EU "AstraZeneca Vaccine, No Approval Application Received... Difficult to Introduce Next Month" (Comprehensive)

Early next month vaccination planned in UK still not approved
US FDA "No application received"...release likely delayed
Dosing controversy unresolved...safety concerns persist

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] AstraZeneca, a pharmaceutical company known as a frontrunner in developing a novel coronavirus disease (COVID-19) vaccine alongside Pfizer and Moderna, has not yet applied for vaccine approval from the European Union (EU), raising concerns that vaccine distribution may be delayed more than expected. In the UK, where vaccinations were expected to begin early next month, health authorities have not yet announced approval. Trust issues surrounding the AstraZeneca vaccine, which has been embroiled in safety controversies such as dosage concerns raised last month, are reportedly hindering progress.

On the 29th (local time), Noel Wathion, Deputy Director of the European Medicines Agency (EMA), responsible for vaccine approval in the EU, stated in an interview with the Belgium Times, "It will be difficult for AstraZeneca's COVID-19 vaccine to be introduced next month," adding, "We have not yet even received an application for approval from AstraZeneca, and based on the limited information received so far, we cannot grant even a conditional marketing authorization."

The AstraZeneca vaccine has also not received approval from UK health authorities, despite earlier expectations of vaccination starting early next month. According to the UK daily Telegraph on the 26th, AstraZeneca formally submitted an emergency use authorization application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the 21st and provided the full clinical trial data for review. Approval was expected to be announced as early as the 27th, with vaccinations starting on the 4th of next month. However, as of now, MHRA has not yet announced approval.

According to CNBC, the U.S. Food and Drug Administration (FDA) also stated, like the EMA, that it has not yet received an approval application from AstraZeneca. Consequently, concerns are emerging that the distribution of the AstraZeneca vaccine, expected by the end of this year or next month, may be delayed.

The delay in AstraZeneca's approval application is presumed to be due to the dosage controversy raised last month. According to the medical news outlet Stat News, AstraZeneca announced interim results of its Phase 3 clinical trials on the 23rd of last month, reporting that clinical trial participants who received only half the dosage in the first vaccination showed a 90% immune response, while those who received the full dosage showed a 62% immune response.

When the global medical community and health authorities raised doubts about this, Mene Pangallos, Vice President of AstraZeneca, admitted at a press conference held immediately after the clinical results announcement that "administering half a dose was a serendipity," acknowledging it was an unintended mistake, which sparked further controversy. AstraZeneca later stated it would resolve the dosage controversy through additional clinical trials, but it has yet to provide clear explanations to health authorities in various countries.

Earlier, Pascal Soriot, CEO of AstraZeneca, suggested the possibility of resolving the dosage controversy in an interview with the UK Sunday Times on the 27th, saying, "We have figured out the formula for vaccine success," but did not disclose specific dosage details or methods, stating, "Because the vaccine will be released soon, I cannot provide detailed information."

This content was produced with the assistance of AI translation services.