The world’s now scrambling for dry ice. It’s just one headache in getting coronavirus vaccines where they need to go

 

Vaccines like to be kept cool, none more so than the Pfizer candidate for Covid-19, which has to be deep-frozen. And that’s going to be an issue for developing countries — and for rural areas in the developed world.

The “cold rain” is just one of the challenges in distributing vaccines worldwide.

There are plenty of others: decisions about priority populations and databases to keep track of who’s received what vaccine, where and when. Additionally, different vaccines may have more or less efficacy with different population groups; and governments will need PR campaigns to persuade people that vaccines are safe.

But the logistics of transporting and storing vaccines– getting them from the factory gate to the patient’s arm– are critical. And as most vaccines are likely to require two doses, the whole chain needs must be repeated within weeks. 

Unique challenges 

The Pfizer-BioNTech vaccine needs to be kept at around -70 degrees Celsius (-94 degrees Fahrenheit) while it’s transported. That’s 50 degrees Celsius colder than any other vaccine currently used.

Moderna says its vaccine can be kept in freezers typically available in pharmacies, and in a refrigerator for up to 30 days. But there are likely to be fewer doses of the Moderna vaccine than of the Pfizer’s available over the next year.

Phase 3 trials have shown both vaccines to be around 95% effective but the results haven’t yet been reviewed by regulators.

On Wednesday, the CEO of BioNTech, the German biotech company partnering with Pfizer, acknowledged the issue of temperature control.

The world's now scrambling for dry ice. It's just one headache in getting coronavirus vaccines where they need to go

Employees fill a clinical and pharmaceutical product shipping box with dry ice at the Va-Q-Tec AG factory in Wurzburg, Germany, on Wednesday, Nov. 18, 2020. 

“We are working on formulation which could allow us to ship the vaccine even maybe at room temperature,” Ugur Sahin told CNN. “We believe that in the second half of 2021 we will have come up with a formulation which is comparable to any other type of vaccine.”

But in the meantime US Health and Human Services Secretary Alex Azar believes the Moderna candidate is “more flexible” for settings like a local pharmacist. Pfiszer’s, he said Monday, would be better suited to “big institutional vaccination, say a while hospital setting, several nursing homes at once.”

Compare Medicare Plans Now

Pfizer plans to ship up to 1.3 billion doses next year, requiring a lot of dry ice (carbon dioxide in solic form at around -78 degrees Celsius), and a lot of isothermic boxes. The boxes will hold up to 95 vials (4,875 doses) and be refilled with dry ice for up to 15 days of storage.

Pfizer is testing the supply chain in four US states. Its CEO, Albert Bourla, said Wednesday he has “zero concerns” about the cold chain requirements.

But shipping such a vaccine can pose big challenges. Dr. Jarbas Barbosa, assistant director of the Pan American Health Organization, told CNN that “the rural and the urban areas in any country in the world are not ready to manage this vaccine today.”

“So, who is prepared in the world? No one.”

One issuee is the availability of dry ice.

The Compressed Gas Association says carbon dioxide production capacity in the US and Canada is about 30,000 tons a day and is confident its members can meet demand for dry ice. It says that vaccine supply-chain officials believe less than 5% of dry ice production will be needed to support ultra-cold storage of Covid-19 vaccines in the United States and Canada.

Others in the industry expect bottlenecks. Several dry ice producers in the US told CNN they’ve already had offers for their entire output. Buddy Collen at Reliant and Pacific Dry Ice told online publication GasWorld: “We are in scramble mode trying to manipulate our production plants.”

Sam Rushing, president of Florida-based Advanced Cryogenics, told CNN there are already regional shortages in the US.

The main problem, Rushing says, is fewer vehicles on the road during the pandemic, meaning lower production of ethanol, from which carbon dioxide is a byproduct. European ethanol production has also fallen sharply this year.

US officials are confident enough dry ice will be available. Paul Ostrowski, director of supply, production, and distribution of Operation Warp Speed, told CNN last week that courier UPS had pledged to “provide dry ice replenishments throughout all of America upon demand.”

But Rushing cautions that dry ice is not very user-friendly and can be hazardous if stored improperly, especially in a confined space. The Federal Aviation Administration classifies it as hazardous cargo.

Compare Medicare Plans Now

Peter Gerber, CEO of Lufthansa Cargo, told CNN that the need for dry ice “clearly reduces also the transport capacity because if you have to load more ice you can’t load so much vaccine. And of course the procedures have to be very special in order to ensure that it always has this degree of coldness.”

US courier DHL is adapting distribution plans according to each vaccine’s specifications. David Goldberg, CEO of Global Forwarding US for the company, says “there is a restriction on the amount of dry ice used on an aircraft– typically 500-1,000 kilos depending on a number of factors.”

Once they arrive, Pfizer vials can be stored at between 2 and 8 degrees Celsius for up to five days before deteriorating. Pfizer says it has developed a “just-in-time system which will ship the frozen vials direct to the point of vaccination.” It will also monitor the temperature of every box being shipped.

Julie Swann, an expert in supply chains at North Carolina State University, says that large hospital systems, which often have ultra-cool freezers, may have a role as distribution hubs. But not all US states have them; Hawaii said last week none of its hospitals has such freezers.

Breaking down shipments of a frozen vaccine for rural areas or small groups of essential workers– without compromising their temperature– will be another headache, Swann said.

When a vaccine needs to be used with a few days, providers will need to ensure they are ready. “You can’t just wait to see who shows up,” Swann told CNN. “And we don’t really have good data yet defining where and who the priority populations are.”

The more links in the supply chain, the more risk that the vaccine’s temperature will be compromised. Last month the US Centers for Disease Control and Prevention advised states they should “limit transport of frozen of ultra-cold vaccine products.”

Prashant Yadav, a supply chain expert and senior fellow at the Center for Global Development said: “It’s a question of how soon can we start thinking about multiple packaging formats.”

Beyond the US

If getting a frozen vaccine to tens of millions of people is a challenge in the US, it’s a far greater problem for poorer countries.

Transport links are slower and medical facilities less equipped in the developing world. CO2 production is scarce, and the cost and hazards of shipping huge amounts of dry ice are also a hurdle, Yadav says.

David Gitlin, the CEO of refrigeration specialists Carrier, told CNN last week: “When you look at places like Africa and India, they just don’t have the cold chain infrastructure. The Untied State spends 300 times more per capita on cold chain than India.”

Compare Medicare Plans Now

Peru is one of many countries that have order the Pfizer vaccine. In the capital, Lime, where large volumes can be administered quickly, it should be effective, says Dr. German Malaga, one of a team working on Peru’s vaccine options. But while there are probably 30 ultra-cold freezers in Lima “for the other 20 million Peruvians including in the Andes and the rainforest there are none.”

“For the rest of the country we could use vaccines like the Chinese one that requires from 2 to 8 degrees is more manageable,” Malaga said.

“It’s about cost-effectiveness, which is not just about the vaccine but the whole process of vaccinating,” said Yadav. But if Pfizer’s candidates proves to be the most effective, demand for ultra-cold freezers would be overwhelming. 

Barbosa says the Pan American Health Organization is urging member states not to spend huge sums on preparing for one vaccine but join a multilateral facility called COVAX– essentially a clearing house for buying vaccines run by the World Health Organization.

Beyond the cold chain, there are other logistical hurdles. 

A massive airlift will be required to get vaccines where they need to go. Pfizer, which has production lines in Europe and the US, says it expects an average of 20 daily cargo flights worldwide.

DHL expects that 15 million cooling boxes will need to be delivered on 15,000 flights over the next two years. David Goldberg told CNN the company has established a high quality cold-chain network and is adding flights between China, Europe and the US.

Compare Medicare Plans Now

Many countries can call on existing programs as models. Peru’s national vaccination program reaches about 75% of its population, Malaga said.

India’s polo vaccination program is ubiquitous– covering more than 90% of children by this year, according to Gagandeep Kang of the Wellcome Trust Research Laboratory at the Christian Medical College in Vellore.

“For polio programs, we have used boats and mules and enterprising health staff,” said Kang. But such programs are designed for less than a tenth of the population, and Covid-19 vaccines will need to focus on different groups, she said.

India will need “a series of waves each addressing a different group as vaccines become available,” she told CNN.

“We will need to see performance characteristics of other vaccines, and their delivery requirements before making a call on what to go with,” said Kang, who is also a member of the World Health Organization’s Global Advisory Committee on Vaccine Safety.

In such a dynamic situation, record-keeping becomes critical. Dr. Anna Blakney, who is working on a vaccine being developed by Imperial College London, said there is no centralized infrastructure in the US for monitoring who is getting what and when, which she describes as a “really critical issue.”

Yadav says that even when the vaccine reaches its destination there will need to be some flexibility to allow people to get their second dose in a different location if desired. And that demands reliable databases.

Barbosa said that beyond the supply chain, governments “must have a good communications strategy to overcome public skepticism and conspiracy theories about vaccines.”

Blakney agrees. “The process [of vaccine development] has been so fast that it’s not surprising people are skeptical as they read about safety and possible side-effects,” she said. Blakney is part of an international effort launched by research scientists to reassure people via social media about the safety and efficacy of Covid-19 vaccines.

Finding enough dry ice is just one in a sequence of challenges to get the world vaccinated against Covid-19.

 

Read More…

Powered by NewsAPI.org

 

Compare Medicare Plans Now

Medicare finalizing coverage policy for coronavirus vaccine

Medicare finalizing coverage policy for coronavirus vaccine

Medicare finalizing coverage policy for coronavirus vaccine

A senior Trump administration official says Medicare will cover the yet-to-be approved coronavirus vaccine free for older people under a policy change expected to be announced soon

Medicare will cover the yet-to-be approved coronavirus vaccine free for older people under a policy change expected to be announced shortly, a senior Trump administration official said Tuesday.

The coming announcement from the Centers for Medicare and Medicaid Services aims to align the time-consuming process for securing Medicare coverage of a new vaccine, drug or treatment with the rapid campaign to have a coronavirus vaccine ready for initial distribution once it is ready, possibly as early as the end of the year.

It’s questionable under normal circumstances if Medicare can pay for a drug that receives emergency use authorization from the Food and Drug Administration, as expected for the eventual coronavirus vaccine. Emergency use designation is a step short of full approval.

Compare Medicare Plans Now

The administration official said Medicare’s announcement will try to resolve several legal technicalities that could conceivably get in the way of delivering free vaccines to millions of seniors, a high-risk group for COVID-19, the disease caused by the coronavirus. The officials spoke to The Associated Press on the condition of anonymity to discuss a pending regulation.

President Donald Trump and lawmakers of both parties in Congress have spelled out their intention that all Americans will be able to get the vaccine for free. But the official said a series of potential legal obstacles that could get in the way of Medicare payment never got unscrambled. 

Earlier this month, Medicare administrator Seema Verma said her agency was close to resolving the issue.

“I think we’ve figured out a path forward,” Verma said at the HLTH conference, a forum for innovators. “It was very clear that Congress wants to make sure that Medicare beneficiaries have this vaccine and that there isn’t any cost-sharing.”

“Stay tuned,” she added.

The $1.8 trillion CARES Act passed by Congress in March called for free vaccination for all Americans, from seniors covered by Medicare to families with employer-sponsored health insurance.

A White House-backed initiative called “Operation Warp Speed” is pushing to have a vaccine ready for distribution in the coming months. The government is spending billions of dollars to manufacture vaccines even before they receive FDA approval, thereby cutting the timeline for delivery. Officials at the FDA have committed that the program will not interfere with their own science-based decisions. Vaccines that don’t meet the test for approval would be discarded.

States have already begun submitting their plans for vaccine distribution to the federal government. 

Initially, it’s expected vaccines will go to people in high-risk groups such as medical personnel, frontline workers and nursing home residents and staff. Older people are also high on the priority list because their risks of serious illness and death from the coronavirus– which has killed more than 225,000 people in the United States– are much higher. It could be well into next year before a vaccine is widely available.

Medicare’s impending announcement was first reported by Politico.

Compare Medicare Plans Now

CVS, Walgreens to help distribute Covid vaccines to nursing homes

CVS, Walgreens to help distribute Covid vaccines to nursing homes

CVS, Walgreens to help distribute Covid vaccines to nursing homes

The federal government has made a deal with retail pharmacies CVS and Walgreens to help distribute coronavirus vaccine — once one or more gets authorized — to long-term care facilities like nursing homes, federal officials said Friday.

The two drugstore chains are the best place to send out mobile units to vaccinate seniors and other vulnerable people on site, Paul Mango, deputy chief of staff for policy at the Health and Human Services Department, told reporters in a telephone briefing.

“This is a completely voluntary program on the part of every nursing home. This is an opt-in program,” Mango said.

It will be up to the drugstore chains to figure out how to deliver the vaccines, including cold storage requirements and personal protective equipment. The retailers also will have to determine how to collect fees from Medicare, Medicaid or private insurers for administering vaccines, which must be provided to people free of charge, officials said.

Compare Medicare Plans Now

Mango said the Operation Warp Speed team did not have any idea of how many nursing homes would choose to use the retailers. “We are not imposing our solution on anyone,” he said.

Operation Warp Speed is the federal government’s program to rapidly develop a coronavirus vaccine.

Dr. Jay Butler, deputy director of infectious diseases at the US Centers for Disease Control and Prevention, noted that a third of coronavirus deaths in the US have been among residents of long-term care facilities.

“We believe that this plan will be the quickest and easiest way to provide vaccines to long-term care facility residents,” Butler told reporters.

Staff and residents of long-term care facilities are expected to be among the first to get vaccinated.

“We fully anticipate that both Pfizer and Moderna will have data of both safety and effectiveness of their vaccines shortly. We are very encouraged because their clinical trials are going extraordinarily well,” Mango said.

“Part of the reason we are doing this is within 24 to 48 hours of the time the emergency use authorization is authorized, we expect to be putting needles into people’s arms,” Mango said. “This is pre-staging for what we believe will be rapid development.”

The CDC had asked states to submit plans for a vaccine distribution by Friday. Army Maj. Gen. Christopher Sharpsten, director of supply and distribution for Operation Warp Speed, said this plan would help provide centralized management and “ensure there is comprehensive vaccine coverage for the American people.”

“Our goal is to broaden vaccine coverage,” Sharpsten said on the call.

Earlier that Friday, President Trump said seniors would be the first to get any vaccine.

“Seniors will be the first in line for the vaccine. And we will soon be ending this pandemic,” Trump said during a visit to Ft. Meyers, Florida.

Pfizer CEO Albert Bourla said in an open letter posted Friday he thought his company would know whether the vaccine it is testing protects against Covid-19 by the third week in November. Moderna CEO Stephane Bancel has made similar predictions for his company’s vaccine.

Compare Medicare Plans Now

Trump administration set to announce Medicare and Medicaid will cover Covid vaccine

Trump administration set to announce Medicare and Medicaid will cover Covid vaccine

Trump administration set to announce Medicare and Medicaid will cover Covid vaccine

The Trump administration is set to announce as early as this week that Medicare and Medicaid will cover out-of-pocket costs for a potential coronavirus vaccine that is granted emergency use authorization, according to a person familiar with the matter.

Coming days before the election, the move could help President Donald Trump among seniors and lower-income Americans even though top medical experts don’t expect a vaccine to be approved until well after Election Day. In the run-up to the election, Trump had applied intense pressure on agencies to deliver policy wins that might help his reelection, aides said.

Officials have been working for several weeks on changing regulations to allow for Medicare and Medicaid recipients to receive free vaccines.

Compare Medicare Plans Now

View Entire Post ›

It’s not clear whether Trump himself will make the announcement of the rule change, though he is working to appeal seniors during stops in Florida later this week.

Politico first reported the coming changes.

There are currently four US Phase 3 trials of coronavirus vaccines as part of the federal government’s Covid-19 vaccine program, Operation Warp Speed.

Dr. Anthony Fauci, the nation’s top infectious disease expert, said Sunday that experts will know by early December whether a potential coronavirus vaccine is safe and effective, but widespread availability will likely not occur until several months into 2021.

Operation Warp Speed aims to have Covid-19 vaccines moved to administration sites within 24 hours of emergency use authorization or Food and Drug Administration license– with the goal of providing the vaccine free of charge.

“In terms of a principle and an aspiration, it’ll be that no American has to pay for a single dime out of pocket to get a vaccine,” Paul Mango, deputy chief of staff for policy at the US Department of Health Human Services, said back in September.

The federal government already struck a deal earlier this month with retail pharmacies CVS and Walgreens to help distribute the coronavirus vaccine– once one or more gets authorized– to long-term care facilities like nursing homes, with no out-of-pocket costs.

Compare Medicare Plans Now

View Entire Post ›