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Ann Falsey and Mary Caserta Weigh in on COVID Adolescent Vaccine Study Findings

Wednesday, March 31, 2021

Interim study data released today show that the Pfizer-BioNTech coronavirus vaccine is 100% effective in preventing infections in 12-15 year olds. The vaccine is currently approved for emergency use in people 16 and older.

“This data is very encouraging and appears to mirror the findings in adults, which show this is a safe and very efficacious vaccine” said Ann Falsey, M.D., professor of Medicine, Infectious Diseases, and co-director of the University of Rochester Medical Center (URMC) Vaccine and Treatment Evaluation Unit. “New vaccines are typically evaluated in descending age groups, so this study represents a critical first step to expand eventual use into children and infants.”

Falsey and Edward Walsh, M.D., have been involved in the Pfizer-BioNTech vaccine clinical trials in adults since May 2020 when volunteers in Rochester were among the first in the nation received the then-experimental vaccine. URMC was not involved in the adolescent vaccine study.

The results reported today came from a clinical trial that included 2,260 adolescents 12 to 15 years of age. During the study, 18 cases of COVID-19 were observed in the placebo group, versus none in the vaccinated group. The study also showed the vaccine elicited a strong immune response and was safe and well tolerated, with side effects that were consistent with those reported in persons 16 to 25 years of age. The companies said they would soon submit the data to the Food and Drug Administration as an amendment to the agency’s prior Emergency Use Authorization for the vaccine.

“These results are a great start in ensuring the public has access to a safe and effective pediatric vaccine,” said Mary Caserta, M.D., a professor in the URMC Department of Pediatrics, Division of Infectious Diseases. “We are optimistic that further trials on younger age groups will show similarly strong data.”

URMC is participating in a clinical trial of the Moderna COVID-19 vaccine in children 6 months to 12 years of age. The study—which is being led locally by Caserta and Jennifer Nayak, M.D.—is expected to launch in the spring. Pfizer and BioNTech have started clinical trials of its vaccine in children age 5 to 10 and will expand to lower age groups in the coming months It is anticipated that URMC will become involved in these studies in the coming months.

How long will the coronavirus vaccines protect you? Experts weigh in.

Monday, March 29, 2021

You may be among the more than 95 million people in the United States who have taken at least one dose of a coronavirus vaccine. Or you may still be awaiting your turn. Regardless, there’s a crucial question on most of our minds: How long will the vaccine really protect us?

As with most aspects of the virus, the answer is not completely clear. Why? Because although we have been battling the pandemic for more than a year, the vaccines were granted emergency use authorization relatively recently. So experts have not had time to observe their long-term effectiveness.

However, that research is underway, and in the meantime, experts say we can make an educated guess.

Can we extrapolate from what we know about natural immunity?

In fact, much of this hypothesizing comes from extrapolating data examining immune responses in people who have had covid-19 and illnesses from other coronaviruses, rather than in people who have been vaccinated, said Dbeibo, who is director of vaccine initiatives for Indiana University.

“But vaccine responses should not be less reliable than in natural infection,” she added.

Current research shows that people who have been infected with covid-19, the illness caused by the coronavirus, retained immunity that was robust after eight months. That gives researchers a starting point in predicting how long immunity may last after vaccination, Dbeibo explained.

But research also shows people who had more severe cases developed a stronger immune reaction than those with milder forms of the disease. And because vaccine-induced immunity appears to be more similar to natural immunity that is derived from severe covid-19 infections, researchers say they believe people who take a coronavirus vaccine will be protected better than most people with natural immunity, said David Topham, a professor of microbiology and immunology at the University of Rochester.

All of that said, antibodies will wane. And although it is a gradual process, once antibodies decline to a level that is no longer protective, reinfection is possible. Still, the infection is likely to be milder, experts said.

Topham, founding director of the Translational Immunology and Infectious Disease Institute at the University of Rochester, has been studying the coronavirus and the role of memory B cells — immune cells that persist for a lifetime and produce antibodies when re-exposed to a pathogen that they have been programmed to fight. He said some people who were hospitalized with severe covid-19 infections still had high frequencies of memory B cells, as well as antibodies, up to nine months after infection.

He said memory B cells can even adapt quickly to a new variant, usually within days.

Read More: How long will the coronavirus vaccines protect you? Experts weigh in.

AstraZeneca COVID Vaccine is 100% Effective at Preventing Severe Disease

Monday, March 22, 2021

According to interim clinical trial results released today, the COVID vaccine developed by AstraZeneca and the University of Oxford is 100% effective at preventing severe COVID and 79% effective at preventing milder infections. The U.S. trial showed no safety concerns of any kind related to the vaccine—including risk of blood clotting. 

Final analysis from the U.S. phase 3 clinical trial is expected in the next few weeks at which point AstraZeneca is expected to apply for FDA approval. Vaccine could be available to Americans as early as April and will be the fourth effective COVID vaccine to gain approval. 

“It’s gratifying to see how well this vaccine was tolerated and how well it protected people from severe disease,” says Ann R. Falsey, M.D., co-lead principal investigator of the U.S. clinical trial and co-director of the URMC Vaccine and Treatment Evaluation Unit. “After working on the front lines last March, to see none of Astrazeneca vaccinated participants in this trial ending up in the hospital with COVID is a huge relief. It is amazing how well this vaccine works.” 

These results draw on data from 32,449 volunteers at 88 sites across the U.S., including over 850 local volunteers who participated at the University of Rochester Medical Center (URMC) site. URMC joined the study on July 27, 2020, led by Falsey and Angela Branche, M.D., who co-directs the URMC Vaccine and Treatment Evaluation Unit alongside Falsey, as well as Michael Keefer, M.D., who leads the URMC HIV Vaccine Trials Unit. 

The phase 3 trial shows that the Oxford-AstraZeneca vaccine, known as AZD1222, is 100% effective at preventing hospitalizations and death, and 79% effective at preventing any COVID symptoms. While earlier European studies failed to produce sufficient data on volunteers over 65 due to low enrollment, the U.S. study enrolled approximately 6,000 volunteers in this age group and found that the vaccine protected this group just as well as others—with 80% efficacy. 

The U.S. independent data safety monitoring board also thoroughly investigated any enhanced risk of blood clotting in light of recent concerns raised in Europe. The board found no increased risk of clotting among the 21,583 participants who received at least one dose of the vaccine and no safety concerns related to the vaccine overall.

“As nations around the world struggle to vaccinate their populations, these results are great news,” says Branche. “More analysis and review is needed, but I am hopeful that this vaccine will soon be added to the existing arsenal of safe, approved COVID vaccines.” 

Once the FDA grants emergency use authorization, all trial volunteers—including those who participated locally—will be able to find out whether they received vaccine or placebo through the study. Anyone who received placebo will be offered the vaccine through the study. 

URMC Joins Pediatric COVID Vaccine Trials

Thursday, March 18, 2021

Continuing our role as a leader in vaccine development, the University of Rochester Medical Center and its referring providers will participate in phase 2 and phase 3 trials in collaboration with Moderna Inc., testing the vaccine on 600-700 healthy children.

URMC—along with other select academic medical centers—plans to test the vaccine in 600-700 healthy children aged 6 months to 12 years. The trials will include two doses of vaccine and will begin in Spring 2021.

The trials will be critical for selecting the appropriate dose and proving the vaccine is safe and generates an immune response in children. These data are necessary because children’s immune systems may respond differently to the virus than adults, according to Jennifer Nayak, M.D., associate professor in the Department of Pediatrics and the Division of Infectious Diseases and Microbiology and Immunology.

“Preliminary data show that children have different disease manifestation with COVID, so it’s important to test the vaccine specifically in children to make sure it’s safe and works,” she said.

Current research shows that children under the age of 10 may be less likely to transmit the COVID virus than adults, but there is evidence that children above the age of 10 can spread the disease as easily as adults. Although the virus tends to cause less severe illness in children, the risk of severe disease in some children and the risk of spreading it to household members, grandparents, teachers, and other children necessitates the development of a pediatric vaccine, according to the American Academy of Pediatrics.

While the CDC and AAP have not recommended that a pediatric vaccine should be required for a full return to school, this vaccine will still facilitate the easing of restrictions in both school and recreational environments for children, which have been significantly disrupted by the pandemic. As a result, pediatric vaccine trials should be a priority, according to Mary Caserta, M.D., professor in the Department of Pediatrics, Division of Infectious Diseases.

“A pediatric vaccine will help provide parents with a level of comfort in getting kids fully back to normal life, including school and activities. It’s ok to start trials with adults first, but we shouldn’t have a long delay to pediatric trials, especially since there could eventually be less infections in the community, which will make the vaccine in children harder and longer to study.”

As part of the rollout of these vaccine trials, URMC and its participating providers are implementing screening protocols where volunteers can sign-up to be pre-screened.

“It is a unique protocol where families interested in new vaccines would be pre-screened.”

Both Nayak and Caserta will be monitoring the progress of the study. Strong results from the adult vaccine trials suggest the possibility for a high rate of success, according to Caserta.

Parents who are interested in volunteering their children for vaccine trials are encouraged to visit the website and click on the ‘get started’ link.

Why Countries Around the World are Suspending Use of AstraZeneca's COVID-19 Vaccine

Wednesday, March 17, 2021

Ann Falsey, M.D., Professor of Medicine and Co-Director of the Vaccine Trials and Evaluation Unit (VTEU), hopes the results of a Phase 3 clinical trial of the AstraZeneca vaccine completed in the VTEU in January will clarify some of the confusion generated by the earlier UK-based study. “It was large, it was rigorously designed, ahead of time, and there were no changes that happened during the study,” she says. Still, Falsey says “there is no reason to panic. To judge the outcome now would be very premature,” she adds. “I do think the bulk of data shows the vaccine is very safe.”

Her comments appeared in the March 16th issue of Time.

New Coronavirus Vaccine Study Seeks to “Boost” Immune Response

Wednesday, February 24, 2021

The University of Rochester Medical Center (URMC) and Rochester Regional Health (RRH) have begun a new clinical trial that will evaluate the safety and efficacy of a third dose of the Pfizer/BioNTech COVID-19 vaccine. The vaccine is currently approved for a two dose regimen. This study represents an important step in the development of long-term vaccination strategies, including the creation of booster doses that target coronavirus variants.

“While widespread vaccination is the key to moving past the current health crisis, COVID-19 has the potential to become a seasonal and mutating virus,” said Ed Walsh, M.D., and infectious disease specialist at URMC. “This study will help us understand important questions about the safety and immunogenicity of multiple doses of an mRNA vaccine, information that could ultimately enable us to extend the protection of vaccines and develop tailor-made, variant-specific boosters.”

URMC and RRH have been involved in the development of the Pfizer/BioNTech vaccine since the launch of phase 1 clinical trials in May 2020 when volunteers in Rochester were among the first in the nation to receive the then experimental vaccine.  Rochester was also a site for the phase 2/3 clinical trials that ultimately led to the vaccine’s emergency use authorization (EUA) by the U.S. Food and Drug Administration last December. Since then, tens of millions of people across the globe have received at least one dose of the Pfizer/BioNTech vaccine.

The new study will involve individuals who participated in the phase 1 trials last spring, all of whom were fully vaccinated more than 6 months ago.  Over the next several weeks, researchers will dose 144 volunteers, including 35 in Rochester, with a booster dose of the EUA-approved Pfizer/BioNTech vaccine.  Rochester is one of four sites in the U.S. involved in the study.

The local studies are led by Walsh and Ann Falsey, M.D.; both hold faculty appointments in the URMC Department of Medicine, Infectious Diseases and are members of the Infectious Disease Unit at RRH. Pfizer contracted with URMC to conduct the clinical trial in Rochester and the recruitment of study volunteers and testing of the vaccine will occur at Rochester General Hospital. 

While the duration of protection provided by the Pfizer/BioNTech vaccine is unknown, it is assumed that immunity wanes over time, a phenomenon common in vaccines for other infectious diseases.  The trial will measure the boost to the immune system and evaluate in the lab whether antibodies and other immune cells generated after the third dose provide protection against coronavirus variants.  The study will also seek to answer is how well a third dose of the vaccine is tolerated in healthy volunteers and researchers will closely monitor participants for side effects. 

The findings of the study will also be important as vaccine developers have turned their focus to the development of vaccines that can be tailored to meet the threat of emerging strains of the virus. Pfizer and BioNTech announced today that the companies had begun discussions with regulatory agencies regarding an early stage clinical study to evaluate a modified version of approved vaccine. 

“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by the vaccine. This booster study is critical to understanding the safety of a third dose and efficacy against circulating strains,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “At the same time, we are making the right investments and engaging in the appropriate conversations with regulators to help position us to potentially develop and seek authorization for an updated mRNA vaccine or booster if needed.”

Angela Branche Describes Efforts to Ensure Diversity in COVID-19 Vaccine Trials in Reuters

Thursday, January 28, 2021

Angela Branche, M.D., Assistant Professor of Medicine (Infectious Diseases), knocked on doors in Rochester neighborhoods to talk about coronavirus and her research to ensure diverse participation in COVID-19 vaccine trials. Her efforts to combat mistrust in the Black community were highlighted in Reuters.