Coronavirus vaccines development and impact on clinical trial supplies
Three vaccines currently in circulation are showing high rates of effectiveness in preventing COVID-19. Pfizer-BioNTech and Moderna are developing vaccines in late-stage clinical trials that are showing over 94 and 95% effectiveness. The University of Oxford, while in earlier clinical trial stages, is showing strong immune responses already in adults over 60.
Pfizer and German mRNA biotech partner BioNTech released information regarding their experimental pandemic vaccine, with the results looking positive. In its phase III clinical trial, Pfizer and BioNTech’s vaccine candidate named BNT162b2 has demonstrated over 94% effectiveness in preventing COVID-19 in subjects without prior SARS-CoV-2 infection.
Pfizer has warned that as more results come in as clinical trials for this vaccine continue, the results could change, increasing or decreasing its effectiveness percentage. Pfizer and BioNTech found 94 confirmed COVID-19 cases among the 43,538 participants that took part in the trial of BNT162b2.
US company Moderna has released similar results, revealing that their vaccine has shown 95% effectiveness in protecting against COVID-19. The trial in the US included 30,000 participants; half of which were given two doses of the vaccine four weeks apart, the rest were given dummy vaccines.
Out of the target group of 95, only five of those given the real vaccine developed the coronavirus, while 90 of the cases were given the dummy vaccine. Moderna hopes to make the vaccine available worldwide in 2021; with the UK announcing that it will have five million doses of the Moderna vaccine, enough for 2.5 million people, in spring.
University of Oxford/AstraZeneca
The University of Oxford vaccine, while in earlier clinical trial stages than Pfizer-BioNTech and Moderna, is showing strong results as it moves into the phase III trial in the coming weeks. In adults in their 60s and 70s, the Oxford vaccine shows a strong immune response; increasing hopes that it can protect older adults most at risk from the virus.
The Oxford vaccine is manufactured by AstraZeneca and has been ordered by the UK government in larger doses than any other vaccine. The government has ordered 100 million doses of the Oxford vaccine compared to 40 million doses of Pfizer-BioNTech and five million of Moderna.
When will the COVID-19 vaccines be rolled out and who is first in line?
How countries plan to roll out the vaccines has not been disclosed, but it has been suggested that Italy, Spain and other EU member states would benefit from small numbers of doses ready in December, with most ready in 2021.
What is the impact of COVID-19 vaccine trials on clinical trials?
COVID-19 vaccine trials have dominated clinical trial resources. Some of the most recent largest clinical trials to take place with experimental agents puts this into context. In accordance with the number of phase III trials registered in clinicaltrials.gov, COVID-19 vaccine trials account for five of the 10 most expansive in terms of participants.
This is because vaccine trials require expansive programmes to identify low-frequency safety risks that might occur in the wider population. Another reason is to ensure there are enough participants involved in the study to be able to gather significant statistics in events that are rare. As such, we have seen a significant concentration of resources into vaccine research. In addition, asthma medication and COVID related medication experience very high demand and potential shortages.
At CSI, we have mapped the entire global market and can successfully supply COVID related medication for your trials.
The advantages of biosimilars vs branded products in clinical trials
The growth in the biosimilar market since 2006 has been significant.