•   
  •   

World The next huge challenge for a Covid-19 vaccine: Keeping it extremely cold

16:05  16 november  2020
16:05  16 november  2020 Source:   vox.com

Coronavirus vaccine production begins in Australia before Oxford-AstraZeneca's products last stage of approval

  Coronavirus vaccine production begins in Australia before Oxford-AstraZeneca's products last stage of approval Coronavirus vaccines could be available by mid-next year, with an Australian company starting to make doses of one product before it has even been approved. Manufacturing of Oxford University's vaccine began in Victoria today.The company, CSL, is making about 30 million doses of the Oxford-AstraZeneca vaccine despite it still going through phase-three clinical trials.The results from these trials won't be known until the end of the year. And if they're positive, the vaccine will still need to get approval from the Therapeutic Goods Administration (TGA).

The vaccine is a "significant step" forward for getting life back to normal, but challenges remain. There are still huge challenges ahead, but the announcement has been warmly welcomed with scientists describing themselves Covid - 19 : Next two weeks 'crucial' for ending England lockdown5.

COVID - 19 Vaccines Are Coming, but They’re Not What You Think. These novel approaches could fail in many ways. Nearly every vaccine currently approved by the Food and Drug Administration introduces foreign proteins into a healthy but nonimmune individual.

The epic global effort to develop a Covid-19 vaccine has been unmatched in its scale, speed, and scientific advances. And a recent announcement about the potentially high rate of efficacy of one leading candidate, from Pfizer and BioNTech, has raised hopes that an end to the pandemic might be in sight.

a car parked in a parking lot: Pfizer and BioNTech’s vaccine for Covid-19 has some of the most stringent cold requirements of any vaccine candidates. It poses a major challenge for distributing the vaccine. © Jean-Christophe Guillaume/Getty Images Pfizer and BioNTech’s vaccine for Covid-19 has some of the most stringent cold requirements of any vaccine candidates. It poses a major challenge for distributing the vaccine.

But the vaccine’s potential to provide immunity to the broader population is now threatened by a massive logistical hurdle in actually getting it to people safely: keeping the vaccine doses very, very cold.

Is social media ready for a Covid-19 vaccine?

  Is social media ready for a Covid-19 vaccine? Facebook, Twitter, and YouTube are bracing for more misinformation.This is tremendous news — and misinformation about it is already circulating on social media. According to research from VineSight, a slew of social Twitter accounts, including those of Donald Trump Jr. and Sen. Ted Cruz, are already questioning the timing of the results’ release just days after the presidential election. By midday, tweets pushing that narrative had racked up more than 20,000 shares. The researchers estimate that Donald Trump Jr.’s tweet alone could have been seen by nearly 7 million people.

A vial containing a Russian Covid - 19 vaccine undergoing human trials © Russian Defense Ministry / RIA Novosti. This month, Moscow's famed Sechenov University announced that the first phase of clinical trials for a vaccine had been a success.

An effective inoculation against Covid - 19 has been billed as the best way to end the global health He said the goal was to deliver more than 300 million doses of the vaccine before April next year, which He said he thought the vaccine could ultimately help reduce transmission of the virus by 50 percent.

Vaccines are fragile drugs that demand strict temperature controls lest they spoil. And they spoil a lot. According to the World Health Organization, about half of the vaccines distributed around the world go to waste, in large part because of a failure to properly control storage temperatures. That in turn undermines efforts to contain and eradicate disease.

“They lose effectiveness and their potency if they’re exposed to temperatures outside of the range that they’re supposed to be kept in,” said Michelle Seidel, UNICEF’s immunization supply chain specialist.

This vulnerability stands to be an even bigger problem for the campaign against Covid-19, where just about everyone in the world is vulnerable so just about everyone will need the shot. Containing the disease will require billions of people to be immunized around the world — likely with two doses — and fast.

The Lame-Duck Vaccine

  The Lame-Duck Vaccine The Trump administration spurred development of a vaccine; the Biden administration has to persuade Americans to take it.In the end, there was no October surprise. Donald Trump spent months declaring that a COVID-19 vaccine was imminent, a gambit that failed to pressure the FDA into an approval before Election Day but did succeed, nevertheless, in eroding the American public’s confidence in a vaccine. It was only yesterday that Pfizer released very early but very promising results suggesting that its COVID-19 vaccine candidate could be more than 90 percent effective.

The race to secure a Covid - 19 vaccine reached a key milestone, even as the pandemic regained strength in the U.S. and Europe. Though some questions remain, the strong reading means Pfizer and BioNTech are on track to be first with a vaccine , after signing advance deals with governments

Here's how a Covid - 19 vaccine could help the global economy. 14 states set new record in Black leaders agree that it 's a challenge to recruit Black people into the vaccine trials, especially since it Here's how to volunteer for a Covid - 19 vaccine trial. Federal law and NIH policy mandate inclusion of

Pfizer and BioNTech have reported that their vaccine is more than 90 percent effective at preventing the disease in a preliminary analysis. But this particular vaccine, which uses strands of genetic material known as mRNA, also has some of the most stringent temperature requirements of any candidate, requiring storage at minus 70 degrees Celsius (minus 94 degrees Fahrenheit) or lower.

Pfizer, BioNTech, and other companies whose vaccine candidates require very cold storage say they are already preparing for this challenge, investing in freezers, transportation, and temperature-tracking devices. But with so many moving parts, there’s a lot that can go wrong. With recent struggles in the United States to maintain adequate supply chains for Covid-19 tests, masks, and personal protective equipment, the concern is that the same mistakes could be repeated in a high-stakes vaccination effort.

Listen: A 90 Percent Effective Vaccine

  Listen: A 90 Percent Effective Vaccine The lead principal investigator of the Pfizer vaccine trial explains the news that it’s 90 percent effective.Stephen Thomas, the chief of infectious disease at SUNY Upstate Medical University and the lead principal investigator of the Pfizer vaccine trial, answers questions on the podcast Social Distance from staff writer James Hamblin and producer Katherine Wells.

Rapid antigen test from BD," Musk said. Something extremely bogus is going on. Was tested for covid four times today. The tweet sparked a heated debate on social media, with some accusing the billionaire businessman of being “irresponsible” by suggesting that Covid - 19 tests are unreliable.

English News Lesson on COVID - 19 Vaccine : Scientists develop COVID - 19 vaccine - FREE worksheets, online activities, listening in 7 Their researchers say they have developed a vaccine that has a 90 per cent success rate in protecting against COVID - 19 . The researchers also say the vaccine

While full approval of a Covid-19 vaccine may still be months away, the foundation for getting it to people has to be laid now.

The vaccine cold chain, explained

Getting a vaccine through clinical trials and approved by the Food and Drug Administration is a tedious, expensive, and time-consuming process. But it’s not the finish line for a Covid-19 immunization campaign. It’s just one of the first hurdles.

“There’s almost an assumption that once a vaccine is created and approved, then everyone is healthy and fine, but the operational component is pretty complex,” said Caesar Djavaherian, an ER physician and chief clinical innovation officer at Carbon Health. “We’ve never tried to administer vaccines to 100 million Americans in a short period of time.”

To prepare for that, Covid-19 vaccine production is already underway. The idea is that once a vaccine does get the green light, doses are ready to roll out right away. Operation Warp Speed, the $10 billion US government vaccine development effort, is aiming to have 300 million doses of a Covid-19 vaccine produced by January 2021.

Vaccine Science Is Working, but Society Needs to Step Up

  Vaccine Science Is Working, but Society Needs to Step Up In distributing a coronavirus vaccine, the U.S. needs to learn from past mistakes.Preliminarily results from clinical trials suggest that the vaccine, a product of a collaboration between Pfizer and BioNTech, might be 90 percent effective at preventing COVID-19 symptoms—a level that would place the new discovery among the world’s most reliable vaccines. More information and a thorough, independent review are still needed, but the trial for this vaccine enrolled a large, ethnically and racially diverse pool of subjects and has so far turned up no serious safety concerns.

But at that point, vaccines have to go from factories to shipping facilities to trucks to hospitals, clinics, and pharmacies, and, eventually, into the arms of people — all while without budging from narrow, specific temperature ranges.

This series of handoffs under strict temperature controls is known as the cold chain. It’s this chain — between the manufacturer and the clinic — that represents one of the biggest challenges of the vaccine distribution effort, and each step could potentially become a weak link.

It’s particularly challenging because vaccines are only manufactured in a handful of facilities around the world, demanding a sprawling international network of transportation and storage sites in order to get immunizations to wherever they’re needed.

Many major hospitals may have the specialized cold storage facilities needed to stockpile vaccines, but smaller clinics and pharmacies don’t. And even some of the big hospitals may not have the specialized ultra-cold freezers needed to store a vaccine like the one developed by Pfizer and BioNTech, especially in large quantities.

That’s why vaccines are typically sent from factories to regional warehouses. These facilities often have sophisticated freezers for long-term storage, as well as a reliable electricity supply and backup generators. They aren’t set up to administer the vaccine to people, however, so the vials still have to be delivered to the final users.

The ethics of deliberately infecting volunteers with Covid-19 to test vaccines

  The ethics of deliberately infecting volunteers with Covid-19 to test vaccines Scientists will soon launch a “human challenge trial.” Here’s why that’s so controversial.They’re young. They’re healthy. And they want scientists to give them a candidate vaccine and then deliberately expose them to the coronavirus, so we can all find out faster whether the vaccine is effective.

But every time a vaccine moves, it introduces yet another risk. Bad weather can delay delivery flights. Freezers can fail on refrigerator trucks. Vaccine shipping containers can end up stuck on the tarmac. Coolers can leak. Even opening freezers repeatedly to move things in and out can harm vaccines stored inside. Every breach in temperature control degrades the vaccine, and every time the vaccine moves, the chances of this happening increase, so health officials need to plan carefully to ensure the absolute minimum amount of movement.

Once a clinic receives a vaccine shipment, health workers can thaw out the vials in a refrigerator as they prepare to give injections to patients. But once a vaccine is warmed up, it’s only viable for a few days. For clinics without their own cold-storage facilities, the clock starts ticking as soon as they receive their doses. So getting everyone vaccinated requires a precisely coordinated series of complex events spanning the globe, and any break therein could derail an effort to control a deadly disease.

Why supply chains are even more complicated for the Covid-19 pandemic

All that said, health systems in the United States and around the world have been administering vaccines for decades, and there is plenty of experience and know-how for effectively bringing vaccines to people.

But again, the Covid-19 vaccination effort has to happen at an even larger scale than just about any other vaccination effort to date. And it can’t seize infrastructure from existing vaccines since immunizations for illnesses like measles, influenza, polio, and meningitis are still needed at the same time.

Pfizer and BioNTech have applied for emergency approval for their Covid-19 vaccine

  Pfizer and BioNTech have applied for emergency approval for their Covid-19 vaccine The companies say their vaccine could begin distribution to high-risk people by mid-December.If granted an EUA, the BNT162b2 vaccine could be administered to certain high-risk groups in the United States — most likely health workers — as soon as mid-December. Pfizer and BioNTech are filing for similar approvals in other countries as well.

That means many of the things needed to distribute a Covid-19 vaccine have to be additional to what’s already on the market; freezers, refrigerated shipping containers, and remote temperature-monitoring systems can’t simply be cannibalized from other vaccine supply chains.

The scale of a Covid-19 vaccination campaign could also create other bottlenecks. Vaccine vials require a specific type of glass that can tolerate low temperatures and remain sterile, and there may not be enough of this glass to go around right away. Even the self-sealing rubber stoppers on the vials could face a shortfall. Syringes, personal protective equipment, and trained personnel to administer vaccines are already facing a crunch from dealing with the ongoing pandemic.

Then there are complications that arise from the Covid-19 vaccines themselves. Covid-19 vaccine development has allowed researchers to showcase new technologies that have never been tried before at scale. In particular, multiple companies are developing vaccines based on the genetics of the SARS-CoV-2 virus, the virus that causes Covid-19, rather than the classical approach of using the structure or pieces of the virus itself.

The problem is that these fragments of DNA and RNA are delicate. They can degrade quickly on their own, even at refrigerated temperatures. That’s why freezing them is so important for keeping them intact.

But that’s hard to do for vaccines like Pfizer and BioNTech’s vaccine candidate, which requires storage at such extreme temperatures. Some experts are concerned these cold requirements could end up being a deal breaker for widely distributing these vaccines. “These mRNA vaccines, which are stored at minus 80°C, from a practical perspective are showstoppers right now,” said Vijay Samant, the former chief operating officer at Merck Vaccines.

A 3rd coronavirus vaccine works

  A 3rd coronavirus vaccine works Hello, Another Monday, another batch of vaccine results. This time:AstraZeneca and the University of Oxford shared that their coronavirus vaccine was 70% effective on average. That comes on the heels of Pfizer and its partner BioNTech and Moderna both sharing last week that their coronavirus vaccines were 95% and 94.5% effective, respectively. Moncef Slaoui, the scientific head of Operation Warp Speed, is anticipating things will move quickly from here. He said on Sunday that he expects Americans will starting getting Pfizer's vaccine as early as December 11, assuming regulators sign off on it.

Ultra-cold freezers that can reach the requisite temperatures cost between $10,000 and $15,000 each. That’s out of the budget for many clinics and hospitals. With these logistical and storage constraints, that may mean that people will have to travel to centralized locations like regional hospitals to get vaccinated instead of to their local clinics and pharmacies.

But Pfizer and BioNTech said they have a solution.

“We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 days,” said Jerica Pitts, a spokesperson for Pfizer, in an email. “The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations.”

Dry ice, which reaches temperatures of minus 78°C, will be an essential part of shipping Pfizer and BioNTech’s vaccine. © Leon Neal/Getty Images Dry ice, which reaches temperatures of minus 78°C, will be an essential part of shipping Pfizer and BioNTech’s vaccine.

According to the Wall Street Journal, Pfizer’s vaccine shipping system can hold up to 5,000 doses of its vaccine at minus 70°C for those 10 days. The company is also spending more than $2 billion to create its own distribution network, aiming to ship these containers on a just-in-time basis to the places that need them, bypassing the need for warehouses.

However, this strategy could run into its own supply chain constraints. There may be shortages in critical components for Pfizer and BioNTech’s containers, like the dry ice required to keep those super-cold temperatures.

Many of the Covid-19 vaccine candidates, including the one from Pfizer and BioNTech, also require two doses, spaced several weeks apart. “It does mean double the capacity requirements, so yes, there is an additional complication,” Seidel said. Ensuring there is the right number of doses available at just the right time for everyone’s second dose will require even more storage capacity and precise tracking and timing of shipments.

The Covid-19 vaccination campaign has to be global

One stark lesson of the Covid-19 pandemic is that an outbreak anywhere in the world can ripple across the whole planet. So the effort to contain the disease has to reach every country, in every circumstance.

Some health systems do have experience with keeping finicky vaccines frigid, even in places with limited resources. The Ebola vaccine, for instance, had to be stored at minus 80°C in remote areas of Guinea and the Democratic Republic of the Congo.

a person standing in front of a refrigerator: Sita Tozno, a World Health Organisation cold storage specialist, monitors Ebola vaccines in Guinea. © Kristin Palitza/Picture Alliance via Getty Images Sita Tozno, a World Health Organisation cold storage specialist, monitors Ebola vaccines in Guinea.

But the looming question is whether limited resources can also be stretched to accommodate a Covid-19 vaccination effort. “We are leveraging our experience in Ebola-prone countries to develop guidance on that, but that is something where we do lack funding,” Seidel said.

And ensuring distribution is seamless and also fast is critical. Every day, thousands of people are dying from Covid-19, so there is intense pressure to get people vaccinated as quickly as possible. That would require a simultaneous effort, in the United States and around the world.

However, if governments and private companies make the investments now, the weaker links in the supply chain can be strengthened and ideally avoid the same mistakes made in the earlier stages of the Covid-19 pandemic that left many scrounging for vital masks, gloves, gowns, and tests. The true test of the vaccine supply chain will come when vaccine vials start leaving factories, which could start before the end of the year.

A 3rd coronavirus vaccine works .
Hello, Another Monday, another batch of vaccine results. This time:AstraZeneca and the University of Oxford shared that their coronavirus vaccine was 70% effective on average. That comes on the heels of Pfizer and its partner BioNTech and Moderna both sharing last week that their coronavirus vaccines were 95% and 94.5% effective, respectively. Moncef Slaoui, the scientific head of Operation Warp Speed, is anticipating things will move quickly from here. He said on Sunday that he expects Americans will starting getting Pfizer's vaccine as early as December 11, assuming regulators sign off on it.

usr: 1
This is interesting!