Vaccine trials at pivotal phase say researchers
OXFORD: Two of the most advanced experimental coronavirus vaccines have entered the pivotal phase of their studies, with the first subjects receiving doses of vaccines developed by Moderna Inc and Pfizer Inc.
Researchers evaluating the vaccines plan to enrol 30,000 people in separate last-stage, or phase-three, trials. The results will determine whether the vaccines protect against symptomatic COVID-19, and whether they should be cleared for widespread use.
Moderna’s two-dose vaccine will be administered at sites across the US. The company also received an extra commitment of up to $US472m ($662m) from the federal government to support the large study, on top of the $US483m in funding earlier in the year for development, testing and preparations to manufacture at large scale.
Moderna, which co-designed the vaccine with the National Institute of Allergy and Infectious Diseases, previously reported promising results of the first study of the vaccine, showing it induced immune responses and was generally safe in a small number of people.
The phase-three trial, titled Cove, is being conducted at nearly 90 sites in the US, including many in states such as Texas where the virus has surged in recent weeks.
Pfizer’s trial, which will begin in the US but expand overseas to include about 120 sites, will evaluate a vaccine developed with partner BioNTech SE. BNTX 2.80 per cent. The shot is one of four candidates the companies evaluated.
As vaccines proceed through the final stages of testing, countries are jockeying to secure enough doses, should they prove safe and effective, and the suppliers to transport them.
Last week, the US agreed to pay Pfizer and BioNTech nearly $US2bn to secure 100 million doses of their experimental COVID-19 vaccine to provide to US patients free of charge.
Pfizer is targeting October to file for regulatory approval or an emergency-use authorisation.
No vaccine has proven to work safely against the coronavirus. Many vaccines developed to target other pathogens have failed in testing, including in phase-three trials.
US officials on Monday said it was the fastest time from the design of a new vaccine to the start of phase-three testing in the US.
NIAID researchers helped design the vaccine, codenamed mRNA-1273, in January after the genetic code of the virus was posted to a public database.
The start of the pivotal Moderna vaccine trial is the latest sign that the most advanced coronavirus vaccine candidates are moving into the final stages of testing, and could be ready for wider use before year’s end if results are positive.
A vaccine co-developed by the University of Oxford and AstraZeneca PLC started a large study in May in the UK, and is due to enter a phase-three study in the US in August.
