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Why the European Medicines Agency has not yet approved the Oxford-AstraZeneca vaccine


The #European #Medicines #Agency (EMA) assured that it is unlikely that the #European #Union will authorize the vaccine developed by #AstraZeneca and the #University of #Oxford in #January REUTERS / #Piroschka van de #Wouw / #File #Photo

#December 30, 2020 will be remembered as a historic day, in which the use of the #Oxford-AstraZeneca vaccine in the #United #Kingdom, and just a few hours later, #Argentina did the same through its regulatory agency, the #National #Administration of #Medicines, #Food and #Medical #Technology (ANMAT), what validated the vaccine AZD1222 for your population under emergency use against the SARS-CoV-2 virus.

#But it’s not all good news yet. The #European #Medicines #Agency (EMA) said it is unlikely that the #European #Union will authorize the vaccine developed by #AstraZeneca and the #University of #Oxford in #January.

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“No formal marketing authorization has yet been submitted to the EMA“#For this vaccine, which means that for now you cannot establish a timetable,” the #Amsterdam-based agency told AFP.

FILE PHOTO: British Prime Minister Boris Johnson poses for a photo with a vial of the University of Oxford and AstraZeneca COVID-19 vaccine at a factory in Wrexham, Wales.  November 30, 2020. Paul Ellis / Pool via REUTERS /
FILE PHOTO: #British #Prime #Minister #Boris #Johnson poses for a photo with a vial of the #University of #Oxford and #AstraZeneca COVID-19 vaccine at a factory in #Wrexham, #Wales. #November 30, 2020. #Paul #Ellis / #Pool via REUTERS /

The #Deputy #Executive #Director of EMA, #Noel #Wathionhe told the #Belgian newspaper on #Tuesday The newspapaer #What is it #Authorization “unlikely” within the next month, the agency confirmed #Tuesday night. The reason? “#We need additional information about the quality of the vaccine, and after that, the company must formally apply.”

The #Oxford-AstraZeneca vaccine is undergoing a “#Continuous examination”, which allows EMA to assess levels of safety and efficacy as they become available, even before the manufacturer makes a formal request for authorization. #This procedure makes it possible to speed up the evaluation of a marketing authorization request once it has been formulated. #In normal time, the agency only examines the data once it has been fully collected.

The EMA approved on #December 21 the #Pfizer / #BioNTech vaccine, to which the #European #Commission had previously given its authorization, and it will have to give an answer on the one of #Moderna the next 6 of #January.

Ursula von der Leyen, president of the European Commission, the body that had previously authorized the Pfizer vaccine REUTERS / File Photo
#Ursula von der #Leyen, president of the #European #Commission, the body that had previously authorized the #Pfizer vaccine REUTERS / #File #Photo

The authorization of the #Pfizer formula opens the door to the first vaccinations in the 27 member countries after the #Holidays. #In addition, given the concern raised by the new strain of COVID-19, very contagious, which has emerged in the south of #England, the EMA said that “there is no evidence” that this antidote is ineffective against this variant.

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#But this decision also took longer than planned. The EMA’s #Committee for #Medicinal #Products for #Human #Use (CHMP), based in #Amsterdam, was forced to move the meeting initially scheduled for #December 29 forward by one week, under pressure from #Germany and other countries, who wanted a decision to be made quickly.

“#It is an important step in the fight against this pandemic, which is causing so much suffering and difficulties,” EMA CEO #Emer #Cooke had said on that occasion. “#This is really a historic scientific achievement, in less than a year a vaccine against this disease has been developed and authorized.”

A 96-year-old resident of Madrid receives the Pfizer-BioNTech vaccine on December 30, 2020 REUTERS / Juan Medina
A 96-year-old resident of #Madrid receives the #Pfizer-BioNTech vaccine on #December 30, 2020 REUTERS / #Juan #Medina

#Pfizer-BioNTech submitted a request for authorization on #December 1, and the EMA responded that it would make its decision on #December 29 during an expert meeting. #But the #United #Kingdom, the #United #States and #Canada gave their green light in an emergency procedure, which has allowed the vaccination campaigns to start earlier.

#Several #States had complained about the slowness in making a decision. The leaders of #Poland and #Hungary urged acceleration during the last #European summit last week, seconded by #Berlin.

The #European regulator also suffered a cyber attack in which data about #Pfizer / #BioNTech and #Moderna was stolen, #Although it has not had any impact on the calendar, according to the EMA.

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#Approval processes around the world

The #United #Kingdom, a step forward

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) can ask questions on the go and get faster answers as a single agency REUTERS / Dado Ruvic
The UK #Medicines and #Healthcare #Products #Regulatory #Agency (MHRA) can ask questions on the go and get faster answers as a single agency REUTERS / #Dado #Ruvic

#Contrary to the #European agency, “the UK #Medicines and #Health #Products #Regulatory #Agency (MHRA) you can ask questions on the fly and get faster answers as a single agency ”said #Penny #Ward of #London #King’s #College.

#In the #European #Union, the EMA, based in #Amsterdam, is in charge of authorizing and controlling medicines in the 27 countries that comprise it. #It uses an expedited method called “continuous review” for analyzing data regarding the safety and efficacy of vaccines.

#And despite the fact that developing a vaccine takes between 10 and 15 years on average, scientists and international leaders say that it against COVID-19 could be ready in much less.

#What happens in the #United #States

Director of the Food and Drug Administration (FDA), Stephen Hahn.  (United States) EFE / EPA / YURI GRIPAS / Archive
#Director of the #Food and #Drug #Administration (FDA), #Stephen #Hahn. (#United #States) EFE / EPA / YURI GRIPAS / #Archive

The #American procedure is slower than the #British one, with a public consultative stage.

#Before making any decision, the agency conducts an internal evaluation and consults an external advisory board. “The FDA’s procedure is absolutely transparent, independent experts question, advise and make recommendations,” explained #Moncef #Slaoui, responsible for the vaccine distribution operation.

#Following expert meetings and recommendations, the FDA must make its decisions. #After issuing the official authorization, the FDA will monitor vaccine production, including inspection facilities, and review the manufacturer’s testing of vaccine batches for ability to achieve desired effect, safety, and purity. The FDA has the right to conduct its own tests on manufacturers’ vaccines.

#Likewise, various systems monitor vaccines after they have been approved. These include #Phase IV trials (optional studies that drug companies can conduct for safety, efficacy, and other potential uses), the #Vaccine #Adverse #Event #Information #System (VAERS) and the #Vaccine #Safety #Datalink.

VAERS was established in that country in 1990 by the #Centers for #Disease #Control and #Prevention (CDC) and the FDA with the objective of “detecting possible signs of adverse reactions related to vaccines.” (#In this case, a signal is a test that indicates a possible adverse reaction observable through the collected data). #Each year approximately 30 thousand events are reported to VAERS. #Between 10 and 15% of these notifications describe serious medical reactions that end in: hospitalization, life-threatening illnesses, disability or death.

#In #Argentina, the last word is the #Anmat

Anmat is responsible for
#Anmat is responsible for “regulating all vaccines for use in human beings, whether they are nationally produced as well as imported ones” (#Gustavo #Gavotti)

#According to the website of the #National #Administration of #Drugs, #Food and #Medical #Technology (#Anmat) the agency is responsible for “regulating all vaccines for use in human beings, whether they are nationally produced as well as imported ones.”

“In the case of emergencies or when sanitary conditions make it necessary to have vaccines under development or with reduced availability of safety and efficacy data, they may be authorized in accordance with the specific procedure established by this #Administration in order to evaluate the conditions of risk / benefit for the availability of this vaccine within the framework of the strategy established by our country ”, communicates the official page of the #Argentine regulatory agency.

#When the regulatory agency approves a drug, in general its standards are always very high in such a way that when one approves, one thinks that they already have enough material to check available ”, he underlined consulted by #Infobae, #Health #Minister #Ginés #González #García, who explained that “sometimes there is what is known as reciprocity between countries, as #Argentina has with #Brazil’s #Anvisa, that is, if we authorize one here, it is immediately approved in #Brazil, and the same the other way around ”.

#As the infectious disease doctor #Roberto #Debbag (MN 60253) explained to this medium “#In #Argentina all the documents of the preclinical investigations, #Phases I, II and III, safety plus the papers of the elaboration techniques and the factory certifications are presented, which must also be reviewed by #Anmat to later approve their product ”.

“In the last 20 years all the vaccines that have been approved were approved with prior approval from the FDA or the EMA; those are usually some conditions that cause the #Anmat to have what is called fast track that makes some processes more accelerated – specified the vice president of the #Latin #American #Society of #Pediatric #Infectology-. #In #Argentina, from the moment a laboratory presented a vaccine until it was approved, at least two years passed; now with the approval of the vaccines in #Anmat they would go to the #National #Immunization #Commission (#CoNaIn) and she is the one who is going to issue a recommendation on their use and to whom ”.

#And although the #World #Health #Organization (WHO) is not the one who has the power to authorize a drug or vaccine, #Debbag clarified that “it has a probability of producing a prequalification, it is called pre quality#This does not mean that afterwards they do not need the approval of each of the countries, but a vaccine that has a WHO prequalification can have a faster approval in the country ”.

I KEEP READING:

#Step by step, this is the approval process for vaccines in the race to prevent COVID-19





[ source link ]
https://www.infobae.com/america/tendencias-america/2020/12/31/por-que-la-agencia-europea-de-medicamentos-todavia-no-aprueba-la-vacuna-de-oxford-astrazeneca/

##European ##Medicines ##Agency #approved ##OxfordAstraZeneca #vaccine

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