Inoculations begin as second vaccine seeks regulatory approval

As the UK became the first country in the world to roll out its COVID-19 vaccination programme, AstraZeneca announced  the results of the peer review for its vaccine.

Those over 80, workers in care homes and those working in the health services will become the first recipients of the vaccine in the UK. They will receive the Pfizer vaccine with 800,000 doses, of some 30 million having been delivered to hospitals across the country.

However, the Pfizer vaccine require storage at extremely low temperatures making transportation and storage complex. The AstraZeneca Oxford University vaccine can be stored in a fridge and  the peer review has been hailed as a major breakthrough, with a 100 million doses of the vaccine  destined for the UK. The vaccine is cheaper and will be mass produced to be shared across the world once national regulators provide approval for its to be administered.

The results of an interim analysis of the Phase III programme conducted by Oxford University have been peer-reviewed and published in The Lancet. AstraZeneca said the review demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation.

Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said: “Today, we have published the interim analysis of the Phase III trial and show that this new vaccine has a good safety record and efficacy against the coronavirus. We are hugely grateful to our trial volunteers for working with us over the past eight months to bring us to this milestone.”

The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University.

As announced on 23 November 2020, the primary efficacy endpoint of the programme statistical plan, based on the pooling of two dosing regimens, showed that the vaccine is 70.4% effective at preventing symptomatic COVID-19 occurring more than 14 days after receiving two doses of the vaccine. A secondary efficacy endpoint of prevention of severe disease demonstrated no cases of severe infections or hospitalisations in the vaccine group.

A further analysis of the efficacy regimens showed that when the vaccine was given as two full doses, vaccine efficacy was 62.1% and 90.0% in participants who received a half dose followed by a full dose.

AstraZeneca Chief Executive Officer Pascal Soriot, said: “Today’s peer-reviewed publication enables a full disclosure of the Oxford programme interim analysis. The results show that the vaccine is effective against COVID-19, with in particular no severe infections and no hospitalisations in the vaccine group, as well as safe and well tolerated. We have begun submitting data to regulatory authorities around the world for early approval and our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses on a global scale at no profit.”

The firm added submission of the data to regulatory authorities around the world has already begun, as part of their ongoing rolling reviews of the vaccine data for temporary use or conditional approval during this health crisis. The Company is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.

In addition to the Oxford led programme, AstraZeneca is conducting a large study in the US and globally. In total, Oxford University and AstraZeneca expect to enrol more than 60,000 participants globally.

The Company is also making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

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