Wednesday, January 20, 2021
Is Novavax the dark horse of COVID-19 vaccines?
Experts say early clinical data on Australia's third COVID-19 vaccine, Novavax, is promising enough to suggest it could play a significant role in the nation's pandemic strategy.
The federal government has signed up to buy 51 million doses of Novavax’s two-shot vaccine and those involved in trials say it is expected to be made available as early as the middle of this year, in addition to COVID-19 vaccines from Pfizer and AstraZeneca that will be available in coming weeks.
Australia's Chief Medical Officer Paul Kelly on Tuesday confirmed the nation's drug regulator was in direct talks with European and Norwegian authorities after several elderly people died after receiving Pfizer's vaccine. It is not yet clear if there was a link between the deaths and the vaccine.
While large phase three studies for the Novavax vaccine are ongoing, early data released in December suggests it is likely to offer strong protection against COVID-19. There are even hints it may do something other vaccines have struggled with: stop the coronavirus' spread.
"The phase one data was really convincing. The immune responses were really strong – up there in the realms we saw with the mRNA vaccines. That level of immune response tends to be a bit of a correlation ... those are the vaccines that have ended up giving very strong efficacy," said University of Sydney professor of medical microbiology James Triccas.
Paul Young, co-leader of the University of Queensland's aborted COVID-19 vaccine project, agreed the data "does look promising".
"The preclinical animal data showed that viral titres in the upper respiratory tract were lower in vaccinated animals, suggesting but not proving that infectivity and transmission may be lower," he said.
Paul Griffin, medical director of the Nucleus Network – contracted by Novavax to conduct clinical trials in Australia – said if all went well, the vaccine could be available for use by May or June.
"I think this is one, just based on where it’s up to timing wise, that has fallen off the radar in this country. There has been a lot of attention on Pfizer, AstraZeneca and Moderna," he said. "It is looking very safe and effective."
It is difficult to directly compare phase one trial results, but data reported in the New England Journal of Medicine in December suggested Novavax’s vaccine produced an immune response similar to vaccines from Pfizer and Moderna.
"They were able to induce higher [antibody] titres than recovered COVID patients. And that’s a really good sign. When we were seeing results like that, it did highlight Novavax is one to watch, and a really promising formulation," said Kylie Quinn, an RMIT vaccine designer.
Griffith University virologist Adam Taylor said the trials showed the vaccine was safe and generated good antibody responses. "Certainly, this is a useful candidate."
Other vaccines have already shown themselves capable of inducing strong immune responses and protecting people from the virus.
What makes Novavax different is a hint in the early data it could not just protect people but also stop the virus spreading. Stopping or reducing transmission of the virus is valuable to protect people who cannot or will not get vaccinated. At this stage, it remains unclear if any of the vaccines available can prevent transmission.
In a small study, Novavax’s vaccine effectively prevented COVID-19 growing in the noses of monkeys. Results in animals often do not translate to humans. But other vaccines have struggled to repeat the achievement; they effectively protect the lungs but still allow the virus to grow in the nose, where it could spread.
While other vaccines quickly moved from phase one to phase three trials and then approval, Novavax's progress has been slower. The company started its key phase three trial on December 28 after several delays due to issues scaling up vaccine manufacture.
Novavax has had a chequered history. Two failed vaccine trials in recent years led to the company’s stock plunging; it sacked 100 employees and closed two manufacturing plants. In its near-30-year history it is yet to develop an approved vaccine.
Nevertheless, the company is aiming to produce 2 billion doses of vaccine this year.
Novavax’s jab combines traditional and cutting-edge technology. Inside each vial are copies of COVID-19’s spike protein – the cellular harpoon it uses to attach to and enter our cells – and a dose of the company’s adjuvant. The adjuvant triggers the immune system, which recognises the spike protein and builds antibodies and immune cells capable of defending the body against the virus.
"It’s more of a traditional vaccine – the same type we have used for other vaccines we have in use," said Professor Triccas.
Novavax produces the spike proteins using moth cells, and then studs them on a nanoparticle, creating a shape that looks much like the spike-covered virus. In theory, immune cells should be much more likely to spot and attack these nanoparticles, as they look just like little viruses.
The company used similar technology in a flu vaccine it is developing. In a late-stage clinical trial, it produced much stronger antibody results than a current flu vaccine.
Addressing the deaths in Norway, Chief Medical Officer Professor Kelly said on Tuesday: "In a normal week, 400 people do pass away in their aged care facilities.
"In general terms, they were very old, they were frail, some of them were basically terminally ill."
It is not yet clear if the deaths are linked to the vaccine, and Australian experts have already said they are no reason to slow the vaccine's rollout.
Professor Kelly said it was possible Australia's drugs regulator would advise against giving the very elderly and frail the vaccine.
"That is a very tricky balance. We know elderly people, as is the case in Norway, elderly people in aged care facilities are towards the end of their life. We know from our own data from the Australian pandemic, of the 900 people who have died, they have mostly been in the very elderly group, they are of the greatest risk of severe infection," he said.
"The mortality rate is very high once you get over 80 or 90 if you get COVID-19. It's that risk balance equation which the [regulator] will need to do around which people should be excluded from the vaccine."
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Relying on Lockdowns, Social Distancing, and Masks Isn’t Working to Curb COVID-19
COVID-19 cases and deaths continue to surge. The seven-day moving average of daily confirmed new cases eclipsed 260,000 on Jan. 9, the highest rate yet recorded. The U.S. is expected to reach the grim milestone of 400,000 COVID-related deaths later this month, around the anniversary of its first confirmed case.
These numbers suggest that the strategy of relying predominantly on social distancing, lockdowns, and mask-wearing is not working. We need better interventions.
Some have called for national mask mandates. We recently examined the effects of mask mandates in the U.S. and Italy, and our findings are not encouraging.
Of the 25 U.S. counties reporting the highest number of new cases during the current surge, 21 had mask mandates in place before August. Looking at the 100 counties with the most confirmed cases during this period, 97 had either a county-level mask mandate, a state-level mandate, or both. Of these 97 counties, 87 instituted their mandates prior to October.
Mask mandates failed to prevent a surge in cases in other countries as well. Italy enforces a national mask mandate, imposing fines of up to 1,000 euros. That mandate did not prevent a surge of cases that began in October and peaked in mid-November. As of early January, Italy was still recording new infections at four times the early October rate.
Our findings do not deny the efficacy of mask-wearing. Nor should they discourage the practice. Public health authorities in the U.S. and throughout the world cite studies showing that mask-wearing slows the pathogen’s rate of spread.
Although mask-wearing may reduce transmission rate, it has not prevented cases from spiking either here or abroad.
Governments should pursue additional strategies. These include adopting better measures to protect nursing home residents and enabling nationwide screening through the widespread use of rapid self-tests.
The U.S. and other governments have done an abysmal job at protecting nursing home patients. As of Jan. 7, U.S. nursing home residents accounted for less than 0.5% of COVID-19 cases but 37% of COVID-related deaths.
Cases and deaths continue to mount even as the process of vaccinating residents and staff has begun. The current federal policy of requiring weekly tests of staff and temporal thermometer screenings of visitors is inadequate. Government should require daily testing of staff, at least until all residents and staff have been immunized. Visitors should be tested before entering the facility.
Government should also take steps to protect the general population. The distribution of rapid, at-home tests that don’t require a prescription or laboratory analysis would inform people of their COVID-19 status and limit the disease’s transmission.
The technology exists to produce low-cost, rapid home tests in sufficient volume for tens of millions of Americans to test themselves daily. Unfortunately, the U.S. Food and Drug Administration has not approved these tests. The agency’s concern is that self-administered, in-home tests are less sensitive than laboratory-analyzed tests used for clinical diagnosis. This view allows the perfect to be the enemy of the good.
Acknowledging this, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently embraced the notion of “flooding the system with tests, getting a home test that you could do yourself, that’s highly sensitive and highly specific.”
Rapid tests are marginally less accurate, but that is more than offset by their volume (testing tens of millions of people daily, as opposed to 2 million), frequency (people can test themselves often), and immediacy (results within minutes, rather than days).
Unlike mask-wearing and lockdown edicts, widespread self-testing is neither culturally nor politically divisive, making it more likely to gain population-wide acceptance. It combats the contagion by empowering and informing people, not confining them, restricting their activities and suggesting that they are to blame for the spread of a contagious pathogen.
Equipping people to make the best decisions for themselves, their families, and their fellow citizens offers a promising new approach to combating the pandemic.
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IN BRIEF
Biden to ask Congress on Day One to legalize 11 million illegal aliens (Daily Wire)
Incoming White House climate team blames "systemic racism" for climate change (Free Beacon)
Biden team already in talks with Iran over return to nuclear deal (Breitbart)
Biden poised to undo Trump alternatives to Obamacare plans (Examiner)
Biden to yank Keystone XL permit on first day of presidency (Politico)
New rule bars banks from targeting gun manufacturers — at least until Biden (maybe) negates it (Free Beacon)
Ben Sasse, in fiery op-ed, appropriately says QAnon is destroying GOP (The Hill)
Nancy Pelosi puts Eric Swalwell back on Homeland Security panel despite spy scandal (NY Post)
Lincoln Project in disarray after founder accused of "grooming" young men for sex (Free Beacon)
Hotel chain cancels fundraising event for Senator Josh Hawley (Examiner)
Minnesota law school students — who can't even get her district right — aim to "cancel" alumna Rep. Michelle Fischbach (Daily Signal)
Thanks to right-wing boycott, Fox News trails both CNN and MSNBC in ratings for the first time since 2000 (Disrn)
Federal court dismisses charges against church deacon arrested for singing outdoors without a mask (Disrn)
Portland City Council demands reparations from Congress (The Federalist)
Welfare fraud scandal leads to resignation of Dutch government (Disrn)
The nuclear energy advancements of the past four years will blow your mind (The Federalist)
Guy accidentally found a dead body on Google Maps that had been missing for 22 years (Not the Bee)
New Yorker releases new 12-minute footage of inside view of Capitol riot (Examiner)
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