The COVID-19 saga: Astrazeneca’s Vaccine Begins Phase 3 Clinical Trials

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The COVID-19 Vaccine called AZD1222 (previously ChAdOx1a), a modified chimp adenovirus vector vaccine, sponsored and manufactured by the University of Oxford and Astrazeneca, has begun its multi-site, Phase 3 clinical trials. According to the National Institutes of Health, the trial will enroll approximately 30,000 adult volunteers at 80 sites in the United States to evaluate if the candidate vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19). These trials may last until August 2021.

"Astra Zeneca headquarters in Mölndal, Southern Gothenburg (Sweden)" by Bjoertvedt is licensed under CC BY-SA 4.0
“Astra Zeneca headquarters in Mölndal, Southern Gothenburg (Sweden)” by Bjoertvedt is licensed under CC BY-SA 4.0

AZD1222 is administered in two doses and the trial is primarily designed to determine if it can prevent symptomatic COVID-19. It will also evaluate if the vaccine candidate can prevent SARS-CoV-2 infection regardless of symptoms and if it can prevent severe COVID-19. It will also assess if it can reduce the incidence of emergency department visits due to COVID-19.

Results of its Phase 2 trials published on the Lancet stated that the vaccine produced Spike-specific antibodies at day 28 and neutralizing antibodies after a booster dose at day 57. Adverse effects noted where pain at the injection site, headache, fever, chills, muscle ache and malaise in more than 60% of participants, fortunately paracetamol allowed some participants to increase tolerability. This was interpreted as an acceptable safety profile, and supports large scale evaluation of this candidate vaccine in an ongoing phase 3 trial.

The Phase 3 trial is being implemented as part of Operation Warp Speed (OWS). OWS was implemented by the Trump administration aiming to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).

Coronavirusprevention.org and ClinicalTrials.gov are currently looking for Volunteers 18 years and older who are eligible and must provide informed consent to participate in the trial.

Meanwhile, an article by Fierce Pharma reported that AstraZeneca is working to secure enough capacity to meet what could be a global 3 billion-dose demand for its COVID-19 vaccine front-runner.

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