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