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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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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Be Afraid, Be Very Afraid

Your Risk Isn't Just COVID-19 Symptoms, It's What Comes Later
Do you know the long term harms COVID-19 may do to your brain, lungs, heart, kidneys and the rest of your body?

Over 500,000 persons worldwide have died from the disease -- and one quarter of them used to live in the United States. But there is now increasing evidence that may be only part of the damage the disease can do.

There has been a recent upsurge of young people becoming infected.

Unfortunately, if they are willing to ignore their moral obligation to avoid infecting others -- as apparently many are -- their use of analytical tools such as risk assessment, benefit-cost, and opportunity cost could rationalize their ignoring masks, social distancing and hand washing.

What's the worst that could happen? How serious would that be? How likely is it to happen? They may not become infected. If infected they may have no symptoms. If they have symptoms they may be mild and quickly pass. So the benefit of masking up is relatively small, and the cost of avoiding crowds, the opportunity cost of missing out on social opportunities at parties and beaches, is (in their minds) very high. Their behavior -- if one can overlook their selfish disregard of others -- is marginally understandable.

Videos of hundreds of young folks without masks gathered shoulder to shoulder, ignoring the warnings, makes it seem hopeless. How can their behavior be changed?

What if we were to significantly increase the "cost" side of their equation? And how might we do that? We could "start spreading the news" (to borrow a line from Sinatra's "New York") of the serious after effects of COVID-19 infections -- starting with the human brain and cognitive function (to focus the attention of college students).

In the years to come, it may well be medical professionals who focus on the brain and cognitive function who are seeing and helping many post-COVID patients. The reason is that hypoxia, cardiac dysfunction, blood clots, strokes and similar conditions — all of which have been observed, to one degree or another, in those suffering COVID-19 — can all have long-term effects on brain function and cognition.

Wilfred Van Gorp, "Wave of cognitive disorders in young people from COVID-19," The Hill (Dr. Gorp is the former president of the American Academy of Clinical Neuropsychology.)

Here are some more excerpts, this time from the BBC: Zoe Cormier, "How Covid-19 can damage the brain; Some scientists suspect that Covid-19 causes respiratory failure and death not through damage to the lungs, but the brain – and other symptoms include headaches, strokes and seizures," BBC, June 22, 2020

For Julie Helms, it started with a handful of patients admitted to her intensive care unit ...and it was not just their breathing difficulties that alarmed her. "[M]any had neurological problems – mainly confusion and delirium,” she says. “this was completely abnormal. It has been very scary, especially because many of the people we treated were very young – many in their 30s and 40s, even an 18-year-old.” [T]he neurological symptoms in their Covid-19 patients, ranging from cognitive difficulties to confusion ... are signs of “encephalopathy” (the general term for damage to the brain) ...

Now, more than 300 studies from around the world have found a prevalence of neurological abnormalities in Covid-19 patients, including mild symptoms like headaches, loss of smell (anosmia) and tingling sensations (arcoparasthesia), up to more severe outcomes such as aphasia (inability to speak), strokes and seizures. This is in addition to recent findings that the virus, which has been largely considered to be a respiratory disease, can also wreak havoc on the kidneys, liver, heart, and just about every organ system in the body.

“In fact, there is a significant percentage of Covid-19 patients whose only symptom is confusion” – they don't have a cough or fatigue, says Robert Stevens, associate professor of anaesthesiology and critical care medicine at Johns Hopkins Medicine in Baltimore, Maryland. “We are facing a secondary pandemic of neurological disease,” says Stevens. “We’ve now learned that the disease affects many different organ systems: patients can die not only from lung failure, but also neurological manifestations. If you had asked me a month ago if there was any published evidence that Sars-CoV-2 could cross the blood-brain barrier, I would have said no – but there are now many reports showing that it absolutely can,” says Stevens.

In fact, some scientists now suspect that the virus causes respiratory failure and death not through damage to the lungs but through damage to the brainstem, the command centre that ensures we continue to breathe even when unconscious. ... The brain is normally shielded from infectious diseases by what is known as the “blood-brain barrier” – a lining of specialised cells inside the capillaries running through the brain and spinal cord. These block microbes and other toxic agents from infecting the brain. If Sars-CoV-2 can cross this barrier, it suggests that not only can the virus get into the core of the central nervous system, but also that it may remain there, with the potential to return years down the line.

Though rare, this Lazarus-like behaviour is not unknown among viruses: the chickenpox virus Herpes zoster, for example, commonly infects the nerve cells in the spine, later reappearing in adulthood as shingles – roughly 30% of people who experienced chickenpox in childhood will develop shingles at some point in their lives. ... David Nutt, professor of neuropsychopharmacology at Imperial College London, says he himself treated many patients in the 1970s and 1980s who had suffered from severe clinical depression ever since the 1957 influenza pandemic in the UK. “Their depression was enduring and it was solid – it was as if their emotional circuits had all been switched off,” he says, warning that we could see the very same thing happen again, but on a much larger scale. “People who are discharged from the ICU with Covid-19 need to be monitored systematically long-term for any evidence of neurological damage – and then given interventionist treatments if necessary.”

And in Pittsburgh, through the Global Consortium Study of Neurological Dysfunction in Covid-19, Sherry Chou, a neurologist at the University of Pittsburgh, has coordinated scientists from 17 countries to collectively monitor the neurological symptoms of the pandemic, including through brain scans. ... Although the virus’s impact on the lungs is the most immediate and terrifying threat, the lasting impact on the nervous system may be far larger and far more devastating, says Chou. "Recovery from neurological injuries is often incomplete and can take much longer compared to other organ systems (for example, lung), and therefore result in much greater overall disability, and possibly more death,” she says.

The final sentence reads, "Patients experiencing lung failure can be put on a respirator, and kidneys can be rescued with a dialysis machine – and, with some luck, both organs will bounce back. But there is no dialysis machine for the brain."

See also, Julie Helms, et al, Strasbourg University Hospital, Strasbourg, France, "Neurologic Features in Severe SARS-CoV-2 Infection," Letter, New England Journal of Medicine, June 4, 2020.

There may be a subsequent blog post regarding the other medical conditions that can be triggered by COVID-19 infections. Until then, here's a Fortune magazine article that groups the potential consequences by areas of the body: Blood, Brain, Eyes, Gastrointestinal tract, Hands, Heart, Limbs, Liver, Lungs, Kidneys, Nose and tongue, Skin, and Toes. "What are the potential long-term effects of having COVID-19?" Associated Press, Fortune Magazine, June 16, 2020

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