Novavax Archives - Medical Design Sourcing

Pfizer and Moderna tout preliminary data in battle against Eris SARS-CoV-2 subvariant

[weyo/Adobe Stock]

COVID-19 vaccine giants Pfizer and Moderna are gearing up for a battle against the Eris SARS-CoV-2 subvariant, which has rapidly emerged as the dominant strain in the U.S. Eris now is responsible for more than one in five COVID infections, based on CDC estimates from August 6 to 19.

Pfizer has noted that its most recent COVID-19 shot, which it is testing against emerging variants, demonstrated neutralizing activity against the “Eris”in a mouse study. The company said it is keeping a close watch on the variant and is ready to produce “variant-modified vaccine templates” if needed. Pfizer intends to launch its updated vaccine commercially by the end of August, pending regulatory approval.

Moderna has also announced positive preliminary testing of its latest vaccine shot against the Eris SARS-CoV-2 subvariant. The company indicates that preliminary clinical trial data demonstra…

How COVID vaccine options stack up for fall 2023

[weyo/Adobe Stock]

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is backing a significant shift in the current COVID-19 vaccine strategy: a move from multivalent to monovalent vaccines focusing on the XBB lineage strains. The advisory committee has set its sights on protecting against XBB.1.5 and has jettisoned is support for vaccines with a Wuhan component, which was included as a component of the bivalent vaccine boosters that debuted in fall 2022. “Continuing to include the original Wuhan strain was unnecessary since early strains are no longer in circulation,” said Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases.

While supporting monovalent vaccines, VRBPAC members acknowledged that the predominant SARS-CoV-2 sublineages could continue to evolve. “We may well find that XBB.1.16 or XBB.2.3 become more dominant than XBB.1…

Japan scraps 140 million dose order of Novavax COVID vaccine, Takeda reveals

In 2021, Takeda (TYO:4502) announced that it would manufacture 150 million doses of COVID-19 vaccine from NovaVax (Nasdaq:NVAX). But the company has disclosed that the Japanese government has canceled the remaining order for the Nuvaxovid vaccine.

The Japanese government acquired 8.24 million vaccine doses but said it would cancel the remaining order for the remaining 141.76 million doses owing to low demand.

Takeda and Novavax are collaborating on developing a new vaccine optimized for future variants in 2023.

Novavax currently has an omicron vaccine candidate in a Phase 3 trial.

The company has data demonstrating that its adjuvanted NVX-CoV2373 vaccine prompts a robust immune response when used as a booster and is effective against forward drift variants of SARS-CoV-2.

Novavax plans to provide a monovalent or bivalent vaccine for the 2023–2024 vaccination season based on FDA feedback. The FDA’s Vaccines and Related Biological Produc…

Novavax launches Phase 2 study for COVID-19-flu shot

Vaccine developer Novavax (Nasdaq:NVAX) has begun a Phase 2 study of its COVID-19-influenza combination (CIC) shot as well as an influenza-only vaccine candidate.

Rivals Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE)/BioNTech (Nasdaq:BNTX) have made similar moves.

Moderna has a slew of flu vaccine candidates in its pipeline, including MRNA-1010, which is the subject of a Phase 3 study. mRNA-1010 and mRNA-1020 are in Phase 2 trials. Two others are in preclinical development. Moderna also has a combination COVID/flu vaccine candidate known as mRNA-1230 that is the subject of a Phase 1 study.

When Moderna announced positive interim data from a Phase 1 study of mRNA-1010 in late 2021, that data disappointed investors.

Pfizer’s PF-07845104 prophylactic saRNA vaccine is the subject of a Phase 1 trial, while PF-07252220 is in a Phase 3 study.

Novavax’s dose-confirming study will test the immunogenicity of various formulations of the CIC and influenza…

Novavax COVID-19 vaccine wins belated U.S. authorization

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 their respective COVID-19 vaccines.

Gaithersburg, Maryland–based Novavax had received a $1.75 billion federal contract to develop and manufacture NVX-CoV2373.

In August, the federal government said it would not provide money for further production until Novavax addressed quality concerns.

Now that the vaccine is authorized, CDC will convene an advisory panel to advise who should obtain the two-dose vaccine.

Before the omicron and delta waves, the Novavax vaccine was 90.4% efficacious in preventing COVID-19 of any severity in. Phase 3 t…

HHS and DOD order 3 million doses of Novavax COVID-19 vaccine

Novavax (Nasdaq:NVAX) announced that its protein-based NVX-CoV2373 COVID-19 vaccine could be the first of its type to be available in the U.S., assuming it wins backing from the FDA and CDC.

The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) have secured 3.2 million doses of Novavax’s COVID-19 vaccine.

There are currently two FDA-approved mRNA vaccines and an authorized adenovirus vector vaccine.

The protein-based Novavax vaccine is built using a more traditional technique than rivals and is adjuvanted to enhance the immune response. Hepatitis B and shingles vaccines are also protein-based and adjuvanted.

The vaccine includes a small amount of the SARS-CoV-2 spike protein.

In June, an FDA advisory committee recommended authorization of the Novavax vaccine.

Typically, FDA grants authorization soon after hearing from its advisors but has not yet authorized the Novavax vaccine.

Novavax note…

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 win authorization in the U.S., following the vaccines from Johnson & Johnson, Moderna, and Pfizer and its partner BioNTech.

The vaccine is likely to win authorization by June, estimated M. Nielsen Hobbs, an analyst for Informa Pharma Intelligence.

While several companies are reading next-generation COVID-19 vaccines, the Novavax vaccine is “not so much a new entrant as a much delayed initial entrant as part of Operation Warp Speed,” Hobbs said.

If it wins authorization, the Novavax vaccine would be the first protein-based COVID-19 vaccine in the U.S.

At pres…

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 on to say that if causally associated, “the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines (for which no cases were identified in pre-authorization evaluation).”

In a statement, Novavax concluded that the rate of myocarditis and a similar condition known as pericarditis was similar across vaccine and placebo recipients. In the vaccine arm, 0.007% experienced such heart inflammation, while 0.005% of placebo recipients did.

Myocarditis is a risk occasionally ass…

FDA signals careful approach in authorizing COVID-19 vaccines 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 to 5 years old.

Get the full story from our sister site, Drug Discovery & Development.

FDA signals careful approach in authorizing COVID-19 vaccines 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 to 5 years old.

The agency has tentatively scheduled three VRBPAC meetings for June 8, 21 and 22 to discuss offering the Moderna and Pfizer-BioNTech vaccines to younger children.

In addition, the FDA will meet to discuss the possibility of recommending modifying the strain composition of COVID-19 vaccines for the fall.

The VRBPAC is scheduled to meet on June 7 to discuss authorization of the Novavax vaccine in adults 18 and older.

The Novavax NVX‑CoV2373 vaccine has received conditional authorization from several regulatory authorities internationally. Its pr…

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 18 years old.

Get the full story from our sister site, Drug Discovery & Development.

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 efficacy of other Quillaja saponin-based adjuvants from Q-VANT.

[Related: Q-VANT aims to rewrite the narrative for Quillaja saponin-based adjuvants.]

Kansas University is also home to the Biosecurity Research Institute, a comprehensive infectious disease high-security research facility.

The CSF vaccine that will be the initial focus of the research was developed by professor Jishu Shi, a professor within the school’s College of Veterinary Medicine who focuses on developing strategies to protect against s…