Novavax is absent from Australia’s 2021 vaccination schedule. But it could be a useful booster later on


Cassandra Berry, Murdoch UniversityNovavax recently released excellent results from phase 3 clinical trials, finding its COVID-19 vaccine demonstrated 90.4% efficacy overall after two doses given three weeks apart.

The results, from close to 30,000 people in the United States and Mexico, found the vaccine demonstrated 100% protection against moderate and severe COVID-19, and was highly protective against circulating variants of interest and concern. It also has a good safety profile.

It’s important to note these results came directly from Novavax in a press release, and we’re still waiting to see the data published in a peer-reviewed journal. Once this happens, it’s likely Novavax will apply for approval from medical regulators around the world.

But this process will take a few months. The Therapeutic Goods Administration has said it doesn’t expect to receive the final data it needs to approve the vaccine until September. And in the COVID Vaccination Allocation Horizons, information the government released this week setting out vaccine allocation until the end of 2021, Novavax is not mentioned.

So by the time Australia is ready to deliver Novavax — the country has 51 million doses on order — we may well have completed most of the vaccine rollout with the AstraZeneca, Pfizer and Moderna vaccines. The situation will be similar in other countries, such as the United States.

However, that doesn’t mean Novavax won’t play an important role in Australia’s fight against COVID-19.

How does Novavax work?

Novavax is designed using protein-based technology. This is different from the AstraZeneca vaccine, which is a viral vector vaccine, and Pfizer and Moderna, which use mRNA technology.

Novavax works by introducing a part of the SARS-CoV-2 virus — the spike protein — to the immune system. The spike protein used is made in insect cells and doesn’t contain any live components of the virus. It can’t replicate or cause COVID-19.

To help the vaccine generate a stronger protective response, it uses an adjuvant, which is a molecule that boosts the immune system. The adjuvant Novavax uses is based on saponin, a natural extract from the Chilean soapbark tree.

An illustration of SARS-CoV-2.
COVID-19 vaccines work by targeting the spike protein, a protein on the surface of SARS-CoV-2.
Shutterstock

In some countries, Novavax could be used as an initial COVID vaccine. It will be relatively easy to distribute because it can be stored at regular fridge temperatures.

In other countries where most people will have already received two vaccine doses by the time Novavax becomes available, the vaccine could be used as an annual booster — on its own or as a supplement in formulated vaccines.




Read more:
What is Novavax, Australia’s third COVID vaccine option? And when will we get it?


A potential booster

Let’s say you’re writing a book. You write your first draft — that’s the first dose of vaccine. Then you edit and refine the final draft — that’s the second dose. You could say annual booster vaccines are like updated editions. Perhaps the original book is also translated into different languages, just as boosters could cover viral variants around the world.

In slightly more scientific terms, after the first vaccine dose, certain cells in our immune system (normal B cells) are activated and produce a primary antibody response. After the second vaccine dose, a slightly different flavour of immune cells (memory B cells) mount a stronger antibody response more rapidly.

But this immune memory can wane over time. Boosters may be needed to enhance immune memory responses to the SARS-CoV-2 spike protein in people who have previously been vaccinated against COVID-19.

Boosters could also be important as new variants emerge. Vaccines can often be reformulated to protect against new viral variants when original formulations aren’t working as well.

So even if Novavax isn’t the first or second COVID vaccine in our arms, it could be an important tool in our arsenal as we continue to navigate the pandemic.

A person with a bandaid on their upper arm.
Novavax could potentially be used as a booster vaccine down the track.
Shutterstock

What about in combination with the flu shot?

Novavax has recently revealed the efficacy of its COVID vaccine was roughly the same in a study where an influenza vaccine was administered simultaneously. This data, although yet to be peer-reviewed, signals Novavax could potentially be given alongside the annual flu shot.

In the future, we could even have the flu shot and Novavax combined in one vaccine. Novavax has designed and is currently testing a vaccine which combines SARS-CoV-2 and influenza spike proteins (called a multivalent vaccine).




Read more:
Can I get AstraZeneca now and Pfizer later? Why mixing and matching COVID vaccines could help solve many rollout problems


SARS-CoV-2 is rapidly evolving and we need to future-proof Australia against viral variants. As our knowledge of COVID-19 builds, we must develop strategies for more robust protection.

Rather than a fast sprint, our immune systems likely need to be primed for an ultra-marathon. Thinking about vaccines beyond the “first wave” of vaccination will be key.The Conversation

Cassandra Berry, Professor of Viral Immunology, Murdoch University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Australia’s COVID vaccine rollout is well behind schedule — but don’t panic


Elizabeth Jackson, Curtin University and Sharyn Curran, Curtin UniversityOn March 11 — exactly a year after the World Health Organization declared COVID a pandemic — Australia’s health department secretary Brendan Murphy fronted a Senate select committee to discuss potential delays to the government’s timetable for the vaccine rollout.

The federal government had initially pledged to vaccinate 4 million Australian adults by early April, and all remaining adults by October. But with each of the approved COVID vaccines requiring two shots, it was unclear whether these deadlines referred to complete vaccination, or merely a first dose.

But Murphy argued this distinction isn’t as clear-cut as it might sound, because of the complex and evolving evidence about what dose interval offers vaccine recipients the best protection.

“The original end-of-October modelling was done when we had a planned four-week dose interval with AstraZeneca,” he told the Senate committee. “Now we’re giving the second dose at a 12-week interval […] I suspect it’s unlikely we will have completed the second doses of the AstraZeneca vaccines by [October].”

What’s more, Murphy also said “the first dose is nearly as good as the second dose” in terms of conferring immunity, although it’s not clear what evidence he was relying on here.

Besides the evidently simplistic deadlines, there is also the fact that the rollout is a hugely complex logistical operation, involving manufacture, transport, storage and administration of the vaccine under very specific conditions.

Given this atypical supply chain, and the rapidly evolving evidence around the vaccines, perhaps we as a society should be respectful of this situation and guard against pushing too hard.

How it started

Australia’s COVID vaccination program began on February 21. The ABC reports 159,294 people have been vaccinated as of March 12. Modelling published by The Guardian suggests 2 million doses would need to have been given by mid-March to meet the April target.

Preliminary research also suggests Australia needs to be administering 200,000 vaccines per day, on average, to hit the October deadline.




Read more:
Australia must vaccinate 200,000 adults a day to meet October target: new modelling


Almost a month into the rollout, the total number of vaccinated Australians is fewer than the number we’ll need to vaccinate each and every day. It’s fair to say we’ve not exactly hit the ground running.

How it’s going

Of course, it is reasonable to expect we might start slow and then speed up. We can assume the rate will pick up once CSL begins domestic production of the AstraZeneca vaccine, towards the end of March, with the aim of producing a million doses a week.

Notwithstanding any teething problems with the manufacture itself, there are already logistics systems in place to move and store the vaccine, and training programs for medical professionals and vaccine hubs to administer it. Domestic manufacture also has a shorter supply chain than international shipping, which helps minimise the risks.

Is Australia behind on its rollout of the COVID-19 vaccine? Yes. Will it catch up? Most likely, yes.

The risks of going too fast

There are risks in accelerating and pressuring the supply chain purely to hit an arbitrary deadline. Even with the very best planning and control, novel supply chain systems are notoriously fragile and frequently crack under excessive pressure.

We’ve seen signs of this already in various countries. The European Union has suffered delays in vaccine supplies and blocked a shipment to Australia. The US vaccine rollout has been hindered by severe winter storms, contract issues and factory fires. Some nations have paused the AstraZeneca vaccine rollout amid fears of side-effects. And the ethical debate continues about the need for wealthy nations to share their vaccine stockpiles with poorer countries.

It’s inevitable there will be mishaps along the way, but excessive haste increases the risk. Already we have seen patients accidentally given multiple doses of the vaccine by medical professions without adequate training, and doses wasted by operator error in Victoria.




Read more:
How the Pfizer COVID vaccine gets from the freezer into your arm


It is understandable the public should hold the federal government to account over its promises about the timetable for the vaccine rollout. But as the federal government’s official vaccine rollout policy states, the entire operation is “complex and atypical”.

Research on situations of humanitarian disaster relief show the dangers of pressuring supply chains to overperform in time-critical, unpredictable situations. By one estimate, more than 40% of humanitarian organisations’ spending on relief is wasted due to factors such as duplication of resources and incomplete spending analysis.

Some countries are already suffering humanitarian disaster at the hands of COVID, but not Australia. We have experienced far less social and economic disruption than many other countries, and have generally weathered the COVID crisis remarkably well.

Given that fact, and the unique challenges of a successful vaccine rollout, it would definitely be wiser for the government to underpromise and over-deliver on COVID vaccines, rather than the other way around.




Read more:
Can I choose what vaccine I get? What if I have allergies or side-effects? Key COVID vaccine rollout questions answered


The Conversation


Elizabeth Jackson, Senior Lecturer in Supply Chain Management & Logistics, Curtin University and Sharyn Curran, Director of Graduate Research, School of Management & Marketing, Senior Academic, Curtin University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Egyptian Couple Shot by Muslim Extremists Undaunted in Ministry


Left for dead, Christians offer to drop charges if allowed to construct church building.

CAIRO, Egypt, June 9 (CDN) — Rasha Samir was sure her husband, Ephraim Shehata, was dead.

He was covered with blood, had two bullets inside him and was lying facedown in the dust of a dirt road. Samir was lying on top of him doing her best to shelter him from the onslaught of approaching gunmen.

With arms outstretched, the men surrounded Samir and Shehata and pumped off round after round at the couple. Seconds before, Samir could hear her husband mumbling Bible verses. But one bullet had pierced his neck, and now he wasn’t moving. In a blind terror, Samir tried desperately to stop her panicked breathing and convincingly lie still, hoping the gunmen would go away.

Finally, the gunfire stopped and one of the men spoke. “Let’s go. They’re dead.”

 

‘Break the Hearts’

On the afternoon of Feb. 27, lay pastor Shehata and his wife Samir were ambushed on a desolate street by a group of Islamic gunmen outside the village of Teleda in Upper Egypt.

The attack was meant to “break the hearts of the Christians” in the area, Samir said.

The attackers shot Shehata twice, once in the stomach through the back, and once in the neck. They shot Samir in the arm. Both survived the attack, but Shehata is still in the midst of a difficult recovery. The shooters have since been arrested and are in jail awaiting trial. A trial cannot begin until Shehata has recovered enough to attend court proceedings.

Despite this trauma, being left with debilitating injuries, more than 85,000 Egyptian pounds (US$14,855) in medical bills and possible long-term unemployment, Shehata is willing to drop all criminal charges against his attackers – and avoid what could be a very embarrassing trial for the nation – if the government will stop blocking Shehata from constructing a church building.

Before Shehata was shot, one of the attackers pushed him off his motorcycle and told him he was going to teach him a lesson about “running around” or being an active Christian.

Because of his ministry, the 34-year-old Shehata, a Coptic Orthodox Christian, was arguably the most visible Christian in his community. When he wasn’t working as a lab technician or attending legal classes at a local college, he was going door-to-door among Christians to encourage them in any way he could. He also ran a community center and medical clinic out of a converted two-bedroom apartment. His main goal, he said, was to “help Christians be strong in their faith.”

The center, open now for five years, provided much-needed basic medical services for surrounding residents for free, irrespective of their religion. The center also provided sewing training and a worksite for Christian women so they could gain extra income. Before the center was open in its present location, he ran similar services out of a relative’s apartment.

“We teach them something that can help them with the future, and when they get married they can have some way to work and it will help them get money for their families,” Shehata said.

Additionally, the center was used to teach hygiene and sanitation basics to area residents, a vital service to a community that uses well water that is often polluted or full of diseases. Along with these services, Shehata and his wife ran several development projects, repairing the roofs of shelters for poor people, installing plumbing, toilets and electrical systems. The center also distributed free food to the elderly and the infirm.

The center has been run by donations and nominal fees used to pay the rent for the apartment. Shehata has continued to run the programs as aggressively as he can, but he said that even before the shooting that the center was barely scraping by.

“We have no money to build or improve anything,” he said. “We have a safe, but no money to put in it.”

 

Tense Atmosphere

In the weeks before the shooting, Teleda and the surrounding villages were gripped with fear.

Christians in the community had been receiving death threats by phone after a Muslim man died during an attack on a Christian couple. On Feb. 2, a group of men in nearby Samalout tried to abduct a Coptic woman from a three-wheeled motorcycle her husband was driving. The husband, Zarif Elia, punched one of the attackers in the nose. The Muslim, Basem Abul-Eid, dropped dead on the spot.

Elia was arrested and charged with murder. An autopsy later revealed that the man died of a heart attack, but local Muslims were incensed.

Already in the spotlight for his ministry activities, Shehata heightened his profile when he warned government officials that Christians were going to be attacked, as they had been in Farshout and Nag Hammadi the previous month. He also gave an interview to a human rights activist that was posted on numerous Coptic websites. Because of this, government troops were deployed to the town, and extremists were unable to take revenge on local Christians – but only after almost the
entire Christian community was placed under house arrest.

“They chose me,” Shehata said, “Because they thought I was the one serving everybody, and I was the one who wrote the government telling them that Muslims were going to set fire to the Christian houses because of the death.”

Because of his busy schedule, Shehata and Samir, 27, were only able to spend Fridays and part of every Saturday together in a village in Samalut, where Shehata lives. Every Saturday after seeing Samir, Shehata would drive her back through Teleda to the village where she lives, close to her family. Samalut is a town approximately 105 kilometers (65 miles) south of Cairo.

On the afternoon of Feb. 27, Shehata and his wife were on a motorcycle on a desolate stretch of hard-packed dirt road. Other than a few scattered farming structures, there was nothing near the road but the Nile River on one side, and open fields dotted with palm trees on the other.

Shehata approached a torn-up section of the road and slowed down. A man walked up to the vehicle carrying a big wooden stick and forced him to stop. Shehata asked the man what was wrong, but he only pushed Shehata off the motorcycle and told him, “I’m going to stop you from running around,” Samir recounted.

Shehata asked the man to let Samir go. “Whatever you are going to do, do it to me,” he told the man.

The man didn’t listen and began hitting Shehata on the leg with the stick. As Shehata stumbled, Samir screamed for the man to leave them alone. The man lifted the stick again, clubbed Shehata once more on the leg and knocked him to the ground. As Shehata struggled to get up, the man took out a pistol, leveled it at Shehata’s back and squeezed the trigger.

Samir started praying and screaming Jesus’ name. The man turned toward her, raised the pistol once more, squeezed off another round, and shot Samir in the arm. Samir looked around and saw a few men running toward her, but her heart sank when she realized they had come not to help them but to join the assault.

Samir jumped on top of Shehata, rolled on to her back and started begging her attackers for their lives, but the men, now four in all, kept firing. Bullets were flying everywhere.

“I was scared. I thought I was going to die and that the angels were going to come and get our spirits,” Samir said. “I started praying, ‘Please God, forgive me, I’m a sinner and I am going to die.’”

Samir decided to play dead. She leaned back toward her husband, closed her eyes, went limp and tried to stop breathing. She said she felt that Shehata was dying underneath her.

“I could hear him saying some of the Scriptures, the one about the righteous thief [saying] ‘Remember me when you enter Paradise,’” she said. “Then a bullet went through his neck, and he stopped saying anything.”

Samir has no way of knowing how much time passed, but eventually the firing stopped. After she heard one of the shooters say, “Let’s go, they’re dead,” moments later she opened her eyes and the men were gone. When she lifted her head, she heard her husband moan.

 

Unlikely Survival

When Shehata arrived at the hospital, his doctors didn’t think he would survive. He had lost a tremendous amount of blood, a bullet had split his kidney in two, and the other bullet was lodged in his neck, leaving him partially paralyzed.

His heartbeat was so faint it couldn’t be detected. He was also riddled with a seemingly limitless supply of bullet fragments throughout his body.

Samir, though seriously injured, had fared much better than Shehata. The bullet went into her arm but otherwise left her uninjured. When she was shot, Samir was wearing a maternity coat. She wasn’t pregnant, but the couple had bought the coat in hopes she soon would be. Samir said she thinks the gunman who shot her thought he had hit her body, instead of just her arm.

The church leadership in Samalut was quickly informed about the shooting and summoned the best doctors they could, who quickly traveled to help Shehata and Samir. By chance, the hospital had a large supply of blood matching Shehata’s blood type because of an elective surgical procedure that was cancelled. The bullets were removed, and his kidney was repaired. The doctors however, were forced to leave many of the bullet fragments in Shehata’s body.

As difficult as it was to piece Shehata’s broken body back together, it paled in comparison with the recovery he had to suffer through. He endured multiple surgeries and was near death several times during his 70 days of hospitalization.

Early on, Shehata was struck with a massive infection. Also, because part of his internal tissue was cut off from its blood supply, it literally started to rot inside him. He began to swell and was in agony.

“I was screaming, and they brought the doctors,” Shehata said. The doctors decided to operate immediately.

When a surgeon removed one of the clamps holding Shehata’s abdomen together, the intense pressure popped off most of the other clamps. Surgeons removed some stomach tissue, part of his colon and more than a liter of infectious liquid.

Shehata could not eat normally and lost 35 kilograms (approximately 77 lbs.). He also couldn’t evacuate his bowels for at least 11 days, his wife said.

Despite the doctors’ best efforts, infections continued to rage through Shehata’s body, accompanied by alarming spikes in body temperature.

Eventually, doctors sent him to a hospital in Cairo, where he spent a week under treatment. A doctor there prescribed a different regimen of antibiotics that successfully fought the infection and returned Shehata’s body temperature to normal.

Shehata is recovering at home now, but he still has a host of medical problems. He has to take a massive amount of painkillers and is essentially bedridden. He cannot walk without assistance, is unable to move the fingers on his left hand and cannot eat solid food. In approximately two months he will undergo yet another surgery that, if all goes well, will allow him to use the bathroom normally.

“Even now I can’t walk properly, and I can’t lift my leg more than 10 or 20 centimeters. I need someone to help me just to pull up my underwear,” Shehata said. “I can move my arm, but I can’t move my fingers.”

Samir does not complain about her condition or that of Shehata. Instead, she sees the fact that she and her husband are even alive as a testament to God’s faithfulness. She said she thinks God allowed them to be struck with the bullets that injured them but pushed away the bullets that would have killed them.

“There were lots of bullets being shot, but they didn’t hit us, only three or four,” she said. “Where are the others?”

Even in the brutal process of recovery, Samir found cause for thanks. In the beginning, Shehata couldn’t move his left arm, but now he can. “Thank God and thank Jesus, it was His blessing to us,” Samir said. “We were kind of dead, now we are alive."

Still, Samir admits that sometimes her faith waivers. She is facing the possibility that Shehata might not work for some time, if ever. The couple owes the 85,000 Egyptian pounds (US$14,855) in medical bills, and continuing their ministry at the center and in the surrounding villages will be difficult at best.

“I am scared now, more so than during the shooting,” she said. “Ephraim said do not be afraid, it is supposed to make us stronger.”

So Samir prays for strength for her husband to heal and for patience. In the meantime, she said she looks forward to the day when the struggles from the shooting are over and she can look back and see how God used it to shape them.

“There is a great work the Lord is doing in our lives, we may not know what the reason is now, but maybe some day we will,” Samir said.

 

Government Opposition

For the past 10 years, Shehata has tried to erect a church building, or at a minimum a house, that he could use as a dedicated community center. But local Muslims and Egypt’s State Security Investigations (SSI) agency have blocked him every step of the way. He had, until the shooting happened, all but given up on constructing the church building.

On numerous occasions, Shehata has been stopped from holding group prayer meetings after people complained to the SSI. In one incident, a man paid by a land owner to watch a piece of property near the community center complained to the SSI that Shehata was holding prayer meetings at the facility. The SSI made Shehata sign papers stating he wouldn’t hold prayer meetings at the center.

At one time, Shehata had hoped to build a house to use as a community center on property that had been given to him for that purpose. Residents spread a rumor that he was actually erecting a church building, and police massed at the property to prevent him from doing any construction.

There is no church in the town where Shehata lives or in the surrounding villages. Shehata admits he would like to put up a church building on the donated property but says it is impossible, so he doesn’t even try.

In Egypt constructing or even repairing a church building can only be done after a complex government approval process. In effect, it makes it impossible to build a place for Christian worship. By comparison, the construction of mosques is encouraged through a system of subsidies.

“It is not allowed to build a church in Egypt,” Shehata said. “We can’t build a house. We can’t build a community center. And we can’t build a church.”

Because of this, Shehata and his wife organize transportation from surrounding villages to St. Mark’s Cathedral in Samalut for Friday services and sacraments. Because of the lack of transportation options, the congregants are forced to ride in a dozen open-top cattle cars.

“We take them not in proper cars or micro-buses, but trucks – the same trucks we use to move animals,” he said.

The trip is dangerous. A year ago a man fell out of one of the trucks onto the road and died. Shehata said bluntly that Christians are dying in Egypt because the government won’t allow them to construct church buildings.

“I feel upset about the man who died on the way going to church,” he said.

 

Church-for-Charges Swap

The shooters who attacked Shehata and Samir are in jail awaiting trial. The couple has identified each of the men, but even if they hadn’t, finding them for arrest was not a difficult task. The village the attackers came from erupted in celebration when they heard the pastor and his wife were dead.

Shehata now sees the shooting as a horrible incident that can be turned to the good of the believers he serves. He said he finds it particularly frustrating that numerous mosques have sprouted up in his community and surrounding areas during the 10 years he has been prevented from putting up a church building, or even a house. There are two mosques alone on the street of the man who died while being trucked to church services, he said.

Shehata has decided to forgo justice in pursuit of an opportunity to finally construct a church building. He has approached the SSI through church leaders, saying that if he is allowed to construct a church building, then he will take no part in the criminal prosecution of the shooters.

“I have told the security forces through the priests that I will drop the case if they can let us build the church on the piece of land,” he said.

The proposal isn’t without possibilities. His trial has the potential of being internationally embarrassing. It raises questions about fairness in Egyptian society during an upcoming presidential election that will be watched by the world.

Regardless of what happens, Shehata said all he wants is peace and for the rights of Christians to be respected. He said that in Egypt, Christians have less value than the “birds of the air” mentioned in the Bible. According to Luke 12:6, five sparrows sold for two pennies in ancient times.

“We are not to be killed like birds, slaughtered,” he said. “We are human.”

Report from Compass Direct News