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7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

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 mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

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. funding to develop the vaccine.

The shot is the fifth to win authorization in Europe. The protein-based vaccine will be the first of its kind in Europe.

The World Health Organization (WHO) also won a second Emergency Use Listing (EUL) for the vaccine. In addition, Indonesia and the Philippines have granted the vaccine emergency use authorization.

The news apparently did not impress investors, and NVAX shares fell 7.07% to $201.95.

Early on, Novavax impressed with solid efficacy figures. In March, the company announced that its vaccine was …

Report: Fujifilm to expand vaccine production plant in England

Fujifilm (TSE:4901) has reportedly spent big to double the size of its United Kingdom-based vaccine manufacturing facility.

The Financial Times reported that Fujifilm is spending about $532.8 million (£400 million) to expand its Teesside (north-east England) plant that is making the Novavax COVID-19 vaccine, transforming it with factories specializing in antibody treatments and viral gene therapies.

Get the full story at our sister site, Pharmaceutical Processing World.

Fujifilm to expand vaccine production plant in England

Fujifilm (TSE:4901) has reportedly spent big to double the size of its United Kingdom-based vaccine manufacturing facility.

The Financial Times reported that Fujifilm is spending about $532.8 million (£400 million) to expand its Teesside (north-east England) plant that is making the Novavax COVID-19 vaccine, transforming it with factories specializing in antibody treatments and viral gene therapies.

According to the report, builders have already begun construction on one facility, while the land for the other remains undeveloped to this point. FT said the facilities are set to open in 2023 with up to 350 highly skilled jobs to be created in contract manufacturing.

Fujifilm manufactures the active ingredient for the vaccines developed by Novavax, FT said. Novavax’s vaccine was recently submitted to regulators, according to the report, but has not received approval in the UK, while the company said months ago that it intended to file for FDA emergenc…

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 with the FDA before planning additional domestic manufacturing. Furthermore, the government told Novavax that it would withhold funding for additional manufacturing until the company had done so.

The company had landed a $1.75 billion contract as part of the U.S. government’s Operation Warp Speed program to produce a COVID-19 vaccine. The U.S. agreed to purchase 110 million doses of the vaccine after it receives emergency use authorization.

Similar to Moderna, the COVID-19 vaccine will be Novax’s first commercial product.

The New York Times report suggests that Novavax has struggled to convince the FDA th…

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 conducted in the U.S. and Mexico was 90.4%, according to a June NIH press release.

But the company had been slow to get its vaccine onto the market. In the U.S., the company plans on filing for emergency use authorization in late September.

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

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.

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

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 enrolled 29,960 participants across 119 locations in the U.S. and Mexico to evaluate the efficacy, safety and immunogenicity of the NVX-CoV2373 vaccine. The primary endpoint was the first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline.

Preliminary safety data demonstrated that the vaccine was generally well-tolerated, with severe adverse events low in number and balanced between vaccine and placebo groups. No sing…

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 preliminary.

The study’s primary efficacy endpoint was protection against laboratory-confirmed COVID-19 seven or more days after administration of the second dose.

The study involved 4,387 participants.

An earlier study found that the vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus. That figure dropped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7) and 49% against the B.1.351 variant.

The Novavax vaccine differs from others that are currently available. Namely, it is a recombi…

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% range in similar studies.

But the efficacy of the Novavax NVX–CoV23 vaccine dipped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7).

Novax could have one of the most-effective COVID-19 vaccines

Novavax 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% range in similar studies.

But in the efficacy of the Novavax NVX–CoV23 vaccine dipped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7).

Because of subtle differences in trial designs and timing, it is difficult to do head-to-head comparisons of clinical trials. The Phase 3 clinical trial results for the Moderna and Pfizer-BioNTech vaccines did not include data on SARS-CoV-2 variants.

In a separate Phase 2b trial in South Africa, the Novaax vaccine has an efficacy of 55.4% in HIV- negative trial volunteers. The majority of COVID-19 cases in the country are the result of the B1.351 variant. The South Africa and Brazil…

Which companies will likely produce the most COVID-19 vaccine in 2021?

Photo by Markus Spiske on Unsplash

Since the beginning of the pandemic, much of society has pinned its hopes on the availability of a vaccine. Now that several are available across the world, there is hope, said Dr. Anthony Fauci, chief medical advisor to President Joe Biden, in a recent JAMA interview. “There’s light at the end of the tunnel.”

One thing that will make the light at the end of the tunnel brighter as we head into the spring is the greater availability of vaccine doses. “The discordance between supply and demand will be diminished,” Fauci said.

The roster of companies producing vaccines is steadily increasing, making it possible to vaccinate a substantial portion of the world’s population this year. (Note: Most of the companies in this list have two-dose vaccines.)

Here’s a roundup of notable companies’ production targets for 2021:

AstraZeneca and Oxford University: Up to 3…