Covid-19 roundup: J&J enters PhIII with a two-dose regimen to play safe; AstraZeneca, Oxford tout promising data in elderly
Johnson & Johnson had the first single-dose Covid-19 vaccine to enter Phase III trials — but to be cautious, the pharma is launching a second Phase III study evaluating the candidate in a two-dose regimen.
“Janssen’s COVID-19 vaccine program has been designed to be extremely thorough and driven by science,” the company announced on Sunday. “As such, we are investigating multiple doses and dosing regimens to evaluate their long-term efficacy.”
The second study, dubbed ENSEMBLE 2, will run in parallel with J&J’s ongoing 60,000-person trial for its single-dose regimen. It’ll enroll up to 30,000 volunteers in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK and the US.
When asked by David Rubenstein, president of The Economic Club of Washington DC, which regimen will potentially hit the market first, J&J CEO Alex Gorsky said in an interview that the company is “going to have to find out more through some of the testing.”
Early-stage interim results showed the single dose triggered a “robust immune response” and was well-tolerated, according to J&J.
“We’re trying to determine … where we would be able to identify the best balance of efficacy, safety, and of course it also has an impact on the number of vaccine shots that would be available, particularly during the course of 2021,” Gorsky said.
Last week, the company partnered with UnitedHealth Group to speed up enrollment in the Phase III trial of its single-dose regimen, which has only enrolled a few thousand participants, according to a Reuters report. The slow enrollment is partially due to a brief pause caused by the unexplained illness of a participant. The trial resumed late last month, and J&J announced there was “no evidence that the vaccine candidate caused the event.”
BARDA kicked in another $454 million last week to support the Phase III vaccine trial, and J&J committed another $604 million.
“Do you get asked every 15 minutes or is it every 30 minutes when their vaccine is going to be available?” Rubenstein jokingly asked Gorsky during their interview, which was live-streamed on Twitter.
“It’s about every 30 seconds or every 5 minutes at the very least,” Gorsky responded with a smile. “The short answer would be not soon enough,” he added, before commending scientists for their efforts. — Nicole DeFeudis
AstraZeneca, Oxford touts promising PhII vaccine data in elderly
Teasing Phase III results expected in a few weeks, AstraZeneca and Oxford say newly published Phase II data suggest that their vaccine induces similar levels of immune response in the elderly as younger adults.
Reporting in the Lancet, investigators say that among 560 healthy volunteers, 240 were over the age of 70 (200 of them received the Covid-19 vaccine, while others were assigned to a meningococcal jab). The other 320 were evenly split between the 18-55 and 56-69 age groups, with the majority receiving ChAdOx1 nCoV-19, which is also known as AZD1222.
“ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose,” they concluded.
Whether that translates to efficacy will only be known when AstraZeneca hits the threshold for interim analysis of its Phase III study. After a weeks-long halt to its late-stage trial in the US due to a severe adverse event, the pharma giant had resumed dosing in late October.
At the cutoff, 13 serious adverse events had been recorded in the Phase II portion of the trial, but none were considered related to either vaccine.
Like Pfizer/BioNTech and Moderna, AstraZeneca is testing a two-dose regimen in late-stage studies. But rather than mRNA, its candidate utilizes a recombinant adenovirus vector to slip in a gene for the spike protein of SARS-CoV-2.
By 14 days after the boost dose, 208 of 209 participants getting that regimen developed neutralizing antibodies, while T cell responses peaked at day 14 after a single dose. — Amber Tong
Turkey set to pre-order Sinovac’s vaccine amid PhIII studies
Sinovac has found a new customer in Turkey, whose health minister said the government is close to signing a contract to buy at least 20 million doses of its Covid-19 vaccine. Turkey is hosting one of its late-stage trials.
Brazil, where Sinovac is conducting a Phase III study, was the first to strike such a purchase deal with the Chinese company. Sinovac’s vaccine consists of an inactivated virus.
Turkey is reportedly also working on buying doses of Pfizer and BioNTech’s mRNA vaccine — the first Covid-19 candidate to be proven 95% effective in a large-scale trial.
While Sinovac has yet to generate efficacy data, the company has already secured emergency use approval in China. Preliminary results from earlier studies indicated that its jab triggered a quick immune response, although the level of antibodies produced were lower than in people who have recovered from the virus.
“We will be able to procure at least 10 million doses of the Chinese vaccine in December. We want to increase this number. It will be just as much in January, too,” Turkish health minister Fahrettin Koca was quoted as saying by the state-run Anadolu news agency, per Reuters.
He added that Turkey would get 1 million doses if talks with Pfizer and BioNTech go through, but there are talks to bring the number up to 25 million. Pfizer and BioNTech have committed at least 570 million doses through supply agreements worldwide, with the US and the EU making the largest orders. — Amber Tong
For a look at all Endpoints News coronavirus stories, check out our special news channel.