based on the independent recommendations of its Human Medicine Committee after a rolling review of trial data, including an interim analysis of the Phase III program led by Oxford University. The data was published in The Lancet on December 8, 2020.
Other safety and effectiveness data of the vaccine will continue to accumulate from ongoing clinical trials. AstraZeneca will continue to work with regulatory agencies around the world to support them in conducting continuous rolling reviews of emergency supplies or conditional marketing authorizations during the health crisis. AstraZeneca is also seeking an emergency use list from the World Health Organization to expedite access to vaccines in low- and middle-income countries.
AstraZeneca said it expects to produce about 3 billion doses of vaccines worldwide in 2021. The vaccine can be stored and transported under normal refrigeration conditions (28 degrees Celsius/36-46 degrees Fahrenheit) for at least six months, and can be used in existing medical institutions.
02 EU failed
It is worth noting that this controversial vaccine has not yet been approved by the European Union.
According to the latest report of foreign media on December 31, after obtaining the approval of its own country, AstraZeneca said that the company has applied to the European Medicines Agency (EMA) for the emergency use of the vaccine in the local area, and all vaccine clinical trial data All have been submitted.
The EMA responded that the agency had received the data from the Phase III trial of AstraZeneca vaccine on December 21 and is currently evaluating these data. However, they believe that in order to further determine the safety and prevention capabilities of the vaccine, more data is still needed before an approval decision can be made.
In other words, the European Medicines Agency believes that the current test data of AstraZeneca vaccine is not sufficient to prove its safety and effectiveness. Therefore, AstraZeneca is likely to need to restart the test to provide more data to pass EU approval.
According to foreign media, Munir Pirmohamed, an official involved in the approval of vaccines in the United Kingdom, pointed out that the effective rate of AstraZeneca vaccine can be as high as 80% when the two injections are three months apart, but there is not enough evidence to support one injection. Wei Shen Lim, another British doctor involved in vaccine approval, also revealed that 21 days after the first dose of vaccine and before the second dose, the effective rate is about 70%.
03 “Major loopholes” in data?
In fact, after AstraZeneca vaccine disclosed the data of the third phase trial, it was questioned by scientists. According to a CCTV News report on December 10, the 70.4% effective rate of the vaccine announced on November 23 was obtained by combining two sets of test data. In its 2-dose regimen trial for 8895 people, the vaccine’s effective rate was only 62%; while in the 1.5-dose regimen for 2741 people, the effective rate was as high as 90%.
Some experts suspect that AstraZeneca’s vaccine data contains “major loopholes.” They believe that the 90% effective rate of trials with a small sample size makes it difficult to explain whether the effective rate is a real result or an accidental deviation result. In addition, some key data lack transparency.
On December 8, AstraZeneca announced in the “Lancet” the interim analysis results of the Phase III clinical trial of its COVID-19 vaccine. The data showed that after the subjects received two standard doses of vaccines, the effectiveness was 62%, which was significantly lower. The effectiveness of Pfizer/BioNTech and Moderna’s mRNA vaccines; after a low dose and then a standard dose of vaccine, the effectiveness is as high as 90%, showing obvious protective efficacy.
It is understood that AstraZeneca disclosed that in the pre-phase III clinical trial, some subjects made mistakes in vaccination. 3000 subjects received only half of the first dose of vaccine. The trial effectiveness of the subjects is 90%.
At that time, some media called it a “beautiful error”, but although the results are beautiful, errors in human clinical trials have also been criticized. After all, the test results of these two dosage regimens are different, so more and more people have doubts about the clinical trial data of the vaccine.
In addition, the age of the vaccine subjects is no more than 55 years old. Generally speaking, the elderly are susceptible to the new coronavirus and have a slower immune response. The results of this study cast doubt on whether the vaccine can withstand further testing.
Currently, AZD1222 is undergoing a clinical trial of 40,000 people in the United States. Pascal Soriot, CEO of AstraZeneca, said that to obtain FDA approval, clinical data in the United States is required. Sarah Gilbert, professor of vaccinology at the University of Oxford, also said, “The results of clinical trials depend on the progress of the trial, and researchers are not sure when clinical data will be available in the United States.”
In addition, the standard dosage regimen of AZD1222 is not good enough. In clinical trials in the UK, the effectiveness of patients receiving the two standard doses was 62%, but the lower limit of the confidence interval was 28%, which was lower than the FDA’s 30% standard. This is one of the reasons why the FDA will not approve AZD1222 in the near future.
It is worth mentioning that in early September this year, a British volunteer experienced an adverse reaction after being vaccinated with AZD1222. AstraZeneca suspended global clinical trials. In October this year, the FDA reviewed the data of this vaccine and considered it to be Safe and authorized to resume this test.
Although AZD1222 has been approved in the UK, it is more difficult to pass the EU. In this regard, AstraZeneca has hinted that it may restart the trial and launch an additional round of phase three trials on the vaccine to verify the ultimate efficiency of the 1.5-dose regimen. In order to obtain the approval of the European Union, the probability of the British company restarting the test is very high.
According to statistics, AstraZeneca has received more than 2 billion doses of vaccine pre-orders due to its early optimism. It is the first company to sign a contract with the European Union. The total dose of the contract is 300 million doses, with an option to increase by 100 million doses.
Up to now, only Pfizer/BioNTech has been approved by EMA for the COVID-19 vaccine. According to the EMA official website, Moderna’s vaccine will hold a meeting on January 6, 2021 to evaluate the effectiveness of the vaccine, and if necessary, another meeting will be held on January 12
(source:internet, reference only)