Novavax (NVAX) finally nabs Covid-19 vaccine EUA

a. 6/22:  vol 6.7M; 2, 4, 5, 10, 11, 52, 95

b.  7/1: vol 6.4M; 12, 23, 60, 67, 82, 83

 

 

 

 

Novavax confirms that its COVID-19 vaccine has received EUA from the FDA

• Co announces that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received EUA from the FDA to provide a two-dose primary series for active immunization.
• "Today's FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine."
• The FDA EUA was based on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants.

In the U.S., the fact sheet accompanying the vaccine warns of a heightened risk of inflammation of the heart and tissues surrounding it following administration. That's in line with the same sheets for Pfizer's (PFE) and Moderna's (MRNA) Covid vaccines. On Thursday, regulators in Europe added a warning against the risk of severe allergic reaction to the Novavax shot.

Still, experts hope adding a third vaccine technology to the U.S. coffers will help bolster the number of people vaccinated against Covid. Novavax's jab uses a protein-based technology and a tree bark chemical from Chile to boost the immune response. Pfizer and Moderna use newer messenger RNA platforms. Johnson & Johnson (JNJ) employs an empty virus to deliver its single-shot vaccine.

NVAX Stock: Small Portion Of Unvaccinated People

Novavax is late to the market, however. Pfizer and Moderna won FDA authorization in December 2020 and J&J followed in February 2021. Further, the company tested its vaccine before the emergence of the delta and omicron variants.

Novavax has global authorizations, including in younger people, but in the U.S. it will only be allowed in adults who have yet to receive a Covid shot. The Centers for Disease Control and Prevention estimates that group accounts for just 10% of people in the country.

-= Vaxart (VXRT) : The FDA cleares IND application for oral COVID-19 vaccine candidate

FDA completed its review of the Company's IND application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate 

The Phase 1, open-label, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study's primary objective is to examine the safety and reactogenicity of two-doses of the vaccine. Secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19.

Vaxart is conducting a SARS-CoV-2 challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen of our vaccine candidate. Results from this study, which began in early August, are expected mid-October.

CureVac (CVAC) and EU in advanced talks for 225 million Covid-19 vaccine doses

• CureVac has said its Covid-19 vaccine could be ready for the public by mid-2021

Shares of CureVac NV soared Thursday after the German biotech firm said it was in advanced talks for the supply of at least 225 million doses of a potential Covid-19 vaccine to EU member states.

CureVac said talks with the EC, the European Union’s executive arm, include an option to supply an additional 180 million doses, once the mRNA-based vaccine has proven to be safe and effective against Covid-19, bringing the total to up to 405 million doses.

The EC is also in talks with Johnson & Johnson (JNJ) and France’s Sanofi (SNY) for their vaccines under development. It also reached an agreement last week with AstraZeneca (AZN) to buy at least 300 million doses of its potential Covid-19 vaccine which it is developing with Oxford University.

CureVac (CVAC) is specializing in the messenger RNA technology that is the basis of many of the leading Covid-19 vaccine programs, including Moderna Inc. (MRNA) and BioNTech S.E. (BNTX).

“In the current pandemic, we are very pleased to further strengthen the European Commission’s endeavor to provide rapid access to a safe and effective vaccine against the Covid-19 virus across Europe and beyond,” Franz-Werner Haas, chief executive of CureVac said.

“Assuming positive results from our ongoing clinical trials and approval from the regulatory authorities, we are fully committed to ensure broad access to our vaccine,” he added.

Backed by Microsoft founder and billionaire Bill Gates, CureVac listed on the Nasdaq Stock Market on Aug. 14, raising $213 million.

In July, GlaxoSmithKline PLC (GSK) said it was taking a stake in CureVac, the latest move by a major drugmaker to boost capabilities to fight pandemics. FTSE 100-listed Glaxo said CureVac’s mRNA technology would complement its own capabilities as it inked a deal worth up to £866 million ($1.09 billion).

-=MediciNova (MNOV) : SARS-CoV-2 vaccine joint development with BioComo and Mie University Japan

Co announced an agreement with BioComo and Mie University (Mie prefecture, Japan) for joint development of a SARS-CoV-2 vaccine using BC-PIV, a human parainfluenza virus type 2 vector developed by BioComo and Tetsuya Nosaka, M.D., Ph.D., professor of the Department of Microbiology and Molecular Genetics, Mie University Graduate School of Medicine. MediciNova has been granted exclusive worldwide development rights to use BC-PIV for SARS-CoV-2 vaccine development from BioComo and Mie University.

=BioNTech (BNTX) and Pfizer (PFE) to deliver 600 mln doses of SARS-CoV-2 vaccine candidate

BioNTech (BNTX) and Pfizer (PFE) reach agreement with the US government for up to 600 mln doses of SARS-CoV-2 vaccine candidate

Pfizer and BioNTech today announced the execution of an agreement with the US Department of Health and Human Services and the Department of Defense to meet the U.S. government's Operation Warp Speed program goal to begin delivering 300 mln doses of a vaccine for COVID-19 in 2021. Under the agreement, the US government will receive 100 mln doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from the FDA.

• The US government will pay the companies $1.95 bln upon the receipt of the first 100 mln doses, following FDA authorization or approval. The US government also can acquire up to an additional 500 mln doses.

Americans will receive the vaccine for free, consistent with US government's commitment for free access for COVID-19 vaccines.

The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 mln doses by the end of 2020 and potentially more than 1.3 bln doses by the end of 2021.

COVID-19 vaccines and treatments

As clinical trials related to COVID-19 continue to ramp up, the focus next week will start to shift on which vaccines and treatments have the best chance to make it to mass production. There has been a lot of discussion about

• Gilead Sciences' (NASDAQ:GILD) remdesivir, Regeneron Pharmaceuticals' (NASDAQ:REGN) cocktail antibodies and 
• Moderna's (NASDAQ:MRNA) vaccine candidate. 

Other companies racing ahead with vaccine trials at various stages include

• BioNTech (NASDAQ:BNTX), 
• Pfizer (NYSE:PFE), 
• Dynavax Technologies (DVAX), 
• Vaxart (NASDAQ:VXRT), 
• GlaxoSmithKline (NYSE:GSK), 
• Heat Biologics (NASDAQ:HTBX), 
• Inovio Pharmaceuticals (NASDAQ:INO), 
• Translate Bio (NASDAQ:TBIO), 
• Heron Therapeutics (HRTX)
• Johnson & Johnson (JNJ), 
• Arcturus Therapeutics (NASDAQ:ARCT), CSL Behring and Novavax (NASDAQ:NVAX). Treatment candidates are being worked on by privately-held CalciMedica, Amgen (NASDAQ:AMGN), 
• Adaptive Biotechnologies (ADPT), Takeda Pharmaceutical (NYSE:TAK), CytoDyn (OTCQB:CYDY), Roche Holdings (OTCQX:RHHBY), Regeneron Pharmaceuticals, Tiziana Life Sciences (NASDAQ:TLSA), Vir Biotechnology (NASDAQ:VIR), Eli Lilly (NYSE:LLY), Sanofi (NASDAQ:SNY) and more.

News:

• (7/16/20) Dynavax (DVAX) and the Icahn School of Medicine at Mount Sinai have entered into a collaboration to develop a universal influenza vaccine. Mount Sinai's current work in this area is funded under a contract award as part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. The Mount Sinai CIVICs team will evaluate a novel approach they have developed called chimeric hemagglutinin designed to protect against all strains of influenza in combination with Dynavax's CpG 1018TM adjuvant.
• (7/16/20) Heron Therapeutics (HRTX) announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with COVID-19. The study initiation follows clearance from the FDA of Heron's Investigational New Drug application for CINVANTI for the treatment of COVID-19.