Text size
Data from BioNTech and Pfizer were particularly promising.
Jeenah Moon / Getty Images
After a hiatus from a late summer break, the news of a Covid-19 vaccine is heating up again as a handful of leading programs are rapidly moving to a decisive phase.
Reports from several companies hit Thursday morning, in what may serve as a warning to investors that it is time to re-focus on the race.
In one notable development, BioNTech (BNTX) and Pfizer (PFE) published data on the experimental vaccine that the companies are testing in Phase 2/3 studies. It is the second of two versions of the vaccine the company tested in Phase 1 tests. A paper published on a non-peer-reviewed preprint server states that it appears more secure than the previous version.
Also on Thursday, The Wall Street Journal reported that Johnson & Johnson (JNJ) is planning a trial of 60,000 people from their Covid-19 vaccine by the end of next month. Phase 3 trials launched by Pfizer and Moderna (MRNA) aim to enroll 30,000 people. The Journal said it is not clear why the Johnson & Johnson lawsuit is intended to be twice as large.
Meanwhile, in an interview with reporters Thursday morning, a Food and Drug Administration official said the external panel could meet with the agency on Oct. 22 to discuss a Covid-19 vaccine, according to Bloomberg. The official did not say what fax the panel would discuss, but Pfizer said it hopes Phase 3 data on its fax will be available by then.
The external advisory committee would probably have to weigh in before the FDA issues an authorization for emergency use. And an October 22 meeting would leave time for a fax before the election is approved. Investors are expecting more and more approval by then, despite concerns from former FDA officials that the timing could undermine confidence in the product.
All this comes after CureVac (CVAC) said earlier Thursday that it was in talks with the European Commission to sell the 225 million doses of its experimental Covid-19 vaccine, and to send shares of the new public share up 14.7% .
Shares of BioNTech were up 2% on Thursday afternoon, while shares of Pfizer were up 0.6%. Shares of Moderna were down 1.1%, and shares of fellow Covid-19 vaccine developer Novavax (NVAX) were down 0.4%. Share in Johnson & Johnson was flat,.
The data from BioNTech and Pfizer were particularly promising. The companies said in late July that they were launching a Phase 2/3 trial of BNT162b2, one of two similar versions of the vaccine they had developed. But the companies had only released Phase 1 data on the other version, called BNT162b1. The paper from Thursday outlines the results of the BNT162b2 test, and says that although the immune responses elicited by the two vaccines were similar, the second version had a better safety profile.
“The dataset presented here leads our decision to advance BNT162b2 … to Phase 2/3,” the paper reads. “The primary consideration driving this decision was the milder systemic reactogenicity profile of BNT162b2, particularly in older adults, in the context of similar anti-antibody responses elicited by both candidate vaccines.”
The flow of news serves as something of a warm-up for the coming months, during which fax developments could bring stock prices across the market.
Write to Josh Nathan-Kazis at [email protected]
.
