Tag Archives: COVID-19 vaccine clinical research

CDC guidelines for antivirals give the unvaccinated the lion’s share

Almost one year ago, the universal rollout of COVID-19 vaccines began in the United States. 

While some initial hesitancy was expected, it was widely assumed the public would embrace a safe, effective, free vaccine once readily available. That a significant percentage of the eligible population would reject such vaccines — too often at the cost of death to themselves or family members — seemed unfathomable. And yet that is precisely what has occurred. 

Paradoxically, of the hundreds of unvaccinated patients treated in my hospital over the course of this pandemic, I have yet to see one refuse therapies such as monoclonal antibodies, all of which carry many more side effects than the vaccines they have declined.  

Though mandates have boosted the vaccine numbers among certain groups, incentives, outreach and appeals continue to meet stiff resistance. There is little reason to believe that will change. Having survived the winter 2021 COVID surge, health care systems experienced a relative lull for an extended period. In my own hospital, the number of COVID patients declined from a high of over 700 during the first wave to single-digit numbers in the spring and summer of 2021. The delta wave that arrived this fall, followed rapidly by omicron, has swelled the number of cases dramatically with rising admissions by the day. 

Waning immunities from the initial vaccines — requiring booster shots — has compounded the problem. It must also be noted that current vaccines and boosters were engineered against a virus that no longer exists. While further boosters will inevitably be required (most diseases require chronic therapies), the current vaccine/booster regimen offers the best protection now available. But we are still vulnerable. 

Breakthrough cases routinely occur among the vaccinated and boosted. Twenty-five percent of our current COVID hospitalizations have been in vaccinated patients, with a small percent having been boosted as well. These numbers will surely grow in the coming months as vaccine immunities continue to wane. While their prognosis will be better than their unvaccinated counterparts, vaccinated patients will still be hospitalized, suffer and potentially die, particularly if they are afflicted with comorbidities.    

As COVID cases surge, there is a corresponding increase in the demand for treatments. 

Current therapies such as Sotrovimab, a monoclonal antibody with activity against omicron, and the oral agents, Paxlovid, and Molnupiavir, exist in very short supply. Already the demand has far outstripped our capacities raising the specter of rationing and a host of medical, social and ethical issues.  

The use and administration of these therapies – funded by the federal government without cost to the end-user – are governed by the Centers for Disease Control and Prevention and state prioritizations. Although immunosuppressed patients are appropriately atop the list, most unvaccinated patients will be granted the next highest level of priority.  

For example, a 35-year-old unvaccinated former smoker with asthma gains priority over a 66-year-old vaccinated cancer patient. Similarly, an unvaccinated 25-year-old smoker with depression takes precedence over a 64-year-old vaccinated patient with chronic pulmonary disease. Indeed, the highest priority on the CDC list does not include a single profile of vaccinated patients other than the immunosuppressed, regardless of other comorbidities. Based on current supplies, unvaccinated patients will receive most of these lifesaving medications.  

Beyond its inherent unfairness, the decision to prioritize unvaccinated patients for scarce therapies is based on assumptions regarding risk factors, and the data regarding which risk factors contribute to a poor prognosis is weak at best. It is this very paucity of evidence that explains the lack of clear prioritizations in the initial vaccine rollout. 

Health systems and society are benefiting greatly from a renewed focus on health equities. Underpinning it all is the question of fairness. The decision to refuse vaccination is a matter of personal choice, but with choice comes consequence. To date, the adverse consequences of such rejections have shifted from the individual to the community.  

The financial cost of caring for sick and hospitalized unvaccinated patients is being borne largely by the taxpayer. The additional cost of the unvaccinated spreading the virus, even to those who are vaccinated and boosted, tears at our social fabric. Personal freedom to refuse a vaccine takes away freedom from nearby susceptible individuals. It deprives them of safe social contact with others. Without personal consequences, refusing vaccination becomes an easier decision. Denying the unvaccinated priority to remedial treatments and therapies needs to be reevaluated.   

Summoning consensus over divisive issues, especially in times of crisis, will always pose a great challenge to a free society. Self-determination and choice are fundamental to our way of life, but so too are the principles of personal responsibility and fairness.    

Bruce Farber, MD, is chief of Public Health and Epidemiology at Northwell Health, and the chief of Infectious Diseases at North Shore University Hospital and LIJ Medical Center. Farber is a fellow of the Infectious Disease Society of America.



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Covid-19 Linked to Four Times Higher Risk of Stillbirth During Delta Era, CDC Finds

Empty newborn beds in the maternity ward of a hospital.
Photo: Sean Gallup (Getty Images)

New research affirms the added risk that pregnant people and their families face from covid-19. Data recently released by the Centers for Disease Control and Prevention shows that pregnant people infected with covid-19 are more likely to have a stillbirth; this link appears to have become stronger after the emergence of the Delta variant.

Studies have suggested for some time that covid-19 is more dangerous for pregnant people. They’re more likely to experience serious illness, death, and delivery complications. This new research, published by the CDC last week, provides a closer look at the risk of stillbirth posed by the coronavirus, particularly the Delta variant.

The study looked at over a million hospital deliveries performed between March 2020 and September 2021. Stillbirths—the loss of a baby before or during delivery—were generally low during the time period. But individuals infected with covid-19 at the time of delivery were still significantly more likely to have a stillbirth. Overall, about 1.26% of infected pregnant people had a delivery that ended in stillbirth, compared to 0.64% of those not infected.

The Delta variant of the coronavirus is much more transmissible than the original strains of the coronavirus that first spread around the globe last year. But there’s mixed evidence on Delta’s ability to cause more serious illness. According to the CDC, there is data showing that people in general may be more likely to become hospitalized as a result of Delta, but that hospitalized people then have similar outcomes as they did with pre-Delta strains. Unfortunately, this doesn’t seem to be the case for pregnant people.

During July 2021 to September 2021, when the Delta variant had become firmly established as the predominant form of the virus, the rate of stillbirth substantially rose among covid-infected people, from 0.98% of deliveries before Delta to 2.70%. Compared to non-infected people, this meant a roughly fourfold increased risk of stillbirth.

The findings seem to confirm anecdotal reports of more stillbirths and other complications during the latest Delta-led peak of the pandemic, and they don’t bode well for the near future, either. Covid-19 cases are undeniably on the rise again, though they remain concentrated among the unvaccinated.

Compared to the general public, however, pregnant people are still less likely to get vaccinated for covid-19, in part due to misconceptions about the vaccines’ safety. In truth, studies have shown no increased risk of negative health outcomes from the vaccination of pregnant people, and experts, including the current study’s authors, continue to urge that they get vaccinated as soon as possible.

“Implementing evidence-based covid-19 prevention strategies, including vaccination before or during pregnancy, is critical to reduce the impact of covid-19 on stillbirths,” the authors wrote.

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Cuba Becomes First Country to Vaccinate Young Kids for Covid-19

A nurse prepares Roxana Montano, 3, to receive her dose of Soberana Plus, a Cuban vaccine against covid-19, on August 24, 2021 at Juan Manuel Marquez hospital in Havana, as part of the vaccine study in children.
Photo: Adalberto Roque/AFP (Getty Images)

Cuba started vaccinating children as young as two years old against covid-19 this week, becoming the first country in the world to inoculate toddlers. At least 12 young kids have died from covid-19 in Cuba this year, while there were no infant deaths from the disease in that country during 2020, according to the Miami Herald.

Cuba developed its own covid-19 vaccine, a two-shot regimen known as Soberana 2 that has an efficacy of 91.2% after a booster called Soberana Plus, according to studies in the country which haven’t yet been peer-reviewed. Cuba developed its own vaccine, a point of pride for Cubans, due to harsh sanctions still imposed by the U.S., an antiquated holdover from the first Cold War.

Cuba, which is averaging roughly 8,000 new covid-19 cases every day, reported 3,727 new covid-19 cases in children on Monday and Tuesday alone, according to the Miami Herald, including 236 infants and 16 newborns.

Getting children vaccinated will be vital to stopping the global pandemic, largely because kids now make up an increasingly large share of the cases. There were at least 243,000 cases of covid-19 in children from Sept 2. to Sept. 9 in the U.S., according to the American Academy of Pediatrics, representing roughly 29% of all cases in the country. Compared to the percentage of cases in children since the start of the pandemic last year, 15%, the virus is clearly making its way through unvaccinated children at an alarming speed.

“After declining in early summer, child cases have increased exponentially, with nearly 500,000 cases in the past 2 weeks,” the AAP said, according to the University of Minnesota’s Center For Infectious Disease Research and Policy.

The youngest people able to get vaccinated in most countries is between 12-16 years old, with the U.S. having authorized the Pfizer covid-19 vaccine for 12-year-olds back in May. The Moderna and Johnson & Johnson vaccines are still only authorized for those 18 and up in the U.S.

Major vaccine makers in the U.S. have yet to submit applications for the use of their jabs on children but that’s expected this fall or winter. But American infants won’t be able to get vaccinated for covid-19 anytime soon. Children as young as five are the next generational batch that could get approval for covid-19 vaccination by the FDA.

“If you look at the studies that we at the (National Institutes of Health) are doing in collaboration with the pharmaceutical companies, there will be enough data to apply for an emergency use authorization both by Pfizer, a little bit later by Moderna,” Dr. Anthony Fauci told CNN on Tuesday.

“I believe both of them, with Pfizer first,will very likely be able to have a situation where we’ll be able to vaccinate children. If the FDA judges the data sufficient enough, we could do it by the fall,” Fauci said.

The U.S. reported 170,109 new covid-19 cases on Wednesday and 2,584 new deaths from the disease.

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