The use of the AstraZeneca vaccine in Argentina is authorized under “emergency registration” – Telam

The authorization “was granted for a period of one year from the date of this provision, subject to sale by prescription”.

National Administration of Drugs, Food and Medical Technology (Anmat) authorized the use of the vaccine against the coronavirus developed by the University of Oxford and the company AstraZeneca SA under the “emergency registration” procedure, of which Argentina has 22 million insured doses in March, it was officially reported today.

By provision 9271/20, the registration in the Register of Medicinal Specialties (REM) of the product “Covid-19 AstraZeneca vaccine and generic name of the recombinant Covid-19 ChAdOx1-S vaccine” has been authorized, according to an official press release.

This is the second authorization issued by Anmat for the use of vaccines against the coronavirus, since it had previously issued an authorization as an “emergency register” to the one developed by the Pfizer and BioNTech laboratories.

Russian Sputnik V, whose first 300,000 doses began to be applied yesterday in the country, has an authorization from the Ministry of Health.

The disposition

“The registration request submitted by the owner of the product is framed within the framework of the provisions of Annex I – point 5 of provision ANMAT 705/05, which provides for the registration of vaccines of health interest in the event of emergency, “said the official report on the AstraZeneca vaccine.

He added that “the product presents an acceptable benefit-risk balance, allowing to support the granting of the registration and the conditional authorization of the product for the requested indication”.

The authorization “was granted for a period of one year from the date of this provision, subject to sale by prescription”.

“The risk management plan (RMP) established for the close monitoring of the safety and efficacy of the drug must be respected and the corresponding progress reports, modifications and updates must be submitted to the National Institute of drug (INAME) “, they concluded.

AstraZeneca had applied to Anmat for an emergency use authorization on October 5.

The vaccine developed by the University of Oxford and AstraZeneca was also approved by the UK on Wednesday for emergency use.

The vaccine

ChAdOx1 nCoV-19 (name of the vaccine) uses a platform called a “non-replicating viral vector,” which is a weakened version of a common cold virus (chimpanzee adenovirus), “which has been genetically modified to be safe and impossible for it to develop in humans, ”explained its developers.

It is a “stable vaccine, easy to manufacture, transport and store at home refrigerator temperature.” (2-8 degrees C), so that it can be easily administered in existing health facilities, ”they added.

AstraZeneca had applied to Anmat for emergency use authorization on October 5.

In November, the Argentine government and AstraZeneca signed an agreement for more than 22 million doses of the vaccine that would be available in the country from March.

In August, mAbxience, part of the Insud group, announced that it would produce between 150 million and 250 million doses of the active ingredient in this vaccine at its factory in the city of Buenos Aires in Garín, and that each would cost around $ 4.

“MAbxience will be in charge of manufacturing the active principle (the raw material) of the Oxford and AstraZeneca vaccine. Once finished, the product will be delivered to this laboratory which will send it to Mexico, where the Liomont laboratory will be responsible for breaking it down and conditioning it. From there, AstraZeneca will distribute the vaccine equally in Latin America (with the exception of Brazil, which has entered into a separate agreement) ”, explained at the time Argentinian businessman Hugo Sigman, director of Grupo Insud.

Sigman also said that “the promised price is $ 4, significantly lower than vaccines from other companies.”

In November, the Argentine government and AstraZeneca signed an agreement for more than 22 million doses of the vaccine.

December 8 the Oxford / AstraZeneca vaccine was the first to publish interim data on phase 3 results in a scientific journal (The Lancet), and there the authors described two schemes of vaccine application, the average effectiveness of which was over 70.4%.

Efficacy data is based on 11,636 volunteers in the UK and Brazil, and is grouped into three groups of people vaccinated: two who received a standard first dose vaccine followed by a standard dose booster vaccine and one group (UK only) who received a low dose first followed by a standard dose vaccine.

“What they found was that in the first pattern of those who received the vaccine, there were 27 cases of Covid-19 while in the control group 71 were infected, giving an efficacy of 62 %; while in the second scheme (with half a dose in the first application), in the vaccinated group there were 3 cases of Covid-19 and in the control 30, which implies an efficiency of 90% ”, explains Emilio Malchiodi, Professor of the Chair, at Telam of Immunology of the Faculty of Pharmacy and Biochemistry, UBA and Director of the Institute for the Study of Human Immunity (UBA-Conicet).

Oxford / AstraZeneca vaccine was the first to publish interim data on phase 3 results in a scientific journal (The Lancet)“

The specialists stated that “70.4% is an average obtained by adding the cases of the first pattern (27 and 71 respectively) to those of the second (3 and 30), which gives a total of 30 cases vaccinated against 101 in the unvaccinated “.

The authors further reported that of the 23,848 volunteers in the trial, only three of the 175 serious adverse events were possibly vaccine-related. “Of these, one was considered ‘possibly related’ to the ChAdOx1 nCoV-19 vaccine, one occurred in the control group and another case of severe fever in the vaccinated group was considered an expected event related to the vaccine. “

The article noted that among the volunteers included in this initial efficacy analysis, “the majority are between the ages of 18 and 55 (UK 87% and Brazil 90%), and those aged 56 and over contribute to the 12 % “.

“Since only five cases included in the main analysis occurred in people over 55 years of age, the efficacy of the vaccine in older groups could not be evaluated, but will be determined in the future. future analyzes after the accumulation of new cases in this age group ”, they noted.

In the phase II study also published in The Lancet, researchers found a good immune response in the elderly (measured by T cells) and caused no serious side effects in those over 60.

On December 11, AstraZeneca and Russia announced that they would conduct joint clinical trials combining their two vaccines (ChAdOx1 nCoV-19 and Sputnik V) against the coronavirus in people over the age of 18. to assess whether the combination of different adenoviruses at doses improves the immune response.