Step Forward: Oxford/AstraZeneca’s AZD1222 Shows Promising Results in Early Human Trials - Kalkine Media

July 21, 2020 09:58 PM AEST | By Team Kalkine Media
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Summary

  • Currently, more than 160 vaccines are under different stages of development (clinical and preclinical).
  • With several ongoing studies around the world, people are eagerly waiting for some good news as the pandemic continues to wreak havoc.
  • AstraZeneca and Oxford University updated that interim findings from their ongoing Phase 1/2 trial demonstrated that AZD1222 was well tolerated and produced robust immune responses against the SARS-CoV-2 virus, offering a ray of hope to billions worldwide.
  • The University stated that these interim findings support further evaluation of AZD1222 in ongoing large-scale Phase 3 clinical trial program.

According to the draft landscape provided by the World Health Organization (WHO) on 20 July 2020, a total of 166 vaccine candidates, with different technologies, are under development. Twenty-four vaccine candidates, out of the 166, have entered clinical assessment while the remaining 142 are in preclinical development.

Healthcare associations, academic institutions, and researchers all over the world are collaborating to develop a vaccine against the novel coronavirus, SARS-CoV-2, that has infected more than 14.5 million individuals and caused 607,389 deaths (as per WHO at 11:26 AM CEST, 21 July 2020).

Governments of several nations are also participating and supporting healthcare companies by providing funds to accelerate the development of COVID-19 vaccine to fight this ongoing global health emergency.

MUST READ: Your Complete Guide: Companies Hitting the COVID-19 Vaccine Charter

In May 2020, the US government introduced Operation Warp Speed (OWS) aiming to deliver nearly 300 million safe and effective COVID-19 vaccine by January 2021. OWS is a part of the broader strategy to speed up the development, production, as well as distribution of COVID-19 vaccines, therapeutics, and diagnostics.

In this article, we are highlighting how Oxford University and AstraZeneca are progressing towards COVID-19 vaccine development.

COVID-19 vaccine AZD1222 demonstrated strong immune responses in all participants in Phase 1/2 clinical trial

On 20 July 2020, AstraZeneca and Oxford University updated that interim findings from the ongoing Phase 1/2 COV001 trial (headed by Oxford) demonstrated that AZD1222 was well tolerated and produced robust immune responses against SARS-CoV-2 virus in all evaluated subjects.

COV001 trial is a multi-centre, blinded, randomised, controlled Phase 1/2 clinical trial with nearly 1,077 healthy participants between 18 to 55 years. In this trial, a single dose of AZD1222 has been assessed against a comparator meningococcal conjugate vaccine. Moreover, 10 participants also received two doses of AZD1222 one month apart.

Oxford University states that the vaccine triggered a T cell response within 14 days of vaccination (white blood cells that can attack SARS-CoV-2 virus-infected cells), and an antibody response within 28 days (antibodies are capable of neutralising the virus so that it cannot infect cells when initially contracted).

Notably, the interim findings corroborated that a single dose of AZD1222 showed a four-fold rise in antibodies to the SARS-CoV-2 virus spike protein in ~95% of subjects one month after injection. In all subjects, a T cell response was stimulated, peaking by day fourteen, and retained two months after injection.

The University disclosed that these encouraging interim findings support further evaluation of this vaccine candidate in the ongoing large scale Phase 3 clinical trial program, that is still needed to assess the ability of the vaccine to safeguard individuals from COVID-19.

Mr Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca stated-

The global clinical trial program comprises of Phase 3 clinical study in the US enrolling ~30k patients, a pediatric trial, and a Phase 3 clinical trials in low-to-middle income nations comprising Brazil and South Africa where clinical trials (currently underway).

What is COV001?

COV001 is a Phase 1/2 single-blinded randomised controlled trial for determination of safety, immunogenicity, as well as the efficacy of Oxford’s COVID-19 vaccine candidate AZD1222 in nearly 1,077 healthy adults in 5-trial centres in the UK. Subjects aged between 18 and 55 years received either a single dose or two doses of AZD1222 at 5x1010 viral particles, or a single dose of MenACWY (meningococcal conjugate vaccine) as a control vaccine.

AstraZeneca and the government of Brazil Inked a US$127 million deal

AstraZeneca is collaborating with various governments to provide vaccine doses on successful clinical development. On 27 June 2020, AstraZeneca and Brazilian government signed a deal valued at nearly US$127 million for manufacturing of adenovirus-based COVID-19 experimental vaccine, AZD1222, as the South American giant fights an increasing count of new coronavirus infection.

Moreover, Brazil's Fundacao Osvaldo Cruz would produce the vaccine and initially manufacture nearly 30 million doses of AZD1222.

COVID-19 vaccine Phase 2/3 Clinical Trials

In May-2020, Oxford University disclosed that researchers had commenced recruiting for the next phase in human trials of a COVID-19 vaccine in human volunteers.

The objective of the Phase 2/3 clinical trial is to test a new vaccine against COVID-19 in healthy volunteers. This study aims to assess how people across a broad range of ages could be protected from COVID-19 by Oxford’s vaccine. Moreover, it will also provide useful information on the safety aspects of the vaccine as well as its ability to generate good immune responses against the novel coronavirus.

Phase 3 Trial commenced in Brazil

On 28 June 2020, Oxford University disclosed that volunteers have started taking part in Latin America’s first clinical trial for a vaccine against COVID-19. Volunteers in Brazil have received a trial vaccine against COVID-19, a first Phase 3 COVID-19 clinical study in Latin America. The University disclosed that the trial officially began on 20 June 2020 and will enrol 5,000 volunteers across the nation.

Trial of COVID-19 Vaccine Starts in South Africa

On 23 June 2020, the University disclosed that Participants in the first clinical trial for a vaccine against COVID-19 are to be vaccinated in South Africa. Moreover, the University of Oxford and Wits University is working in partnership and the Oxford Vaccine Group on the clinical trial in South Africa.

About AstraZeneca Plc:

Cambridge, UK based healthcare company AstraZeneca Plc (Nasdaq:AZN) is a global biopharmaceutical player that focuses on the discovery, production as well as commercialisation of prescription medicines. The biopharmaceutical player’s focus is on the treatment of diseases in the therapeutic field of oncology, cardiovascular, respiratory, and renal & metabolism.

Stock Information: On 20 June 2020, AZN stock last traded at US$58.68 down by 3.96% from its previous close. The market capitalisation of AZN stock stood at ~US$154.01 billion.


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