Novavax Inc NVAX.O said on Wednesday it has signed an agreement with the Australian Government to supply 40 million doses of the its COVID-19 vaccine candidate, NVX-CoV2373.
Under the agreement, the company will deliver its vaccine to Australia starting as early as the first half of 2021, Novavax said.
The company added it expects to report late-stage data from its UK trial as soon as the first quarter of 2021.
2020 Financial Guidance
Allogene continues to expect full year GAAP net losses to be between $260 million and $280 million including estimated non-cash stock-based compensation expense of $70 million to $75 million and excluding any impact from potential business development activities.
Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 2637139. The webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.
Fosun will focus instead on seeking Chinese approval for BioNTech’s other experimental vaccine which is in final-stage human trials in the United States, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview.
The vaccine candidate developed by BioNTech and U.S. drugmaker Pfizer Inc is under real-time regulatory review in Europe and could seek emergency use authorisation in the United States after enough safety data is provided as early as this month.
But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer.
Hui said he did not regret testing BNT162b1 without waiting for more complete data.
“For ordinary vaccines, it does not matter if you wait for a few days, or a month,” Hui said. “But for (COVID-19 vaccines), how many more people would have died had you waited just for one day?”
Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.
A bridge clinical trial is required for pharmaceutical products which are approved abroad but do not have data to show that ethnic differences can affect their efficacy and safety, China’s National Medical Products Administration said.
Hui expected the late-stage candidate could be greenlighted for use in China “around the same time” as the vaccine’s global clearance.
Fosun is licensed to exclusively develop and commercialize COVID-19 vaccine products developed by using BioNTech’s mRNA technology in mainland China, Hong Kong, Macau and Taiwan. In return it agreed to pay up to $85 million in licensing fees and invest $50 million for a stake in the German firm.
A vaccine that works is seen as a game-changer in the battle against the coronavirus, which has killed more than 1.2 million people worldwide, shuttered swathes of the global economy and turned normal life upside down for billions of people.
“I’m optimistic that we could reach that point before the end of this year,” Oxford Vaccine Trial Chief Investigator Andrew Pollard told British lawmakers of presenting trial results this year.
“But unfortunately it doesn’t mean we can all go back to normal immediately because it takes time to roll out vaccines, not everyone will take them,” he said. “We will still have people getting this virus because it is just too good at transmitting.”
Pollard said working out whether or not the vaccine worked would likely come this year, after which the data would have to be carefully reviewed by regulators and then a political decision made on who should get the vaccine.
“Our bit - we are getting closer to but we are not there yet,” Pollard, director of the Oxford Vaccine Group, said.
Asked if he expected the vaccine would start to be deployed before Christmas, he said: “There is a small chance of that being possible but I just don’t know.”
The Oxford/AstraZeneca vaccine is expected to be one of the first from big pharma to be submitted for regulatory approval, along with Pfizer and BioNTech’s candidate.
Work began on the Oxford vaccine in January. Called AZD1222, or ChAdOx1 nCoV-19, the viral vector vaccine is made from a weakened version of a common cold virus that causes infections in chimpanzees.
Pollard said the U.S. Food and Drug Administration had set the bar for a vaccine being at least 50% effective - a level that would have a transformative impact on the pandemic.
“But to be able scientifically able to test 50% is a lot harder - you need a lot more cases to occur in the trials,” he said. “So I think we are all hoping the vaccine will be more effective than that which means we will have an answer sooner.”
