- CanSino Biologics, one of the front-runners in the global push to develop a coronavirus vaccine, said it is in talks with multiple countries to gain emergency authorization ahead of Phase 3 data demonstrating whether it's effective in preventing COVID-19, the Wall Street Journal reported. The news comes about two weeks after Russia approved a vaccine on the basis of early-stage data on safety and immune response. China, too, said it began inoculating citizens with a vaccine last month, before testing was complete.
- Many countries are jostling for a leadership position on vaccine approvals and supply. The European Commission is in talks with several vaccine developers to gain hundreds of millions of doses, while Moderna announced Friday it is in talks with Japan to provide at least 40 million doses. The U.S., meanwhile, has secured supply deals with multiple developers, and the Food and Drug Administration has scheduled an advisory committee meeting Oct. 22 to review data on vaccines in late-stage development. In a speech Thursday night, President Trump said a vaccine could arrive "before the end of the year — or maybe even sooner."
- The developments are another sign of what's being called "vaccine nationalism" as countries vie to be the first to drive cases of COVID-19 to low levels. It puts rich nations at an advantage over developing countries, as the U.S. and other industrialized nations have promised billions of dollars and hinted at speedy regulatory review in return for early access.
China already approved CanSino's vaccine for use in its military at the end of June. The biotech was one of the earliest to generate clinical results from a coronavirus vaccine, but the finding that the shot stimulated an immune response was marred by the fact that many subjects had a pre-existing immunity to one of its components, limiting its potency.
Yet this finding doesn't seem to be discouraging countries from wanting access. In the Wall Street Journal's report, Pierre Morgon, CanSino's senior vice president for international business, said the company is in talks with "Pakistan and countries in Latin America as well as some developed nations," but would not name them all for business confidentiality reasons.
By inoculating more people, Morgon told the WSJ, the company could accrue safety and efficacy data that would add to a planned 40,000 patient Phase 3 trial that could begin recruiting patients by the end of August. The Shaukat Khanum Memorial Cancer Hospital and Research Center in Pakistan, however, is the only trial location listed for that study. CanSino just reversed plans to run a trial in Canada, and is preparing to run a 5,000-person trial in Saudi Arabia.
Last week, the company neared the halfway point of enrollment for its 30,000-subject Phase 3 trial. Rivals from BioNTech/Pfizer and AstraZeneca are on similarly speedy paths as well, and all three will likely be the subject of an advisory panel the FDA has set for Oct. 22.
Experts won't debate the potential approval of a specific vaccine at the meeting. Rather, the focus will be "the development, authorization and/or licensure of vaccines to prevent COVID-19," according to an announcement from the agency.
Given the current pace of enrollment, patients late to enter the Moderna trial would only be receiving their booster shot — the dose that has stimulated the biggest immune response so far in early testing — in the days before that meeting. That means, in all likelihood, there won't be a final analysis by then showing whether the shot can prevent COVID-19 infections.
However, industry observers have suggested that an interim analysis could potentially reveal data robust enough to make a decision on whether to authorize broader use or stop development. Pfizer, for instance, has said it may seek a regulatory review as early as October.
The FDA meeting will carry even more weight now that President Donald Trump, in accepting the Republican Party's renomination for the White House on Thursday, promised a vaccine by the end of the year. This was a reiteration of the ambitious goals laid out when the administration unveiled Operation Warp Speed earlier this year.