Showing posts with label vaccine. Show all posts
Showing posts with label vaccine. Show all posts

Friday, August 06, 2021

Protecting Animals While Evicting Humans

Protecting Animals But Not Humans

Nicholas Johnson
The Gazette, August 6, 2021, p. A5

Why does the law permit evicting the mammalian species Homo sapiens from shelter, but not mammalians like dogs and cats?

Of course, I support laws protecting animals’ rights. I love and attempt communication with all creatures. (Fish and ants are the most obstinate.) Increasing penalties and enforcement for animal mistreatment are encouraging.

But an Aspen Institute analysis reveals 30 to 40 million American Homo sapiens are at risk of eviction.

This is made worse by COVID. We knew since January 2020 COVID elimination is possible (test, trace, quarantine, isolate). Some elected officials preferred the path that produced 600,000 deaths.

Vaccine creation was appropriately celebrated. But vaccine in bottles is much less effective than vaccine in arms.

Rather than vaccination, some of our “leaders” prefer our “freedom” to choose risk of death to ourselves and others. So, more die.

Meanwhile, 7000 miles away in Wuhan, China, all 11 million residents are being tested. Since May 2020 Wuhan eliminated positive cases. Recently, when three symptomatic and five asymptomatic cases popped up, they resumed test, trace, isolate and quarantine.

Evictions in China? Yes, housing is a challenge for migrants. But during the 2020 lockdown Wuhan built shelters for about 5000 persons.

Like Americans, the Chinese have even more concern for animals. Bloomberg reports they are building 13-story condominiums for hogs to protect them from disease – with on-premises vets and individually prepared and served meals.

It’s unlikely that capitalist America will ever provide the housing for humans that China provides for hogs.

But can’t our Democrats and Republicans, the religious and agnostics alike, at least agree to provide every member of our species with shelter? It’s what we insist on for our fellow mammalians. It’s what the Universal Declaration of Human Rights says is a basic human right.

So how do we do that?


Start by skipping the 38 percent of Americans who own their homes free and clear. Concentrate on the 30 to 40 million who are housing insecure – starting with the homeless. [Photo credit: Wikimedia.org Creative Commons]

Iowa City’s Shelter House is building a second “housing first” facility for Homo sapiens. Housing first is a movement demonstrating why it’s more effective and cheaper to assist the homeless and unemployed with housing before addressing their other challenges. Duplicate it across America.

It’s how Finland is eliminating homelessness.

Let’s start saving life on Earth while searching for life on Mars. We spend more on military than the next 11 nations combined. It used to be 10. Cut it to five.

Explain to those devoid of compassion how much we’ll save by housing the homeless. Cost? We can’t afford not to.

Then address the housing insecure. Forbes has headlined, “Housing Shortage Worse Than Ever.”

We need the government to start creating homes, not Section 8 vouchers. Learn from the early public housing “projects” problems. Build homes tenants and communities welcome. Charge no more than 30 percent of tenants’ income.

Let’s treat our own species at least as well as we rightfully require for other animals, starting now.
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Nicholas Johnson of Iowa City is former co-director of the Institute for Health, Behavior and Environmental Policy. He is the author of "Columns of Democracy." Comments: mailbox@nicholasjohnson.org

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SOURCES

Tougher animal protection laws. Kat Russell, “Tougher law ‘step in the right direction’ for animal abuse cases,” The Gazette, Aug. 2, 2021, p. A1, https://www.thegazette.com/crime-courts/tougher-law-step-in-the-right-direction-for-animal-abuse-cases/ (‘the animal abuse and neglect cases reported to Cedar Rapids police so far this year — a year that to date has seen more arrests for the offenses than in the entire four previous years.” “recent changes to the state code strengthened penalties for some of the state’s animal cruelty laws … Under House File 737, if an animal was seriously injured or killed as a result of abuse or neglect, the crime would be an aggravated misdemeanor and punishable by up to two years in prison.”) And see, Rod Boshart, “Iowa Senate adopts tougher animal cruelty law,” The Gazette, March 4, 2020, https://www.thegazette.com/article/iowa-senate-adopts-tougher-animal-cruelty-law/

Evicting Americans. Emily Benfer, et al, “The COVID-19 Eviction Crisis: an Estimated 30-40 Million People in America Are at Risk,” Aspen Institute, August 7, 2021 (“The United States may be facing the most severe housing crisis in its history. … in the absence of robust and swift intervention, an estimated 30–40 million people in America could be at risk of eviction ….”[101 M Americans in renter households] [“eviction risk disproportionately impacts black and Latinx renters, and renters with children”] [People at risk of eviction by state: Iowa 118,000-239,000] “Foreclosure can lead to a lack of maintenance, urban blight, reduced property values for neighboring properties, and erosion of neighborhood safety and stability. Without rental income to pay property tax, communities lose resources for public services, city and state governments, schools, and infrastructure ….” See text under heading “Proposed policy interventions avoid suffering, save lives, and prevent severe harm”

Wuhan testing 11 M. Vivian Wang, “Wuhan, where the virus emerged, will test all residents after its first outbreak in over a year,” New York Times, Aug. 3, 2021, https://www.nytimes.com/2021/08/03/world/wuhan-china-covid-new-cases.html (Wuhan in Hubei Province) “Wuhan … is planning to test all of its 11 million residents for the coronavirus …. The city … had not recorded any local cases since May of last year, after a harsh two-and-a-half month lockdown helped eradicate the virus there. But city officials said they had detected three symptomatic local cases in the previous 24 hours, as well as five asymptomatic ones.”

Homelessness in China. “Homelessness in China,” Wikipedia, https://en.wikipedia.org/wiki/Homelessness_in_China (during the 2020 lockdown “The Wuhan Civil Affairs Bureau set up 69 shelters in the city to house 4,843 people.” “In 2017, the government responded to a deadly fire in a crowded building in Beijing by cracking down on dense illegal shared accommodations and evicting the residents, leaving many migrant laborers homeless.”)

Hog Hotels. “China’s Putting Pigs in 13-Story ‘Hog Hotels’ to Keep Germs Out,” Bloomberg News, August 1, 2021, https://www.bloomberg.com/news/articles/2021-08-01/china-s-putting-pigs-in-13-story-hog-hotels-to-keep-germs-out (“more than 10,000 pigs are kept in a condominium-style complex, complete with restricted access, security cameras, in-house veterinary services and carefully prepared meals.” Another is “equipped with robots that monitor animals for fever, air filtration, and automatic feeding and disinfection systems.”)

Owned homes. Jonathan Jones, “Cities Whose Residents Have Paid Off Their Homes [2020 Edition],” Construction Coverage, Nov. 4, 2020, https://constructioncoverage.com/research/where-residents-have-paid-off-homes (“According to Census Bureau data, over 38 percent of owner-occupied housing units are owned free and clear. For homeowners under age 65, the share of paid-off homes is 26.4 percent.”)

Housing First. “Housing First,” National Alliance to End Homelessness,” April 20, 2016, https://endhomelessness.org/resource/housing-first/ (“belief that people need basic necessities like food and a place to live before attending to anything less critical, such as getting a job, budgeting properly, or attending to substance use issues.”)

Caleb McCullough, “Shelter House breaks ground on second ‘Housing First’ project,” The Gazette, June 18, 2021, https://www.thegazette.com/news/shelter-house-breaks-ground-on-second-housing-first-project/

Finland eliminating homelessness. Tahiat Mahboob, “Housing is a human right: How Finland is eradicating homelessness,” CBC Radio, Jan 24, 2020, https://www.cbc.ca/radio/sunday/the-sunday-edition-for-january-26-2020-1.5429251/housing-is-a-human-right-how-finland-is-eradicating-homelessness-1.5437402

US military spending. “THE UNITED STATES SPENDS MORE ON DEFENSE THAN THE NEXT 11 COUNTRIES COMBINED, Peter G. Peterson Foundation, July 19, 2021, https://www.pgpf.org/blog/2021/07/the-united-states-spends-more-on-defense-than-the-next-11-countries-combined

Housing shortage. Graison Dangor, “The Housing Shortage Is Worse Than Ever—And Will Take A Decade Of Record Construction To Fix, New Reports Say,” Forbes, June 16, 2021, https://www.forbes.com/sites/graisondangor/2021/06/16/the-housing-shortage-is-worse-than-ever-and-will-take-a-decade-of-record-construction-to-fix-new-reports-say/

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Wednesday, December 16, 2020

The Vaccines Are Coming!

The Vaccines Are Coming, Eventually

Nicholas Johnson
The Gazette, December 16, 2020, p. A6

The vaccines are coming! The vaccines are coming!

Hold it. No, they’re not. Not for most of us. Not now.

For maybe six months our “vaccine” remains “wear your mask, social distance, and wash your hands.”

By then, hopefully, over 70 percent of Americans will be vaccinated or next in line -- the participation required to restrain COVID-19. Can enough anti-vax folks be converted? Acceptance percentages are increasing, but a recent poll indicated, at that time, even 60 percent of nurses and 40 percent of doctors were not planning to be vaccinated.

There are reasons why most drugs’ clinical trials take years not months. Participants in the BioNTech SE (Pfizer) trial will be followed for two more years while the vaccine is being administered.

There’s no rational reason to refuse inoculation. But there are still questions, and evolving answers, as the world’s beta test group expands from thousands to millions. Here’s a checklist. [Photo credit: maine.gov]

Global pandemics require global eradiction. It took the World Health Organization 25 years to eradicate smallpox.

The BioNTech SE vaccine requires refrigeration at minus 94 degrees. Packing requires dry ice, now in short supply. Dry ice produces CO2 that, on planes, risks combustion.

Only 25 countries have access to minus-94-degree refrigeration, thereby excluding five billion people from vaccination.

Nor is equity guaranteed in the U.S. distribution to people of color, the poor, immigrants, prisoners, and low population rural areas.

Best case, distribution from manufacturers’ plants to Americans’ arms is a logistics nightmare, and the last mile is 50 governors’ responsibility. How has that been working for us the last 10 months?

What does “inoculation” mean? Will everyone show up for their second shot? What’s known about dosages? AstraZeneca discovered cutting the first dose in half dramatically improved results. Protection for mild infections only or more? For six months or a lifetime? Will annual vaccinations be required? Can those vaccinated still infect others? Has anyone been tasked with maintaining a national database of those vaccinated?

Little is known about the vaccines’ safety and effectiveness with children, pregnant women, and the oldest of the elderly. Five of the FDA’s Advisory Committee did not vote for approval, two because it was approved for those 16 and above. Two cases have revealed additional side effects for those with allergies. What additional side effects may emerge, for which groups, and how serious will they be?

Follow the money. Is this a profit maximization operation? Or is healthcare a right – especially when no one is protected from a global pandemic until everyone is? Who pays? Who profits? How much? Vaccine recipients? Individual states? The federal government? Pfizer’s CEO glowingly proclaimed its vaccine a success. The stock price escalated and he sold $5 million of his Pfizer shares at a profit.

Ultimately, every American who wants a vaccine can have one. By then we’ll know more about these vaccines. They can help mitigate COVID-19 cases and deaths. Sadly, our need, our goal is not mitigation but global eradication.
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Nicholas Johnson, Iowa City, is former Co-Director of the Institute for Health, Behavior and Environmental Policy. mailbox@nicholasjohnson.org

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SOURCES

Note: References for the data cited within this column are contained, below, sometimes with additional information, in the order in which they appear in the column.

70% for protection.

Janelle Wang, “Doctors: 70% Need to Get Vaccinated for Herd Immunity,” NBC Bay Area, last visited December 11, 2020, https://www.nbcbayarea.com/news/coronavirus/doctors-70-need-to-get-vaccinated-for-herd-immunity/2417183/ (“Doctors say at least 70% of people need to get the coronavirus vaccine in order to eradicate the pandemic.”)

60% nurses, 40% doctors won’t get vaccinated. David Martin, "Inside the Operation Warp Speed effort to get Americans a COVID-19 vaccine," CBS, 60 Minutes, Nov. 8, 2020, https://www.cbsnews.com/news/covid-19-vaccine-distribution-60-minutes-2020-11-08/ ("[New Jersey Health Commissioner] Judith Perisichelli: 'We surveyed 2,000 health care individuals, physicians and nurses and we know that over 60% of the physicians said that they would get the vaccine. We know that about 40% of the nurses said that they would line up to get the vaccine.'")

Ed Silverman, "STAT-Harris Poll: The share of Americans interested in getting Covid-19 vaccine as soon as possible is dropping," Stat News, Oct. 19, 2020, https://www.statnews.com/pharmalot/2020/10/19/covid19-coronavirus-pandemic-vaccine-racial-disparities/

Trials take years.

Elan Kantor, "How Long Do Clinical Trials Take?" Antidote, March 24, 2020, https://www.antidote.me/blog/how-long-do-clinical-trials-take (“Looking at the big picture, it takes approximately ten years for a new treatment to complete the journey from initial discovery to the marketplace. Clinical trials alone take six to seven years on average to complete.”)

Katie Thomas, David Gelles and Carl Zimmer, "Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective," New York Times, Nov. 12, 2020; print edition Nov. 10, 2020, p. A1, https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html (“Independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected.”)

Pfizer to follow for 2 years.

Erika Edwards, "Pfizer's Covid-19 vaccine promising, but many questions remain; Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination," NBC News, Nov. 10, 2020, https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102 (Pfizer's chief executive officer, Albert Bourla, told CNBC Monday that the drug maker will follow participants for two years to analyze safety and ongoing protection. 'As time progresses, we will find out about the durability of the protection,' Bourla said.”)

There are still questions.

“Erika Edwards, "Pfizer's Covid-19 vaccine promising, but many questions remain; Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination," NBC News, Nov. 10, 2020, https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102 ("Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination before and experts caution that much remains unknown about its safety, how long it might work and who might benefit most.")

Smallpox.

History of Smallpox, CDC, https://www.cdc.gov/smallpox/history/history.html

-94F.

Catherine Ho, “Pfizer Vaccine Needs to be Stored at minus 94 Degrees Fahrenheit; Is the Bay Area Prepared to do that?” San Francisco Chronicle, November 9, 2020, https://www.sfchronicle.com/bayarea/article/Some-coronavirus-vaccines-need-to-be-stored-at-15711275.php

Dry ice; combustion.

Elisabeth Buchwald, “The perils of transporting millions of COVID-19 vaccines with dry ice across the U.S.,” MarketWatch, December 10, 2020, https://www.marketwatch.com/story/the-challenges-and-perils-of-transporting-millions-of-covid-19-vaccines-with-dry-ice-across-the-u-s-11607355179 (“there are safety concerns about transporting large quantities of dry ice, which can emit carbon dioxide, on airplanes. Packaging dry ice in a container that does not allow adequate release of the gas could cause the container to explode from the built-up levels of pressure, a process known as sublimation. Dry ice can also deprive a confined space of oxygen, making it difficult to breathe. . . . the U.S. Department of Transportation and the International Air Transport Association classify dry ice as hazardous when transported. . . . The FAA has said it would allow United Airlines … to carry 15,000 pounds of dry ice per flight — five times more than normally permitted, The Wall Street Journal reported.”)

David Gelles, “How to Ship a Vaccine at –80°C, and Other Obstacles in the Covid Fight,” New York Times, September 19, 2020, https://www.nytimes.com/2020/09/18/business/coronavirus-covid-vaccine-cold-frozen-logistics.html ("When dry ice melts, it emits carbon dioxide, making the air on planes potentially unsafe for pilots and crew." "Dry ice . . . is made from carbon dioxide, . . . created as a byproduct during the production of ethanol. . . . This spring . . . people began driving less . . . ethanol production slumped, and so did the supply of carbon dioxide.")

25 countries with refrigeration.

David Gelles, “How to Ship a Vaccine at –80°C, and Other Obstacles in the Covid Fight,” New York Times, September 19, 2020, https://www.nytimes.com/2020/09/18/business/coronavirus-covid-vaccine-cold-frozen-logistics.html (“A recent study by DHL and McKinsey found that a cold vaccine would be accessible to about 2.5 billion people in 25 countries. Large parts of Africa, South America and Asia, where super-cold freezers are sparse, would be left out.”)

Governors’ responsibility.

Katie Thomas, David Gelles and Carl Zimmer, "Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective," New York Times, Nov. 12, 2020; print edition Nov. 10, 2020, p. A1, https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html (“it remains unclear where people will receive the shots, and what role the government will play in distribution.")

Astrazeneca half-dose.

Kaiser Health News, “New Results Confirm AstraZeneca’s Half-Dose ‘Mistake’ Is 90% Effective,” December 9, 2020, https://khn.org/morning-breakout/new-results-confirm-astrazenecas-half-dose-mistake-is-90-effective/ (“The partial results published in The Lancet on Tuesday confirmed that the two full doses given at least one month apart appeared to be 62% effective, while a half dose followed by a full dose was about 90% effective.”)

Immunization meaning.

Katie Thomas, David Gelles and Carl Zimmer, "Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective," New York Times, Nov. 12, 2020; print edition Nov. 10, 2020, p. A1, https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html (“no one knows how long the vaccine’s protection might last.” “an independent board reviewing the data has not told her or other company executives other details, such as how many of the people developed mild versus more severe forms of Covid-19.”)

Erika Edwards, "Pfizer's Covid-19 vaccine promising, but many questions remain; Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination," NBC News, Nov. 10, 2020, https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102 (“would people previously sick with Covid-19 be protected against reinfection? That remains unclear.”)

Erika Edwards, "Pfizer's Covid-19 vaccine promising, but many questions remain; Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination," NBC News, Nov. 10, 2020, https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102 (“This first analysis only included data on 94 confirmed Covid-19 cases, meaning there is no proof yet that the vaccine prevented infection.”)

Children, pregnant women, elderly.

Erika Edwards, "Pfizer's Covid-19 vaccine promising, but many questions remain; Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination," NBC News, Nov. 10, 2020, https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102 ("'We don't know anything about groups they didn't study, like children, pregnant women, highly immunocompromised people and the eldest of the elderly,' Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota, said.")

Four dissenters.

Laurie McGinley, Carolyn Y. Johnson and Joel Achenbach, “FDA says it ‘will rapidly work toward’ authorization of Pfizer-BioNTech coronavirus vaccine,” Washington Post, December 11, 2020, https://www.washingtonpost.com/health/2020/12/10/fda-advisory-panel-recommends-covid-vaccine/ (“The committee voted yes, 17 in favor, four against and one abstention. . . . at least two dissenters objected to inclusion of 16- and 17-year-olds, given . . . how few had participated in the trial.”)

Alergies.

Danica Kirka, “UK Probes Whether COVID-19 Vaccine Caused Allergic Reactions,” Associated Press, December 9, 2020, https://apnews.com/article/uk-allergic-reaction-pfizer-vaccine-64ddccd70c38a39f880da27941db3540 ; The Gazette, December 10, 2020, p. A4

Who pays?

Riley Griffin, Drew Armstrong and Bloomberg, "Germany funded the development of Pfizer’s COVID vaccine—not U.S.’s Operation Warp Speed," Fortune, Nov. 9, 2020, https://fortune.com/2020/11/09/pfizer-vaccine-funding-warp-speed-germany/

Katie Thomas, David Gelles and Carl Zimmer, "Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective," New York Times, Nov. 12, 2020; print edition Nov. 10, 2020, p. A1, https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html (“Operation Warp Speed, the federal effort to rush a vaccine to market, has promised Pfizer $1.95 billion to deliver 100 million doses to the federal government”).

Pfizer CEO. Reuters Staff, "Pfizer CEO made $5.6 million stock sale on same day as COVID-19 vaccine update: filing," Business News, Reuters, Nov. 11, 2020, https://www.reuters.com/article/pfizer-albert-bourla-stake/pfizer-ceo-made-5-6-million-stock-sale-on-same-day-as-covid-19-vaccine-update-filing-idUSKBN27R1XL

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Tags: anti-vax, AstraZeneca, BioNTech, children, COVID-19, doses, dry ice, eradication, FDA, herd immunity, immunization, infection, logistics, mitigation, Moderna, Pfizer, smallpox, vaccine, vaccination

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Friday, November 13, 2020

Why Vaccine Is Not The Answer

Why Vaccine Is Not The Answer
Nicholas Johnson
November 12, 2020

Two days ago, in "Eradicating COVID-19 Should Be Goal" (The Gazette, November 10, 2020, p. A6), with strict space limits, this is all that was said about vaccines:
What about a vaccine . . . ?

Yes, a vaccine ultimately eliminated global smallpox. But consider the history. . . .

In 1959 the World Health Organization began its global eradication effort. The last death occurred in 1978, and WHO declared mission accomplished in 1980. Although . . . “vaccination” might mitigate [COVID-19's spread it is not] the answer. [Vaccination] is rejected by many, takes too long, and produces many thousands of avoidable additional deaths.
COVID-19 is a global pandemic. The world's people will not be safe from its spread until it has been eradicated in all nations. It took the WHO 21 years from start to completion of that task for smallpox -- and that was after it already had been eradicated in the U.S. and Europe! There is no reason to believe that global eradication of COVID-19 can be accomplished any quicker.

With a quick response and properly done, the test-trace-quarantine-isolate approach can eradicate COVID-19 from a given population and area in roughly two months. See "How to Eliminate COVID-19," (The The Gazette, April 4, 2020, p. A6). (Obviously, it would take much longer if there are delays in response, the coronavirus has spread to a large percentage of the population, and large areas and populations are involved -- as currently is the case in the U.S.)

1. Delay. So lengthy delays are one reason "why vaccine is not the answer." Obviously, a vaccine can be one of a number of efforts at mitigation ("flattening the increasing curve" of infected persons) along with mandatory masks, social distancing, shelter in place, limiting the size of gatherings, and closing some businesses. However, as the column, "Eradicating COVID-19 Should Be Goal," linked above, points out, mitigation efforts, while helpful, are not eradication.

There are many other drawbacks to vaccines in general and the Pfizer vaccine in particular. A list of categories (with discussion of each below) might include: distribution, new technology untested on humans, lengthy trials to prove they are safe and effective, the risks with "Warp Speed," groups omitted from study (e.g., children, pregnant women, eldest), lack of knowledge about nature of immunization, possibility of reinfection, impact on contagion, the widespread public rejection of vaccines, need for two doses.

2. Distribution logistics; Cold-Chain complications; Equitable distribution. Global distribution of a vaccine to 7.5 billion people is an extraordinary logistics challenge under the best of conditions. Pfizer's vaccine requires jumping over even more severe hurdles.

Cold-chain complications. "Wide distribution of Pfizer’s vaccine will be a logistical challenge. Because it is made with mRNA, the doses will need to be kept at ultra cold temperatures. While Pfizer has developed a special cooler to transport the vaccine . . . it remains unclear where people will receive the shots, and what role the government will play in distribution." [NYT] "A number of the leading Covid-19 vaccines under development will need to be kept at temperatures as low as . . . minus 112 degrees Fahrenheit . . . [until] they are ready to be injected into patients’ arms. . . . [These vaccines are] made with genetic materials that fall apart when they thaw. . . . Vaccines may be manufactured on one continent and shipped to another. They will go from logistics hub to logistics hub before ending up at the hospitals and other facilities that will administer them. . . . 'We’re only now beginning to understand the complexities of the delivery side of all of this,' said J. Stephen Morrison, senior vice president at the Center for Strategic and International Studies, a research firm."

Nor is temperature maintenance easy when shipping the vaccine by air. "When dry ice melts, it emits carbon dioxide, making the air on planes potentially unsafe for pilots and crew." Moreover, "Dry ice . . . is made from carbon dioxide, . . . created as a byproduct during the production of ethanol. . . . This spring . . . people began driving less . . . ethanol production slumped, and so did the supply of carbon dioxide."

"Pfizer has designed . . . boxes . . . [to] hold a couple of hundred glass vials, each containing 10 to 20 doses of vaccine. . . . All of this leads to another problem: Glass often cracks in extreme cold." Moreover, "There wouldn’t be enough cold-resistant glass vials to handle a frozen vaccine, said Brendan Mosher, Corning’s head of pharmaceutical technologies."

Equitable distribution. "[E]everyday pharmacies are unlikely to be equipped to stockpile large quantities of vaccines that require ultracold storage. . . . strict temperature requirements 'will make it very difficult for community clinics and local pharmacies to store and administer.'. . . [A] cold vaccine would be accessible to about 2.5 billion people in 25 countries. Large parts of Africa, South America and Asia, where super-cold freezers are sparse, would be left out. 'The consequence is to reinforce the staggering bias in favor of the wealthy and powerful few countries,' said Mr. Morrison, of the Center for Strategic and International Studies." [NYT-2]

3. New Technology. "Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination before and experts caution that much remains unknown about its safety, how long it might work and who might benefit most." [NBC]

4. Lengthy trials and "Warp Speed." "[I]t takes approximately ten years for a new treatment to complete the journey from initial discovery to the marketplace. Clinical trials alone take six to seven years on average to complete." [Antidote] [FDA] "Operation Warp Speed's goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics . . .." [HHS] [Photo credit: InsideHigherEd]

"Independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. . . . The data released by Pfizer Monday was delivered in a news release, not a peer-reviewed medical journal. It is not conclusive evidence that the vaccine is safe and effective, and the initial finding of more than 90 percent efficacy could change as the trial goes on." [NYT] Warp speed is a worrying speed when it comes to vaccines -- not the least of which is what we don't know for sure about its safety and efficacy, and the other topics in this blog post.

5. Trial's omissions. "'We don't know anything about groups they didn't study, like children, pregnant women, highly immunocompromised people and the eldest of the elderly,' Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota, said." [NBC]

6. Immunization, Infection, Contagion. "It's also uncertain how long such protection might last. That answer can only come with time, as it's impossible to know yet whether immunity remains for months, a year, two years — or a lifetime. . . . Pfizer's chief executive officer, Albert Bourla, told CNBC Monday that the drug maker will follow participants for two years to analyze safety and ongoing protection. 'As time progresses, we will find out about the durability of the protection,' Bourla said. 'We will see how long the immunogenicity lasts and how long the cell immunity lasts.'" "This first analysis only included data on 94 confirmed Covid-19 cases, meaning there is no proof yet that the vaccine prevented infection." "It is unclear whether people who received the vaccine were less likely to be contagious." "'It's not necessarily going to protect you from infection, and it may not work for everyone,' Haseltine said Monday on MSNBC. 'But it should be useful for many people. And it should moderate the severity of disease.'"[NBC]

"[N]o one knows how long the vaccine’s protection might last. . . . [Pfizer senior vice president Dr. Kathrin] Jansen said that because the trial is continuing, an independent board reviewing the data has not told her or other company executives other details, such as how many of the people developed mild versus more severe forms of Covid-19 — crucial information that the F.D.A. has said it will need to evaluate any coronavirus vaccine." [NYT] "We don't yet have details about whether the vaccine blocked mainly mild cases, or if there is evidence that it seemed to prevent some severe infections, too. . . . [A]t this point, there’s no way to estimate how long protection from this or any Covid vaccine would last. The duration of protection will only become clear after the vaccines are in use for a while." [Stat] "[Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group pointed out] 'And would people previously sick with Covid-19 be protected against reinfection? That remains unclear.'" [NBC]

7. Public rejection. "Overall, 58% of the U.S. public said they would get vaccinated as soon as a vaccine was available . . .. That change suggests growing concern that the regulatory approval process for a Covid-19 vaccine has been politicized by the Trump administration . . .. 'There’s a historical level of distrust,' said [Harris Poll Managing Director Rob] Jekielek. 'And when you think about stalling the spread of Covid-19, these findings indicate that we face an increasingly bigger problem.'" [Stat-2] "[New Jersey Health Commissioner] Judith Perisichelli: 'We surveyed 2,000 health care individuals, physicians and nurses and we know that over 60% of the physicians said that they would get the vaccine. We know that about 40% of the nurses said that they would line up to get the vaccine.'" [CBS] The point of these percentages is the huge proportion of Americans who will not be vaccinated, making vaccination at best a part of a path to mitigation, but not eradication.

8. Two doses. "Pfizer has said it will not apply for emergency use authorization of its vaccine candidate until it has collected two months of safety information following the final dose of the vaccine. Pfizer's vaccine requires two doses, about a month apart." [NBC] Another drawback of the Pfizer vaccine is the requirement of two doses a month apart. For the populations within a school or workplace it is relatively easier to complete this routine: a week can be designated during which everyone will get the first shot, and a month later another week designated to give them the second dose, with records kept, and follow ups for those who missed one or the other dose during the designated times. But for individuals outside of such groups many things can interfere with the scheduled second dose: simple forgetfulness, a change of mind, the rationalization that one dose was probably enough, a trip or move out of town, being laid up with some other disease. The possibilities are endless. And there is still that resistance, described above in "Public rejection," of those unwilling to take any vaccine, for any disease, whether it's one dose or two.

9. Follow the money. Pfizer claimed to have received no taxpayer money. "Vice President Mike Pence was among Trump administration officials saying support from the government’s Operation Warp Speed program helped accelerate the development of the vaccine . . .. [Pfizer's] Chief Executive Officer Albert Bourla has repeatedly said that the drug giant has avoided taking taxpayer dollars for research and development purposes. . . . Pfizer didn’t receive any funding from Operation Warp Speed for the development, clinical trial and manufacturing of the vaccine. Rather, its partner, BioNTech SE, has received money [$445 million] -- from the German government." And Pfizer was promised in advance the U.S. government would buy 100 million doses of the vaccine for $2 billion. ("The Trump administration agreed in July to pay almost $2 billion for 100 million doses, with an option to acquire as many as 500 million more, once that clearance comes. . . . As part of that agreement, the U.S. gets to decide who gets the vaccine first . . .."). [Fortune] Since two doses are required, that works out to $40 per person. Oh, and don't forget: "Pfizer [CEO] Albert Bourla sold $5.56 million worth of company shares on Monday [Nov. 9], the day the drugmaker said its COVID-19 vaccine was 90% effective based on interim trial results . . .." After Pfizer's stock price rose, and CEO sold off $5.56 million worth of Pfizer stock one can't help but wonder what he knew that we don't. [Reuters]

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SOURCES

Antidote. Elan Kantor, "How Long Do Clinical Trials Take?" Antidote, March 24, 2020, https://www.antidote.me/blog/how-long-do-clinical-trials-take

CBS. David Martin, "Inside the Operation Warp Speed effort to get Americans a COVID-19 vaccine," CBS, 60 Minutes, Nov. 8, 2020, https://www.cbsnews.com/news/covid-19-vaccine-distribution-60-minutes-2020-11-08/

FDA. "Step 3: Clinical Research," U.S. Food & Drug Administration, https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

Fortune. Riley Griffin, Drew Armstrong and Bloomberg, "Germany funded the development of Pfizer’s COVID vaccine—not U.S.’s Operation Warp Speed," Fortune, Nov. 9, 2020, https://fortune.com/2020/11/09/pfizer-vaccine-funding-warp-speed-germany/

HHS. "Fact Sheet: Explaining Operation Warp Speed; What's the goal?" Coronavirus, HHS, Oct. 28, 2020, https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

NBC. Erika Edwards, "Pfizer's Covid-19 vaccine promising, but many questions remain; Pfizer's vaccine is a new type of technology that's never been used in mass human vaccination," NBC News, Nov. 10, 2020, https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102

NBC-2. David Gelles, "How to Ship a Vaccine at –80°C, and Other Obstacles in the Covid Fight; Developing an effective vaccine is the first step. Then comes the question of how to deliver hundreds of millions of doses that may need to be kept at arctic temperatures," New York Times, Sept. 19, 2020, print edition Sept. 19, 2020, p. A7, https://www.nytimes.com/2020/09/18/business/coronavirus-covid-vaccine-cold-frozen-logistics.html

NYT. Katie Thomas, David Gelles and Carl Zimmer, "Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective," New York Times, Nov. 12, 2020; print edition Nov. 10, 2020, p. A1, https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html

Reuters. Reuters Staff, "Pfizer CEO made $5.6 million stock sale on same day as COVID-19 vaccine update: filing," Business News, Reuters, Nov. 11, 2020, https://www.reuters.com/article/pfizer-albert-bourla-stake/pfizer-ceo-made-5-6-million-stock-sale-on-same-day-as-covid-19-vaccine-update-filing-idUSKBN27R1XL

Stat. Helen Branswell, "Four reasons for encouragement based on Pfizer’s Covid-19 vaccine results," Statnews, Nov. 9, 2020, https://www.statnews.com/2020/11/09/four-reasons-for-encouragement-based-on-pfizers-covid-19-vaccine-results/

Stat-2. Ed Silverman, "STAT-Harris Poll: The share of Americans interested in getting Covid-19 vaccine as soon as possible is dropping," Stat News, Oct. 19, 2020, https://www.statnews.com/pharmalot/2020/10/19/covid19-coronavirus-pandemic-vaccine-racial-disparities/

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