First announced in January 2020, Novavax’s (Nasdaq:NVAX) NVX-CoV2373 COVID–19 has won FDA authorization for primary immunization. However, it is presently not authorized as a booster. NVAX shares ticked up 0.27% to $69.95. Novavax is late to the COVID-19 vaccine partner, scoring authorization more than a year and a half after Moderna (NYSE:MRNA) and Pfizer (NYSE:PFE) won emergency use authorization for…
FDA advisory panel backs Novavax COVID-19
Novavax (Nasdaq:NVAX) has won unanimous backing from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) for its NVX-CoV2373 COVID-19 vaccine. Voting 21 to 0 with one abstention, the VRBPAC recommended that FDA grant emergency use authorization (EUA) to the vaccine for adults 18 and older. The Novavax would be the fourth vaccine to…
FDA considers possible myocarditis link in Novavax COVID-19 vaccine recipients
In reviewing clinical trial data related to the Novavax (Nasdaq:NVAX) COVID-19 vaccine, FDA expressed concerns about the product’s potential to cause myocarditis, a type of heart inflammation. In a briefing document, FDA noted that the “identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern.” The agency goes…
FDA signals careful approach in mulling COVID-19 vaccine authorization in young children
FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months…
Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan
Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine. Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX). The approval covers the use of the vaccine as both a primary and booster immunization in adults at least…
Q-VANT Biosciences signs master agreement with the Kansas State University College of Veterinary Medicine
Quillaja saponin-based adjuvant specialist Q-VANT Biosciences announced that Kansas University College of Veterinary Medicine will test its adjuvants in several of its veterinary vaccines. The project’s first focus will test Q-VANT’s sustainable saponin-based adjuvants against other adjuvants using K-State’s subunit classic swine fever (CSF) vaccine. The Kansas University researchers will also validate the safety and…
7 potential applications of mRNA-based therapies
Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…
Novavax COVID-19 vaccine wins belated marketing authorization in Europe
Novavax (NSDQ:NVAX) has announced that the European Commission has granted it conditional marketing authorization (CMA) for its Nuvaxovid COVID-19 vaccine. Novavax had received funding early in the pandemic but encountered manufacturing-related delays. In August, the U.S. announced that it was withholding funding from the company over these concerns. The company had initially received $1.7 billion in…
U.S. government withholds funding from Novavax
Although Novavax (NSDQ:NVAX) disclosed the news in a July 31 SEC filing, investors apparently didn’t react to the development until today. In mid-day trading, the stock dipped 20% to $188.18. The company’s stock had surged earlier in the week. In the SEC filing, Novavax said the U.S. government told the company to align its analytic methods…
Novavax stock surges after striking EU COVID-19 vaccine deal
Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine. The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial…
Novavax’s COVID-19 vaccine demonstrates 90% efficacy
Novavax (NSDQ:NVAX) announced today that its COVID-19 vaccine demonstrated 90.4% efficacy in protecting against COVID-19. Gaithersburg, Md.–based Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine demonstrated 100% protection against moderate and severe disease, with 90.4% efficacy overall as it met the primary endpoint in the Prevent-19 pivotal Phase 3 trial. According to a news release, the study…
Novavax vaccine 51% effective against the South African variant
A Phase 2a-b trial found that the Novavax (NASDAQ: NVAX) NVX-CoV2373 vaccine was 51% effective against the B.1.351 variant in HIV-negative participants without evidence of prior SARS-CoV-2 infection. The overall vaccine efficacy against SARS-CoV-2 was 49% and 60% for HIV-negative participants, according to the study published in NEJM. The study authors note that the efficacy figures are…
Novax could have one of the most-effective COVID-19 vaccines
Novavax (Gaithersburg, Md.) may not be the best-known vaccine developer, but its COVID-19 vaccine offers performance in line with those from Moderna and Pfizer. Its vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus in a Phase 3 study. The Moderna and Pfizer vaccines offered efficacy in the mid-90%…
4 ways SARS-CoV-2 variants could change the battle against the pandemic
Highly-transmissible COVID-19 variants have likely been circulating undetected for months in places like the U.K., South Africa and Brazil. They then seemed to burst onto the scene, fueling large outbreaks that dwarfed preceding ones. While the variants aren’t well understood, they suggest that SARS-CoV-2 is mutating in ways that confer an evolutionary advantage. They thus…
BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants
Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants. The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination. But it proved less effective in South Africa, where a new variant of…
Novavax launches Phase 3 COVID-19 vaccine trial in UK
Novavax (NSDQ:NVAX) today announced that it has begun its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of its COVID-19 vaccine candidate, NVX-CoV2373. The trial is underway in the UK, in partnership with the UK government’s Vaccines Taskforce. Gaithersburg, Md.-based Novavax said it expects to enroll up to 10,000 individuals between 18…
Drug companies agree not to release COVID-19 vaccine until it’s ready
Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine. The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as…