U.S. authorization is likely not a priority for Novavax since half the population is already vaccinated. But with other parts of the world, there’s still plenty of room for a Novavax vaccine.
Thiago Prudêncio/SOPA Images/LightRocket via Getty Images
Gaithersburg, Maryland-based Novavax presented its second-quarter financial results, and although it is already filing with some countries for its COVID-19 vaccine, it expects to delay its filing in the U.S. until the fourth quarter.
It has already filed for regulatory approval in India, Indonesia and the Philippines. It also expects to submit to the World Health Organization (WHO) for emergency use listing this month. WHO approval would allow the vaccine to be distributed worldwide by way of WHO’s vaccine sharing initiatives.
U.S. authorization is likely not a priority for the company because half the population is already vaccinated with the Pfizer-BioNTech, Moderna or Johnson & Johnson vaccines. But with other parts of the world still struggling to get vaccines distributed, there’s still plenty of room for a Novavax vaccine.
In February, the company signed a Memorandum of Understanding (MOU) with Gavi, the Vaccine Alliance, to supply 1.1 billion doses of its vaccine candidate for the COVAX Facility.
The vaccine uses more traditional technology, designed with a stable, prefusion protein manufactured using the company’s proprietary nanoparticle technology and Matrix-M adjuvant. It is easier to manufacture than the Pfizer-BioNTech and Moderna mRNA vaccines and does not require ultra-cold storage.
In the PREVENT-19 U.S. and Mexico Phase III trial, the vaccine demonstrated 90.4% efficacy against mild, moderate, and serious diseases and 100% protection against moderate and severe illnesses. It has also completed enrollment in its pediatric expansion of PREVENT-19 Phase III trial by enrolling 2,248 adolescents aged 12-17 in 75 sites in the U.S.
Data from clinical trials indicate that a booster dose of a Novavax vaccine six months after a two-dose shot of other approved vaccines could increase protection against the Delta and other variants. It also shows a four-fold increase in neutralizing antibodies after a two-dose version of another vaccine.
At this time, even with all the delays, it is on schedule to manufacture 100 million doses per month by the end of the third quarter and 150 million per month by the end of the year.
“We are highly encouraged by the filing of regulatory submissions in multiple markets, made in partnership with Serum Institute of India. We view these submissions as the first of many filings to come, which will allow NVX-CoV2373 to be made available at a global scale,” said Stanley C. Erck, president and chief executive officer of Novavax.
“Our clinical successes over the second quarter reaffirm our confidence in NVX-CoV2373’s differentiated efficacy profile. We continue to see the circulation of new variants and inequitable access to vaccine globally, demanding that we bring our COVID-19 vaccine to market as swiftly as possible.”
Financially, the company reported a net loss of $352 million, or $4.75 per share, for the second quarter. Revenue for the quarter was $298 million compared to $36 million in the same period in 2020. The increase came from development activities associated with the COVID-19 vaccine for services with the U.S. government and Coalition for Epidemic Preparedness Innovation deals.
Research and development expenses rocketed to $571 million in the quarter compared to $35 million in the second quarter of 2020. This was primarily related to its COVID-19 vaccine programs.
At the end of June, the company had $2.1 billion, cash equivalents, and restricted cash.
In addition to the COVID-19 vaccine, the company is working on NanoFlu, a recombinant hemagglutinin (HA) protein nanoparticle flu vaccine.
Jefferies analyst Kelechi Chikere wrote in a note to investors, “While we appreciate the exact timing for U.S./EU filings still appears in flux, the rollout of Novavax’s vaccine appears on track to occur soon, which couples with additional positive newsflow could push shares higher over time.”
Shares doubled this year to a high of $236.20 yesterday, although they dropped 10% after the announcement to $212.
