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 . . . ?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.
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.
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]
"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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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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