Why Pfizer’s vaccine won’t fix everything instantly for U.S.A. & the rest of the world.

Why Pfizer’s vaccine won’t fix everything instantly for U.S.A. & the rest of the world.

Friday, November 13, 2020 source: TIMEHealth

Why Pfizer’s vaccine won’t fix everything instantly for the U.S.A & the rest of the world.

This week began with a rare piece of good pandemic news: Pfizer announced that its two-part COVID-19 vaccine is 90% effective at preventing disease, making it the most promising candidate yet. If borne out by yet-to-be-published data and granted approval by the U.S. Food and Drug Administration (FDA), a vaccine with efficacy levels that high could make a serious dent in a pandemic that continues to set new records daily in the U.S. and ravage the rest of the world.

But creating a vaccine and getting it approved are only the first steps. “The asterisk is that actually getting the vaccine to people who need it will not be easy,” says my colleague Jamie Ducharme, who recently wrote about the challenges facing Pfizer’s vaccine. Among them: the genetic material (called mRNA) used to make the vaccine breaks down unless it’s kept at ultra-low temperatures, so the vaccine must be stored at -94° F, requiring expensive specialized freezers. That complicates the rollout logistics for under-resourced communities, like rural areas, nursing homes and developing nations.

A lack of fancy freezers isn’t the only obstacle. Dosing out Pfizer’s vaccine requires a strong type of glass that’s in short supply, and distributing it requires dry ice, which is already in high demand because it’s used in food delivery. “Even once the vaccine is approved, distributing it will still be a huge logistical challenge,” Jamie says.

Some potential solutions have been proposed. Centralizing vaccine distribution in large “vaccine depots,” as some U.S. states are considering, may make it easier to corral resources. But doing so comes with additional problems, like staffing, cost and long travel times for vaccine recipients. Other, hardier vaccines could also eventually prove effective. And further medical innovation may eventually yield a version of the Pfizer vaccine that doesn’t require such extreme storage measures—but that will, of course, take time.

Why You May Not Be Able to Get Pfizer’s Frontrunner COVID-19 Vaccine

The freezer in your kitchen likely gets down to temperatures around -20° C (-4° F). “That keeps your ice cream cold, but it doesn’t turn your ice cream into an impenetrable block of ice,” says Paula Cannon, an associate professor of molecular microbiology and immunology at the University of Southern California’s Keck School of Medicine.

Pfizer’s promising COVID-19 vaccine, by contrast, must be stored at about -70° C (-94° F)—a temperature cold enough to harden ice cream into a spoon-breaking block of ice, and that only specialized freezers can produce.

Those cold storage requirements are raising serious questions about who could get the Pfizer vaccine if it’s approved, and when. The reality, experts say, is that the Pfizer vaccine probably won’t be available to everyone, at least not right away. Large medical centers and urban centers are the most likely to have the resources necessary for ultra-cold storage. People without access to these facilities, such as those living in rural areas, nursing homes and developing nations, may have to wait for other vaccines working their way through the development pipeline.

Pfizer’s vaccine candidate, which has not yet been approved by the U.S. Food and Drug Administration but is reportedly 90% effective at preventing COVID-19, uses genetic material called mRNA. If it’s not kept at extremely cold temperatures, mRNA can break down, rendering the vaccine unusable.

If the Pfizer vaccine is kept at -70° C, it can last up to six months. But many hospitals, to say nothing of community medical offices and pharmacies, do not have ultra-cold freezers, which cost around $10,000 up front and are expensive to run because of their high energy usage. Retrofitting existing freezers to reach these temperatures isn’t possible either, Cannon says. “It would be like going from a Fiat car to a Tundra truck”—the technology and energy requirements are simply different.

There may also be shortages of the type of pharmaceutical-grade glass needed to make vials that can withstand such cold temperatures, says Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. New York-based glass company Corning won a $204 million government grant in June specifically so it could increase production of its sturdy glass, which is made without boron.

Distributing the vaccine will also be difficult, since it must remain frozen during shipping. Pfizer has built a storage container that, with the help of dry ice, can keep doses cold for up to 10 days in transit without any additional freezer equipment. Periodically replenishing the containers with dry ice can buy another 15 days, but depending on how often the containers are opened, and for how long, that timeline could be considerably shorter. (Dry ice is also in short supply right now because of the increase in food delivery during the pandemic, combined with the fact that fewer people are driving and buying gas, driving down the ethanol production required to make dry ice.)

Once they’re out of the box, the shots can last for about five days in standard refrigeration. But the boxes hold from 200 to 1,000 vaccine vials, each of which contains about five doses of the shot—more than most doctor’s offices could reasonably expect to use before some doses start to defrost and become useless, as ProPublica recently reported.

A Pfizer spokesperson told TIME that the company “is committed to ensuring everyone has the opportunity to have access to our vaccine working closely with local government.” The spokesperson added that global distribution has gone smoothly during clinical trials, and that portable and under-the-counter-sized ultra-cold freezers are available for smaller vaccination sites.

“We believe all countries will be able to effectively dose patients even with our cold chain requirements,” the spokesperson said.

For mass U.S. distribution, Cannon says the most practical solution may be setting up large, centralized vaccination centers that could rapidly go through doses, rather than trying to get the jab into every doctor’s office and pharmacy nationwide. The U.S. Department of Health and Human Services on Nov. 12 announced it will work with pharmacies nationwide to distributes COVID-19 vaccines for free, but it’s not yet clear which vaccines will be available through that partnership.

Some states are considering large vaccine depots, as indicated by their draft plans for vaccine rollout sent to the CDC, but such centralized hubs require additional staff, equipment and cost that some states can’t afford. Plus, in rural areas, reaching a “centralized” location may still require lengthy travel for some people. The Pfizer vaccine must also be given in two separate doses, which could be a hard sell to people who have to drive hours to get it.

Moss adds that those who need the vaccine most—like the elderly and those with prior health conditions—may be the least able to travel to get one. And distributing an ultra-cold vaccine may be a pipe dream in countries poorer than the U.S., Moss says.

“It would be extremely challenging, if not impossible, to get such a vaccine out to, say, countries and people in Sub-Saharan African and many parts of Asia, where the infrastructure is not what we have in the United States,” he says.

Pat Lennon, who oversees cold-chain storage at the global health nonprofit PATH, says ultra-cold vaccines were distributed during the recent Ebola outbreak in the Democratic Republic of the Congo, but that was an easier feat, since the virus did not spread as widely.

Moss says he’s not overly concerned about distribution challenges, at least right now. Pfizer’s COVID-19 vaccine is one of many currently in development, and “I don’t have any reason to think this Pfizer vaccine is special in such a way that its efficacy is going to be substantially higher than another vaccine,” Moss says. (Time will tell, of course, exactly how the efficacy and availability of the different shots stack up.)

Many of the other vaccine candidates currently going through clinical trials do not have such stringent cold-storage requirements. Pharmaceutical companies Moderna, Johnson & Johnson and AstraZeneca have all said their COVID-19 vaccine candidates could be kept at temperatures of -20° C or above, which should make distribution easier.

Cannon adds that Pfizer and other vaccine makers may refine their formulas over time. Some other vaccines, such as those for measles and yellow fever, are shipped in a freeze-dried format and reconstituted with water before they’re administered. Something similar may be possible for COVID-19 vaccines in the future, Cannon says. The Pfizer spokesperson says the company hopes to release a COVID-19 vaccine that could be stored at temperatures between 2-8° C in 2022.

But for now, people should be prepared to wait awhile before life returns to normal. Even once vaccines are available, it will take time to achieve the widespread inoculation required to stop the virus from spreading unchecked. “I would say a best-case scenario may be toward the end of 2021,” Moss says. “But it’s going to depend on not just vaccine availability and approvals, but the willingness of people to accept the vaccine. There’s a whole other challenge and layer there.”


The Global Situation

More than 52.7 million people around the world had been diagnosed with COVID-19 as of 1 a.m. E.T. today, and nearly 1.3 million people have died. Here’s where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:

On Nov. 12, there were 606,497 new cases and 9,020 new deaths confirmed globally. Here’s how the world as a whole is currently trending:

Here is every country with over 700,000 confirmed cases:

Diwali, the five-day Hindu festival of lights, takes place this weekend across India just as the country’s annual pollution season begins, and experts are worried that both threats will further fuel India’s coronavirus outbreak, CNN reports. While the number of active cases in India isn’t as high as it was in September, it remains the second-leading country for cases in the world, with more than 8.7 million cases and nearly 130,000 deaths.

Israeli Prime Minister Benjamin Netanyahu announced today that Israel will buy enough of Pfizer’s COVID-19 vaccine to cover 4 million citizens, the New York Times reports. Vaccination is set to begin in January, but the vaccine must first be approved by American and Israeli health authorities. The deal comes as Israel has reported 322,159 cases and 2,706 total deaths.

Peter Sutcliffe, also known as the “Yorkshire Ripper” and who was convicted of murdering 13 women in northern England and attempting to kill seven more in the 1970s and 80s, died today after testing positive for the coronavirus, CNN reports. Sutcliffe, 74, was serving a life sentence in prison and had underlying health conditions.

The Situation in the U.S.

The U.S. had recorded more than 10.5 million coronavirus cases as of 1 a.m. E.T. today. Nearly 242,500 people have died. Here’s where daily cases have risen or fallen over the last 14 days, shown in confirmed cases per 100,000 residents:

On Nov. 12, there were 153,496 new cases—another new daily record—and 919 new deaths confirmed in the U.S. Here’s how the country as a whole is currently trending:

More than 130 United States Secret Service officers who protect the White House and travel with U.S. President Donald Trump have tested positive for the coronavirus or have had to quarantine or isolate because they’ve had close contact with someone who has tested positive, the Washington Post reports. The spread is likely linked to the many campaign rallies Trump held before the election, during which many attendees failed to wear masks. Trump was also criticized for potentially jeopardizing Secret Service agents when he left the hospital to greet supporters while being treated for the coronavirus last month.

Chicago Mayor Lori Lightfoot and Health Commissioner Dr. Allison Arwady announced a new stay-at-home advisory today as COVID-19 numbers climb throughout the Windy City. The advisory, which begins Monday and ends 30 days later, encourages residents to only leave their homes for school, work, grocery shopping or other essential outings—but residents won’t be penalized for flouting the suggestions. Chicagoans are also “strongly advised” to avoid travel, cancel traditional Thanksgiving plans and not have guests in their homes. The number of new and probable cases in Illinois exceeded 15,000 today, setting a record for the state.

Very few places in the U.S. have good pandemic news to report, but the Charlottesville area of Virginia is one of them. The number of new cases there has trended downwards since the start of October, and the region now has the state’s lowest positivity rate, according to the Charlottesville Tomorrow. People in the area seem to be more willing to wear masks than in the rest of the state, and strict safety rules at the University of Virginia, located in Charlottesville, has prevented campus breakouts.

All numbers unless otherwise specified are from the Johns Hopkins University Center for Systems Science and Engineering, and are accurate as of Nov. 13, 1 a.m. E.T. To see larger, interactive versions of these maps and charts, click here.


Coronavirus-Free Countries Are Seeing Their First Cases

Remote island nations in the Pacific Ocean are beginning to report their first cases of COVID-19, my colleague Amy Gunia reports, as the virus reaches the few stretches of Earth that had so far been spared. Though they’ve had extra time to prepare, even a few cases can quickly overwhelm these under-resourced areas.

Eight months after the World Health Organization declared a global pandemic, COVID-19 is reaching the last places on Earth that remained untouched by the coronavirus.

On Wednesday, Vanuatu, a Pacific island nation about 1,200 miles northeast of Australia, reported its first COVID-19 case. Two other countries in the Pacific Ocean, the Marshall Islands and Solomon Islands, reported their first infections in October. In Samoa, workers who serviced a ship with COVID-19-positive crew members are in quarantine.

By most estimates, just nine countries have not yet reported any COVID-19 cases. Except for North Korea and Turkmenistan, where experts say COVID-19 likely exists, all of them are far-flung Pacific island nations—Kiribati, the Federated States of Micronesia, Nauru, Palau, Tonga, Tuvalu and Samoa.

Most Pacific island countries closed their borders early in the COVID-19 outbreak. But as infections surge around the globe, with cases surpassing 50 million, the coronavirus is beginning to creep in.

Many Pacific islands ‘can’t cope with even a few cases of COVID-19’

The good news is that, because COVID-19 took so long to get there, these Pacific nations had time to prepare—and may be able to stop the virus from spreading through their populations through effective tracing, etc.

Lana Elliott, an expert on public health in the Pacific at the Queensland University of Technology, is hopeful that Vanautu’s first case can be contained. She says that not having a COVID-19 case until this week has bought the country of some 300,000 people crucial time.

The Nightmare Pandemic Economy Joe Biden Is Inheriting, in 5 Charts

When Joe Biden takes office in January, it will be the second time he enters the White House amid an economic catastrophe. But this crisis is different from the Great Recession, as the current economic situation is inexorably linked to the pandemic, my colleague Emily Barone reports. Read more here.

Health Care Workers Are Burning Out

As Americans face a third surge that eclipses the first two, health care workers are struggling to meet demand. “Some health-care workers told me that COVID-19 patients are the sickest people they’ve ever cared for: They require twice as much attention as a typical intensive-care-unit patient, for three times the normal length of stay,” writes Ed Yong in his new story for The Atlantic. Read more here.

Wisconsin’s Outbreak Is Literally Off the Charts

Wisconsin’s coronavirus situation has gotten so severe that all but seven of its counties now exceed what was previously the state’s most extreme classification for viral spread, NBC 15 reports. To adjust the scale, health officials there recently created a new top category: “critically high,” which means at least 1,000 cases per 100,000 residents. Read more here.

Thanks for reading. We hope you find the Coronavirus Brief newsletter to be a helpful tool to navigate this very complex situation, and welcome feedback at [email protected].

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Today’s newsletter was written by Mandy Oaklander and edited by Alex Fitzpatrick.

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