AstraZeneca COVID vaccines receive WHO emergency use listing

Regulatory NewsRegulatory News | 15 February 2021 |  By 

The World Health Organization (WHO) has granted two additional vaccines against COVID-19 emergency use listing (EUL). Two versions of the vaccine co-developed by AstraZeneca and the University of Oxford received EUL status from WHO on Monday, following an all-day meeting and one the previous Friday to weigh safety and efficacy recommendations and manufacturing and quality considerations.
The two vaccines had to be considered separately, said WHO director-general Tedros Ghebreyesus in a press briefing held Monday evening, because they are produced by two separate facilities – SK Bio in South Korea, and the Serum Institute of India.  “The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan,” explained WHO in a press release announcing the new EULs.
The favorable reviews, “completed in just under 4 weeks from the time we received the full dossiers,” mean WHO now adds two more arrows to its global vaccines quiver, said Tedros. The global health agency issued an EUL in December 2019 to the messenger RNA vaccine co-developed by Pfizer and BioNTech, marketed as Comirnaty in Europe.
However, said Tedros, “We need to scale up manufacturing… We continue to call for vaccine developers to submit their dossiers to WHO at the same time they submit them to regulators in high income countries.” Global support for vaccination in developing countries, he said, “is a rounding error compared with the trillions of dollars that have been mobilized in G7 countries to stabilize their economies.”
The EULs come the week after WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization Working Group issued a favorable report on efficacy and safety of the AstraZeneca vaccine formulation. The vaccine presents a thorny problem for those working on the COVAX facility, the global initiative for COVID-19 vaccination. Though its efficacy is lower than the near-perfect marks reached by the two mRNA vaccines that have been authorized or approved in many countries, the AstraZeneca vaccine comes without the requirements for cold-chain storage that mark mRNA vaccines.
Though specialized transport and storage equipment is not needed for the AstraZeneca vaccine, recent data show the vaccine has reduced efficacy against a SARS-CoV-2 variant exploding in South Africa and cropping up elsewhere around the world. Despite this, SAGE recommended use of the AstraZeneca vaccine globally, including in South Africa, noting that the sample size to date is small, and the vaccine may still provide protection against severe COVID-19 disease.
“We have an absence of evidence from that trial about whether or not the AZ product has efficacy against severe disease hospitalization and death, and that is the outcome of most interest and most impact for early rollout of vaccines, noted WHO’s Katherine O’Brien, MDCM, MPH, in a 10 February press conference discussing SAGE’s recommendations. She pointed to experience with other vaccines for “plausible” confidence that the AstraZeneca vaccine will still forestall many hospitalizations and deaths globally.


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Tags: coronavirus, SAGE, WHO

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