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Moderna’s Case for a COVID-19 Booster Shot: Its Vaccine Protection Wanes by 36% After 12 Months, According to a New Study

Studies from COVID-19 vaccine makers and public health officials have been suggesting for a while that protection provided by the vaccines wanes over time. In a new study published on Sept. 15 to a preprint server—the study is not yet peer-reviewed—researchers at Moderna, which makes one of the two mRNA COVID-19 vaccines (the other is from Pfizer-BioNTech), report that people vaccinated within the last eight months had 36% fewer breakthrough infections than those who were vaccinated a year ago. That suggests vaccine-induced immunity is likely highest shortly after people get their recommended two doses of the vaccine, and starts to drop afterward. The Moderna vaccine received emergency use authorization (EUA) from the U.S. Food and Drug Administration in Dec. 2020; the FDA is currently reviewing the company’s request for full approval of the shot.

The latest data are part of an ongoing Phase 3 study of that includes more than 14,000 people who were randomly assigned to receive either two doses of the Moderna vaccine or two doses of placebo from July to October 2020, and more than 11,000 people who were originally assigned to receive placebo doses from December 2020 to March 2021 and, after the EUA was granted, chose to receive two doses of the vaccine. In that latter group, which completed its two-dose regimen about eight months ago, 88 people tested positive for COVID-19, compared to 162 people who had breakthrough cases in the earlier vaccinated group. That means the more recently vaccinated people had a 36% lower incidence of breakthrough infections than those immunized a year ago. (Overall, only 19 of the 250 breakthrough cases were severe.)The results, Moderna says, suggests protection wanes over time, which is why the company submitted data to the FDA to authorize a booster dose to provide better protection against COVID-19. To make its case for an additional dose, Moderna’s scientists published results from another study on Sept. 15, in the journal Nature Medicine, comparing the efficacy of four different types of booster approaches. In the small study of 79 people, some received a third dose of the same two-dose vaccine they already received, some got a dose of a vaccine developed specifically against the Beta variant, some received a lower dose of this Beta variant vaccine, and a final group received a combination of the original and Beta variant shots. The data confirmed that about six months after people are fully vaccinated with two doses, levels of antibodies that can neutralize the original version of SARS-CoV-2 dropped by about six- to seven-fold. But boosting with an additional dose of any of the four vaccines the researchers tested increased levels of antibodies about a month later. The combination dose was the most effective, increasing antibody levels by 46-fold, compared to a 16.7-fold increase with a third dose of existing vaccine, an 11.3-fold increase with the Beta-specific booster, and a 9.2-fold increase with the lower dose Beta-specific booster.

More encouraging, the researchers say, is that these antibody levels reached or exceeded—in some cases as high as by 4.4 times—those produced in the first month after two doses of the vaccine—even against variants like Beta, Gamma and Delta. That suggests the immune system retains some memory of SARS-CoV-2 and the booster can amplify and accelerate the immune response to build on the original protection against the virus and even tackle variants that have mutated from the original form. “We’ve been saying that we are going to have to have a variant booster, and that booster is going to have to be multivalent [and able to recognize different variants],” says Dr. Stephen Hoge, president of Moderna. “Then the clinical trial data came in … and we see a small benefit when we match a variant strain with the booster. But it’s not dramatic, and it’s not overwhelming benefit. In fact the [original] vaccine does really well against Delta.” The idea is similar to the concept of a rising tide lifting all boats. The Delta variant, fortunately, has not learned to escape the immune system’s defenses; its success spreading among human populations has largely been because of its ability to flood the zone and quickly infect as many cells as possible in any unprotected person. Confronting that onslaught with an equally massive immune response, which, it seems, can be generated by a booster dose of the original vaccine, is sufficient to keep Delta at bay—and keeping any virus that does get through from causing severe disease. Hoge says he is not worried so much about Delta, as about what might come after Delta. While the Delta variant hasn’t learned to escape the immune system yet, other variants, including Beta and Gamma, have shown signs of such evolution. If, over the course of the next few months, some of the known strains find a way to meld their respective strengths, the resultant variant could become a public health nightmare. Moderna is working on a vaccine that would target Beta, Gamma and Delta, in case such a strain does actually emerge this winter. “The [mRNA] platform allows us to take a chance and get ahead of that possibility and be ready if we need it,” says Hoge. That booster could be ready and tested in a small group of people by the end of the year and available more widely in the first quarter of 2022 if needed, he says. In the meantime, Moderna has already developed a vaccine designed specifically to protect against the Delta variant, but Hoge says it’s not likely it would be necessary as a booster, since the existing vaccine can generate an adequate enhanced immune response even against Delta. Researchers at Pfizer-BioNTech, who have also developed an mRNA COVID-19 vaccine, built a Delta-specific vaccine as well, and have begun testing it in the lab. But infectious-disease experts don’t agree on whether a COVID-19 booster is even needed at this point. While both Pfizer and Moderna have submitted data to the FDA as a part of requests to green-light an additional dose of their vaccines, and the White House COVID-19 team backs the idea, experts at the FDA do not seem convinced a booster is necessary. Ahead of a Sept. 17 FDA advisory committee meeting of independent experts who will review the latest data on Pfizer-BioNTech’s booster, the agency recently posted a report expressing the need for strong data to support the need for a booster dose. “Overall, the data indicate currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” the FDA scientists said. “There are many potentially relevant studies, but the FDA has not independently reviewed or verified the underlying data or their conclusions.”

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Indonesia’s President Ruled Guilty of Neglecting Jakartans’ Right to Clean Air

An Indonesian court ruled that President Joko Widodo is guilty of neglecting people’s right to clean air in Jakarta in a rare victory for environmental activists. Jokowi, as the president is known, along with the Jakarta governor, the minister of home affairs, the health minister and the environment minister must take strong action and establish an adequate measure to uphold the people’s right to healthy air in the capital, according to Judge Saifuddin Zuhri in his ruling at the Central Jakarta court on Thursday. The lawsuit was lodged in 2019 by a group consisting Jakarta residents and activist groups, accusing the government of acting unlawfully by allowing air pollution in the capital to exceed healthy limits. The court on Thursday rejected allegations that the government has conducted human rights violation in the pollution case. Indonesia ranks ninth among the world’s most polluted countries with an average score of 40.7 last year, which is considered unhealthy for people who are sensitive to pollution, according to IQAir index for air quality. Jakarta, the city of 10 million people, scored 39.6 on the index.

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43 Hospitals Turned Away Alabama Cardiac Patient Due to COVID-19 Surge, Obituary Says

(MONTGOMERY, Ala.) — As hundreds of mostly unvaccinated COVID-19 patients filled Alabama intensive care units, hospital staff in north Alabama contacted 43 hospitals in three states to find a specialty cardiac ICU bed for Ray Martin DeMonia, his family wrote in his obituary. The Cullman man was finally transferred to Meridian, Mississippi, about 170 miles (274 kilometers) away. That is where the 73-year-old antiques dealer died Sept. 1 because of the cardiac event he suffered. Now, his family is making a plea. “In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non-COVID related emergencies,” his obituary read.

“Due to COVID-19, CRMC emergency staff contacted 43 hospitals in three states in search of a cardiac ICU bed and finally located one in Meridian, MS,” his obituary read, referencing Cullman Regional Medical Center. “He would not want any other family to go through what his did.” Alabama for weeks has seen a surge of mostly unvaccinated patients filling hospitals and intensive care units, making it increasingly difficult to transfer patients to other facilities for specialty care, said Dr. Don Williamson, the former state health officer who now heads the Alabama Hospital Association. “Every day hospitals are trying to find a place to transfer patients, and it is very difficult,” Williamson said. “We’ve had patients transferred to Georgia, to Kentucky to Florida.” Jennifer Malone, a spokesperson for the Cullman hospital, confirmed DeMonia was a patient and said he needed to be transferred to receive a higher level of specialized care not available at Cullman Regional Medical Center. She could not comment more for privacy reasons, but said, the “continued surge in COVID patients has saturated tertiary care hospitals creating an ongoing and increasing challenge for Cullman Regional staff to find hospitals able to receive patient transfers when needed.” Williamson also could not comment on DeMonia’s case but said the struggle to find an open bed to transfer a patient is a scenario being played out daily. “Basically, half of our ICU beds are now filled with COVID patients,” Williamson said. Alabama on Monday had 2,474 COVID-19 patients in state hospitals of which 86% were unvaccinated, according to the Alabama Hospital Association. Nearly half of the state’s intensive care unit beds, or 772 beds, are occupied by a person with COVID-19. And the surge of patients meant some hospitals had to convert other space to ICUs. Patients who normally would be treated in ICU wards are instead being cared for in emergency rooms, normal beds or even gurneys left in hallways, state officials said. The state had 1,562 ICU patients Monday, but 1,551 dedicated ICU beds. The situation was even worse on Sept. 1 when DeMonia passed away. The state that day had 92 more patients needing ICU care than it had dedicated beds. DeMonia’s daughter did not immediately respond to a Facebook message seeking comment.

After threatening to reach an all-time high for hospitalizations during the coronavirus pandemic, state hospitals have seen a slight decline in recent days, Dr. Scott Harris, head of the Alabama Department of Public Health, said last week. “We continue to have a real crisis in Alabama with our ICU bed capacity,” Harris said. While Harris said Alabama’s vaccination numbers have improved in recent weeks as the state recorded double-digit deaths daily for a month or so, just under 40% of the state’s residents are fully vaccinated, compared with 53% nationally, according to the Centers for Disease Control and Prevention. In his obituary and in a story in his hometown paper, The Cullman Times, DeMonia was remembered as a family man who developed a love of antiques as a child and volunteered his auctioneering skills, and sense of showmanship, at community fundraisers. “Ray DeMonia was like no other,” his family wrote.

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The Gates Foundation’s 2021 Report Shows That Childhood Vaccinations Dropped During the Pandemic—But There’s a Bright Side

This time last year, the Bill and Melinda Gates Foundation warned of a grim potential side effect from the COVID-19 pandemic: its disruptions to routine medical care could erase 25 years of progress on childhood vaccination, setting back global health by decades. The 2021 installment of the foundation’s annual Goalkeepers report, which details progress on 18 metrics related to global health, equity and sustainability, contains some good news and some bad news. Childhood vaccination rates have suffered during the pandemic—but only about half as much as the Gates Foundation originally predicted, signaling that many countries were able to restore regular medical services faster than expected.

In 2020, 30 million children around the world—10 million more than in an average year—missed appointments for routine vaccinations, such as those that protect against measles, diphtheria and pneumococcal disease, according to estimates from the Institute for Health Metrics and Evaluation included in the Goalkeepers report. That translates to about a seven percentage point dip in routine vaccinations—not great, certainly, but considerably less than the expected drop of 14 percentage points. “I still don’t want to understate it,” says Gates Foundation CEO Mark Suzman. “It takes us back to 2005 levels. That’s still a loss of 15 years of progress.” But, Suzman says, it’s encouraging that countries around the world were able to maintain supply chains and resume distribution of vaccines for diseases other than COVID-19. A U.S. Centers for Disease Control and Prevention (CDC) study published in June 2021 found that, across 10 U.S. jurisdictions, administration of routine childhood shots fell by up to 70% in early 2020 compared to previous years—a harbinger of a potential public health catastrophe on top of COVID-19. But the situation improved toward the end of 2020, as many medical centers resumed normal care. It was still not enough to make up for the dismal drop earlier in the year, but ongoing recovery efforts can still make a difference. “The great thing about vaccines is you can catch up,” Suzman says. “That’s where we hope we can still see some continued improvements and make up that lost ground.” Aside from vaccination, the COVID-19 pandemic has slowed or halted progress on many of the goals tracked by the Gates Foundation. The pandemic has pushed an additional 31 million people worldwide into extreme poverty, and about 13 million fewer women are expected to be employed throughout this year compared to 2019. (Employment levels among men, by contrast, are projected to return largely to pre-pandemic levels at some point this year.) Disruptions in medical care also threaten long-standing progress on reducing child and neonatal mortality, the report says. There were a few bright spots in the report. For example, the world can expect sustained progress on smoking elimination, adoption of universal health coverage and access to financial services, the report says.

The pandemic has also revealed a number of “no-brainer” areas in which investments from wealthy countries could dramatically improve global health, Suzman says. Building up genomic surveillance systems around the world, not just in rich countries, could ensure that the world is better equipped to stymie future pandemics and monitor the spread of existing infectious diseases like malaria. Similarly, the beefing up of global supply chains to accommodate mass production and distribution of COVID-19 vaccines could prepare us to do the same for other critical medical supplies, like routine vaccines and medical oxygen. Suzman says he is optimistic the world can recover from the COVID-19 pandemic and emerge stronger. “But as always,” he says, “optimism depends on both getting the resources behind it and getting the attention from policymakers to prioritize those interventions.”

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