COVID-19 News Update: Moderna Files for EUA in Adolescents and More

COVID

Although the COVID-19 pandemic is waning in the U.S., there is still plenty of research and news about the disease. Here’s a look.

Moderna Seeks EUA for COVID-19 Vaccine in Adolescents

Moderna filed with the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for its COVID-19 vaccine in adolescents. In May, the company announced that its Phase II/III TeenCOVE trial in adolescents hit the primary immunogenicity endpoint. The efficacy in almost 2,500 adolescents who received the vaccine was 100%, meaning none came down with COVID-19. 

“We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger population,” stated Stephane Bancel, Moderna’s chief executive officer.

Risk Factors for COVID-19 in Group Home Residents

Syracuse University researchers published research in adults with intellectual and developmental disabilities (IDD) living in New York City group homes. They identified the risk factors for COVID-19 as older age, larger residential settings, Down syndrome, and chronic kidney disease. Heart disease was identified as a risk factor associated with death. The study evaluated outcomes for 543 people of these group homes operated by a single nonprofit organization in all five boroughs of New York City from March 1 to October 1, 2020.

Pfizer-BioNTech Vaccine 89% in Real-World Study after 2 Doses

A study based on Israeli population research found that the Pfizer-BioNTech COVID-19 vaccine had 89% vaccine effectiveness (VE) seven or more days after the second dose. The study evaluated 6,286 people. Of them, 30.2% were unvaccinated; 23.0% had one dose; and 46.8% had two doses. For unvaccinated individuals, the incidence rate was 53 cases per 10,000 person-days.

Study Suggests COVID-19 Vaccines Effective Against Variants

A study published yesterday in Nature suggests that the various COVID-19 vaccines prevent infections from COVID-19 variants. The study evaluated blood from patients who received the Johnson & Johnson vaccine, studying the neutralizing antibody levels.

“What we show is that the neutralizing antibodies are reduced about fivefold to the B.1.351 variant,” said Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconness Medical Center in Boston. This variant, now dubbed Beta by the WHO, first appeared in South Africa.

Other similar research around the world has suggested that the Pfizer-BioNTech and Moderna vaccines also work against variants, although perhaps not as effective as they do against the original Wuhan wildtype strain. It’s not yet clear how long the T-cell response will last.

Who’s Still Dying from COVID-19 in the U.S.?

In the U.S., COVID-19 deaths have plunged about 90% since peaking in January 2021, according to early data from the U.S. Centers for Disease Control and Prevention (CDC). But, there are still hundreds of deaths per day reported. Before vaccinations, deaths tended to be higher in people 75 years of age or older. Now, the younger population seems to be suffering the worst, although the number of deaths in all age groups has dropped. Currently, about half of COVID-19 deaths are in people between the age of 50 and 74. It also appears to be mostly people who have not been vaccinated. The steepest declines are in older whites and Asians under 30.

AstraZeneca-Oxford Vaccine Associated with Slightly Higher Risk of ITP Bleeding Disorder

A new research report evaluating 2.53 million adults in Scotland who received the first doses of either the AstraZeneca-Oxford vaccine or the Pfizer-BioNTech vaccine found a slightly higher risk of a bleeding disorder in the AstraZeneca group. There was no evidence of increased risk of the blood disorders with the Pfizer-BioNTech vaccine. 

The bleeding disorder is immune thrombocytopenic purpura (ITP), which results in bruising in some and serious bleeding in others. The risk was about 1.13 cases per 100,000 people after the first dose, up to 27 days after receiving it. In addition to the typical UK incidence rate, which before the vaccines were distributed, was about six to nine cases per 100,000. ITP is treatable, and none of the cases were fatal. The AstraZeneca vaccine and the Johnson & Johnson vaccines have also been associated with relatively rare blood clotting disorders.

The authors noted that blood disorders like ITP could be difficult to diagnose, and they need to study the connection more. “Nonetheless,” they wrote, “the risk of vaccination-induced ITP at the rate proposed seems to be far lower than the many risks associated with COVID-19 itself.”

Severe COVID-19 After Vaccination Rare, but Expected

The COVID-19 vaccines authorized in the U.S., namely the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines, have unusually high efficacy rates, more than 90%. And numerous studies have shown that even if people get the disease after receiving a vaccine, they prevent hospitalization and death. 

On occasion very rare occasions, a fully vaccinated person catches the disease anyway and does die. One example is a woman in Napa County, California. She was over 65 and had underlying medical conditions. She had tested positive for the Alpha variant, which originated in the UK.

Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told The New York Times, “There is not a vaccine in history that has ever been 100% effective. This is your best chance of avoiding severe, critical disease. But as is true of everything in medicine, it’s not perfect.”

The CDC reported 10,262 so-called breakthrough infections by April 30 in the U.S., out of 101 million people who had been vaccinated at that point. Of those breakthrough cases, 10% of the patients were hospitalized, with 2% deaths. In some cases, the patients who were hospitalized or died did so for reasons unrelated to COVID-19. The median age of the 2% who died was 82.

“Stories about breakthrough infections, while extraordinarily rare, can be confusing for the public, said Karen Relucio, Napa County’s public health officer. “We know that when stories like this emerge, the temptation might be for some to question the efficacy of the vaccines.” But she went on to emphasize they are highly effective.

 

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