There’s plenty of COVID-19-related news today. Here’s a look.
There’s plenty of COVID-19-related news today. Here’s a look.
Novavax Inks MoU with Gavi for 1.1 Billion Doses of COVID-19 Vaccine
Novavax announced a Memorandum of Understanding (MOU) with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of NVX-CoV2373, its COVID-19 vaccine candidate, for the COVAX Facility. The vaccine will be manufactured and distributed around the world by Novavax and Serum Institute of India (SII). SII has an existing deal with Gavi.
Currently, the vaccine is being evaluated in two ongoing pivotal Phase III trials in the U.S. and Mexico, as well as the UK. On January 28, the company reported positive interim data from the UK trial. The vaccine demonstrated efficacy of 95.6% against the original Wuhan wildtype strain and 85.6% against the U.K. variant. Novavax also reported progress from its ongoing Phase IIb trial in South Africa, demonstrating a 60% efficacy. That study included HIV-positive patients, who had a 49% efficacy against the South African variant.
Biden Administration Pledging $4 Billion to Global Vaccination Effort
The Biden Administration has agreed to make good on last year’s pledge to donate $4 billion to a global program to distribute COVID-19 vaccines around the world. The deal was approved last year by the Democratic-led House and Republican led-Senate during President Donald Trump’s tenure. The international effort is COVAX, and as noted above, is being helped along by a deal with Novavax.
Bill Gates Praises J&J and Novavax Vaccines for Capability Against Variants
Bill Gates told CNBC that Johnson & Johnson and Novavax’s COVID-19 vaccines are showing a lot of promise against the emerging variants, such as those first appearing in the U.K., South Africa and Brazil. The Novavax vaccine demonstrated about a 90% efficacy in the U.K., but a 49% efficacy in South Africa, although a big part of that group was HIV-positive immunocompromised patients. The J&J vaccine was 66% effective overall, but about 57% effective in South Africa.
J&J Submitted to WHO for Emergency Use Listing
Johnson & Johnson Family of Companies submitted for Emergency Use Listing (EUL) to the WHO for its one-shot COVID-19 vaccine. The submission included interim efficacy and safety data from the Phase III ENSEMBLE trial. This completes its rolling submission to WHO. In December 2020, J&J signed an agreement in principle with Gavi to provide up to 500 million doses of the vaccine through 2022. The vaccine has also been submitted to the FDA for an EUA, with an advisory committee meeting scheduled for February 26, and also submitted for Conditional Marketing Authorization in Europe.
Vaccine Hoarding and Shipping Problems
Problems finding and scheduling the second shots of the Pfizer-BioNTech and Moderna vaccines in the U.S. are creating frustration and worry. Some regions have held doses in reserve to ensure the second dose, which overall slowed the pace of the initial vaccinations. There have also been some issues with shipping. For example, in Anne Arundel County, in the Washington DC region, a data error disrupted shipments for a time, forcing public health authorities to cancel two second-dose clinics. A similar situation occurred in Harford County, when hundreds of people trying to get their first shot disrupted a second-shot clinic.
“The system has been so disordered and chaotic that it’s led to panic,” stated Maryland state Sen. James C. Rosapepe (D-Prince George’s).
On the other hand, public health officials in Montgomery County said they avoided cancellations by not scheduling second-dose appointments at the time of the first shots. Instead, they email residents four to seven days prior to the second dose, telling them to visit a website where they can make their appointment.
Fauci: Vaccine for Variants Could Take Months
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), suggested that a vaccine for variant strains, such as the South African mutation, will likely take “several months.”
He added, “We’re already, for example, working with the Moderna company. Pfizer’s doing it on their own, I’m sure. It’s a good company, a big company. But what we’re doing is, we’re working with them to get a sample of the vaccine that you can actually have it code for the protein that’s the appropriate protein for the South African isolate.”
At this time, it’s not clear if they will be needed. The primary factor will be if people completely vaccinated with the Pfizer-BioNTech or Moderna vaccines begin showing up with severe COVID-19 in the hospital or dying from it. Currently, most tests and trials are suggesting the existing vaccines are effective against the variants, although not as effective as they are against the wildtype Wuhan strain.
Pfizer and BioNTech Initiated Vaccine Trial in Pregnant Women
Pfizer and BioNTech dosed the first patients in a clinical trial of 4,000 women in the late stages of pregnancy yesterday. The two companies will run the Phase II trial for 350 volunteers between 27 and 34 weeks’ gestation to confirm safety before moving into the Phase III portion for women between 24 and 34 weeks of pregnancy. AstraZeneca and Johnson & Johnson also plan to run trials in the coming months on pregnant women.
“While it’s good news that vaccine trials in pregnant women are finally beginning, the results from these trials are unlikely to be available before the autumn,” said Marian Knight, professor of maternal and child population health at the University of Oxford.
Israel Study Shows Pfizer-VioNTech Vaccine has 85% Efficacy After 1st Shot
A study out of Israel demonstrated that a single dose of the Pfizer-BioNTech has 85% efficacy in preventing symptomatic disease 15 to 28 days after being dosed. In addition, there was a 75% decrease in all COVID-19 infections, symptomatic or asymptomatic. They do not know how long the single dose protection would last. A two-dose regimen has an efficacy of 95% a week after the second shot. An earlier trial by Pfizer and BioNTech demonstrated an efficacy of 52.4% after a single shot, but that study didn’t differentiate between before and after two weeks.
Problems Finding Vaccine Ingredients
From a historical perspective, the development and scale-up of the COVID-19 vaccines has been nothing short of amazing, there are naturally some unexpected problems. One of them is difficulties in finding some of the basic ingredients needed. For example, Acuitas Therapeutics, a biotechnology company in Vancouver, BC (Canada), has only 30 staffers and leases its facilities from the University of British Columbia. Acuitas’ proprietary molecule, an ionizable cationic lipid, is a required piece of the mRNA vaccine by Pfizer-BioNTech, and the demand is enormous. The company previously outsourced production of only small volumes of the lipid nanoparticles.
“It’s on a scale that hasn’t been done before,” said Pieter Cullis, chairman of Acuitis, who is also one of the early developers of lipid nanoparticle technology.
CMTx Biotech Received $315,000 Grant from the NIH for Phase II Trial of Incyclinide
CMTx Biotech received a $315,000 Clinical Trial Planning Grant from the NIH’s National Center for Advancing Translational Sciences to finalize a Phase II trial of incyclinide. The drug is its candidate for treatment of hospitalized COVID-19 patients. The drug is a non-antimicrobial tetracycline formulation, which is the specialty of CMTx.
“Incyclinide has already been shown to be highly effective in a number of animal models of acute respiratory distress syndrome across several species,” noted Lorne Golub, co-founder of CMTx and SUNY Distinguished Professor of Oral Biology and Pathology.
