Phase 3 studies, approval and arrival in the country: the details of the purchase of the AstraZeneca vaccine by Argentina

This afternoon, the AstraZeneca laboratory, which together with the University of Oxford is developing the vaccine against COVID-19 disease produced by the new coronavirus SARS-CoV-2, announced an agreement with the government for the distribution of 22 million doses “During the first half of 2021”.

Hours earlier, the Minister of Health of the Nation, Ginés González García, he explained in a radio interview that he will guarantee it the coronavirus vaccines that will be introduced in the country will have passed “all tests of efficiency and safety”. Furthermore, he confirmed that his question “will not be mandatory” and said that in order to carry out the mass vaccination process the use of electoral lists is evaluated. And promptly, regarding the AstraZeneca vaccine, he reported that “a first batch will arrive in February and another in March “.

11 months after the emergence of the new coronavirus in the city of Wuhan, China, there is a race against time to find an effective and safe vaccine against the new virus, which has already infected 50 million people and killed 1,2 millions. they.

In that aspect, the World Health Organization recognizes 155 projects to date of vaccines that are in the preclinical stage. Further, there are 47 others that have passed it and are in the clinical phase, with human trials. Of these, 10 are in phase 3, awaiting final results and before their commercialization.

Yesterday, during the announcement of the end of the Isolation, Social, Preventive and Mandatory for the AMBA region, President Alberto Fernández Alberto Fernández He said: “We want Argentines to be able to count as quickly as possible and in sufficient quantity with the vaccine that allows us to end this pandemic and that allows all of us to recover the life that has been altered today.”

In that sense, he confirmed that morning that he had spoken on the phone with his counterpart from the Russian Federation, Vladimir Putin, with whom he spoke about the Sputnik V vaccine.On October 29, the National Congress empowered the Executive Branch to carry out the necessary procedures for acquiring the vaccines that are being developed to address COVID-19 and this week the Government National announced that it has advanced negotiations with Russia acquire 25 million doses of the vaccine manufactured by the Gamaleya Research Institute of Epidemiology and Microbiology.

“Hopefully”, the Russian vaccine can be applied to around 10 million people “by the end of December”. However, He clarified that Argentina has also signed agreements with other suppliers and that all “have a very high technical quality”. The president explained that they could also reach the country in December other 750 thousand vaccines from Pfizer. And he also confirmed that agreements have been signed to receive the vaccines produced by Astrazeneca-Oxford and China since March.

Today, in statements a Radio Miter, Ginés González García said that although “it is very difficult to talk about times, beyond the desire we have”, he felt that next December “it is possible that we can start vaccinating risk groups, as the different vaccines successfully pass phase 3”. In this sense, he stressed that Russia and Pfizer have announced that they will be able to deliver doses to Argentina for the next month. And regarding the AstraZeneca vaccine, he reported that “a first batch will arrive in February and another in March”.

“We are already working on it, because it is something unprecedented in its scope, since the premise is to vaccinate as many people as possible in the shortest possible time,” he elaborated and said the procedure is planned “with various ministries such as those of Defense and Security. ”He also announced that the armed forces will collaborate in logistics and said so From this Monday they will start working with all the provinces “to find out how many people are able to be vaccinated and what vaccination capacity each district has”.

“We want the vaccine to be free, paid for by the state and then distributed equally across the country. This is why we began to collaborate with the provinces to organize the logistic process throughout the national territory. We are also working with the Ministries of Defense and Security to coordinate all efforts, which is monumental, “Ginés González García said.

During the speech, González García said the president Alberto Fernandez “He asked me to get safe vaccines for all Argentines as soon as possible, which is why we have negotiated with everyone, North Americans, Europeans, Chinese and Russians.” In this sense, he recalled that “we have improved relations with the Russians in recent days by direct contact between President Fernández and President (Vladimir) Putin”.

Regarding the safety and effectiveness of the doses purchased by the government, he said: “We will ensure that the vaccines we apply to Argentines have passed all tests of efficiency and safety, as we must be calm.”

In relation to the health strategy that the vaccine will bring, he stressed that “firstly, it is a question of abruptly lowering mortality, and secondly, that the circulation of the virus stops and the epidemic and the pandemic are diluted”. In this way, he warned that it is necessary to avoid here “the major outbreaks that are occurring in Europe, and in this the vaccine will be of vital importance”.

Vaccines in Argentina

This week, the authorities of the Ministry of Health of the Nation provided details of the pre-agreements that have been signed for the arrival of several coronavirus vaccines, although at the moment only two of them have requested authorization to National Administration of Drugs, Food and Medical Technology (Anmat), as published by the health authority in a statement, which clarifies which vaccines are advanced with the process, which will take several weeks to approve. “Anmat makes available the list of holders who have started submitting the documentation for the registration of the vaccine for SARS-CoV-2“Says and Immediately Provides” the updated list of product owners who have begun submitting the necessary documentation to register their SARS-CoV-2 vaccine.

-Astra Zéneca SA, name AZD-1222

Documentation submission start date: 05 October 2020

The AZD1222 vaccine consists of a chimpanzee adenovirus (ChAdOx1), to which genetic material has been added so that it can produce the Spike protein (found on the surface of the coronavirus). The vaccine tries to train the body’s immune system to deliver an aggressive response to the SARS-CoV-2 coronavirus when it enters.

-HLB Pharma Group, name: SPUTNIK V

Documentation submission start date: 02 November 2020

The drug uses human adenovirus technology of two different vectors, Ad5 and Ad26, for a first and second injection. However, Sputnik V does not contain live human adenoviruses, but human adenoviral vectors that are unable to multiply and are completely safe for health. It is based on an existing dual-vector vaccine platform, developed in 2015 to treat Ebola, which has passed all stages of clinical trials and was used to defeat the epidemic of that disease in Africa in 2017.

The Another vaccine that has been applied in phase 3 studies in Argentina for months and is produced by the Pfizer / Biontech laboratory, Until now, the formal request has not been submitted to the Argentine regulatory body. This vaccine, based on messenger RNA technology, carries the DNA instructions for cells in the human body to generate certain protective proteins. It began its trials in Germany in late April and in the United States in early May.

I keep reading:

Ginés González García: “No vaccine will be distributed or applied unless it has adequate approval”

Alberto Fernández: “Hopefully, we could vaccinate 10 million people by the end of December”

Argentina has purchased 22 million doses of the AstraZeneca / Oxford vaccine against COVID-19