Shares of vaccine maker Novavax (NASDAQ:NVAX) surged 9% in pre-market trading, setting up a second week of gains. NVAX stock rose 14.6% last week.
The Gaithersburg, Maryland biomed developer announced this morning that its Covid-19 vaccine demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 Phase 3 trial.
Novavax has been keeping investors on the edges of their seats for months waiting for U.S. vaccine data for months. At a June 1 investor conference, management noted that they would be revealing data from the trial shortly.
The company also stated in early May that it wouldn’t submit the vaccine for regulatory approval until sometime in Q3. It reiterated that in today’s announcement, “The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.”
G7 Vaccine Distribution Could Stoke NVAX Stock
Leaders of the G7 countries meeting this past week in the U.K. announced a plan to donate a billion Covid-19 vaccine doses to low-income countries. Many of the promised doses will flow through COVAX, a global vaccine buying system backed by the World Health Organization and Gavi, the vaccine alliance.
The pledge does not represent entirely new resources, and the donation is far short of the 5 billion to 6 billion shots needed by poorer nations, various reports noted.
“Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines,” said Stanley C. Erck, Novavax president and CEO.
Dr. Anthony Fauci recently said “Although the vaccines currently authorized by the U.S. Food and Drug Administration offer strong protection against Covid-19, we need to prepare for the possibility of needing booster shots to counter waning immunity and to keep pace with an evolving virus.”
So far, the NVAX vaccine has not been included in ongoing studies testing the efficacy of mixing vaccines in booster shots for fully vaccinated people. But the National Institutes of Allergy and Infectious Diseases (NAIAD) said that they may add new vaccines to the trial upon their approval.
This bodes well for Novavax as it moves closer to regulatory approval and should serve to push prices up.
On the date of publication, Robert Lakin did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
InvestorPlace contributor Robert Lakin is a veteran financial writer and editor, including previous stints with Bloomberg News and as a buyside equity research editor. His Substack newsletter, TLV Strategist, covers the Israel business scene.