There is a lot to be optimistic about regarding the new safe and highly effective vaccines, which are moving society closer toward the goal of close human contact once again.
To be clear, these vaccine candidates for COVID-19, both authorized and not yet authorized, are highly effective and safe. In fact, across all trials and sites, all six vaccines were 100% effective in preventing hospitalizations and death from COVID-19.
All Vaccines' Phase 3 Clinical Data
Complete protection against hospitalization and death from COVID-19 exhibited by all vaccines with phase 3 clinical trial data.
This astounding level of protection from SARS-CoV-2 from all vaccine candidates across multiple regions is likely due to robust T cell response from vaccination and will "defang" the virus from the concerns that led to COVID-19 restrictions initially: the ability of the virus to cause severe illness. This is a time of hope and optimism. After the devastating third surge of COVID-19 infections and deaths over the winter, we finally have an opportunity to stem the crisis – if only people readily accept the vaccines.
Amidst these incredible scientific advancements, however, public health officials and politicians have been pushing downright discouraging messaging. The ubiquitous talk of ongoing masks and distancing restrictions without any clear end in sight threatens to dampen uptake of the vaccines. It's imperative that we break down each concern and see if we can revitalize our public health messaging accordingly.
The first concern: we currently do not know if the vaccines block asymptomatic infection as well as symptomatic disease, since none of the phase 3 vaccine trials were set up to answer this question. However, there is biological plausibility that the antibodies and T-cell responses blocking symptomatic disease will also block asymptomatic infection in the nasal passages. IgG immunoglobulins (generated and measured by the vaccine trials) enter the nasal mucosa and systemic vaccinations generate IgA antibodies at mucosal surfaces. Monoclonal antibodies given to outpatients with COVID-19 hasten viral clearance from the airways.
Although it is prudent for those who are vaccinated to wear masks around the unvaccinated in case a slight risk of transmission remains, two fully vaccinated people can comfortably abandon masking around each other.
Moreover, data from the AztraZeneca trial (including in the phase 3 trial final results manuscript), where weekly self-swabbing was done by participants, and data from the Moderna trial, where a nasal swab was performed prior to the second dose, both showed risk reductions in asymptomatic infection with even a single dose. Finally, real-world data from a large Pfizer-based vaccine campaign in Israel shows a 50% reduction in infections (asymptomatic or symptomatic) after just the first dose.
Therefore, the likelihood of these vaccines blocking asymptomatic carriage, as well as symptomatic disease, is high. Although it is prudent for those who are vaccinated to wear masks around the unvaccinated in case a slight risk of transmission remains, two fully vaccinated people can comfortably abandon masking around each other. Moreover, as the percentage of vaccinated people increases, it will be increasingly untenable to impose restrictions on this group. Once herd immunity is reached, these restrictions can and should be abandoned altogether.
The second concern translating to "doom and gloom" messaging lately is around the identification of troubling new variants due to enhanced surveillance via viral sequencing. Four major variants circulating at this point (with others described in the past) are the B.1.1.7 variant ("UK variant"), B.1.351 ("South Africa variant), P.1. ("Brazil variant"), and the L452R variant identified in California. Although the UK variant is likely to be more transmissible, as is the South Africa variant, we have no reason to believe that masks, distancing and ventilation are ineffective against these variants.
Moreover, neutralizing antibody titers with the Pfizer and Moderna vaccines do not seem to be significantly reduced against the variants. Finally, although the Novavax 2-dose and Johnson and Johnson (J&J) 1-dose vaccines had lower rates of efficacy against moderate COVID-19 disease in South Africa, their efficacy against severe disease was impressively high. In fact J&J's vaccine still prevented 100% of hospitalizations and death from COVID-19. When combining both hospitalizations/deaths and severe symptoms managed at home, the J&J 1-dose vaccine was 85% protective across all three sites of the trial: the U.S., Latin America (including Brazil), and South Africa.
In South Africa, nearly all cases of COVID-19 (95%) were due to infection with the B.1.351 SARS-CoV-2 variant. Finally, since herd immunity does not rely on maximal immune responses among all individuals in a society, the Moderna/Pfizer/J&J vaccines are all likely to achieve that goal against variants. And thankfully, all of these vaccines can be easily modified to boost specifically against a new variant if needed (indeed, Moderna and Pfizer are already working on boosters against the prominent variants).
The third concern of some public health officials is that people will abandon all restrictions once vaccinated unless overly cautious messages are drilled into them. Indeed, the false idea that if you "give people an inch, they will take a mile" has been misinforming our messaging about mitigation since the beginning of the pandemic. For example, the very phrase "stay at home" with all of its non-applicability for essential workers and single individuals is stigmatizing and unrealistic for many. Instead, the message should have focused on how people can additively reduce their risks under different circumstances.
The public will be more inclined to trust health officials if those officials communicate with nuanced messages backed up by evidence, rather than with broad brushstrokes that shame. Therefore, we should be saying that "vaccinated people can be together with other vaccinated individuals without restrictions but must protect the unvaccinated with masks and distancing." And we can say "unvaccinated individuals should adhere to all current restrictions until vaccinated" without fear of misunderstandings. Indeed, this kind of layered advice has been communicated to people living with HIV and those without HIV for a long time (if you have HIV but partner does not, take these precautions; if both have HIV, you can do this, etc.).
Our heady progress in vaccine development, along with the incredible efficacy results of all of them, is unprecedented. However, we are at risk of undermining such progress if people balk at the vaccine because they don't believe it will make enough of a difference. One of the most critical messages we can deliver right now is that these vaccines will eventually free us from the restrictions of this pandemic. Let's use tiered messaging and clear communication to boost vaccine optimism and uptake, and get us to the goal of close human contact once again.
In the U.S. and Europe, it is illegal to reuse pacemakers and other implants. Therefore, cardiologists export them to the global South where they save the lives of people of all ages.
Often he observed there were no doctors in the E.R.s, and hte nurses could render only basic first aid. “When somebody fell into a coma, they fell into a coma,“ Israel remembers. “There weren’t even any defibrillators to restart a patient’s heart,” while defibrillators are standard equipment in most clinics in the U.S. and Europe as lifesaving devices. When Israel finally visited the largest and most modern hospital in Nairobi, he found it better equipped but he learned that its services were only available to patients who could afford them. The cardiologist there had a drawer full of petitions from patients with heart ailments who couldn’t afford lifesaving surgery. Even two decades ago, a pacemaker cost $5,000 in Kenya, which made it unaffordable for most Kenyans who earn an average of $600 per month.
Since 2003, Israel and a team of two doctors and two nurses visit Kenya and Zambia once or twice a year to implant German pacemakers for free. Notably, the pacemakers and defibrillators Israel exports to Africa would end up in the landfill in Germany. Clinics have to pay for specialized services to dispose of this medical equipment. “In Germany, I could go to jail if I used a defibrillator that is one day past its expiration date,“ Israel says, “but in Kenya, people don’t have the money for the cheapest model. What nonsense to throw this precious medical equipment away while people in poorer countries die because they desperately need it.“
Israel works at the breakpoint between the laws in a wealthy country like Germany and the reality in the global South. The U.S. and most European countries have strict laws that ban the reuse of medical implants and enforce strict expiration dates for medical equipment. “But if a pacemaker is a few days past its expiration date, it still works perfectly fine,“ Israel says. “And it also happens that we implant a pacemaker and five months later it turns out that the patient needs a different kind. Then we replace it and we’d have to trash the first one in Germany, though it could easily run another 12 years.“
“If we get this right, we have lots of devices we can implant, hips and knees, etcetera. Where this will lead is limitless," says Eva Kline Rogers, the program coordinator for My Heart, Your Heart.
Israel has been collecting donations of pacemakers and defibrillators from manufacturers but also from other doctors and from funeral homes for his nonprofit Pacemakers for East Africa since 2003. Most funeral homes in the U.S. and Europe are legally obliged to remove pacemakers from the dead before cremation. “Most pacemakers survive their owners,“ says Israel. He sterilizes the pacemakers and finds them a new life in East Africa. Studies show that reused pacemakers carry no greater risk for the patients than new ones.
In the U.S., University of Michigan professor Thomas Crawford heads up a similar initiative, My Heart, Your Heart. “Each year 1 to 2 million individuals worldwide die due to a lack of access to pacemakers and defibrillators,” the organization notes on its website. The nonprofit was founded in 2009, but it took four years for the doctors to get permission from the FDA to export pacemakers. Since receiving permission, the organization has sent dozens of devices to the Philippines, Haiti, Venezuela, Kenya, Sierra Leone and Ukraine. “We were the first doctors ever to implant a pacemaker in Sierra Leone in 2018,” says Crawford, who has traveled extensively to most of the recipient countries.
Even individuals can donate their pacemakers; the organization offers a prepaid envelope. “My mother recently passed and she donated her device,” says Tina Alexandris-Souphis, one of the doctors at University of Michigan who collaborates on My Heart, Your Heart. The organization works with World Medical Relief and the U.K. based charity Pace4Life to maintain a registry of the most urgent patients and send devices to where they are needed the most.
My Heart, Your Heart is also conducting a randomized controlled trial to provide further evidence that reused pacemakers pose no additional risk. “Our vision is that we establish this is safe and create a blueprint for organizations around the world to safely reuse these devices instead of them being thrown in the trash,” says Eva Kline Rogers, the program’s coordinator. “If we get this right, we have lots of devices we can implant, hips and knees, etc. Where this will lead is limitless.” She points out that in addition to receiving the donated devices, the doctors in the global South also benefit from the expertise of renowned cardiologists, such as Crawford, who sometimes advise them in complex cases.
And Adrian Baranchuk, a Canadian doctor at the Kingston General Hospital at the Queen’s University, regularly travels through South America with his “cardiology van” to help villagers in remote areas with heart problems.
Israel says that he’s been accused of racism, in thinking that these pacemakers are suitable for those in the global South - many of whom are people of color - even though officials in wealthier countries consider them to be trash. The cardiologist counters such criticism with stories about desperate need of his patients. At his first medical visit to Nairobi that he organized with a local cardiologist, six patients were waiting for him. “In Germany, they would all be considered emergencies,” Israel says. One eighty-year old grandmother had a heartrate of 18. “I’ve never before seen anything like this,” Israel exclaims. “At first I thought I couldn’t find her pulse before I realized that her heart was only beating once every three seconds.” After the surgery, she got up, dressed herself and hurriedly packed her bag, explaining she had a ton of work to accomplish. Her family was in disbelief, Israel says. “They told me she had been bedridden for five years because as soon as she tried to get up she would faint.”
Israel has been accused of racism, in thinking that these pacemakers are suitable for those in the global South even though they're considered to be trash by officials in wealthier countries. The cardiologist counters such criticism with stories about desperate need of his patients.
Carsten Israel
The hospital in Nairobi where Israel conducts the surgeries, charges patients $200 for the use of its facilities. If patients can’t afford that sum, Israel will pay it from the funds of his nonprofit. For some people, $200 far exceeds their resources. Once, a family from the extremely poor Northern region of Kenya told him they couldn’t afford the $3 for the bus ride to Nairobi. Israel suspected this was a pretense because they were afraid of the surgery and agreed to reimburse the $3, “but when they came, they were wearing rags and were so rail-thin, I understood that they really needed every cent they had for food.”
Israel is a renowned cardiologists in Germany. And yet, he considers his work in East Africa to be particularly meaningful. “Generally, most patients in Germany will get the treatment they need,” he says, “and I never before experienced that people have an illness that is easily curable but simply won’t be treated.” He also feels a heavy responsibility. Many patients have his personal cell phone and call him when they have problems or good news about how they’re doing.
Some of those progress reports come much faster than in Israel’s home country. Before he implanted a pacemaker in a tall Massai in Kenya, the man had been picked on by his family because he wouldn’t help much with the hard work on the family peanut farm. “When I examined him, he had a pulse of 40,” Israel says. “It’s a miracle he was even standing upright, let alone hauling heavy bags.” After the surgery, Israel advised his patient to stay the night for observation, but the patient couldn’t wait to leave. Two hours later, he returned, covered in sweat. He’d been running sprints with his brothers to test the new device. Israel shakes his head. In Germany, it would be unthinkable for a patient to engage in athletics immediately after surgery. But the patient was exuberant: “I was the fastest!”
The success stories are notable partly because the challenges remain so steep. In Zambia, for instance, there is a single cardiologist; she determined to become one after losing her younger sister to an easily curable heart disease. Often, the hospitals not only lack pacemakers but also sterile surgery equipment, antibiotics and other essential material. Therefore, Israel and his team import everything they need for the surgeries, including medication. If necessary, they improvise. “I’ve done surgery with a desk lamp hanging from the ceiling by threads,” Israel says. He already knows that he will need to return to Kenya in six months to replace the pacemaker of one of his patients and replace the batteries in others. If he doesn’t travel, lives are at risk.