It was my pleasure to be a panelist during a recent virtual forum titled “Building Vaccine Confidence: Best Practices to Combat Misinformation and Vaccine Hesitancy in COVID-19 Vaccines.” The forum took place during the American Association for Cancer Research’s Annual Meeting 2021, which had more than 13,500 registrants. This screenshot shows the panel getting ready for our informative discussion on building confidence in the COVID-19 vaccines. The panelists are (from top l-r): Gilbert S. Omenn (co-moderator), University of Michigan, Ann Arbor; Antoni Ribas (co-moderator), University of California Los Angeles; yours truly Francis Collins; E. John Wherry, University of Pennsylvania, Philadelphia; Grace Cordovano, Enlightening Results, LLC, West Caldwell, NJ; Lisa Richardson, Centers for Disease Control and Prevention, Atlanta; Liz Hamel, Henry J. Kaiser Family Foundation, San Francisco; Lee Greenberger, Leukemia & Lymphoma Society, Rye Brook, NY; and Mary Gullatte, EMORY Healthcare, Atlanta. The forum took place on April 14, 2021.
We need to know if the vaccines we are using will stop all the variants. I read “The Coming Plague” a long time ago- in the book, the scientists fly into remote ares with virus outbreaks to get information as soon as possible and prevent the outbreak from getting bigger.
I wish we had flown a bunch of different vaccines into Manaus and administered them to people there. By now, we would have some idea of their efficacies against P1.
Or we could have just sent them into Rio de Janeiro or Sao Paolo and we would soon have data, since, as expected, the P1 variant is now rampaging through those cities.
Do we know the vaccines we are administering now can stop all the known variants?
To be clear – this is very pertinent to vaccine acceptance, because in the media, the question of efficacies against variants is being avoided – if/when the public discovers the vaccines were not very good protection against variants, there may be a big backlash against the vaccines. Better to raise this issue now, while pointing out we are saving ourselves from the current dominant types, than try to tiptoe around it and hope no one notices later.
Insisting that all vaccines are safe lacks credibility and hinders detailed analyses of prior inadvertent errors in vaccine development. The error that I am most familiar with is the production of polio vaccines in cytomegalovirus infected monkeys. This allowed variant forms of monkey cytomegaloviruses to infect humans with subsequent human to human transmissions. A striking feature of these viruses is the lack of accompanying inflammation, the hallmark of most infectious diseases. The viruses were accordingly designated as being stealth adapted. Unequivocal DNA sequence data on several such viruses are publicly available on GenBank under the term stealth virus. Moreover, numerous peer-reviewed articles featuring illnesses caused by these viruses have been published and shared with Public Health officials. The unwillingness of Public Health officials to understand stealth adaptation has an immune evasion mechanism has further limited their appreciation that viruses can also be suppressed by a non-immunological defense mechanism. This mechanism provides a potential alternative to Covid-19 vaccines. It can also be applied to the range of current human illnesses attributed to stealth adapted viruses …
We need to educate primary care physicians. Several people have told me that their doctors advised against getting a Covid19 vaccine. One reason given was “it’s experimental, and Covid19 can be treated.”
The medical/public health community needs to provide better data on vaccine efficacy for individual subgroups. In the FDA briefing documents for both the Pfizer and Moderna vaccines, the vaccine efficacy 95% confidence intervals for Black, Asian, Indigenous, Pacific Islander, and multiracial people were enormous, sometimes extending into the negative range. At times there was so little efficacy data for people of certain subgroups that confidence intervals were not even constructed. People want to see the specific efficacy for the group for which they belong. The scientific community has to have a thoughtful, compelling, scientifically and statistically sound answer to the question: if there is insufficient data to determine vaccine efficacy for a particular racial group with a high degree of confidence, how do know that the vaccine actually works for that racial group? The situation is further exacerbated by the fact that members of underserved communities were more likely to join the clinical trials later, making them more under-represented in the person-years category and less likely to have reached two months by the data cutoff date. Recall that Moderna paused its trials in order to enroll more African-Americans.
It is also troubling that the data reports tended to lump all the Black people together, regardless of where they live or their actual ancestry. People of African descent have the most diverse genetics in the world with more haplogroups than anyone else. Most African-Americans have ancestry located near the hump of West Africa: Ghana, Nigeria, Benin, Togo, Cote D’Ivoire, etc, with contributions also from Angola and Central African Republic. No compelling case has been made for why we should expect substantially similar results for them as for Black people in South Africa.
Additionally, there needs to be much more transparency around what protocols and procedures the vaccine researchers implemented during the trials to ensure that bias on the part of those conducting the trials did not affect the trials’ results. To be clear, I am not referring to recruiting people of color into the trials. I am referring to ensuring that there was equitable treatment for all participants in the trials. Were the people conducting the trial screened for or trained on racial, ethnic, and gender biases in medicine? Was there a process to remove biased researchers from conducting the trials, or to ensure that people of color within the trials did not receive inferior care or have their concerns taken less seriously? Let’s remember that medical racism didn’t start or end with Tuskegee and Johns Hopkins’ treatment of Henrietta Lacks.
Regarding Johnson and Johnson’s vaccine, many people still remember that J&J could not bother to remove asbestos from its talcum powder over a period of decades, leading to various cancers in a massive number of women. Its recent manufacturing issues haven’t helped.
Let’s all remember that science is based on skepticism. The null hypothesis is always that the intervention doesn’t make a difference.
We need to know if the vaccines we are using will stop all the variants. I read “The Coming Plague” a long time ago- in the book, the scientists fly into remote ares with virus outbreaks to get information as soon as possible and prevent the outbreak from getting bigger.
I wish we had flown a bunch of different vaccines into Manaus and administered them to people there. By now, we would have some idea of their efficacies against P1.
Or we could have just sent them into Rio de Janeiro or Sao Paolo and we would soon have data, since, as expected, the P1 variant is now rampaging through those cities.
Do we know the vaccines we are administering now can stop all the known variants?
To be clear – this is very pertinent to vaccine acceptance, because in the media, the question of efficacies against variants is being avoided – if/when the public discovers the vaccines were not very good protection against variants, there may be a big backlash against the vaccines. Better to raise this issue now, while pointing out we are saving ourselves from the current dominant types, than try to tiptoe around it and hope no one notices later.
Insisting that all vaccines are safe lacks credibility and hinders detailed analyses of prior inadvertent errors in vaccine development. The error that I am most familiar with is the production of polio vaccines in cytomegalovirus infected monkeys. This allowed variant forms of monkey cytomegaloviruses to infect humans with subsequent human to human transmissions. A striking feature of these viruses is the lack of accompanying inflammation, the hallmark of most infectious diseases. The viruses were accordingly designated as being stealth adapted. Unequivocal DNA sequence data on several such viruses are publicly available on GenBank under the term stealth virus. Moreover, numerous peer-reviewed articles featuring illnesses caused by these viruses have been published and shared with Public Health officials. The unwillingness of Public Health officials to understand stealth adaptation has an immune evasion mechanism has further limited their appreciation that viruses can also be suppressed by a non-immunological defense mechanism. This mechanism provides a potential alternative to Covid-19 vaccines. It can also be applied to the range of current human illnesses attributed to stealth adapted viruses …
We need to educate primary care physicians. Several people have told me that their doctors advised against getting a Covid19 vaccine. One reason given was “it’s experimental, and Covid19 can be treated.”
The medical/public health community needs to provide better data on vaccine efficacy for individual subgroups. In the FDA briefing documents for both the Pfizer and Moderna vaccines, the vaccine efficacy 95% confidence intervals for Black, Asian, Indigenous, Pacific Islander, and multiracial people were enormous, sometimes extending into the negative range. At times there was so little efficacy data for people of certain subgroups that confidence intervals were not even constructed. People want to see the specific efficacy for the group for which they belong. The scientific community has to have a thoughtful, compelling, scientifically and statistically sound answer to the question: if there is insufficient data to determine vaccine efficacy for a particular racial group with a high degree of confidence, how do know that the vaccine actually works for that racial group? The situation is further exacerbated by the fact that members of underserved communities were more likely to join the clinical trials later, making them more under-represented in the person-years category and less likely to have reached two months by the data cutoff date. Recall that Moderna paused its trials in order to enroll more African-Americans.
It is also troubling that the data reports tended to lump all the Black people together, regardless of where they live or their actual ancestry. People of African descent have the most diverse genetics in the world with more haplogroups than anyone else. Most African-Americans have ancestry located near the hump of West Africa: Ghana, Nigeria, Benin, Togo, Cote D’Ivoire, etc, with contributions also from Angola and Central African Republic. No compelling case has been made for why we should expect substantially similar results for them as for Black people in South Africa.
Additionally, there needs to be much more transparency around what protocols and procedures the vaccine researchers implemented during the trials to ensure that bias on the part of those conducting the trials did not affect the trials’ results. To be clear, I am not referring to recruiting people of color into the trials. I am referring to ensuring that there was equitable treatment for all participants in the trials. Were the people conducting the trial screened for or trained on racial, ethnic, and gender biases in medicine? Was there a process to remove biased researchers from conducting the trials, or to ensure that people of color within the trials did not receive inferior care or have their concerns taken less seriously? Let’s remember that medical racism didn’t start or end with Tuskegee and Johns Hopkins’ treatment of Henrietta Lacks.
Regarding Johnson and Johnson’s vaccine, many people still remember that J&J could not bother to remove asbestos from its talcum powder over a period of decades, leading to various cancers in a massive number of women. Its recent manufacturing issues haven’t helped.
Let’s all remember that science is based on skepticism. The null hypothesis is always that the intervention doesn’t make a difference.