COVID-19: Oxford/AstraZeneca’s DNA Vaccine Scores Emergency Use Approval in the UK
December 30th, 2020 – After a long and dark year of multiple waves of the COVID-19 outbreak, the first vaccines made it to the market in December 2020. In the largest vaccination program that needs to be managed on a global scale, it would be extremely difficult to maintain the logistics and supply chain with just two authorized vaccines. Besides, the BioNTech/ Pfizer and Moderna vaccines are mRNA-based and need to be stored at freezing temperatures, requiring specialized refrigerators for storage, transportation, and distribution of the vaccine in remote areas with fragile healthcare infrastructure. A DNA vaccine, which is stable at 2-8°C for up to six months, can be shipped at room temperature and is cheaper to manufacture.
Today, AstraZeneca announced that its DNA-based COVID-19 vaccine has been approved for emergency use in the UK for adults 18 years and older. In concurrence with the UK government, NHS (National Health Service), and PHE (Public Health England), AstraZeneca plans to roll out the vaccine doses in early January 2021, with an agreement for a total of 100 million doses.
The vaccine named AZD1222 is a result of a collaboration between Oxford University and AstraZeneca. It is designed as a replication-deficient adenovirus that contains the genetic code for SARS-COV2-Spike protein. Upon injection, it triggers antibody production against the SARS-CoV-2 virus. Tested on patients with symptomatic COVID-19 infection, the vaccine had a primary efficacy endpoint of 70% with no severe infections or hospitalizations in those who received the vaccine. It tested safe and effective in four independent Phase III clinical trials with over 20,000 participants across the UK, Brazil, and South Africa. The results of the trials were published in The Lancet on December 8th. This indicates that the vaccine is well-tolerated in diverse racial and geographical populations. Adenovirus-based vaccine by Johnson and Johnson has been previously approved for Ebola.
Pascal Soriot, AstraZeneca Chief Executive Officer, said: “Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer, and is supplied by AstraZeneca at no profit. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government, and the tens of thousands of clinical trial participants.”
The authorization by the Medicines and Healthcare Products Regulatory Agency (MHRA) is the first for AZD1222. It is also under review for approval from regulatory authorities from WHO, the EU, and the USA, following which AstraZeneca plans to roll out 3 billion doses of the vaccine globally in 2021, focusing on low- and middle-income countries.
Similar to the BioNTech and Pfizer vaccines, this one requires two doses, several weeks apart. The MHRA is expected to provide the dose-regimen details later as the vaccine roll-out is expected as early as next week. Since the first dose could provide very effective protection from the infection, it will help vaccinate a large number of people. The second dose is important for long-term protection.
By Sahana Shankar, Ph.D. Candidate
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