Slaoui updates on COVID-19 vaccines, warns about slow enrollment in adolescent trial
If clinical trials yield positive results, Johnson & Johnson’s COVID-19 vaccine could be authorized in the U.S. by mid-February, the Oxford/AstraZeneca vaccine could receive Emergency Use Authorization in late March, and a vaccine from Novavax could be authorized in late April, Moncef Slaoui, scientific adviser and co-leader of Operation Warp Speed said Tuesday.
Correlates of protection that could speed the development of additional COVID-19 vaccines could be validated in the middle of next month, facilitating the development of additional vaccines, he added.
Along with positive news on vaccine development, Slaoui lamented slow recruitment of adolescents in a trial of the COVID-19 vaccine from Moderna Inc. (NASDAQ:MRNA).
Analysis of data from a Phase III trial of the vaccine candidate from the Janssen unit of Johnson & Johnson (NYSE:JNJ) “will be completed before the end of the month and the EUA submission will take place at the end of this month,” Slaoui said. FDA could issue an EUA in mid-February, he added.
Operation Warp Speed expects to have “single digit millions” of doses of the J&J available in the second half of February, with inventories ramping up substantially in March and April, Slaoui said. The company is testing and expects to deploy a single-dose regimen.
Slaoui expects AstraZeneca plc (LSE:AZN; NASDAQ:AZN) to complete the U.S. Phase III trial of its COVID-19 vaccine and submit an EUA request to FDA in the first week of March. Authorization could come “somewhere towards the latter part of the month of March” he said.
Novavax Inc. (NASDAQ:NVAX), which, like Moderna, J&J, and AstraZeneca is receiving financial support from Warp Speed, has recruited about 8,000 volunteers for its Phase III trial and is recruiting 800 individuals per day, Slaoui reported. Trial recruitment is expected to be completed in early February, and outcomes data could be available in late March or April, he said.
Sanofi (Euronext:SAN; NASDAQ:SNY) plans to start a Phase IIb trial in mid-February of a vaccine it is developing in partnership with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). The trial will compare the adjuvanted protein-based vaccine to an mRNA vaccine, Slaoui said.
Slaoui did not provide an estimated timeline for the Sanofi vaccine, but he suggested that rather than launching a Phase III trial, it could be be reviewed based on correlates of protection that NIH and COVID-19 vaccine manufacturers are working to validate.
The validation of immune correlates of protection for COVID-19 vaccines is “super important,” Slaoui said because they will “dramatically accelerate potential approval of other vaccines, including the protein vaccines, particularly the vaccine from Sanofi.”
In contrast to the rapid recruitment of volunteers for trials in adults, a trial in 12-18 year-olds of the COVID-19 vaccine from Moderna is “a real challenge,” Slaoui said. In four weeks, only 800 adolescents have enrolled in the trial, which is designed to include 3,000 volunteers.
“It’s really very important for all of us, for all the population in America to realize that we can’t have that indication unless adolescents age 12 to 18 decide to participate” in the trial, he said.