Friday morning, President Donald Trump tweeted that he and First Lady Melania had tested positive for the Covid-19 coronavirus. Now it’s up to his immune system and available treatments, but the president’s infection dramatizes the need for a preventive vaccine.
Covid vaccine developers—and a masked nation—are hoping that government regulators will grant emergency-use authorization for vaccines soon after any successful Phase 3 trial. Meetings have already been scheduled this month for science advisors at two of the relevant federal agencies. On Oct. 22 the U.S. Food and Drug Administration will host a meeting of an advisory committee on Covid vaccines. Then on Oct. 29 the Centers for Disease Control and Prevention will hear from advisors on immunization practices.
In anticipation of those meetings, the analysts at Canaccord Genuity Capital Markets put out a note Thursday on the status of the five vaccines now in pivotal Phase 3 clinical trials.
A vaccine developed by Oxford University researchers has been in global trials sponsored by AstraZeneca (ticker: AZN). Those trials were put on hold in September when a British volunteer developed a serious neurological illness. The trial has resumed in the U.K., India and South Africa, but not in the U.S., where the FDA has asked for information on other Oxford vaccines.
Pfizer (PFE) executives have repeatedly said that they may have results from their trial as early as this month, for the vaccine the company is developing with BioNTech (BNTX). Pfizer’s trial design allows independent monitors to perform an interim analysis after fewer events, and more frequently, than its rivals’ trials—so evidence on the vaccine’s effectiveness may become visible sooner. The trial has dosed around 30,000 people of a planned total of 44,000.
Moderna (MRNA) was the first to start trials of its vaccine, which uses the novel technology of messenger-RNA that Pfizer and BioNTech also use. As of September 25, more than 27,000 of the planned 30,000 volunteers had been doses, with about 15,500 of them already having gotten the second booster shot of the vaccine. The company thinks its trial will yield an answer in November.
Johnson & Johnson (JNJ) started a 60,000 person Phase 3 trial on Sept. 23—months later than the others. But the company says its vaccine should work with just one shot, instead of needing a month-later booster like the other vaccines. The company’s technology has already been used against other daunting viruses, like Ebola. So J&J thinks its trial results should appear just a month or so after Moderna and Pfizer.
Write to Bill Alpert at firstname.lastname@example.org