After a brief summer respite, the news about a Kovid-19 vaccine is heating up again as a handful of major programs rapidly come to a decisive stage.
Reports from several companies came in on Thursday morning, which could serve as a warning to investors to once again start focusing on the race.
In a notable development, BioNTech (BNTX) and Pfizer (PFE) have published data on experimental vaccines that the companies are testing in Phase 2/3 trials. This is the second of two versions of the vaccine that the company tested in Phase I trials. A paper published on a non-peer-reviewed preprint server states that it is more secure than the previous version.
Also on Thursday, The Wall Street Journal reported that Johnson & Johnson (JNJ) is planning a 60,000-person trial of its Kovid-19 vaccine by the end of next month. Phase 3 trials initiated by Pfizer and Moderna (MRNA) aim to recruit 30,000 people. The Journal stated that it is unclear why the Johnson & Johnson trial aims to be twice as large.
Meanwhile, in a call with reporters on Thursday morning, a Food and Drug Administration official said that according to Bloomberg, the agency’s external vaccine-advisory panel, Kovid-19 could meet on October 22 to discuss the vaccine. The official did not say which vaccine the panel would discuss, but Pfizer said it expected to have Phase 3 data on its vaccine by then.
An external advisory committee would have to be weighed before the FDA issued an Emergency Use Authority. And the October 22 meeting will allow time for a vaccine to be approved before the election. Investors were hoping for a speedy clearance by then, despite concerns from former FDA officials that confidence in the product could be reduced.
CureVac (CVAC) said early Thursday that it was negotiating with the European Commission to sell 225 million doses of its experimental Kovid-19 vaccine, sending shares of new public stock 14.7%.
BioNTech shares were up 2% on Thursday, while Pfizer shares were up 0.6%. Modern’s shares were down 1.1%, and the shares of fellow Kovid-19 vaccine developer Novavax (NVAx) were off 0.4%. Stock was flat in Johnson & Johnson,.
BioNTech and Pfizer data were particularly promising. The companies said in late July that they were beginning a phase 2/3 trial of BNTT2B2, one of two similar versions of the vaccine that they had developed. But the companies had released only Phase 1 data on the second version, called BNTT 2B1. The paper out outlines the results of the BNT162b2 trial on Thursday, and states that while the immune responses elicited by the two vaccines were similar, the second version had an improved safety profile.
“The data set presented here dictates our decision to pursue BNT 162 B2 … in step 2/3,” the paper reads. “The primary consideration driving this decision, BNT162B2, particularly in older adults, was the mild systemic reactogenicity profile, in terms of comparable antibody responses by both candidate vaccines.”
The buzz of news for the coming months serves as some warm-up, where the development of vaccines can increase stock prices in the market.
Write Josh Nathan-Kazis at [email protected]