The British pharmaceutical AstraZeneca and the University of Oxford have requested this Tuesday to the European Medicines Agency (EMA, for its acronym in English) a conditional authorization for the marketing of its vaccine against covid-19 in the European Union. The agency plans to respond to the request on January 29 and, if approved, it would be the third approved in the EU, after those of Pfizer and Moderna, whose first doses have arrived in Spain this Tuesday.
The evaluation of the vaccine, known as the COVID-19 AstraZeneca Vaccine, “will be carried out in an accelerated period of time,” according to the EMA in a statement. According to the regulatory body, “an opinion could be issued on January 29”, during the meeting of the scientific committee for human medicines (CHMP, in its acronym in English), “provided that the data presented on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that all additional information necessary to complete the evaluation is promptly submitted ”.
The president of the European Commission, Úrsula von der Leyen, celebrated the “good news” that implies that “AstraZeneca has requested that the use of its vaccine be authorized in the EU” and assured that “once the drug receives scientific approval” , Brussels will work “at full speed to authorize its use in Europe”.
Normally the evaluation processes are much slower, and take months, but the exceptional nature of the pandemic has caused an accelerated process to be enabled, which has already passed the Pfizer-BioNTech and Moderna vaccines. This is possible “because the EMA has already examined some data on the vaccine during an ongoing review,” the note explains. “During this phase, the EMA evaluated data from laboratory studies (non-clinical data), data on the quality of the vaccine (on its ingredients and the way it is manufactured) and some evidence on safety and efficacy. from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa. The company also provided additional scientific information on issues related to the quality, safety and efficacy of the vaccine at the request of the CHMP and is currently being evaluated, ”he adds.
The regulator analyzes the documentation provided by the laboratories that develop the vaccines and, if applicable, recommends the authorization of their marketing, which is automatic in all member countries of the European Union. This permission is more comprehensive than the emergency authorizations being granted by regulators in countries such as the United Kingdom or the United States. In the last 10 years, the EMA has granted another thirty, and none have had to be revoked or suspended.
The UK started using the AstraZeneca vaccine on January 4, after its regulator approved it on December 30. This product is easier to transport and preserve than Pfizer’s vaccine, the first to be mass-supplied. The latter needs to be kept at a temperature of 70º below zero, and only lasts three and a half days in conventional refrigerators. The Oxford one is notably cheaper (between three and four euros, compared to 15 for the first one) and holds up without problems at a temperature between 2º and 8º.
This vaccine has shown an efficacy of 62% in its largest trial, with 11,636 volunteers. However, in a subsequent trial with a subgroup of 2,741 volunteers in the UK, who were given a first half dose and a full dose four weeks later, the efficacy reached 90%.
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